Kornimate/medical-research-clean huggingface dataset:
project interact study

Conditions: Violence; Substance Use; Criminal Behavior

Summary: this study will use a randomized control trial design (rct) to pilot test a multisession remote therapy behavioral intervention for risky firearm behaviors and associated behaviors/consequences among adolescents. the study will pilot a state-of-the-art intervention delivery approaches (e.g., remote therapy, smartphone-based app intervention content delivery) for reducing violence and associated behaviors among urban youth. given the significant morality and mortality associated with firearm violence, the study will have significant impact by identifying optimal intervention strategies for future large-scale behavioral intervention trials.

the specific aim of this pilot study is to pilot test an m-health intervention, as compared to enhanced usual care \[n=70; 35/group\], with eligible youth to assess intervention acceptability, feasibility, and fidelity, as well as trends towards decreased risky firearm behaviors, substance use, and criminal justice involvement. specifically, 70 youth (ages 16-24) in the ed screening positive for firearm carriage and smartphone ownership will be randomly assigned (stratified by age/gender) to either the interact group or the control group. interact group participants will receive an emergency department (ed) session of behavioral therapy, followed by five additional remote therapy sessions of behavioral therapy delivered over the 5 weeks following their ed visit. behavioral therapy will be comprised of motivational interviewing (mi), cognitive behavioral therapy (cbt), and strengths-based care management (cm). in addition, youth in the interact group will also receive a smartphone app that will be downloaded to their phone. the app will deliver daily surveys, daily tailored mi and cbt messages in response to survey results, one-touch access to pro-social supports, psycho-educational materials, gps-enabled message alerts, and facilitated access to cm resources. youth enrolled in the control group will receive a pamphlet with local violence, substance use, and mental health resources. a follow-up assessment will be completed in each group at 4 months post-ed visit. pilot data will aid in refining and clarifying content and clinical trial design elements for a future fully powered randomized control trial of the intervention (i.e., r01 proposal).

Eligibility criteria:
inclusion criteria: * past 4-month firearm carriage * ownership of a smartphone with app capabilities exclusion criteria: * non-english speaking patients * patients unable to provide informed consent due to mental incompetence, incarceration (i.e., active police custody), medically unstable (abnormal vital signs requiring urgent resuscitation) * patients presenting for acute suicidal ideation or acute suicide attempt, child abuse or sexual assault.
study of oral oteseconazole (vt-1161) for acute yeast infections in patients with recurrent yeast infections

Conditions: Recurrent Vulvovaginal Candidiasis

Summary: recurrent vulvovaginal candidiasis (rvvc), also known as recurrent yeast infections, is defined as at least 3 episodes of acute vulvovaginal candidiasis (vvc) in the past 12 months. several properties of oteseconazole (vt-1161) suggest it might be a safer and more effective treatment of rvvc than other oral antifungal medications. this study will evaluate the effectiveness and safety of oteseconazole (vt-1161) for the treatment of acute vvc episodes in patients with rvvc and consists of 2 parts. the first part of the study is a 2-week induction phase for the treatment of the patient's current vvc episode when the patient will take either fluconazole or oteseconazole (vt-1161) according to a random assignment. the second part consists of an 11-week maintenance phase, when the patient will take either oteseconazole (vt-1161) or a placebo according to the random assignment from the first part of the study, and then a 37-week follow-up period.


Eligibility criteria:
inclusion criteria: * 3 or more episodes of acute vvc in the past 12 months * positive koh test * total vulvovaginal signs and symptoms score of ≥3 at screening visit * total vulvovaginal signs and symptoms score of \<3 at day 14 * must be able to swallow pills exclusion criteria: * presence or a history of another vaginal or vulvar condition(s) * evidence of major organ system disease * history of cervical cancer * poorly controlled diabetes mellitus * pregnant * recent use of topical or systemic antifungal or antibacterial drugs * recent use of immunosuppressive or systemic corticosteroid therapies
study to validate novel seizure-detection algorithm

Conditions: Seizures, Motor; Seizures; Seizure Disorder; Epilepsy; Epileptic Seizures; Epileptic

Summary: the specificity and sensitivity of a novel seizure-detection mobile software application with a generalized tonic/clonic seizure detection algorithm (motor seizure detection algorithm \[msda\]) installed on a wearable device to be worn by the subject. the software will be tested using subjects from a patient population in an epilepsy monitoring unit (emu) undergoing video and electroencephalograph (veeg) observation. the number of generalized major motor seizures detected by the msda will be compared with those detected by veeg.

seizures are paroxysmal, abnormal behaviors which usually are associated with altered awareness and amnesia. the frequency of seizures is not easily documented. the individual who suffers from seizures may be unaware that a seizure is occurring. many seizures, including generalized major motor seizures, have stereotyped, vigorous motor activity associated with the events. currently, accurate seizure detection relies on eeg and video which are limited by time, size and mobility. seizure detection can also use biomarkers such as movement patterns described by gyroscopes. these devices can monitor patterns of movement which correspond to the activity during seizures and kept in a log of seizures without patient input. the log can be used to notify patients or caregivers of seizures. this study is to determine the accuracy of a system using a commercial, wearable device linked to a computer algorithm based in the cloud which stores the movement pattern and notifies the patient and others of a generalized major motor seizure. the accuracy will be determined by a comparison of the system detections to simultaneously recorded video electroencephalogram, considered the "gold standard" of seizure detection.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form. 2. stated willingness to comply with all study procedures and availability for the duration of the study. 3. meets the standard of care criteria for admission to an epilepsy monitoring unit (emu). 4. male or female. 5. aged 18 and above. 6. the patient has experienced at least one generalized major motor seizure prior to admission. 7. agreement to wear a wristwatch throughout the duration of the study on the left wrist. 8. ability to cancel false positive alarms via interaction with the application on the watch. exclusion criteria: 1. concurrent physiological diseases with movement disorders (parkinson's, tremor, ataxia, huntington's, paralysis of the upper body, pseudo-seizures). 2. known allergic reactions to components of the (watch materials). 3. treatment with another investigational drug or other intervention within the study 4. children under the age of 18. 5. women who are pregnant or nursing. 6. inability to give consent to the study. 7. active skin infection or rash on the upper extremities

Keywords: epilepsy mobile health seizure major motor seizure epileptic convulsion epilepsy monitoring
clinical investigation of the mitroflow aortic pericardial heart valve

Conditions: Heart Valve Diseases

Summary: this is a trial to demonstrate the safety and effectiveness of the mitroflow aortic heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

bioprosthetic heart valves offer several advantages over mechanical valves, the most important being freedom from the need for anticoagulation and a low rate of thromboembolic events. pericardial bioprosthetic valves are known to have hemodynamic performance superior to porcine valves, and the excellent hemodynamic performance of pericardial valves is particularly relevant in patients with a small aortic root. however, long-term durability continues to be the main concern with use of pericardial valves. although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation techniques and design failure rather than the pericardial tissue.the unique desing of the mitroflow aortic heart valve may provide superior hemodynamic performance over other tissue valves.

Eligibility criteria:
inclusion criteria: * the subject is male or female 18 years old or older * the subject or subject's legal representative is willing to sign the informed consent * a bioprosthesis is the most suitable alternative for replacement of a dysfunctional or diseased native aortic valve or prosthesis accord gin to the current medical practice for valve selection at the center * the subject is able to return for all follow-up evaluations for the duration of the study (i.e. geographically stable exclusion criteria: * the patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position * the patient requires a double or triple valve replacement * the patient had a mitroflow heart valve during the clinical study but who then had the valve explanted * the patient has active endocarditis * the subject is or will be participating in a concomitant research study of an investigational product * the subject is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent * the patient has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient the patient is pregnant or lactating

Keywords: aortic valve insufficiency aortic valve aortic disease aortic incompetence
dance-movement therapy programme in fibromyalgia.

Conditions: Fibromyalgia

Summary: fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with generalized hyperalgesia and allodynia. it can be accompanied by other concomitant symptoms like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. this condition is very prevalent. it has been reported to be about 2-5% of the general global population. fibromyalgia is associated with balance problems and increased fall frequency. the objective of this study was to examine the effects of an 8 weeks dance-movement therapy programme on balance, strength, flexibility and quality of life in patients with fibromyalgia.

fibromyalgia is a chronic condition associated with balance problems and pain. it has been previously described that fibromyalgia may affect peripheral and/or central mechanisms of postural control. balance or postural stability is a very complex task that involves the integration of multiple sensory inputs to execute appropriate neuromuscular activity needed to maintain balance. patients with fibromyalgia have also muscle weakness. muscle strength depends on both the cross-sectional area of the muscle and the neural activity. range of movement and quality of life have also been reported to be affected.

Eligibility criteria:
inclusion criteria: * women diagnosed of fibromyalgia attending to the fibromyalgia association of granada. * women who can complete the assessment battery of tests at the beginning and at the end of the study exclusion criteria: * auditive and visual disturbances. * cognitive problems. * psychiatric pathology. * traumatic pathology of lower limbs.

Keywords: dance-movement therapy balance fibromyalgia
minimal residual disease-guided adjuvant therapy for gastric cancer

Conditions: Stage II-III Gastric Cancer

Summary: this is a multicenter, single-arm, interventional study to explore the feasibility of circulating tumor dna (ctdna)-mrd testing to guide postoperative adjuvant treatment strategies in patients with stage ii-iii gastric cancer.


Eligibility criteria:
inclusion criteria: 1. patients who have undergone d2 gastrectomy, achieved r0 resection, and are pathologically diagnosed with stage ii-iii gastric cancer. 2. no preoperative neoadjuvant or adjuvant therapy received. 3. voluntary participation with signed informed consent, demonstrating good compliance and willingness to cooperate with follow-up procedures. 4. age between 18-75 years, with no gender restrictions. 5. eastern cooperative oncology group (ecog) performance status of 0-1. 6. estimated survival of 6 months or more. 7. baseline hematological and biochemical parameters within specified limits: a. hemoglobin ≥ 80g/l. b. absolute neutrophil count ≥ 1.5×10\^9/l. c. platelet count ≥ 100×10\^9/l. d. aspartate or alanine aminotransferase ≤ 2.5 times the upper limit of normal. e. alkaline phosphatase ≤ 2.5 times the upper limit of normal. f. thyroid-stimulating hormone (tsh) ≤ 1 times the upper limit of normal (if abnormal, t3 and t4 levels must be normal). exclusion criteria: 1. pregnant or lactating women, or women of childbearing potential with a positive pregnancy test at baseline. 2. evidence of postoperative recurrence or metastasis. 3. previous anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy. 4. positive resection margins identified in postoperative pathology. 5. history of other malignancies within the past five years, except certain skin cancers, superficial bladder cancer, in situ cervical or breast cancer. 6. uncontrolled pleural effusion, pericardial effusion, or ascites. 7. severe cardiovascular conditions such as symptomatic coronary artery disease, congestive heart failure (grade ≥ ii), uncontrolled arrhythmias, or myocardial infarction within the last 12 months. 8. uncontrolled infection, severe kidney disease, or other significant concurrent diseases. 9. allergic reactions to study drugs. 10. receipt of any anti-tumor therapy within 4 weeks prior to enrollment. 11. administration of live attenuated vaccines within 4 weeks prior to the first study treatment dose or plans to receive such vaccines during the study period. 12. positive hiv antibody, active hepatitis b or c (with specific viral load criteria). 13. positive for covid-19 nucleic acid or antigen test. 14. other conditions deemed by the investigator to potentially affect patient safety or trial compliance, including serious illnesses requiring treatment, severe laboratory abnormalities, or other social or family reasons.
mental health and academic performance in covid-19

Conditions: Depression, Anxiety

Summary: this study aims to identify the preference of the class modalities (classroom or online) in undergraduate and graduate students. additionally, to explore if the presence of any mental state alterations such as depression or anxiety due to the covid-19 pandemic can alter their perception of academic performance.


Eligibility criteria:
inclusion criteria: * \> 18 years * students of any undergraduate or graduate course who are attending their semester online exclusion criteria: * students who are not attending an online course * students who are not registered in a university undergraduate or graduate course.

Keywords: covid-19 depression anxiety public health academic performance
safety and immunogenicity of preservative free inactivated split influenza vaccine, using the strain composition 2006/2007 in non-elderly adult and elderly subjects

Conditions: Influenza

Summary: due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to who (world health organization) and chmp (committee for medicinal products for human use) recommendations. immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (cpmp/bwp/214/96).


Eligibility criteria:
inclusion criteria: * healthy adults aged \>18 years exclusion criteria: * serious chronic diseases or significant acute infections requiring systemic antibiotic treatment * history of any anaphylaxis, serious vaccine reactions * hypersensitivity against vaccine components * history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine * known or suspected impairment/alteration of immune function * more than one injection of influenza vaccine received or laboratory confirmed influenza disease * within last 6 months: influenza vaccination received

Keywords: influenza vaccine
berlin prehospital or usual delivery of acute stroke care 2.0 (b_proud 2.0)

Conditions: Stroke

Summary: prehospital stroke care in specialized ambulances increases thrombolysis rates, reduces alarm-to-treatment times, and improves prehospital triage. preliminary analyses suggest cost-effectiveness. however, scientific proof of improved functional outcome compared to usual care is still lacking. the objective of this trial is to show improved functional outcomes after deployment of a stroke emergency mobile (stemo) compared to regular care.

this is a pragmatic, prospective, multi-center trial with blinded outcome assessment of treatment candidates three months after stroke. treatment candidates will be defined as patients with final discharge diagnosis of cerebral ischemia, and onset-to-alarm time ≤4 hours, disabling symptoms not resolved at time of ambulance arrival, and able to walk without assistance prior to emergency. these patients will be included if their emergency call from a predefined catchment area in berlin, germany, caused a stroke alarm at the dispatch center during stemo hours (7am-11pm, monday-sunday). about 50% of stemo dispatches will be handled by regular ambulances since stemo will be already in operation creating the quasi-randomized control group. because of several organisational issues during the transition of the stemo service into provisional regular care, the b_proud 1.0 evaluation has been defined as implementation study and will be complemented by the b_proud 2.0 study. b_proud 2.0. recruits patients with index event after may 1st, 2019. b_proud uses data from the berlin - specific acute treatment in ischemic and hemorrhagic stroke with longterm outcome (b-spatial) registry. the b-spatial registry started recruitment in january 2016.

Eligibility criteria:
inclusion criteria: 1. suspected acute stroke according to the dispatcher stroke identification algorithm during stemo hours (7am-11pm, monday-sunday) and within the stemo catchment area inclusion criteria for primary study population: 2. final diagnosis of ischemic stroke (icd 10: i63) or tia (transient ischemic attack, icd 10: g45 except g45.4) 3. confirmed onset-to-alarm time ≤ 4 hours at dispatch 4. pre-stroke modified rankin scale ≤ 3 (being able to ambulate, in routine clinical care, patients with mrs up to 3 are usually deemed suitable for tissue plasminogen activator treatment) exclusion criteria: 1. remission of disabling symptoms until arrival of emergency medical service 2. malignant or other severe primary disease with life expectancy \< 1 year additional exclusion criteria for primary study population: 3. major surgery within 4 weeks before study inclusion 4. confirmed stroke within 3 months before study inclusion 5. absolute contraindications for thrombolysis and thrombectomy

Keywords: stroke prehospital telemedicine thrombolysis endovascular treatment functional outcome
physical exercise for prevention of dementia

Conditions: Memory Disorders; Mild Cognitive Impairment; Aging

Summary: the principal aim of this study is to verify whether a program of supervised, multimodal physical exercise improves cognitive function and/or reduces the rate of cognitive decline in older adults

community-dwelling volunteers, recruited from social centers, were invited to an in-person assessment that included a medical history questionnaire and examination, anthropometric measurements, blood tests for cardiovascular risk, and several outcome measures. participants meeting the inclusion criteria were divided in 3 groups (participants without subjective or objective cognitive impairment, with subjective memory complaints and with mild cognitive impairments) and randomly assigned (1:1) to an experimental group or a control group, using a list of random numbers generated by a statistical software. the list was kept in a sealed envelope and a researcher, not directly involved in the recruitment and in the evaluation of the participants, assigned the allocation numbers.

Eligibility criteria:
inclusion criteria: age \> 50 years old exclusion criteria: * medical conditions that compromise survival or limit physical activity * geriatric depression scale-15 score of 6 or higher * alcohol intake \> 4 units/day * mini- mental state examination \< 24 * clinical dementia rating score of 1 or more

Keywords: dementia prevention physical activity
manual therapy, kinesiotape and strength training in soccer players with recurrent ankle sprains

Conditions: Ankle Sprains

Summary: introduction. the ankle sprain is one of the most prevalent injuries in soccer players. the muscle strength deficit is one of the variables that can most influence the development of a sprain. it has been indicated how the kinesiotape and the myofascial direct induction technique can improve functionality. aim. to verify the effectiveness of the kinesiotape and the myofascial technique combined with strength training, in the reduction of pain, rom increase, stability and strength in subjects who suffered ankle sprains. study design. randomized, multicentric clinical study with follow-up. methods. a random assignment of the subjects recruited in two study groups will be carried out: experimental and control group. the treatment will last 4 weeks, with 2 weekly sessions, of 50-60 minutes. the intervention includes the application of kinesiotape and myofascial treatment with strength training. the study variables will be pain (vas), mobility (goniometer), stability (prokin balance) and strength (microfet). a descriptive statistical analysis will be carried out calculating the main statistical characteristics. by means of the kolmogorov-smirnov test the distribution of the normality of the sample will be assessed. with the t-student test for related samples we will calculate the difference of means between the evaluations made in both groups. with an anova of repeated measures we will calculate the intra and intersubject effect. the calculation of the effect size will be done with the cohen formula. expected results. improvement in stability, increase in range of motion, decrease in pain and increase in strength.


Eligibility criteria:
inclusion criteria: * male soccer players * 18 to 35 years old * history of ankle sprain recurrences exclusion criteria: * players who suffered a sprain in the previous month * footballers who were taking anti-inflammatory drugs * players undergoing another type of physiotherapy treatment at the time of the study * soccer players who do not sign the informed consent document.

Keywords: kinesiotape myofascial ankle sprain pain stability