Kornimate/medical-research-clean huggingface dataset:
bromelin, a compound prepared with ananas comocus extract and honey, for acute cough

Conditions: Cough, Acute

Summary: cough is the most bothersome symptom for patients with the common cold. the objective of the study is to compare the phytotherapic "bromelin", a compound preparation of honey from the bee apis mellifera with the extract of the pineapple (ananas comosus) with placebo in reducing cough episodes in patients with the common cold.

common cold is very frequent and cough is one of the most troublesome symptoms. over-the-counter medications are used by patients without prescription, many times with important side effects. bromelin, a compound made with honey and pineapple extract could offer cough symptomatic relief as a soothing agent. this study aims to compare this compound with placebo in reducing cough in patients with common cold in an clinical trial designed in conformity to consort guidelines.

Eligibility criteria:
inclusion criteria: * cough for less than 24 hours * common cold symptoms : nasal obstruction, headache, myalgias, runny nose. exclusion criteria: * declared chronic pulmonary diseases declared nervous diseases declared diabetes declared cardiac diseases known primary or secondary immunodeficiencies

Keywords: cough common cold child adolescent
viewflex x ice first-in-human study

Conditions: Cardiac Arrhythmias

Summary: this prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the viewflex x ice catheter, sensor enabled (viewflex x se) and viewmate multi ultrasound console (vmm) ice data integration with the ensite x ep system (hereafter referred to as the viewflex x ice system).


Eligibility criteria:
inclusion criteria: a patient will be eligible for clinical trial participation if they meet the following criteria: 1. able and willing to provide written informed consent prior to any clinical investigation-related procedure. 2. plans to undergo any ep procedure utilizing ice 3. at least 18 years of age exclusion criteria: a patient will be excluded from enrollment in the study if they meet any of the following criteria: 1. subject is currently participating in another clinical investigation. 2. implanted left atrial appendage occluder 3. implanted mechanical mitral or tricuspid valve replacement 4. implanted intracardiac device within 30 days 5. pregnant or nursing 6. presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Keywords: intracardiac echocardiography cardiac electrophysiology
gm1 and gm2 gangliosidosis prospective neurological disease trajectory study (pronto)

Conditions: GM1 Gangliosidosis; Sandhoff Disease; Tay-Sachs Disease

Summary: the study aims to characterize prospectively longitudinal progression of neurological domains in gm1 and gm2 gangliosidosis patients with high-quality standards (gcp compliant).

the study is a prospective longitudinal, multicentric decentralized trial which will be performed in children diagnosed with late infantile or juvenile onset of neurological disease of either gm1 or gm2 gangliosidoses (tay-sachs or sandhoff disease). the study anticipates to include a total of approximately 35 patients. a large set of neurological functions will be evaluated by rating scales used by physicians and questionnaires answered by parents. digital tools will be used to support the study procedures with virtual visits and also a passive monitoring approach with a medical device.

Eligibility criteria:
inclusion criteria: * genetically confirmed gm1 gangliosidosis or genetically confirmed tay-sachs or sandhoff disease * onset of neurological symptoms on or after the patient's first birthday * achieved 12-month developmental milestones at normal developmental time points as per principal investigator's judgement * abnormal gait and/or speech disturbance exclusion criteria: * patients who have received (within 6 months before screening), are currently receiving or are planned to receive (within the following 6 months) gene therapy, stem cell transplantation, experimental drugs, or any drug, which, in the investigator´s opinion, may (have) interfere(d) with disease progression

Keywords: gm1 gangliosidosis gm2 gangliosidosis natural history study lysosomal storage disorders nervous system diseases tay-sachs disease sandhoff disease genetic diseases, inborn hexosaminidase a and b deficiency β-galactosidase deficiency
long term evaluation and management of atrial fibrillation in pacemaker patients

Conditions: Permanent Pacemaker Implantation

Summary: this study is prospective randomized study which was performed in multicenter (general hospital) in korea. inclusion criteria is patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among af-pacemaker study (clinicaltrials.gov identifier: nct03303872). the purpose is to investigate the recurrence rate of af/afl/at in both groups after randomization for 60 months (5 years) in patients post pacemaker implantation and assess long term clinical results.


Eligibility criteria:
inclusion criteria: * patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among af-pacemaker study (clinicaltrials.gov identifier: nct03303872). * age: 18-80 years * patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised korean indication guideline on cardiac pacemaker implantation * estimated percentage of atrial pacing \>40% under sinus rhythm (lr≥60bpm, close hysteresis and rest rate) * estimated percentage of ventricular pacing \>40% under sinus rhythm (lr≥40bpm, ddd pacing, close hysteresis and rest rate) * patients who are willing to sign the informed consent. * patients who are willing to receive the implantation and post-operative follow-up. exclusion criteria: * persistent or permanent af * severe hepatic and renal insufficiency (ast or alt ≥ three times of normal upper limit; scr \> 3.5 mg/dl or ccr \< 30ml/min) * thyroid gland dysfunction * pregnancy * malignant tumor * severe organic heart disease (such as moderate to severe mitral regurgitation, severe valvular regurgitation and stenosis, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease) * life expectancy \< 12 months * patients unable or unwilling to cooperate in the study procedures.

Keywords: ablation atrial fibrillation stroke
a clinical study to investigate the effectiveness and safety of tanezumab in treating pain associated with endometriosis

Conditions: Endometriosis

Summary: the purpose of this study is to determine whether tanezumab is effective and safe in the treatment of pain associated with endometriosis.


Eligibility criteria:
inclusion criteria: * pre-menstrual women with moderate to severe endometriosis. the diagnosis of endometriosis must have been confirmed surgically within the last 8 years. * subjects should have regular menstrual cycle (21 - 35 days) and must be willing to use adequate contraception (2 forms of birth control, one of which must be a barrier method). contraception is required throughout the study (screening to 16 weeks post treatment), even if subjects discontinue prematurely. exclusion criteria: * previous hysterectomy * surgical treatment for endometriosis within last 6 months. * medical treatment for endometriosis other than combined oral contraceptive pill within the last 3 months * current use of the coil or progesterone only contraceptive (the combined oral contraceptive pill is allowed). * any history of malignant disease (cancer)

Keywords: endometriosis pain tanezumab nerve growth factor questionnaires
the cortical shield for facial bone reconstruction

Conditions: Tooth Loss; Tooth Diseases; Tooth Fracture; Tooth Injuries; Periodontal Bone Loss; Periodontitis; Peri-Implantitis; Tooth Decay

Summary: to evaluate a novel technique of bone regeneration and simultaneous implant placement in severely damaged sockets.

patients requiring a single implant, presenting severe facial bone loss as a result of previous infection, failed socket grafting or trauma, will enter this cross-sectional study. socket reconstruction and simultaneous implant placement will be performed through periosteal-guided bone regeneration (pgbr). implant timing: immediate or delayed. implants will be encased in a customized shield of autogenous cortical bone harvested from an adjacent site. a re-entry surgery will be performed at 12-17-weeks to evaluate bone regeneration. peri-implant tissues will be assessed following established success criteria. implants will be evaluated for the presence of periimplantitis.

Eligibility criteria:
inclusion criteria: * asa1 or asa2 (american society of anesthesiologists) * healthy individuals with good oral hygiene and motivation * no systemic uncontrolled diseases * not taking drugs known to modify bone metabolism exclusion criteria: * individuals with untreated \& generalized severe periodontitis * heavy smokers (\>10 cigarettes/day) * poor oral hygiene * diabetes (hba1c \>6.5% as cutoff value) * uncontrolled cardiovascular disease * poor overall health (asa iv)

Keywords: tooth socket bone grafting bone regeneration dental implant osseointegration
acute effects of alcohol use on chronic orofacial pain

Conditions: Temporomandibular Joint Disorders

Summary: self-medication of pain with alcohol is a common, yet risky, behavior among individuals with chronic orofacial pain. chronic pain status may affect the degree to which alcohol use relieves pain, but the independent contributions of pain chronification and alcohol-related expectations and conditioning have not been previously studied. this project addresses this gap in knowledge and will inform further research and clinical/translational efforts for reducing risk associated with these behaviors.


Eligibility criteria:
inclusion criteria: * positive diagnosis of jaw pain, including temporomandibular joint and muscle disorder (tmd) (jaw pain group only) * consume at least 1 drink/month over the past 6 months exclusion criteria: * history of chronic pain other than jaw pain or tmd * current use of opioids * current major depression * history of any psychotic disorder * undercontrolled hypertension or diabetes * history of neurologic disease * history of serious medical illness * history of drug or alcohol dependence, including nicotine, or a pattern of hazardous alcohol use

Keywords: alcohol effects
study on the molecular mechanism of diarrhea-predominant irritable bowel syndrome with anxiety and depression based on multi-omics correlation analysis

Conditions: Irritable Bowel Syndrome With Diarrhea

Summary: the research group intends to carry out a case-control study to recruit ibs-d patients with anxiety and depression symptoms, by collecting intestinal mucosa for single-cell transcriptome sequencing, collecting peripheral blood for proteomic analysis, the two groups and patient symptoms are associated, and then discover the characteristics of molecular level changes associated with brain-gut axis dysfunction, explore the pathophysiological mechanism of comorbid anxiety and depression and ibs, and discover potential targets for effective treatment. this project can help to construct the colonic single-cell map of ibs-d patients and explore the differentially expressed genes in the colon of ibs patients and their signaling pathways related to neuroregulation, providing an effective therapeutic target for the treatment of comorbid anxiety and depression and ibs.


Eligibility criteria:
inclusion criteria: 1. meet the rome iv diagnostic criteria for diarrhea-predominant irritable bowel syndrome; 2. aged between 18 and 65 years old (inclusive), male or female; 3. hama assessment ≥ 14 points or hamd assessment ≥ 17 points exclusion criteria: 1. patients with severe cardiovascular and cerebrovascular diseases (such as myocardial infarction, cerebral infarction, coronary heart disease, etc.); 2. abnormal liver and kidney function (alt or ast \> 1.5 times the upper limit of normal, or t-bil \> 1.5 times the upper limit of normal, or cr more than the upper limit of normal), hematopoietic system diseases and tumors; 3. patients with a history of abdominal surgery (except appendectomy and cholecystectomy); 4. previous diagnosis of organic diseases of the digestive system, such as inflammatory bowel disease, intestinal tuberculosis, etc., or still associated with peptic ulcer, infectious diarrhea, etc.; 5. previous diagnosis of diseases similar to irritable bowel syndrome symptoms, such as eosinophilic enteritis, microscopic colitis (including collagen colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome; 6. previous diagnosis of non-intestinal digestive system diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis; 7. previous diagnosis of diseases affecting the digestive tract function, such as hyperthyroidism or hypothyroidism, endometriosis, autoimmune diseases, diabetes, etc.; 8. 4. patients who have taken drugs with bleeding risk or increased bleeding risk before treatment; 9. 4. patients who have taken antidepressant drugs and psychotropic drugs before treatment; 10. 4. use drugs that affect gastrointestinal motility and function, such as prokinetic drugs, anticholinergic drugs, calcium channel blockers, 5-ht receptor agonists/antagonists, antidiarrheal agents, antacids, intestinal bacteria modulators and antibiotics; 11. allergic constitution; 12. pregnant and lactating women; others that may affect study compliance or adversely affect the results as judged by the investigator.
the effect of kinesiological taping applied to the tibialis anterior muscle on gait parameter in stroke patients

Conditions: Stroke

Summary: the effect of kinesiological taping applied to the tibialis anterior muscle on gait parameter in stroke patients: sham controlled study

objective: the aim of this study was to compare the immediate effect of kinesiological and / or sham taping to the tibialis anterior muscle on walking parameters in stroke individuals. methods: the study included 28 adults stroke patients . the subjects who received scores of 7 or more in the hodkinson mental test and 3 and above in the functional ambulation classification with subjects who gastrocnemius muscle spasticity 2 and below points according to modified ashworth scale were included in the study. the walking parameters of the participants were evaluated with the bts g-walk spatio-temporal walking analysis system. the walking parameters of the participants who were selected by randomization method were evaluated separately by applying kinesiological taping and sham taping or without any taping or interference on a 10 meter track.

Eligibility criteria:
inclusion criteria: * 28 stroke individuals (hemiplegic / hemiparetic) who were treated in the adult * neurological rehabilitation unit of pamukkale university medical faculty hospital were included in the study. * being between the ages of 25-70 * volunteers with written consent * with a 1-year history of stroke * who had a stroke for the first time * having a lesion in one brain hemisphere exclusion criteria: * having neurological or orthopedic comorbid disease * patients with a gastrocnemius spasticity greater than 2 according to the modified ashworth scale * patients with communication problems * patients with cognitive functions below 7 points according to the hodkinson mental test * patients with ambulation level below 3 according to functional ambulation classification

Keywords: stroke kinesiological taping walking tibialis anterior
influence of neuromuscular block on mask ventilation

Conditions: Effect of a Neuromuscular Block on Ventilation

Summary: difficult mask ventilation might lead to a life-threatening situation, if endotracheal intubation is also impossible and neuromuscular blocking agents (nmba) inhibit spontaneous ventilation. however, controversies exist if nmba improve or impede face mask ventilation. therefore, the effect of nmbas on mask ventilation is assessed in patients with predictors for difficult face mask ventilation.


Eligibility criteria:
inclusion criteria: * patients with risk factors for difficult face mask ventilation * patients scheduled for general anaesthesia with endotracheal intubation exclusion criteria: * increased risk for pulmonary aspiration * scheduled for awake fiberoptic intubation * pregnancy

Keywords: ventilation face mask nmba
phase i, open-label study of the safety, tolerability, and immunogenicity pek fusion protein vaccine

Conditions: Cervical Intraepithelial Neoplasia

Summary: phase i, open-label study of the safety, tolerability, and immunogenicity of a three dose regimen of escalating doses of pek fusion protein vaccine in women with lsil or hsil. pek fusion protein vaccine (pek + gpi-0100) is safe and well tolerated in patients with low-grade squamous intraepithelial lesions (lsil) or high grade squamous intraepithelial lesions (hsil) of the cervix and induces a measurable immune response.


Eligibility criteria:
inclusion criteria: * female age 18 to 45 years * written informed consent in accordance with institutional guidelines * negative pregnancy test * lsil or hsil on papanicolaou (pap) smear within the prior 6-8 weeks * normal electrocardiogram (ecg), laboratory values (chemistry, complete blood count) and urinalysis, as judged by grade 0-1 as per national cancer institute common toxicity criteria (nci-ctc) performed up to 30 days prior to administration of study treatment. * body mass index (bmi) ≤32 kg/m2 * women of child-bearing potential (wocbp) agree to use two forms of medically effective contraception (e.g. hormonal contraception, intrauterine device, barrier method, spermicide, etc...) during the study and for at least 12 weeks following the completion of treatment. patients agree to inform the investigator immediately if they become pregnant during the study or within 12 weeks following completion of treatment and to provide information about the pregnancy, delivery and health of the infant until the age of one month. * able and willing to comply with all study procedures exclusion criteria: * active infection with herpes simplex virus (hsv) * positive serologic test for human immunodeficiency virus (hiv), hepatitis c virus (hcv), or hepatitis b surface antigen (hbsa) * pregnant or breast-feeding * history of any prior cervical surgical treatment * history of any active autoimmune disease or current medical condition requiring the use of systemic or topical corticosteroids (excluding steroid containing eye drops or inhaled steroids) or other immunosuppressive agents within 4 weeks prior to enrollment * history of cancer (excluding basal cell carcinoma of the skin) * eastern cooperative oncology group (ecog) performance status ≤ 2 * administration of any blood product within 3 months of enrollment * administration of any vaccine within 6 weeks of enrollment * active infection requiring antimicrobial treatment * participation in any study with an investigational compound or device within 30 days prior to signing informed consent * any hematologic disorder involving platelets or clotting abnormalities or any condition requiring treatment with transfusions, anticoagulants or platelet inhibitors * active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study protocol * any condition which, in the opinion of the investigator, would limit the evaluation of the patient.

Keywords: pek fusion protein healthbanks
misoprostol prior to intrauterine device (iud) insertion in nulliparous women

Conditions: Pain

Summary: the purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.

the intrauterine device (iud) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after iud removal. despite advantages associated with the iud, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. some providers have started pre-medicating nulliparous patients with misoprostol prior to iud insertion because of the drug's known effect as a cervical ripening agent. limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of iud insertion in nulliparous women. the goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases iud insertion and decreases pain.

Eligibility criteria:
inclusion criteria: * 14 years old or older * negative pregnancy test * no prior pregnancies lasting beyond 19 6/7 weeks * minimum 2 weeks after spontaneous or medical abortion * minimum 4 weeks post 2nd trimester or surgical abortion * no previous iud insertions * no pid in last 3 months * no current cervicitis * willing to follow-up in 1-2 months for an iud string check exclusion criteria: * active cervical infection * current pregnancy * prior pregnancy beyond 19 6/7 weeks gestation * known uterine anomaly * fibroid uterus distorting uterine cavity * copper allergy/wilson's disease (for paragard) * undiagnosed abnormal uterine bleeding * cervical or uterine cancer

Keywords: misoprostol iud insertion nulliparous women contraception family planning iud insertion in nulliparous women
persistence of protective antibody titers 12-24 months after nmvac4-a/c/y/w-135-dt vaccination: follow up study

Conditions: Meningococcal Meningitis; Meningococcal Infections

Summary: to determine the persistence of protective antibody levels for subjects who seroconverted after vaccination with nmvac4-a/c/y/w-135-dt™ participants in trial # jn-nm-002, who seroconverted for serogroups a and c will be contacted and asked to provide a blood sample at 12-24 months after vaccination with nmvac4-a/c/y/w-135-dt. serum bactericidal assays will be performed to evaluated duration of protective antibody titer for nmvac4-a/c/y/w-135-dt for all four serogroups. to determine if subjects who seroconverted with lower titers retain protective levels of antibody (titer ≥:8) at 12-24 months after vaccination.

the purpose of this study is to collect serum samples to evaluate duration of protection for nmvac4-a/c/y/w-135-dt, based on titers determined by serum bactericidal assay with human complement (hsba). this assay is used to evaluate immunogenicity of meningococcal vaccines, as a surrogate for efficacy. a titer ≥ 1:8 is considered protective. objectives are to evaluate duration of protective antibody titer for nmvac4-a/c/y/w-135-dt for all four serogroups, and determine if subjects with lower titers, but ≥:8 retain protective levels of antibody at 12-24 months. participants in trial # jn-nm-002, who seroconverted for serogroups a and c will be contacted and asked to provide a blood sample at 12-24 months after vaccination with nmvac4-a/c/y/w-135-dt™. serum bactericidal assays will be performed to evaluated persistence of protective antibody titer for nmvac4-a/c/y/w-135-dt for all four serogroups, to determine if subjects who seroconverted with lower titers retain protective levels of antibody (titer ≥:8) at 12-24 months after vaccination.

Eligibility criteria:
inclusion criteria: * willing and able to give informed consent * participant in trial jn-nm-002 * seroconverted in trial jn-nm-002 for both serogroups a and c exclusion criteria: * chronic medication use or medical history that, in the opinion of the investigator, may impact the quality of the sample or safety of the subject