Kornimate/medical-research-clean huggingface dataset:
a phase 2 trial to evaluate the safety and efficacy of ub-621

Conditions: Genital Herpes

Summary: to evaluate the efficacy of two dose levels of ub-621 administration in reducing the hsv-2 genital shedding rate in patients with recurrent genital hsv-2 infection.

this is a 2-stage, randomized, double-blind, dose-ranging, multi-center phase 2 study designed to evaluate the efficacy, safety, and pk of ub-621 given at 2.5 or 5 mg/kg in adult subjects with recurrent genital hsv-2 infection. the study consists of 2 stages of enrollments, in which 40 subjects will be enrolled in the first stage and randomly assigned to receive placebo or ub-621 at 2.5 mg/kg in a 1:3 ratio into cohort 1 at bv6 (day b57), and another 40 subjects will be enrolled in the second stage and randomly assigned to receive placebo or ub-621 at 5 mg/kg in a 1:3 ratio into cohort 2 at bv6 (day b57) after review by the data safety monitoring committee (dsmc). the dsmc will review safety data after all subjects of cohort 1 complete the visit fv6 (day f28) and make the recommendation whether to proceed with enrollment for cohort 2.

Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age inclusive. * subject must be hsv-2 seropositive * subjects have a history of recurrent genital herpes in the past year * subjects have a negative result on the hiv ab/ag assay * subjects must agree to use contraception during study participation * subjects must be willing not to use any topical genital therapy and systemic anti-hsv therapy from the beginning of the study till the end of week 16. * subjects must be willing to collect a swab each day from their genital area (non-lesional as well as lesional, if appropriate) during the swabbing periods, which are 8 weeks prior to and upon the administration of study drug. * female subjects must have a negative serum β-hcg at screening and a negative urine pregnancy test prior to study drug administration. exclusion criteria: * serious medical conditions, including poorly controlled diabetes, significant autoimmune diseases, co-existing sexually transmitted disease presentation (except hsv) in the anogenital area, etc. that may interfere with the assessment of the efficacy of ub-621. * documented hsv resistance to acyclovir, valacyclovir, famciclovir, or penciclovir * history or current evidence of malignancy except for a localized non-melanoma skin cancer * known immunosuppression * exposure to hsv vaccine * medical history of macular or maculopapular skin reactions to antibody (ie, as evidenced by igg or plasma administration) * any other conditions that in the judgment of the investigator would preclude successful completion of the clinical study * treatment with systemic steroids or other immunomodulating agents within 30 days prior to screening or planned treatment with systemic steroids or immunomodulators during the study period. * renal impairment and/or hepatic impairment * ecg abnormalities of clinical relevance or cardiovascular conditions
study evaluating the safety, tolerability, pk, and activity of topical atx201 gel in outpatients with impetigo

Conditions: Impetigo

Summary: this is a phase 2 study evaluating the safety, tolerability, systemic exposure, and activity of topical atx201 gel (2% and 4%) treatment for 1, 2, or 5 days in outpatients with primary nonbullous or bullous impetigo.


Eligibility criteria:
inclusion criteria: * diagnosis of primary nonbullous or bullous impetigo * affected area comprising 1 to 100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. * target area has total sirs score of at least 3, including pus/exudate of at least 1 * normally active and otherwise in good health by medical history and physical examination exclusion criteria: * has a pre-existing skin condition or skin trauma with clinical evidence of secondary infection * has an infection that could not be appropriately treated with a topical antibiotic or severe manifestation of impetigo warranting systemic therapy * clinically significant mental illness * pregnant or breast-feeding * recent history, or strong potential for, alcohol or substance abuse. * skin condition that may interfere with the placement of study treatment or impede clinical evaluations * receipt of systemic drugs that affect the immune system within the past 3 months * receipt of any topical medication on the regions to be treated or topical antibiotics used for nasal decolonization within the past 24 hours
radiofrequency ablation in tir3a nodules with negative genetic evaluation

Conditions: Thyroid Nodule

Summary: the goal of this clinical trial is to demonstrate that tir3a nodules with negative genetic test can be safely and effectively treated by radiofrequency ablation, with nodular shrinkage and improvement of clinical symptoms. fine needle aspiration cytology is the gold standard test for differential diagnosis of thyroid nodules, but sometimes the result can be indeterminate with a risk of malignancy of 10-30%. in these cases the ablation is not indicated and many patients with benign nodules that may benefit from the procedure are not treated. all the patients enrolled must have a tir3a cytology and negative genetic test for mutations associated with thyroid carcinoma. before the ablation blood, evaluation of serum tsh, anti-thyroglobulin antibodies, anti-thyroid peroxidase antibodies and calcitonin levels will be performed.


Eligibility criteria:
inclusion criteria: * patients with thyroid nodule eligible for radiofrequency ablation, with low-risk indeterminate lesion cytology (tir3a) and negative genetic test for mutations associated with thyroid carcinoma exclusion criteria: * patients who are not able to sign the informed consent * patients with contraindications to radiofrequency ablation * patients with cytology different from tir3a * patients with positive genetic test for mutations associated with thyroid carcinoma

Keywords: thyroid nodule indeterminate genetic radiofrequency ablation follow-up
impact of aligner replacement protocols on predictability of planned dental movements: evaluation of double aligner

Conditions: Malocclusion; Clear Aligner Appliance; Orthodontics; Tooth Movement

Summary: the study will evaluate the impact of replacing aligners after 7 days with new aligners made of different materials on the predictability of planned dental movements. three groups of participants will follow different aligner protocols, and the planned movements will be compared with the achieved ones. the study aims to provide relevant data for clinical practices with orthodontic aligners and assess participants' satisfaction with the treatment.

this prospective clinical trial aims to determine whether replacing an aligner after 7 days with a new aligner of a different material affects the predictability of planned dental movements. a total of 114 adult patients undergoing orthodontic treatment with aligners-requiring bilateral tooth movements (extrusion, intrusion, rotation, tipping, or mesiodistal translation)-will be recruited and randomized into three groups with distinct aligner exchange protocols. group 1: 10 days of exclusive flx aligner use. group 2: 7 days of flx aligner use followed by 3 days of flx35 use. group 3: 7 days of flx aligner use followed by 3 days of a new flx aligner. within each group, patients will be further categorized into subgroups based on horizontal, vertical, and rotational movements. digital study models, radiographs, and standardized clinical photographs will be used to compare planned versus achieved tooth movements. the primary outcome is the predictability of movement, defined as the difference and percentage of planned versus actual movement. secondary outcomes include participant satisfaction measured via the ohip-14 questionnaire. data will be analyzed using descriptive statistics and paired tests appropriate for the split-mouth design. the study is conducted in accordance with the declaration of helsinki, and all treatment costs will be covered by the sponsor, neodent (jjgc industria e comercio de materiais dentarios s.a.).

Eligibility criteria:
inclusion criteria: * adults aged 18 years or older, with full permanent dentition. * interested in orthodontic treatment with aligners. * planned movements include extrusion, intrusion, rotation, tipping, or mesiodistal translation. * signed informed consent. exclusion criteria: * contraindications to aligner use, including allergies to polyurethane or petg. * poor oral hygiene or active periodontal disease. * malocclusions involving multiple missing teeth or short clinical crowns.

Keywords: orthodontics tooth movement removable appliances
peer-led group intervention for coping with disaster

Conditions: Anxiety Disorder; PTSD; Depressive Symptoms; Anger; Depressive Disorder

Summary: the present project partners with leading faith communities in houston to provide expert-led educational workshops to a diverse sample of adults on normative and concerning response to disaster. secondly implementing peer-led interventions where a trained adult leads others through an evidence-based manualized intervention. lastly, identifying and referring individuals who require more intensive services to a higher level of care.

approximately 20% of individuals have significant behavioral health concerns. exposure to a disaster like hurricane harvey and its aftermath often exacerbates pre-existing issues and/or brings new issues, with post-traumatic stress presenting in manners such as anxiety, depression, conduct issues and/or somatic issues. approaches are needed that educate community members about both normative and concerning responses to disaster focused on coping skills development. a particular approach, peer-led intervention groups have been shown effective at delivering these types of intervention. brief, psycho-educational peer-led programs have shown effectiveness in a variety of forums including helping promote adjustment among those who have experienced trauma. there will be six group sessions every two weeks. sessions will include how to teach appropriate coping techniques to respond to the distress, confronting distressing memories related to the disaster, and emotion regulation techniques. after the group sessions end, individuals who require a more intensive service will be referred to a higher level of care.

Eligibility criteria:
inclusion criteria: * 18 years and older and english speaking. exclusion criteria: * individuals under the age of 18 and non-english speaking and participants who do not wish to participate in this study.
pressure pain threshold of jaw muscles in tmd patients submitted to a conservative treatment

Conditions: Pain; Myofascial Pain; Temporomandibular Disorder Syndrome; Therapeutic Exercise; Facial Pain

Summary: pain is an unpleasant sensory and emotional experience that is one of the main symptoms of temporomandibular disorder (tmd). one way to assess pain is through algometry. the aim of this study was to evaluate, by the pressure pain threshold measurements, the efficacy of a short-term conservative treatment for the management of temporomandibular disorders. this study is a randomized controlled clinical trial where 84 participants were diagnosed with myofascial pain according to the research diagnostic criteria for temporomandibular disorders (rdc/tmd), with a mean age of 44 years old ranging from 18 to 76 years old. these individuals were asked about parafunctional habits and the treatment was applied by providing an explanation concerning the role of pain, possible aetiological factors of the patient's tmd, the relationship between chronic pain and psychosocial distress, and its benign character. they also had to perform once daily application of hot packs on both sides of the face for 20 minutes and after that they must perform active free therapeutic exercise of mouth opening for 10 times. the pressure pain threshold of the masseter and temporalis muscles and the lateral pole of the condyle were obtained at baseline (t0), between 15 and 30 days after (t1) and at 75 to 90 days after (t2) representing the end of the treatment. two groups of subjects were obtained. the first was considered the study group (sg) and included those who underwent the treatment proposed. the control group (cg) consisted of participants who did not undergo treatment because they did not believe in it.


Eligibility criteria:
inclusion criteria: * more than 18 years old have diagnosis of myofascial pain according rdc/tmd signed the informed consent exclusion criteria: * people under 18 years old

Keywords: pressure pain threshold temporomandibular disorder syndrome therapeutic exercise conservative treatment facial pain
minimally-invasive surgery versus craniotomy in patients with supratentorial hypertensive intracerebral hemorrhage

Conditions: Intracranial Hemorrhage, Hypertensive

Summary: the effectiveness of craniotomy in the treatment of intracerebral hemorrhage remains controversial. two main types of minimally invasive surgery, endoscopic evacuation and stereotactic aspiration, have been attempted for hematoma removal and show some advantages. however, prospective and controlled studies are still lacking. this is a multi-center randomized controlled trial designed to determine whether minimally invasive hematoma evacuation with endoscopic or stereotactic aspiration will improve the outcome in patients with hypertensive intracerebral hemorrhage compared with small-boneflap craniotomy. patients will be randomly assigned to endoscopy group, stereotactic aspiration group or small-boneflap craniotomy group in a 1:1:1 ratio.

hypertensive intracerebral hemorrhage (hich) is the most common hemorrhagic stroke. the morbidity and mortality exceed 60% and only 12% patients could live independently. the choice of surgical or conservative treatment for patients with hich is controversial. some minimally invasive neurosurgeries have been applied to hematoma evacuation and may improve prognosis to some extent. in endoscopic evacuation, a small burr hole is created and hematoma is removed through suction and irrigation under neuroendoscope. endoscopic surgical evacuation promise to maximize hematoma evacuation while minimizing damage to normal tissue. stereotactic aspiration uses image guidance to place a catheter into the main body of the hematoma and aspirate blood. it is estimated that 720 patients (240 patients in each treatment group) would provide 90% power and a type i error probability of .05 to detect an effect size of 13% with a 10% dropout rate taken into consideration. patients will receive endoscopic evacuation, stereotactic aspiration or craniotomy according to the results of randomization. patients will be followed up at 7 days, 30 days and 6 months. outcomes of different groups of patients will be collected and compared. the study is designed to find a best surgical method for hypertensive intracerebral hemorrhage.

Eligibility criteria:
inclusion criteria: * supratentorial hypertensive intracerebral hemorrhage on ct scan with the hematoma volume ≥25ml * adult patients with gcs score ≥5 * admitted within 24h of ictus exclusion criteria: * intracerebral hemorrhage caused by tumor, coagulopathy, aneurysm, or arteriovenous malformation * concurrent head injury or history of head injury * multiple intracerebral hemorrhage * known advanced demential or disability before * with indications of terminal brain hernia * severe concomitant diseases that affect life expectancy * patients having taken anti-platelet or anticoagulant drugs for a long time * with severe intraventricular hemorrhage * pregnant women

Keywords: intracerebral hemorrhage,hypertensive minimally invasive surgery neuroendoscopic surgery stereotactic aspiration
maternal body composition regulates placental function

Conditions: Obesity; Pregnancy

Summary: this study examined the relationships between maternal body composition, placental function, and fetal nutrition and body composition, and sought to determine the most accurate method of maternal body composition analysis in late pregnancy.

this study examined the relationships between maternal body composition, placental function, and fetal nutrition and body composition, and sought to determine the most accurate method of maternal body composition analysis in late pregnancy. this project integrates body composition analysis, nutrition, and metabolic factors to study the impact of maternal body composition and diet on placental function and fetal growth. research project: the proposed enrollment of 41 pregnant women at term (\>37 weeks gestation) was completed in september 2013. the subjects underwent four body composition measurements (bioelectrical impedance, skin-fold thickness, bodpod, and deuterium dilution) and dietary surveys along with a fasting blood draw. the subjects returned 2 weeks postpartum for repeat measurements along with a dexa scan.

Eligibility criteria:
inclusion criteria: healthy pregnant women at term with singleton gestation exclusion criteria: medical condition requiring daily medication fetal congenital anomalies diabetes
clinical aspects of patients with benign paroxysmal positional vertigo (bppv) and migraine

Conditions: Migraine; Positional Vertigo

Summary: the aim of this study is to analyze the clinical aspects of patients with bppv associated with migraine. it is our purpose to clarify weather migraine is a risk factor for bppv if the clinical aspect and the therapeutic outcome is different.

two hundred and sixty-three patients with bppv were enrolled in this retrospective study. all patients' charts were reviewed by independent observer. the type of bppv and associated problems were noted. patients with migraine were investigated in terms of age, gender, symptoms, affected side and the cure rate. their data were compared with those having no migraine. mean values and standard deviations (± sd) were calculated. one way anova test was used for the analysis. significance was set at p \< 0.005.

Eligibility criteria:
inclusion criteria: * patients who had history of head-induced positional and brief vertigo and who have been confirmed by vng were included exclusion criteria: * patients with balance problem other than bppv, * patients receiving any medication prior to therapeutic maneuver were excluded

Keywords: migraine benign paroxysmal positional vertigo
hypofractionated radiation therapy combined with concurrent chemotherapy for patients with non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety of accelerated hypofractionated three-dimensional conformal radiation therapy (3 gy/fraction) concurrent with chemotherapy for patients with unresectable stage iii non-small cell lung cancer.

increasing the biological effective dose (bed) of radiotherapy for non-small cell lung cancer (nsclc) can increase local control rates and improve overall survival. compared with conventional fractionated radiotherapy, accelerated hypofractionated radiotherapy can yield higher bed, shorten the total treatment time, and theoretically obtain better efficacy. however, currently, there is no optimal hypofractionated radiotherapy regimen. based on phase i trial results, we performed this phase ii trial to further evaluate the safety and preliminary efficacy of accelerated hypofractionated three-dimensional conformal radiation therapy(3-dcrt) combined with concurrent chemotherapy for patients with unresectable stage iii nsclc. patients with previously untreated unresectable stage iii nsclc received 3-dcrt with a total dose of 69 gy, delivered at 3 gy per fraction, once daily, five fractions per week, completed within 4.6 weeks. at the same time, platinum doublet chemotherapy was applied.

Eligibility criteria:
inclusion criteria: * pathological or cytological diagnose of unresectable stage iii non-small cell lung cancer * the karnofsky performance status (kps) score ≥70. * the expected survival time ≥3 months. * adequate blood, liver, lungs and kidney function * accessible contact information * informed consent required before enrollment. exclusion criteria: * pregnant or breastfeeding. * another malignant tumor history (with the exception of patients with cervical carcinoma in situ and non-malignant melanoma skin cancer that had been clinically cured for at least 5 years) * cannot receive concurrent chemotherapy due to medical reasons. * superior vena cava syndrome. * severe lung diseases that affected lung function.

Keywords: accelerated hypofractionated radiotherapy three-dimensional conformal radiation therapy concurrent radiochemotherapy
study of v117957 in interstitial cystitis/bladder pain syndrome

Conditions: Interstitial Cystitis/Bladder Pain Syndrome

Summary: the purpose of this study is to evaluate the safety, tolerability and efficacy of v117957 in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo.


Eligibility criteria:
key inclusion criteria include: 1. female, age ≥18 years and capable of voiding independently. able to comply with acceptable methods of contraception. 2. diagnosis of ic/bps or meets criteria for ic/bps as defined by the american urology association as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms for more than six weeks duration, in the absence of infection or other identifiable causes". 3. subject has bladder pain/interstitial cystitis symptom scale (bpic-ss) total score of ≥19 and worst bladder pain/discomfort sub-score of ≥4 to ≤9. 4. has undergone evaluation to rule out other conditions that cause bladder pain/discomfort. any microscopic or gross hematuria that has not been evaluated in the past 12 months will require appropriate clinical evaluation to determine study eligibility. key exclusion criteria include: 1. pelvic floor tenderness in the absence of bladder tenderness on physical examination by primary investigator. 2. urinary tract infection (uti) within the past 30 days, or history of recurrent uti. 3. hematuria determined to be associated with bladder malignancy or other significant pathology. 4. had surgical procedure at any time that affected bladder function. 5. received intravesical therapy or had bladder hydrodistension, fulguration, botulinum toxin, or triamcinolone bladder injection, percutaneous nerve stimulation. a subject receiving such treatment(s) prior to screening is eligible if in the opinion of the investigator the procedure/ treatment resulted in no notable or enduring effect and subject continues to exhibit stable symptomology. 6. has current or history of clinically significant kidney disease or abnormal kidney function, or nephrolithiasis. other protocol-specific inclusion and exclusion criteria may apply.
biological biomarkers in moms partnership

Conditions: Psychological Stress

Summary: the investigators propose to evaluate the potential utility of stress-related biomarkers obtained via dried blood spots (dbs) and retinal scans by collecting new data from mothers and children within the new haven moms partnership, a well-established community-partnered research setting. the proposed research could greatly advance the application of stress-related biomarkers within community-based research by increasing our understanding of how stress, trauma, and depression influence biology in childhood and adulthood, as measured using minimally-invasive approaches.


Eligibility criteria:
inclusion criteria: * english-speaking adult mothers (age 21 or older) of at least one biological child mothers must be able to answer three verification questions to confirm they are the biological parent of their child exclusion criteria: * non-english speakers * women not able to provide informed consent and with no biological children * mothers under the age of 21