Kornimate/medical-research-clean huggingface dataset:
six months evaluation of next science acne creams on facial acne in adult females.

Conditions: Acne Vulgaris

Summary: to assess facial acne vulgaris clinical and psychological outcomes by measuring differences in lesions counts, investigator global assessment, and subjects quality of life scores over 6 months in adult females treated with next science™ acne cream 2x or next science™ acne cream 1x in a double blind manner.

this is a 6-month, single-site, double-blind, controlled study in 20 female subjects with mild to moderate facial acne. subjects will be randomized 1:1 to apply either topical next science™ acne cream 2x or next science™ acne cream 1x daily. subjects will be evaluated for clinical acne and quality of life outcomes at baseline, 6, 12, 18 and 24 weeks.

Eligibility criteria:
inclusion criteria: 1. female ages 18 and above 2. has 20 or more inflammatory lesions on the face (papules and pustules) as determined by qualified examiner at start of treatment. 3. in the area to be treated, has no significant facial dermatological conditions other than acne (as determined by the investigator) that would interfere with any study treatment or procedure 4. is willing and able to discontinue use of all baseline acne treatments for the duration of their trial participation 5. agrees to refrain from professional facial treatments during their trial participation. 6. agrees to avoid tanning booth use and minimize sun exposure during their trial participation. 7. is willing and able to follow instructions and procedures including attending scheduled study visits, which will require adequate transportation to the study site 8. is able to read, understand and sign the informed consent document and communicate with study staff and investigator. exclusion criteria: 1. has more than 2 nodules/cystic acne lesions on the face 2. has a history of significant reactions to topical acne treatments, or a known allergy or hypersensitivity to any listed ingredients 3. has any history of skin malignancy 4. has used any systemic medications (including antibiotics, estrogens, retinoids) primarily for treatment of acne in the 21 days prior to randomization. 5. has used estrogens primarily as treatment for acne in the 21 days prior to randomization (estrogens prescribed for other reasons will be allowed if stable for at least 30 days prior to randomization). 6. has had any professional facial treatments in the 14 days prior to randomization. 7. has received any investigational treatment in the 30 days prior to randomization. 8. have any significant medical problems or other issues that would, in the investigator's judgment, affect their suitability for participation in this trial.
comp.act for chronic pain exercises in an act group intervention for chronic pain

Conditions: Chronic Pain

Summary: this study tests the efficacy of adding explicit self-compassion meditation exercises in an act intervention for chronic pain (comp.act). comp.act is an 8-session, 2h each, psychological intervention for women with chronic pain. half of participants will receive an act intervention + 2 q\&a sessions, and half of participants will receive an act intervention + 2 compassion-focused sessions with explicit self-compassion exercises.

acceptance and commitment therapy (act) is a transdiagnostic approach, with empirical support in adapting to several chronic health conditions, such as chronic pain (cp), and its main purpose is to improve functioning and decrease interference of pain with valued life goals. although the american psychological association (apa) has stated act as having empirical support in cp (http://www.div12.org/psychologicaltreatments/treatments/chronicpain_act.html), with several studies showing its efficacy, there is still room for improvement. this might be attained by adding theoretically compatible components such as self-compassion. although act has recently incorporated self-compassion as one of its outcomes, this has not been considered in any act intervention study for cp. compassion-based approaches has been effective in targeting self-criticism, and has been effective in reducing a large array of psychopathological symptoms that are also common in cp (e.g. depression and anxiety). the current study aims to test the adding value of explicit self-compassion exercises in an act group intervention for cp. general study design participants previously diagnosed with cp by a physician will be assigned into two different conditions/groups: a group intervention for cp that includes explicit self-compassion exercises (comp.act); and a group intervention that does not include explicit self-compassion exercises (act). the efficacy of comp.act will be assessed by comparing it with the act condition. sample this study aims to focus on musculoskeletal cp as it is the most common cause of cp. also, the study will recruit women with cp. patients will be provided a study description, a consent form and the research team contact for further clarifications. the comp.act protocol has the following goals: (a) promote engagement in meaningful and effective activities, even with pain and distress, (b) improving present-focused awareness and acceptance of thoughts, feelings, and physiological sensations; (c) developing a self-compassion stance towards personal difficulties, and (d) promote commitment and engagement with valued actions.

Eligibility criteria:
inclusion criteria: * chronic pain diagnosis(es), * age between 18-65, * residence in center region of portugal, * availability to attend sessions. exclusion criteria: * symptoms of psychosis, * non-suicidal self-injury, * suicide ideation, * severe depression, * substance abuse.

Keywords: chronic pain acceptance and commitment therapy (act) compassion
evaluation of prophylactic endotracheal intubation

Conditions: Intubation;Difficult; Gastrointestinal Bleeding

Summary: upper gastrointestinal (gi) bleeding is defined as patients who either presented with hematemesis or presented with melena along with evidence of hemodynamic compromise. these patients have risk of aspiration of blood along with gastric content. the mortality rate can be 15% to 20% in the cases with variceal bleeding. from a practical standpoint, it is widely accepted that the best way to secure an airway during upper gi bleeding is prophylactic endotracheal intubation (pei). the aim of this study is to determine the incidence of complications among critically ill patients with upper gi bleeding and received urgent endoscopy.

this is a prospective observational study. after irb approval, consecutive patient with upper gi bleeding and undergoing urgent endoscopy will be enrolled to the study over 24 months period. data pull will be requested from parkland office of research administration (ora) regarding eligible subjects and protocol requiring data elements. the data pull will be requested at the end of the 24 months-period. primary endpoint: the incidence of cardiovascular unplanned event within 48 hours of the upper gastrointestinal endoscopy procedure. secondary end points: the incidence of pulmonary unplanned event within 48 hours of the upper gastrointestinal endoscopy procedure.

Eligibility criteria:
inclusion criteria: * age 18 years and older * presence of upper gastrointestinal bleeding either presented with hematemesis or melena along with evidence of hemodynamic compromise. * received procedural (conscious) sedation * undergoing urgent upper gastrointestinal endoscopy procedures exclusion criteria: * intubation other than airway protection * prior tracheostomy before onset of gastrointestinal bleeding * subjects intubated before transfer to gastrointestinal suite * subjects without hemodynamic instability * subjects with a diagnosis of pneumonia, acute respiratory distress syndrome, myocardial infarction, pulmonary edema, arrhythmia, or cardiac arrest before endoscopy * endoscopy done for other than upper gastrointestinal bleeding * pregnant subjects
ric regimen for low- and intermediate-risk mds receiving haplo-hsct

Conditions: Myelodysplastic Syndromes

Summary: this study aimed to evaluate the efficacy of reduced intensity conditioning (ric) regimen in low- and intermediate-risk myelodysplastic syndrome (mds) patients who receive haploidentical hematopoietic stem cell transplantation (haplo-hsct). haplo-hsct is an effective treatment option for mds patients who did not have identical sibling donor (isd) or unrelated donor (urd). however, post-transplant transplant-related mortality (trm) is one of the major causes for transplant failure in mds patients, and the risk of trm for haplo-hsct recipients was higher than that of isd recipients. ric regimen can decrease the risk of trm for haplo-hsct recipients; however, the risk for relapse may increase in these patients. thus, ric regimen may be more appropriate for low- and intermediate-risk mds patients receiving haplo-hsct. the study hypothesis: using ric haplo-hsct regimen in patients with low- and risk mds can reduce trm and improve survival.

ric regimen was given for low and intermediate mds patients who would receive haplo-hsct. the primary end point was transplant-related mortality. the secondary end points were overall survival, disease-free survival, relapse, , graft-versus-host disease (gvhd), and infections. following time is 1 years.

Eligibility criteria:
inclusion criteria: * patients who had low- and intermediate-risk mds without isd nor urd receiving haploidentical hematopoietic stem cell transplantation exclusion criteria: * patients having isd or urd; patients having high-risk mds; patients with active infection; patients with poor compliance; patients with organ failure

Keywords: ric regimen; mds; haplo-hsct; survival
transcranial magnetic stimulation for the treatment of poorly controlled partial epilepsy

Conditions: Partial Epilepsy; Seizures

Summary: transcranial magnetic stimulation (tms) is a non-invasive technique that can be used to stimulate brain activity and gather information about brain function. it is very useful when studying the areas of the brain related to motor activity (motor cortex, corticospinal tract, and corpus callosum). epilepsy is a condition associated with seizures as a result of an over excitable cerebral cortex. despite the introduction of several new antiepileptic medications, less than half of the patients diagnosed with partial epilepsy are well controlled. however, studies have shown that non-invasive stimulation of the brain can decrease the excitability of the cerebral cortex. researchers are interested in the potential therapeutic effects of tms on patients with epilepsy that have responded poorly to standard medication. this study will use tms to decrease the excitability of the areas of the brain responsible for seizures.

the purpose of this protocol is to study the effects of transcranial magnetic stimulation (tms) at 1 hz on the excitability of the seizure focus in patients with poorly controlled epilepsy refractory to pharmacological treatments. 1 hz tms is a rate proven to induce long term depression in animal models and reported to decrease the excitability of both human and animal cerebral cortex.

Eligibility criteria:
age 5 to 60 at entry to protocol. history of partial or complex partial epilepsy for two or more years. patients should be on a stable anti-convulsant regimen defined as unchanged medicines and dose modifications lower than 20% in the last month. blood levels of anti-convulsants will be measured at the beginning of the study, prior to stimulation and after the study to assure that the type and dose of medication will remain constant. seizures not completely responsive to medical treatment (1 or more seizures per week for at least 6 months) and patients have failed at least two anti-convulsant regimens in the past. the patients have a localized seizure focus. epilepsy refractory to medical treatments. no pregnant women (will be tested with urine pregnancy test). no severe coronary disease. no metal anywhere in the cranium except the mouth. no intracardiac lines. no increased intracranial pressure as expressed by the presence of papilledema. no cardiac pacemakers. must not be taking neuroleptic or antidepressant medications. no progressive neurologic disease.

Keywords: seizures partial epilepsy intractable tms
new treatment perspectives in adolescents with anorexia nervosa: the efficacy of non-invasive brain-directed treatment

Conditions: Anorexia in Adolescence

Summary: the present randomized, double blind, placebo-controlled trial aims at evaluating the efficacy of a tdcs treatment in improving the clinical outcome of adolescents with an and investigate brain mechanisms acting in an.

the investigators hypothesized that excitatory tdcs over the left pfc and inhibitory tdcs over the right pfc (anode left/cathode right) may aid in altering/resetting inter-hemispheric balance in children and adolescents with an, reducing their control over eating behaviors and improving the an psychopathology. furthermore, the investigators will employ tms-eeg to directly explore the dlpfc activity of children and adolescent with an, with specific attention to the differences between hemispheres. moreover, paired pulse tms and repetitive tms protocols will be used to investigate the functional mechanisms within the prefrontal cortex of youth patients with an. then, the investigators will assess if potential changes of specific biomarkers, such as those related to the endogenous stress response system functioning, will occur after tdcs treatment and will correlate with clinical improvement.

Eligibility criteria:
inclusion criteria: * diagnosis of an according to the diagnostic and statistical manual of mental disorders, fifth edition - dsm-5 (american psychiatric association \& american psychiatric association, 2013); * condition of under-weight (bmi \<18.5 kg/m2); * intelligence quotient higher or equal to 85 (iq ≥ 85); * ability to give informed consent under parents' surveillance and guidance exclusion criteria: * a personal history of neurological/medical/genetic diseases; * a personal history of epilepsy; * suicide risk; * receiving cns-active drug, other counseling or psychological therapies during the treatment.

Keywords: tdcs eeg tms cortisol eating disorder neuromodulation
a multiple dose study of pf-05161704 in healthy volunteers

Conditions: Diabetes Mellitus, Type 2

Summary: the primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of pf-05161704 in healthy volunteers


Eligibility criteria:
inclusion criteria: * healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive * body mass index (bmi) of 24.5 to 35.5 kg/m2 and a total body weight \>50 kg (110 lbs.) exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * any condition possibly affecting drug absorption (e.g., gastrectomy). * history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening. * history or evidence of habitual use of tobacco or nicotine containing products within 3 months of screening or positive cotinine test at screening or day -1.

Keywords: multiple ascending dose phase 1 safety and tolerability pk healthy subjects
isoflavone treatment for postmenopausal osteopenia.

Conditions: Osteopenia; Osteoporosis

Summary: the aim of the project is to execute a double-blind, parallel, randomized 12-month intervention trial on postmenopausal women with osteopenia (low bone mineral density), in order to determine the effects of daily intake of fermented red clover (rc) extract on estrogen dependent bone mineral resorption when compared to placebo. both groups will recieve equivalent daily calcium, vitamin d and magnesium supplements. the project will also assess whether bioactive compounds in rc can reduce the risk of developing cardiovascular disease.

the project aims to determine whether red clover derived isoflavones have capabilities to exert positive effects in conditions of osteoporosis and osteopenia in states estrogen deficiency and/or dysregulation. the cause of osteopenia in women is thought to arise from the deficiency of and/or dysregulation by estrogen on target tissues. hormone replacement therapy (hrt) has proven to be an effective treatment, however it retains limited use as there is general consensus that it also increases cancer risk. plant derived compounds that emulate the chemical structure and behaviour of estrogen (known as isoflavones) offer a compelling alternative to hrt, due to their potential to adopt the regulatory roles of estrogen without incurring equivalent negative side effects of hrt. there are, at present, few or no direct head to head clinical trials assessing combination treatments of isoflavones, vitamin d and calcium in contrast to standard vitamin d and calcium supplementation proscribed to osteopenic patients. research in this area will therefore provide valuable insight into the effectiveness of isoflavones to reduce resorption and/or to stimulate the formation of bone tissue. moreover the study will provide a comprehensive assessment of the potential of isoflavones to enhance the efficacy of existing preventative treatments. outcomes of the project have the prospect to help thousands of middle aged and pm women suffering. moreover, the project may enable development of functional foods and/or nutraceuticals that can be used as either a preventative measure and/or as a treatment for osteoporosis in states of estrogen deficiency and thereby provide an alternative to hormone replacement therapy that does involve the same side effects and risks.

Eligibility criteria:
inclusion criteria: * age 50-85 years, only women * have osteopenia (t score between -1 and -2.5) * body mass index (bmi) between 20 and 40 exclusion criteria: * taken specific osteoporosis drugs (i.e. bisphosphonates, pth, estrogen or strontium ranelate) in the past 3 months * taken other selective estrogen receptor modulator preparations (raloxifene, tamoxifen or isoflavones) in the past 3 months * participation in other clinical trials within the last 3 months * previous history of cardiovascular, psychiatric, neurological, and / or kidney disease * alcohol or substance abuse or acute illness * blood pressure\> 160/110 * pregnant and breastfeeding women

Keywords: aglycones isoflavones red clover osteopenia menopause bone turnover bone mineral density
clinical study to evaluate the efficacy of hudc_vt in patients with bacterial vaginosis

Conditions: Bacterial Vaginosis; HUDC_VT; Haudongchun

Summary: the objective of the study is to confirm the pharmacological mechanism and evaluate the efficacy and safety after hudc-vt administration compared to placebo in patients with bacterial vaginosis. vaginitis in adult women is extremely common and it often results in marked suffering. epidemiologic studies indicate the high prevalence of vaginitis and the large number of causes in us. the broad-spectrum antibiotics such as metronidazole have been used as a treatment of vaginitis.however, it is not desirable using of these antibiotics caused appearance of resistant bacterium and killing normal bacterium including lactobacillus. in addition, it has been reported that long term treatment of antibiotics can be caused body toxicity through absolution by vagina. the product, hudc_vt, is a effective and safe vaginal tablet composed glucose and sodium chloride for treatment of vaginitis by preserving healthy condition in vagina.


Eligibility criteria:
inclusion criteria: 1. fertile women 2. clinical diagnosis of bacterial vaginosis with criteria on below (3 out of 4 fulfilled criteria) * light gray adherent vaginal discharge * ph \>4.5 * presence of clue cells ≥20% * positive "10% koh whiff test" 3. nugent score ≥ 4 exclusion criteria: 1. pregnant or breast-feeding patient or planning pregnancy 2. patient with candidiasis, chlamydia trachomatis, trichomonas vaginalis, neisseria gonorrhoeae or herpes simplex virus infection 3. patient who received antifungal or antimicrobial therapy (systemic or intravaginal) within 30 days of randomization 4. any condition or circumstance that would interfere with analysis of study results 5. patient who have a plan to treat other disease (e.g cervical carcinoma) during clinical study period
medial patellofemoral ligament reconstruction with or without lateral retinaculum release

Conditions: Episodic Patellar Dislocation

Summary: the investigators hypothesis is lateral retinaculum release has no effect on treatment of patellar recurrent dislocation with medial patellofemoral ligament (mpfl) reconstruction.


Eligibility criteria:
inclusion criteria: * age between 18yo and 45yo * indication for mpfl reconstruction * unilateral or bilateral indication exclusion criteria: * indication for bony procedures * previous surgery for pf disorders * patient refusal

Keywords: mpfl patella dislocation release
ultrasound rf data for discriminating between benign and malignant ovarian masses

Conditions: Ovarian Cancer

Summary: ultrasound imaging provides useful information for the characterization of ovarian masses as benign or malignant. the most accurate mathematical model to categorize ovarian masses is the iota adnex model.this model estimates the risk of malignancy and performs similarly to subjective assessment by an experienced ultrasound examiner for discriminating between benign and malignant adnexal masses. the ability of iota adnex to discriminate between benign and malignant masses is very good (area under the receiver operator characteristic curve 0.937 (95% ci: 0.915-0.954). the adnex model maintains its accuracy even in the hands of operators with different experience and training. according to iota terminology, 13% of ovarian masses detected on ultrasound examination are classified as solid. solid ovarian masses have a risk of malignancy of 60%-75%2 and the discrimination between benign and malignant in this morphological category is challenging. additionally, it has been estimated that 30% (25/84; 95% ci 18 to 44%) of solid malignant ovarian masses are metastases from non-ovarian tumors. the discrimination between primary ovarian cancer and metastatic tumors in the ovary is also clinically important for planning adequate therapeutic procedures. it is worth exploring the predictive performance of the diagnostic tools in identifying ovarian masses with ultrasound solid morphology. preliminary data (unpublished) on radiomics analysis and ovarian masses provided that benign and malignant ovarian masses with solid morphology have different radiomics features in a monocentric retrospective study. however, no statistically significant differences have been observed between primary ovarian cancer and metastases to the ovary. a new technology is emerging in engineering ultrasound field: the analysis of ultrasound summed rf data- raw data generated by the interface of ultrasound beams with human tissues. to date, raw data are not utilized for conventional imaging and their eventual role in clinical practice is unknown. indeed, summed rf data could better correlate with biological parameters then parameters identifiable in b-mode images. summed rf data could also improve radiomic analysis.


Eligibility criteria:
inclusion criteria: 1. patients with a preoperative ultrasound diagnosis of a solid ovarian mass (solid according to iota terminology, i.e. 80% of the tumor consists of solid tissue). 2. patients who will undergo surgery within 120 days after the ultrasound examination. 3. patients at least 18 years old. 4. informed consent signed. exclusion criteria: 1. patients under 18 years of age. 2. patient refusal

Keywords: ovarian cancer ultrasound