Kornimate/medical-research-clean huggingface dataset:
a first in human study in healthy volunteers and in participants with frontotemporal dementia with granulin (grn) mutation

Conditions: Healthy; Frontotemporal Dementia

Summary: a first in human phase 1 study in healthy volunteers and participants with granulin (grn) mutation causative of frontotemporal dementia (ftd) to assess al001 safety, tolerability, pharmacokinetics, and pharmacodynamics

this is a first-in-human phase 1 study designed to investigate the safety, tolerability, pk and pd of intravenously administered al001 in healthy volunteers and ftd-grn mutation carriers.

Eligibility criteria:
inclusion criteria: * bmi 18.0-35.0 kg/m2 * 45-120 kg, inclusive * at screening, females must be non-pregnant and non-lactating, or of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1-year postmenopausal (amenorrhoea duration of 12 consecutive months); nonpregnancy will be confirmed for all females by a pregnancy test conducted at screening, (each) admission, and at follow-up. * female participants of child-bearing potential must agree to use adequate contraception from screening until 90 days after the follow-up visit. * in good physical health on the basis of no clinically significant findings from medical history, physical examination (pe), laboratory tests, 12 lead ecg, and vital signs, as judged by the investigator. * willingness and able to comply with the study protocol, in the investigator's judgement. exclusion criteria: * known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins. * positive drug or alcohol at screening and prior to first dose * history of alcohol abuse or substance abuse
a study to determine if there is a possible association between naion and phosphodiesterase type 5 (pde5) inhibitors

Conditions: Nonarteritic Anterior Ischemic Optic Neuropathy

Summary: study h6d-mc-lvhq is an observational, non-interventional, multi-center, prospective, case-crossover study to evaluate the possible association between the use of phosphodiesterase type 5 (pde5) inhibitors and the risk of acute nonarteritic anterior ischemic optic neuropathy (naion) in males. subjects with newly diagnosed naion will be asked via a structured questionnaire about their use of pde5 inhibitors and other risk factors prior to the onset of their vision loss.


Eligibility criteria:
inclusion criteria: * adult male subjects, at least 18 years of age, who are willing to participate in the study * participants who experienced abrupt visual loss in one eye (defined as typically less than a 1-day period or visual loss noted upon awakening) and presented for an initial visit within 45 days of onset of naion symptoms to an ophthalmologist that resulted in a diagnosis of suspected naion by the investigator exclusion criteria: * previous history of naion * previous history of arteritis (anywhere in the body) or clinical or diagnostic testing evidence of temporal arteritis * history of glaucoma in either one or both eyes * history of multiple sclerosis or diagnostic testing evidence of optic neuritis * have dementia or other reasons for memory impairment in the opinion of the investigator * have participated in other non-observational studies within 3 months of naion onset

Keywords: naion
health-related quality of life and emotions in patients with thyroid nodules

Conditions: Thyroid Nodule

Summary: the purpose of this observational research is to evaluate and compare the health-related quality of life and emotional well-being of patients with thyroid nodules before and after treatment. this is a data collection study by allowing investigators to access information generated before and after treatment.

the incidence of thyroid nodules is rising worldwide. papillary thyroid carcinoma (ptc), the most common type of thyroid cancer, has a favorable prognosis, with a low mortality rate and over 90% 10-year survival rate. thyroidectomy is often applied to manage thyroid nodules as a traditional method. however, thermal ablation (ta), including microwave ablation (mwa), radiofrequency ablation (rfa), and laser ablation, has emerged as an alternative option for selected patients with thyroid function. ta methods are effective, safe, feasible, and have litter influence on thyroid function. patients with thyroid nodules frequently exhibit higher levels of emotional stress compared to the general population. additionally, health-related quality of life (qol) has become an important endpoint and a strong predictor of survival time in medical and health research, underscoring the importance of treatments that not only prolong life but also preserve or enhance qol. considering the long survival time of patients with thyroid noduls and the similar therapeutic outcomes between surgery and mwa , it is crucial to pay more attention on patients\&#39; qol and emotional well-being before and after treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of benign thyroid nodules or papillary thyroid carcinoma ; * underwent microwave ablation or thyroidectomy; * ability to understand and cooperate with the survey exclusion criteria: * serious primary diseases in the liver, kidney, hematopoietic, or endocrine systems； * a history of mental illness, personality disorders, cognitive impairments, or organic brain disease

Keywords: quality of life anxiety depression spiritual health thermal ablation microwave ablation thyroid nodules papillary thyroid carcinoma
next-generation sequencing of small cell lung cancer to identify susceptibility gene and to assess treatment

Conditions: SCLC

Summary: participants will be consented into the study after they are found to meet the study inclusion criteria. the clinical staff will schedule a tissue biopsy and a blood draw for the participant to give ngs(next-generation sequencing).one is according to the germline mutation data to screen susceptible gene in sclc(small cell lung cancer); two is to explore the extensive consistency detection of blood and tissues in patients with sclc gene mutation information; three is to conduct dynamic monitoring of blood ctdna(circulating tumor dna) in patients with sclc during treatment, by changing the types of mutations / abundance (for example: the clonal evolution of typical samples analysis) and change of tumor load, , investigating the patients treatment effect , for the significant change of mutations, to study whether it can be used as molecular marker; four is to analyze of the molecular typing of sclc, according to the clinical and pathological features of patients.


Eligibility criteria:
inclusion criteria: * patients must understand the rigors of the study and provide written informed consent and hipaa authorization prior to initiation of any study procedures * life expectancy \> 10 months * karnofsky performance status ≥ 70 * diagnosis of histological or cytologically confirmed sclc, * age ≥ 18 years * good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy. exclusion criteria: * poor compliance, reluctant to undergo research medication, or follow-up. * tumor inaccessible for biopsy * it is currently included in clinical trials of other drugs, or at the same time, into other medical studies that are considered incompatible with the study. * it has a history of other cancers, unless the cancer is completely relieved and has not been treated for more than 3 years.

Keywords: ngs,sclc, ctdna
cureduchenne link®: a resource for research

Conditions: Duchenne Muscular Dystrophy; Becker Muscular Dystrophy

Summary: cureduchenne link is a data hub comprised of integrated biospecimens, clinical data, and self- and/or caregiver-reported information from participants. anyone over 4 weeks old who has been diagnosed with dmd or bmd or who is a carrier of dmd or bmd can join. parents or legal guardians can sign up their child(ren).

individuals can participate through the cureduchenne link™ application (accessible via mobile device or web interface) and receive communications about research opportunities and community programs. participation may be done using virtual methods, at a project site, and/or at community events nationwide. all collected information will be stored in a secure, hipaa-compliant data warehouse for approved researchers to use for studies relevant to dmd, bmd and other neuromuscular disorders. combining health and outcomes data with biospecimens provides an impactful solution and novel resource for researchers, allowing for effective translational research.

Eligibility criteria:
inclusion criteria: 1. any of the following are true: 1. currently has a confirmed diagnosis of dmd/bmd based on genetic testing, muscle biopsy, or clinical diagnosis. 2. currently has a confirmed diagnosis of carrier status for dmd/bmd based on genetic testing. 2. parent/guardian (for minor participants) or participant gives informed consent and/or assent as required by local regulations. 3. is age 4 weeks or older at the time of consent. exclusion criteria: 1. is a foster child or ward of the state. 2. is a prisoner.

Keywords: carrier dmd bmd
complications after thyroid surgeries: 10 years' experience

Conditions: Thyroid

Summary: thyroidectomy is one of the commonest elective surgeries in surgical practice nowadays. it is associated with wide range of complications, from unnoticed events up to lifelong problems and even life-threatening complications. the most troublesome are bleeding, nerve injury and hypocalcemia. the current study was conducted to report the incidence and predictive factors for perioperative complications, aiming to point out preventive measures.

all files of all patients that had thyroidectomy in the hospital in the last 10 yeas will be reviewed. all demographic and peri-operative data will be collected, tabulated and analyzed. incidence and pre-operative predictive factors of every single complication will pointed out and discussed.

Eligibility criteria:
inclusion criteria: * all patients had thyroid disease and performed thyroidectomy in the last 10 years in our hospital. exclusion criteria: * uncompleted files.

Keywords: thyroidectomy hypocalcemia stridor bleeding recurrent laryngeal nerve
artemisia and green tea extracts for gastric mucosal health

Conditions: Functional Dysphonia

Summary: this clinical trial aims to determine whether artemisia and green tea extracts promote gastric mucosal health in adults with functional dyspepsia and to assess its safety. the main questions are: * does artemisia and green tea extracts promote gastric mucosal health in participants? * what side effects occur when participants take artemisia and green tea extracts?

researchers will compare artemisia and green tea extracts to placebo to evaluate their effectiveness in promoting gastric mucosal health. participants will: * take artemisia and green tea extracts or a placebo daily for 8 weeks. * visit the clinic every 4 weeks for checkups and tests.

Eligibility criteria:
inclusion criteria: * rome iv-based functional dyspepsia- exclusion criteria: * patients with gastrointestinal symptoms requiring immediate drug treatment. * individuals with a history of hypersecretory gastric disorders like zollinger-ellison syndrome. * individuals who received helicobacter pylori eradication therapy within 4 weeks prior to the trial. * individuals who have taken nonsteroidal anti-inflammatory drugs, steroids, antibiotics, aspirin, antithrombotic agents, or acid suppressants within the last month. * individuals with a history of upper gastrointestinal surgery, stricture, bleeding, or procedures like esophageal dilation or mucosal resection within the last year. * individuals with gastric ulcers (active or healing), duodenal ulcers (active or healing), reflux esophagitis (la grade a or higher), or malignant tumors identified within the last 6 months through endoscopy. * patients with uncontrolled hypertension (resting bp ≥160/100 mmhg). * patients with uncontrolled diabetes (fasting glucose ≥160 mg/dl). * individuals with creatinine levels ≥ 2 times the upper limit of normal at the research institution. * individuals with aspartate aminotransferase or alanine aminotransferase levels ≥ 2 times the upper limit of normal at the research institution. * alcohol abusers. * individuals taking medications for psychiatric disorders (except those taking intermittent medication for sleep disorders). * pregnant or breastfeeding women or those planning to become pregnant during the clinical trial period. * individuals with allergies to any components of the study foods. * individuals who participated in or plan to participate in another drug clinical trial within the last month. * individuals deemed unsuitable for the study by the investigator for other reasons.
the effect of a local injection of a platelet concentrate on infection and healing of surgical wounds

Conditions: Wound Infection and Wound Healing

Summary: the purpose of this project is to investigate whether a combination of a local injection of platelet rich plasma (prp) combined with a daily supplement of vitamin c, zinc, l-arginine, as well as high protein diet (1.5 g of protein per kilo body weight per day) can promote tissue healing in patients undergoing open upper-abdominal surgery. primary endpoint is cases of wound infection and secondary endpoints are time of tissue regeneration (days), judged by traditional clinical observation and experimentally assessed by ultrasound. the experiment is performed as a parallel two-armed, randomized, controlled trial. a total of 40 subjects will be included in the trial i order to ensure the power of the study, despite a drop off of up to 25%.


Eligibility criteria:
inclusion criteria: * patient at rigshospitalets surgical gastroenterology clinic * planned to have a pancreaticoduodenectomy preformed * being able to understand danish, the trial and what it means to be enrolled in the trial * capable of signing a written consent * living i the regional capital (excl. bornholm) or the regional of sjælland (north of næstved) exclusion criteria: * dysregulated diabetes mellitus type i or ii * alcohol consumption above 14 or 7 x 12 g alcohol per week (men vs women) * participating in another clinical trial
study evaluating safety, tolerability, and immunogenicity of meningococcal b vaccine in healthy infants

Conditions: Meningitis, Meningococcal

Summary: the primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal b vaccine in healthy infants.


Eligibility criteria:
inclusion criteria: * investigators should always use good clinical judgment in considering a subject's overall fitness for trial participation. in addition, any condition that in the opinion of the investigator may interfere with the evaluation of study objectives should be carefully considered prior to enrolling subjects. * male or female subjects aged 2 months (42 to 98 days of age) at the time of enrollment. * available for the entire consented period and whose parent/legal guardian can be reached by telephone. * healthy infant as determined by medical history, physical examination, and judgment of the investigator. * parent/legal guardian must be able to complete all relevant study procedures during study participation. exclusion criteria: * previous vaccination with licensed or investigational vaccines: meningococcal b, meningococcal c, pneumococcal, hib, diphtheria, tetanus, acellular pertussis, poliovirus, rotavirus, varicella, measles, mumps, or rubella. any of the following illnesses/conditions that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study: * a previous anaphylactic reaction to any vaccine or vaccine-related component. * contraindication to vaccination with meningococcal b, meningococcal c, pneumococcal, hib, diphtheria, tetanus, acellular pertussis, hepatitis b (hbv), poliovirus, rotavirus, varicella, measles, mumps, or rubella. * bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. * known or suspected immune deficiency or suppression. * history of culture-proven invasive disease caused by n meningitidis or neisseria gonorrhoea. * major known congenital malformation or serious chronic disorder. * significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. does not include resolving syndromes due to birth trauma such as erb palsy. * receipt of blood products or gamma-globulin (including hepatitis b immunoglobulin and monoclonal antibodies). * received any investigational drugs, vaccines or devices (aside from those specified in the protocol) within 4 weeks before administration of the first dose of test article or at any time throughout the study. * participation in purely observational studies is acceptable. * infant who is a direct descendant (child, grandchild) of the study site personnel.

Keywords: meningococcal b vaccine infants safety immunogenicity
the role of il33/st2 axis in ards patients

Conditions: Acute Respiratory Distress Syndrome

Summary: the main objective is the study of the role of il33/st2 axis in the pathogenesis of ards, it´s value as prognosis marker and as therapeutic target.


Eligibility criteria:
inclusion criteria: * ards * risk pathologies to develop ards (sepsis, pancreatitis, pneumonia, massive transfussion, politraumatics) exclusion criteria: * age under 18 * pregnancy * undergoing a clinical trial
targeted beacopp variants in patients with newly diagnosed advanced classical hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: the purpose of this trial is: * to determine complete response rate (crr) after six cycles of chemotherapy * to determine complete remission rate (cr/crr) as final treatment outcome after completion of treatment


Eligibility criteria:
inclusion criteria: * histologically proven classical hodgkin lymphoma * first diagnosis, no previous treatment, age: 18-60 years * stage iib with large mediastinal mass and/or extranodal lesions, stage iii or iv disease exclusion criteria: * composite lymphoma or nodular lymphocyte- predominant hodgkin lymphoma (nlphl) * previous malignancy * prior chemotherapy or radiation
minimally invasive groin dissection for melanoma

Conditions: Melanoma

Summary: the purpose of this this study is to determine if a structured educational training program is successful in teaching surgeons a new operative technique. it will then be determined if this new operative technique is safe.

this study is a multi-center, phase 1 clinical trial to determine the safety and feasibility of minimally invasive inguinal lymph node dissection for patients with melanoma. licensed surgeons who have undergone special training, including a course at the mayo clinic rochester in minimally invasive lymph node dissection (milnd) will perform the new procedure at their home institutions. the study will characterize the learning curve of milnd in the clinical setting, and evaluate the safety of the new operative technique. the hypotheses for this study are: 1) minimally invasive groin dissection is a safe procedure. 2) a structured educational training program is a feasible and effective method to train practicing surgeons in this novel procedure and 3) pre-course generic laparoscopic technical skills correlate with minimally invasive superficial groin dissection performance in a clinical setting, including operative oncologic standards and safety metrics.

Eligibility criteria:
inclusion criteria: * malignant melanoma present in an inguinal nodal basin requiring superficial inguinal lymph node dissection. * plan for superficial inguinal dissection alone or combined superficial inguinal and deep pelvic node dissection is acceptable. * clinical or radiographic evidence of superficial inguinal lymph node disease or a prior positive single lymph node biopsy of the superficial inguinal basin as an indication for superficial inguinal lymph node disease is acceptable. * patients must be eastern cooperative oncology group (ecog) performance status 0 or 1 and be healthy enough to undergo a general anesthetic (no epidural or spinal anesthetics). * female patients of child bearing age must have a negative pregnancy test, be surgically sterile or post-menopausal greater than 1 year. * patients must be able to return to surgical facility for 30 and/or 90 day (+/- 20 days) for follow-up appointment. exclusion criteria: * prior ipsilateral superficial inguinal lymph node dissection * invasion or ulceration of inguinal nodal disease into the overlying skin * prior radiation therapy to the same regional nodal basin.

Keywords: melanoma lymph nodes lymph node dissection minimally invasive
data collection study to review novel methods for diagnosing obstructive sleep apnea

Conditions: Obstructive Sleep Apnea (OSA)

Summary: this study will collect data on a range of signals such as facial scans, videos (including speaking, blinking and swallowing) and heart rate variability to assess whether any of these measures are useful for diagnosing obstructive sleep apnea


Eligibility criteria:
inclusion criteria: adults aged \>= 18 ability to read and comprehend english exclusion criteria: * previous diagnosis of osa * respiratory diseases (such copd, lung cancer, fibrosis of the lungs, lung injury) * subjects who are or may be pregnant, breastfeeding or within 6 weeks postpartum (which may impact hrv temporarily) * subjects with a pacemaker

Keywords: diagnosis screening