Kornimate/medical-research-clean huggingface dataset:
safety study of bromfenac ophthalmic solution in subjects with diffuse diabetic macular edema (dme) refractory to laser

Conditions: Diabetic Macular Edema

Summary: this is an investigator-sponsored trial (ist), an open-label pilot study, assessing the safety and biologic activity of bromfenac in subjects with diffuse dme refractory to laser.

ten subjects will be enrolled in this study, which will be conducted at ophthalmic consultants of boston, boston, ma. all subjects must be diagnosed with diffuse dme that is either refractory to laser photocoagulation or in patients who have refused laser. consented subjects will be screened to determine eligibility. eligibility will be determined by the investigator, a retinal specialist. only one eye will be chosen as the "study eye." only the study eye will receive bromfenac drops during the study. eligible subjects will self-administer bromfenac two times per day (bid) for three months (treatment period). subjects will have monthly examinations during the treatment period, followed by follow up visits at month 4 and month 6.

Eligibility criteria:
inclusion criteria: * age \> 18 years * center-involved macular edema secondary to diabetes mellitus exclusion criteria: * study eye with edema amenable to focal laser * treatment with laser, intraocular steroids, and anti-vegf agents within 90 days * current eye infections

Keywords: diabetic macular edema bromfenac ophthalmic solution
tuberculosis volatile organic compounds

Conditions: Pulmonary Tuberculosis

Summary: the pulmonary colonization test is a non-invasive breath test for markers of lower respiratory tract infection, which may predict the probability of mycobacterial organisms in the lower respiratory tract. it consists of: * a breath collection apparatus for collection of volatile organic compounds in breath onto a sorbent trap and tedlar bag, as well as for the collection of a separate sample of room air. * analysis of the volatile organic compounds in breath and room air by short acoustic wave/gas chromatography. * interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of lower respiratory tract colonization and infection. * analysis of the volatile organic compounds in sputum culture by short acoustic wave/gas chromatography. this study will test the hypothesis that the investigators can identify the presence of mycobacteria in an individual by sampling the breath of patients with active tuberculosis and by sampling "head space" above culture media of sputum provided. this study will test the hypotheses: * that the investigators can identify positive cultures for mycobacterium tuberculosis through sampling of the headspace above the cultures prior to standard laboratory culture identification * that the investigators can identify control of tuberculosis by sampling exhaled breath


Eligibility criteria:
inclusion criteria: * suspected tuberculosis infection or disease * positive tuberculosis skin test * positive sputum culture for tb * x-rays indicated possible tuberculosis infection or disease * ability to give breath and sputum samples at regular intervals exclusion criteria: * heavy smoker * history of or active pulmonary disease other than tuberculosis

Keywords: mycobacterium tuberculosis pulmonary tuberculosis electronic nose gas chromatography
program to promote engagement in care for the prevention of recidivism

Conditions: Suicide; Health Care Seeking Behavior; Case Management

Summary: in france, the number of emergency visits for suicide attempts is estimated at 220,000 per year. suicide management aims to reduce suicide risk factors in order to improve the mental health of patients and prevent recurrences. to day, no study has compared the approaches to health surveillance and case management in a clinical trial, nor established the benefit of each on commitment to care and beyond the prevention of suicidal recurrence.


Eligibility criteria:
inclusion criteria: * age ≥18. * male and female. * admission to ch st denis for a suicide attempt. * referral for outpatient follow-up. * patient with no psychiatric follow-up or who has been out of follow-up for at least three months. * patient having given their written informed consent. exclusion criteria: * patients not affiliated with social security or state medical aid. * patients who do not have the required faculties to be evaluated (cognitive and delusional disorders). * patients treated for more than 72 hours after their procedure (maximum length of stay in the uas and/or in medical intensive care. * patient currently under psychiatric care. * patients who cannot be called back by telephone (no telephone, homeless, incarceration). * patients who do not master the french language.
"effects of kinesio taping in adjunct to traditional physical therapy on pain, range of motion and gait parameters in patients with plantar fasciitis : a randomized controlled trail"

Conditions: Plantar Fascitis

Summary: this study is a randomized control trial and the purpose of this study is to determine the effects of kinesio taping on gait parameters in patients with plantar fascitis

the purpose of this study is to determine the difference between efffects of kinesio taping combined with traditional physical versus physical therapy alone. the individual of age 20-40 years among both genders and are diagnosed cases of plantar fasciitis pain levels will be assessed using the numeric pain rating scale (nprs). rom will be assessed through goniometry. gait parameters will be assessed through 30 meter walk test. participants of interest would be approached and explained about the research. informed written consent will be taken. it is a single-blinded study and randomization will be done through coin toss method. both groups will receive conventional intervention. additionally, group b will receive kinesio taping treatment. baseline and post intervention scores would be recorded for both groups.

Eligibility criteria:
inclusion criteria: * both genders * age 20-40 years * diagnosed cases of plantar fasciitis as per diagnosis criteria established by apta as described by american physical therapy association: plantar medial heel pain: most noticeable with initial steps after a period of inactivity but also worse following prolonged weight bearing * heel pain precipitated by a recent increase in weight-bearing activity * pain with palpation of the proximal insertion of the plantar fascia * positive windlass test * negative tarsal tunnel tests * limited active and passive talocrural joint dorsiflexion range of motion * abnormal foot posture index score exclusion criteria: * recent steroid injections * history of ankle or foot surgery * arthritis history * radiculopathy * diabetic foot
towards a post-exposition pharmacological prophylaxis for post-traumatic stress disorder

Conditions: Intrusive Thought; Psychological Trauma; Inflammatory Response; Physiological Stress

Summary: in this study, we investigate the role that deep sleep plays in the prevention of posttraumatic stress disorder after someone has been exposed to a trauma by boosting deep sleep with two drug conditions compared to placebo condition. each volunteer in the study goes through all three conditions. the quantity of intrusive memories of the trauma will be compared between the three conditions.

the present study seeks to investigate the potential to pharmacologically modulate slow-wave sleep in the acute aftermath of an experimentally-induced trauma in the interest of developing a secondary prevention of posttraumatic stress disorder. the effects of a gabaergic compound will be compared with that of a noradrenergic compound. memory, sleep and stress-related immune response factors will be quantified and compared across drug conditions.

Eligibility criteria:
inclusion criteria: * speaks and understands german * bmi 18.5 -\< 25 * non-smoker status * habitual 5 or fewer alcoholic beverages / week * habitual 3 or fewer caffeinated beverages / day * habitual average sleep duration 7-9 h / night * normal or corrected-to-normal vision * insomnia severity index score between 8-14 exclusion criteria: * travel across 3 or more time zones within 3 months of study start * habitual napping * extreme chronotype, determined by morningness-eveningness questionnaire * history of or presence of a trauma- or stressor-related disorder * history of or presence of neurological disorder, psychiatric disorder or head injury * history of or presence of a sleep disorder * history of or presence of cardiovascular disorder * use of illicit drugs * atypical preference for excessively violent portrayals * faints at the site of blood or brutality * has participated in a study \< 30 days or a study such as this (i.e., experimental trauma) at all.
the quatro study: acceptability study of (placebo) vaginal delivery forms for preventing hiv and unintended pregnancy

Conditions: HIV; Contraception

Summary: the purpose of the quatro study is to assess the acceptability, preferences, user experience and effect on sexual behavior of four different vaginal microbicide or multi-purpose technology (mpt) delivery forms, using placebo products in 18-30 year old african women: rapidly disintegrating vaginal insert, intravaginal ring (ivr), film and gel. the study also examines adherence to the dosage forms through objective markers, developed for each dosage form prior to the commencement of the study.


Eligibility criteria:
inclusion criteria: * age 18-30 * in good health, as determined by the site investigator or designee based on clinical history * willing and able to comply with study procedures and attend monthly follow-up visits * willing and able to provide informed consent * fluent in one of the languages being used in the study (english, shona or zulu) * not intending to travel or move out of the research catchment area for the next 6 months * sexually active defined by vaginal intercourse with a male at least 4 times per month in the past 3 months and plan to be sexually active during the study duration exclusion criteria: * hiv positive * pregnant, or intention to become pregnant during the clinical study * prior participation in any hiv-prevention or mpt product demonstration study or clinical trial * any current or historical health (including vaginal or genitourinary conditions) or psychological issues that the site investigator or his/her designee determines should exclude the potential participant

Keywords: hiv dce mpt microbicide
flupenthixol treatment in schizophrenic cocaine abusers - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate the safety and efficacy of flupenthixol for cocaine dependence in individuals with schizophrenia/schizoaffective illness.


Eligibility criteria:
please contact site for information.

Keywords: cocaine dependence
partial pressure of oxygen control method in identification of intersegmental plane

Conditions: Lung Cancer

Summary: in recent years, an increasing number of pulmonary nodules have been detected through ct screening. the traditional surgical method for lung cancer is lobectomy combined with lymph node dissection. however, recent studies have demonstrated that sublobar resection for early non-small cell lung cancer (nsclc) is an effective alternative with the additional benefit of preserving more pulmonary function. however, it also faces many problems, the most prominent of which is the rapid and accurate identification of the intersegmental plane (isp) during surgery. the modified inflation-deflation method for identifying the isp is the most commonly used method in anatomical sublobar resection. nevertheless, the lengthy waiting periods and the lack of clear delineation represent significant challenges in clinical practice. the partial pressure of oxygen control method facilitates the efficient determination of the isp by reducing the oxygen inhalation concentration and ventilator ventilation time during surgery. this results in a reduced pao2 in arterial blood, thereby accelerating the rapid appearance of the isp. thus, the investigators conducted a prospective, randomized, controlled trial to ascertain whether the oxygen partial pressure control method affects the occurrence time of the isp and pao2 during one-lung ventilation, in comparison to the modified inflation-deflation method. furthermore, the objective was to confirm the safety and efficacy of partial pressure of oxygen control method.


Eligibility criteria:
inclusion criteria: 1. between the ages of 18 and 75; 2. gender unlimited; 3. eastern cooperative oncology group（ecog） performance status（ps） score 0-1 points; 4. thin slice ct indicates that the maximum tumor diameter is ≤ 2.0cm and 0 ≤ ctr\<1.0; （consolidation tumor ratio，ctr） 5. those who voluntarily sign the informed consent form for research can comply with the requirements of the research visit plan and other protocols. exclusion criteria: 1. individuals with a history of lung surgery in the past; 2. patients with interstitial pneumonia, pulmonary alveoli, pulmonary fibrosis, or severe emphysema; 3. those who undergo chest surgery due to various reasons or change the surgical plan during the operation; 4. the subjects do not understand, cooperate or refuse to sign the informed consent form regarding the research protocol.

Keywords: sublobar resection intersegmental plane non small cell lung cancer(nsclc) partial pressure of oxygen control method video-assisted thoracoscopic(vats)
asv therapy for insomnia

Conditions: Insomnia; Insomnia (Moderate)

Summary: this will be a single center, prospective study designed to evaluate the effect of adaptive servo ventilation therapy on insomnia severity among patients with moderate to severe chronic insomnia.

the primary objective of the study is to evaluate the effectiveness of adaptive servo ventilation therapy to reduce insomnia severity in primary insomnia patients.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * complaint of insomnia when presenting at clinic * diagnosis of moderate to severe insomnia through the insomnia severity index (isi) with a score ≥ 15 * meet diagnostic criteria of insomnia disorder (per american academy of sleep medicine) * naïve to treatment for sleep-disordered breathing (sdb), including cpap, apap, asv; mandibular repositioning devices (mrds), and any other nasal or oral therapy with a primary indication of treating sdb * owns a smartphone and is able to install an application for hsat data syncing. * able to fully understand study information in english and sign informed consent exclusion criteria: * primary complaint of sleep-disordered breathing or issues with apneas during sleep or excessive daytime sleepiness * pregnant or planning to be pregnant * any prior diagnosis of severe respiratory disorder or severe sleep disorder such as restless leg syndrome (rls), idiopathic hypersomnia, or narcolepsy * high risk for moderate to severe osa based on stop-bang score. * bmi \> 40 kg/m2 * anticipated changes to start or stop sedative or psychotropic medications during the course of the trial. * medical history of congestive heart failure (chf) or other potentially unstable cardiac disease as well as chronic lung diseases or other debilitating medical conditions that manifest as more prominent in the patient's health compared to their sleep complaints. * daily use of opiate medications * known contraindications to pap therapy as listed in the indication for use (i.e. heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef ≤45%) and moderate to severe predominant central sleep apnea). * inability to pre-emptively comply with study procedures * patients who wish to continue using sleeping pills/hypnotics during the study * patients with conditions affecting the rotation of the condyle in the temporo-mandibular joint.

Keywords: insomnia asv pap
dosing music for anxiety reduction in parturients

Conditions: Anxiety

Summary: this is a clinical study that aims to determine the effective dose of music listening duration that is required to reduce anxiety in patients awaiting scheduled cesarean section. it will also compare types of music to accomplish this goal, both of which have been shown effective in prior studies. methods will involve enrolling and playing music for patients awaiting scheduled c-section, and scoring their anxiety with pre- and post-music questionnaires. music duration for each subject will be predetermined, and analysis of response will be performed to determine the effective dose 95%, or dose at which 95% of subjects should have a positive response.


Eligibility criteria:
inclusion criteria: * age 18 years or older * planning on scheduled cesarean section or non-emergent unscheduled cesarean section * able to provide informed consent * american society of anaesthesiologists (asa) physical status score of ii-iii exclusion criteria: * patient refusal * impaired hearing * patient is taking at least one anxiolytic medication daily at baseline * no anxiety (a score of 0, on a scale of 0-10, of pre-music exposure anxiety) after consent is given * asa iv or higher
testosterone and vascular function in reproductive-aged females with chronic kidney disease

Conditions: Chronic Kidney Diseases; Cardiovascular Diseases

Summary: cardiovascular disease (cvd) is the leading cause of death among women and women with chronic kidney disease are at an even greater risk of cvd. the aim of this observational study is to examine the relationship between total testosterone levels and measures of vascular function (pulse wave velocity, aortic augmentation index, flow mediated dilation and velocity time integral) in reproductive-aged women living with chronic kidney disease.


Eligibility criteria:
inclusion criteria: * female sex * a diagnosis of chronic kidney disease or end stage kidney disease * age 18-51 exclusion criteria: pregnancy, breastfeeding, current use of menopausal hormone therapy or gender affirming hormone therapy, or factors that would affect ovarian function, such as polycystic ovarian syndrome, premature ovarian insufficiency, ovarian malignancy, gonadotoxic chemotherapy, surgical oophorectomy, or previous radiation to the pelvis.
a retrospective review of enseal laparoscopic vaginal assisted hysterectomy (lavh) versus traditional lavh

Conditions: Benign Uterine Disease

Summary: retrospective charts review from one surgeon to compare group a- cases where the laparoscopic portion of the case used an en\~seal device to group b - the laparoscopic bso was done using a 3mm en-seal device through 2 lateral 5mm ports.

79 women with benign uterine disease underwent laparoscopic assisted vaginal hysterectomy with or without bilateral salpingo-oophorectomy. subjects charts were divided into two groups based on surgical technique and the following parameters were reviewed retrospectively: surgical time, blood loss, uterine weight, patient weight, patient age, post operative fever \>100.4 f, readmission to hospital within one week, return to operating room within 24 hours, length of hospital stay, and blood transfusion. group a, n=35 used traditional suture technique vaginally. group b, n=44 used enseal coagulation cutting device vaginally.

Eligibility criteria:
inclusion criteria: * none, observational study exclusion criteria: * none, observational study

Keywords: laparoscopic vaginal hysterectomy
effect of probiotics on recurrent urinary tract infections

Conditions: Urinary Tract Infections

Summary: randomized clinical trial to evaluate the effect of a probiotic mixture of lactobacillus plantarum on recurrent urinary tract infections in women. secondary outcomes comprise variation in vaginal/perianal microbiota, product tolerability, safety and consumer's satisfaction with the product.

double-blind, randomized, placebo-controlled clinical trial to determine the effect of two probiotic strains of lactobacillus plantarum on recurrent urinary tract infections in women. women are randomized 1:1 to one of the following study groups: one group will receive a capsule/day of the mixture of lactobacillus plantarum in combination with cranberry, and vitamine c; and the other group will receive a capsule of placebo for 6 months. main study outcome is the number of women who have recurrence of utis during th estudy compared to the placebo group. secondary outcomes comprise the duration of disease free period, duration and severity of symptomatology, the number of symptomatic utis during the study, variation of lactobacillus plantarum levels in the vaginal/perianal microbiota, product tolerability, safety and consumer's satisfaction with the product.

Eligibility criteria:
inclusion criteria: * women over 18 years of age. * women who have had at least one episode of uti in the past 2 months * women with a well-documented history of recurrent utis: ≥2 infections in the past 6 months or ≥3 in the past 12 months. * women who have been treated with an antibiotic regimen for each episde of uti * recurrence due to reinfection, not relapse: multiple infections should be spaced by a minimum of 2 weeks or in case of a shorter time, with negative urine culture between them * women who use contraception to prevent pregnancy and who do not plan a pregnancy during the study period exclusion criteria: * pregnant or breastfeeding women * underlying chronic disease: diabetes mellitus, kidney failure, cancer, spinal cord injury, polycystic ovary * women wih catheters in the urethra * women who consume probiotics or foods, beverages or supplements containing extracts or parts of the genus vaccinum sp, including other forms of v. macrocarpon (blueberry), v. myrtillus (european blueberry), v. angustifolium (wild or low buch blueberry), v. corymbosum (tall bch blueberry) or v. vitis-ideae (mountain blueberry) during the 2 weels prior to recruitment. * high consumption of fruits rich in phenolic compounds, with special reference, to berries * women allergic to red fruits * bmi ≥ 40 kg/m2

Keywords: probiotics women health microbiota