Kornimate/medical-research-clean huggingface dataset:
objective measurements of lens opacification after intravitreal injections

Conditions: Lens Opacification; Intravitreal Injections (IVT)

Summary: the main hypothesis is the opacification of the lens would be increase by the ivt. the opacification of the lens can be objectived by : * the objective scatter index (osi) on the oqas device * the average lens density (ald) on the iolmaster device. eligible patients will be followed at least 12 months after in intravitreal injection and the opacification of their lens is regularly controlled with osi and ald. the objective is to study the dynamics of lens opacification in ivt-treated eyes evaluated by osi for at least 1 year.


Eligibility criteria:
inclusion criteria: * an indication of an intravenous injection of a dexamethasone 700 μg (ozurdex®) or anti-vegf for at least one of the two eyes for macular edema or neovessels linked to dmla, retinal venous occlusion, diabetic macular edema or posterior uveitis * phake patient, at least of the injected eye exclusion criteria: - pseudophakia of the injected eye

Keywords: cataract objective scatter index (osi) average lens density (ald)
preservation study of ovarian function and hemostasis, and its safety of surgiguard@ during laparoscopic ovarian cystectomy

Conditions: Ovarian Cyst Benign

Summary: the purpose of this study is to compare hemostasis, ovarian function preservation effect, and safety about intraoperative bleeding with surgiguard@ in women who underwent laparoscopic unilateral ovarian cystectomy

in women who underwent laparoscopic unilateral ovarian cystectomy, the effect of surgiguard@ was assessed by randomization, using surgiguard@ and bipolar electro cauterization, followed by comparative evaluation of hemostasis, ovarian function preservation, safety using postoperative hb, anti-mullerian hormone (amh), pelvis ultrasonography (usg), and physical examination

Eligibility criteria:
inclusion criteria: * female, 18 years ≤ ages \<45 years * laparoscopic unilateral ovarian cystectomy scheduled patients with benign unilateral ovarian cyst confirmed by ultrasonography * women with regular menstruation * women with regular menstruation cycle from 21 days to 45 days * proper state for laparoscopic operation (american society of anesthesiologists physical status classification 1 or 2) * patients who signed and approved informed consent exclusion criteria: * patients without ovarian cyst * patients with malignant female genital disease * patients with bilateral ovarian cysts * age ≥ 45 * pregnancy or lactating women * serum amh\<0.05 ng/ml * patients with endocrine disease such as thyroid abnormality, hyperprolactinemia, cushing disease, etc * patients with hormone replacement therapy during 3 months * patients who is considered to be difficult to perform the clinical trial when researchers judge

Keywords: laparoscopic unilateral ovarian cystectomy surgiguard hemostasis ovarian function preservation bipolar electrocauterization
efficacy of a semi-occluded mask in the treatment of patients with voice disorders

Conditions: Voice and Resonance Disorders; Vocal Fold Polyp; Vocal Cord Cyst; Vocal Cord Polyp; Atrophy of Vocal Cord

Summary: current semi-occluded vocal tract therapies limit the type of vocalizations that can be produced to single vowels, which does not promote learning of the healthy voice behavior in connected speech or generalization to conversation. however, recent preliminary results using a semi-occluded mask indicate that the use of certain mask port diameters may allow for natural speech production while increasing supraglottal pressure and impedance, and thereby result in elicitation of voice with increased efficiency. in addition, the use of a semi-occluded mask provides the possibility for a better transition from phonating single phonemes in therapy to training the target therapy techniques in connected speech.

treatment of voice disorders varies but often involves voice therapy and/or surgical intervention. voice therapy, a non-invasive behavioral treatment for voice disorders, helps patients develop beneficial voice habits, prevents recurrence of voice disorders, and facilitates long-lasting vocal improvement. many voice therapy techniques involve a semi-occluded vocal tract (sovt). sovt treatment is often characterized by sustained (straw phonation, voiced fricatives, nasals), oral oscillatory (lip buzzes, tongue trills, raspberries) or transitory phonation (plosives and glides). straw phonation therapy, one of the most utilized sovt methods, was first proposed in 1904 and involved phonating at different pitches into small glass tubes with varying diameters and lengths providing simultaneous semi-occlusion and extension of the vocal tract. voice therapy exercises involving voice production with a semi-occluded and sometimes lengthened vocal tract have demonstrated improved vocal efficiency and loudness, reduced mechanical trauma to the vocal fold mucosa, and improved source-filter interaction.our group recently developed a semi-occluded facemask for use in patients with and without voice disorders. recent preliminary results using this semi-occluded facemask indicated that the use of a certain mask port diameters may elicit voice with increased efficiency. a study of 5 participants without voice disorders revealed that a mask occlusion diameter of 6.4 and 3.2 mm resulted in improved vocal efficiency. a study of the immediate effects of a semi-occluded facemask in 20 patients with voice disorders revealed that occlusions diameters of 9.6, 6.4, and 3.2 mm all resulted in significant improvements in acoustic and aerodynamic voice outcomes.

Eligibility criteria:
inclusion criteria: * age 18 to 60 * diagnosed with vocal fold lesion or polyp or cyst or atrophy or other voice condition (such as muscle tension dysphonia) * recommended for voice therapy as treatment for voice disorder exclusion criteria: * current smoker (greater than 5 cigarettes/week)

Keywords: sovt semi occluded vocal tract voice disorder voice therapy muscle tension dysphonia mtd vocal fold lesions vocal fold atrophy
clinical drug trial in healthy male subjects to determine and compare the blood concentrations of bi 144807 following administration as oral solution and tablet under fasted and fed conditions

Conditions: Healthy

Summary: the purpose of this trial is to investigate the relative bioavailability of a bi 144807 tablet formulation compared to the oral solution formulation after single dose administration (intermediate and high dose) under fasted conditions. further objectives are to assess whether and to what extent food affects single dose pharmacokinetics of bi 144807 administered as tablet, and to compare the relative bioavailability of two different tablet formulations.


Eligibility criteria:
inclusion criteria: - healthy male subjects exclusion criteria: - any relevant deviation from healthy condition
study to evaluate the safety of at2220 (duvoglustat) in pompe disease

Conditions: Pompe Disease

Summary: the main purpose of this study was to determine the safety and tolerability of 3 different doses of duvoglustat (at2220) in participants affected by pompe disease. the study also evaluated the effects of duvoglustat on functional parameters in pompe disease.

this was a phase 2, open-label study in participants with pompe disease, a lysosomal storage disorder. duvoglustat is designed to act as a pharmacological chaperone of alpha-glucosidase, in order to restore enzyme activity. this study consisted of a 28-day screening period, an 11-week treatment period, and a 1-week follow-up period. three dosing regimens of oral duvoglustat were to be evaluated (cohort 1: 2.5 g daily for 3 days, followed by no study drug for 4 days; cohort 2: 5 g daily for 3 days, followed by no study drug for 4 days; cohort 3: 5 g daily for 7 days, followed by no study drug for 7 days). participants meeting all eligibility criteria underwent physical examination, electrocardiogram, spirometry, muscular strength test, functional muscle test, 6-minute walk test (when appropriate), laboratory tests, magnetic resonance imaging, and muscle (needle) biopsy. quality of life was assessed via the 36-item short form health survey questionnaire. functional ability and level of handicap was assessed by rotterdam handicap scale.

Eligibility criteria:
inclusion criteria: * male or female, 18 to 74 years of age inclusive * diagnosis of pompe disease based on clinical assessment, enzyme assay, and/or genotyping. confirmatory genotyping will be performed on all participants who are screened for the study * naïve to enzyme replacement therapy (ert) or has not received ert in the 3 months prior to screening * willing not to initiate ert or other prohibited treatment during study participation * functional grade for arms and/or legs ≥2 or sitting forced vital capacity ≥30% and \<80% of predicted value, reproducible between screening and baseline (±15%) * participants of reproductive potential agree to use reliable methods of contraception during the study * participant or legal representative is willing and able to provide written informed consent exclusion criteria: * any intercurrent condition that may preclude accurate interpretation of study data * obstructive pulmonary disease * invasive ventilatory support * use of noninvasive ventilatory support \>8 hours/day while awake * history of qtc prolongation \>450 milliseconds (msec) for males and \>470 msec for females * history of allergy or sensitivity to the study drug, including any prior serious adverse reaction to iminosugars (such as miglustat or miglitol) * pregnancy or breast-feeding * current or recent drug or alcohol abuse * treatment with another investigational drug within 30 days of study start * use of prohibited medications ≤3 months prior to screening * otherwise unsuitable for the study in the opinion of the investigator

Keywords: amicus therapeutics duvoglustat at2220
freezing breast cancer in brazil: a before-after study

Conditions: Breast Cancer; Breast Neoplasms

Summary: image-guided tumor ablation is a non-surgical, minimally invasive therapy available for local therapy of some carcinomas as an alternative to surgical treatment. this study assesses whether cryoablation can be used as an alternative to surgery in cases of early invasive breast carcinoma.

purpose: to evaluate the effectiveness of cryoablation in the local treatment of breast cancer, through the absence of neoplastic cells (invasive or in situ). outline 1. core biopsy 2. mammogram 3. magnetic resonance imaging 4. ultrasound 5. tumor cryoablation 6. mammogram (post-cryoablation) 7. magnetic resonance imaging (post-cryoablation) 8. ultrasound (post-cryoablation) 9. surgery 10. evaluation of outcomes

Eligibility criteria:
inclusion criteria: * unifocal primary invasive breast carcinoma * pathological report should be complete (with the result of er, pr , her2, ki67 and fish report of erbb2 gene if necessary) * maximum tumor size ≤2.5 cm in its greatest diameter * ultrasound visible lesion exclusion criteria: * multifocal or multicentric invasive breast carcinoma * ductal carcinoma in-situ * breast cancer with skin involvement * clinically positive axilla (n1, n2 or n3) * distance from lesion and skin less than 5 mm * prior neoadjuvant systemic therapy for breast cancer * distant metastasis

Keywords: cryoablation, cryotherapy, breast cancer
relationship between endoplasmic reticulum stress and pain in patients with endometriosis

Conditions: Endometriosis; Endoplasmic Reticulum Stress; Endometriosis-related Pain

Summary: the correlation between painful symptoms (dysmenorrhea, dysparonia, dysuria, chronic pelvic pain) symptoms and endoplasmic reticulum stress was investigated in 86 patients diagnosed with endometriosis. for this, xbp-1 (x box binding protein-1) level was measured in patients. xbp-1 is an endoplasmic reticulum stress indicator and is known to be involved in pain pathogenesis.

women between the ages of 18-50 who were diagnosed with endometriosis by surgery and ultrasound, without known rheumatological or metabolic diseases were included in the study. most of the patients are composed of newly diagnosed patients.

Eligibility criteria:
inclusion criteria: * diagnosed endometriosis with ultrasound or surgery * no metabolic diseases * no rheumatological diseases exclusion criteria: * immune modulator, hormonal, anti-inflammatory use history in the last 3 months
clinical benefits of b-flow ultrasound

Conditions: Evidence of Liver Transplantation; Arterial Occlusive Diseases; Hypertension; Pregnancy, High Risk; Pregnancy

Summary: the goals of this study are to evaluate the efficacy of the b-flow capability on the logiq e9 system in three clinical focus areas. 1. liver transplant patients: improved real-time visualization of liver vessels is needed to improve diagnosis and assessment following stenting or angioplasty. 2. renal artery disease: improved real-time visualization of the renal arteries would enable a more rapid and accurate assessment of renal artery disease (stenosis, dissection, occlusion, aneurysm) and facilitate follow-up evaluations after renal artery interventions. 3. pregnancy: we are proposing to use b-flow ultrasound as a way to evaluate placenta perfusion and assay for potential ischemia.


Eligibility criteria:
inclusion criteria: subjects must be referred for a standard clinical ultrasound exam. * patients who have had a liver transplant and are referred for a liver ultrasound or angioplasty \& stent placement; * patients with hypertension, impaired renal function, or renal artery disease who are referred for a renal ultrasound or angioplasty \& stent placement; * pregnant women referred for an obstetrical ultrasound to evaluate a normal pregnancy for example to determine gestation or gestational age; * pregnant women referred for an obstetrical ultrasound to evaluate a high risk pregnancy due to a medical condition present before or during pregnancy for either the mother or the baby. exclusion criteria: * minors; * prisoners; * unable to understand the nature of the study or to consent; * very sick or experiencing significant pain; * undergoing an emergency ultrasound; * pregnant and undergoing an ultrasound to evaluate suspected congenital malformation, abruptio placenta or fetal death.

Keywords: ultrasound ultrasonography liver transplantation arterial occlusive diseases hypertension pregnancy, high risk pregnancy
a novel neurobehavioral intervention for emotion regulation in anxiety and depression across the lifespan

Conditions: Depression, Anxiety; Cognitive Training; Emotion Training; Emotion Regulation

Summary: the research proposes to use an innovative solution to shape brain circuits that support executive function and emotion reactivity -using targeted neurobehavioral intervention.

participants will be recruited locally in the san francisco bay area with certain symptoms of anxiety and depression. they will complete a clinical assessment and then take part in a cognitive-emotion training delivered online.

Eligibility criteria:
inclusion criteria: * diagnosis of depression on the scid, a total ham-d≥16 and ham-d anxiety/somatization subscale ≥ 7. exclusion criteria: * current medication for psychiatric disorders * pregnant females * head trauma or injury that resulted in loss of consciousness * mri contraindication
intervention for resistant pregnant smokers

Conditions: Cardiovascular Diseases; Lung Diseases, Obstructive; Chronic Obstructive Pulmonary Disease

Summary: this 31-month supplement to sustaining women's smoking cessation postpartum (project panda) designed, implemented, and evaluated an intensified intervention for pregnant women who were unable to stop smoking with minimal assistance.

design narrative: the substudy was a population-based experiment with white, black, and hispanic pregnant women whose continued smoking made them ineligible for randomization into the parent study. it was unique in focusing on heavier, more addicted pregnant smokers. panda research sites and protocols offered a special opportunity for a low cost test of a disseminable intervention which this project team was uniquely qualified to design and implement. the new intervention, one- to-one, used telephone counselors to assess the counselee's stage in the change process and give stage-appropriate messages, using established techniques of motivational interviewing. between the two counselor calls spaced 10 days apart, counselees received personalized written feedback and suggestions. the primary aim, increasing quitting during pregnancy, was assessed by unobtrusive urine samples taken during prenatal visits in the ninth month and identified only by study group. a series of postpartum interviews with subsample cotinine validation was used to examine the second important aim, reduction of infant smoke exposure. a combination of messages, peer modeling, and support helped women sustain cessation after delivery and eliminate smoking around the baby. project panda videotapes and newsletters already contained these messages and required only minimal supplementation to be used with the one-to-one experimental group, regardless of their success in quitting in pregnancy. as in project panda, the assessments were separated from the experiment by enrolling subjects in a university-sponsored study of new mothers' health practices and baby care and by presenting the program as usual care by the health care site.

Eligibility criteria:
no eligibility criteria
hyperbaric oxygen therapy induced neuroplasticity in post stroke patients suffering chronic neurological deficiencies

Conditions: Chronic Neurological Deficiency; Stroke

Summary: the aim of the current work was to evaluate, for the first time in a prospective randomized study, the effect of hbot on patients with chronic neurological deficiency due to stroke.

objective: evaluate the effect of hyperbaric oxygen therapy (hbot) on patients with chronic neurological deficiency due to stroke. methods: a prospective, randomized, control-crossed over trial including patients who had stroke 6-36 months prior to their inclusion. all patients had at least one motor dysfunction. after their inclusion patients were randomized to treated or cross group. the neurologic functions were evaluated by nihss, adl, life quality and brain spect. patients in the treated group were evaluated twice-at baseline and after hbot. patients in the cross group were evaluated three times-baseline, after 2 months control period of no treatment and after a consequent 2 month of hbot. the following hbot protocol was practice: 40 daily sessions, 90 minutes each, 100% oxygen at 2ata, 5 days/week,. results: the study included 74 patients (8 were excluded). during the control period, in the cross group, nihss and the adl had not changed, while in the treated group both significantly improved. after the cross-over, when the cross group received hbot, nihss and adl had significantly improved. same trend of changes were in life quality. the spect correlated with the clinical improvement. the improvements were mostly in territories where there was a noticeable discrepancy between the ct and spect. interpretation: in this study, for the first time, it was demonstrated that hbot can induce neuroplasticity in patients with chronic neurologic deficiencies due to stroke. the beneficial effect of the hbot is mostly in territories where there is a brain spect/ct mismatch.

Eligibility criteria:
inclusion criteria: * age 18 years or older, who had ischemic stroke and 60 patients who had hemorrhagic stroke 6-18 months prior to their inclusion in the study. exclusion criteria: * dynamic neurologic improvement or worsening during the last 4 weeks. * had been treated with hbo for any other reason prior to their inclusion. * have any other indication for hbot * chest pathology incompatible with pressure changes * inner ear disease * patients suffering from claustrophobia. * inability to give written informed consent.

Keywords: chronic neurological deficient due to stroke
dry needling and bobath treatment clinical effects focused on stroke patients

Conditions: Ischemic Stroke; Spasticity

Summary: the investigators aim to determine if dry needling technique in a non myofascial trigger point area generate the same changes in spasticity, function and pain responses as with dry needling in a myofascial trigger point area.

spasticity is a consequence of multiple diseases that affect the central nervous system, such as stroke and other neurodegenerative diseases. its pathophysiology is unclear and the variety of clinical symptoms is determined by the injury location. several studies have suggested the possibility of active pain treatment effectiveness through myofascial trigger points management. one of these interventions is dry needling, which has been used in several scientific studies. however, these investigations have been based on spasm response or deep dry needling mechanisms always over a trigger point, but none of the participants compare the possible mechanical effects of the insertion of a needle into a spastic muscle without targeting specifically a trigger point. therefore, the aim of this study is to evaluate the effects on spasticity, pain and motor function after a dry needling intervention versus the insertion of a needle into a non trigger point area in patients who had experienced a stroke.

Eligibility criteria:
inclusion criteria: * medical diagnosis of unilateral ischemic stroke * unilateral hemiplegia resulting from stroke * evolution of at least 6 months since the stroke * age between 35 and 81 years of age * presence of hypertonia in the upper extremity * restricted shoulder range of motion exclusion criteria: * recurrent stroke * previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time, or with btx-a in the previous 6 months * cognitive deficits * progressive or severe neurological diseases, eg, heart conditions, unstable hypertension, fractures or implants in upper extremity * belonephobia (fear to needles) * have received pharmacological treatment for shoulder pain 3 months before the study * existence of peripheral nerve injury * previous history of fracture in the gleno-humeral joint * episodes of epilepsy in the year prior to participation in the study

Keywords: muscle spasticity dry needling stroke
therapeutic drug monitoring of antiinfectives for patients with severe illness = tapsi

Conditions: Infection, Bacterial

Summary: therapeutic drug monitoring of antiinfectives in intensive care patients is an usual research topic of the last years. based on research result, which have shown subtherapeutic plasma concentrations of antibiotics, a routines therapeutic drug monitoring for β-lactam-antibiotics was implemented in january 2018 at clinic for anesthesiology at university hospital, lmu munich, germany. this study is an prospective evaluation of these tdm-program.

bacterial infections are associated with high mortality in intensive care patients. antibiotic therapy is the only causal opportunity to treat those infections. pharmacokinetic and -dynamic changes in critically ill patients lead to unpredictable plasma concentrations of the applied drugs. research results of the last years with many quantified plasma concentrations in subtherapeutic levels yield to the recommendation of the paul-ehrlich-society for an routines therapeutic drug monitoring of antibiotics in intensive care patients. these was implemented in january 2018 at clinic for anesthesiology at university hospital, lmu munich, germany for all intensive care patients as a routines procedure. the introduced study is a prospective evaluation of the tdm-program with regard to improvement opportunity, influencing factors and parallels to other studies.

Eligibility criteria:
inclusion criteria: * routines tdm of antiinfectives exclusion criteria: * tdm is not available

Keywords: tdm routine intensive care patients