Kornimate/medical-research-clean huggingface dataset:
light physics enhanced camera navigation in hysteroscopy

Conditions: Infertility

Summary: office hysteroscopy is the gold standard technique in the diagnosis of the intrauterine pathologies. some interventions may also be carried out through the hysteroscopy. no-touch hysteroscopy technique confers several advantages in terms of patient discomfort over the traditional technique. clinicians performing the hysteroscopy find their way from the vaginal introitus to the uterine cavity through direct visualization of the anatomic structures on their route. the investigators hypothesize that the utilization of the information derived from the 'light physics' would facilitate camera navigation during no-touch hysteroscopy and consequently ease reaching the uterus. this study aimed to compare the standard no-touch technique with the 'light physics' enhanced camera navigation in terms of patient comfort and procedural pain.

office hysteroscopy is basically used in the diagnosis of the intrauterine pathologies. 'no touch' vaginal hysteroscopy does not require a speculum or tenaculum; thus, confers advantages in terms of patient discomfort over the traditional technique. the source of the pain in traditional hysteroscopy is the distention of the uterine cavity with the saline and the contact of the hysteroscopy equipment with the vagina and the cervical canal. the benefit in the pain obtained with the 'no-touch' technique is derived from the limitation of the contact of the hysteroscopy equipment with the vagina and the cervical canal. clinicians performing the hysteroscopy find their way from the vaginal introitus to the uterine cavity through direct visualization of the anatomic structures on their route. physics has been critical in the development of endoscopic techniques such as laparoscopy, cystoscopy, and hysteroscopy. the light source provides an illumined environment during the imagination with these techniques. during hysteroscopy, the light reflecting from the adjacent tissue appears bright, however, this reflection is weaker in farther tissue and these structures appear dark. with this in mind, the investigators hypothesize that the utilization of the information derived from the 'light physics' would facilitate camera navigation during no-touch hysteroscopy and consequently ease reaching the uterus. this study aimed to compare the standard no-touch technique with the 'light physics' enhanced camera navigation in terms of patient comfort and procedural pain.

Eligibility criteria:
inclusion criteria: * must be scheduled for no-touch office hysteroscopy procedure with a diagnostic purpose * must be nulliparous exclusion criteria: * multiparous women * previous cesarean section * cervical stenosis
catheter ablation of arrhythmias with high density mapping system in the real world practice.

Conditions: Cardiac Arrhythmias

Summary: the charisma study is a non-randomized, multicenter, prospective study in which consecutive patients indicated for arrhythmia will be enrolled. patients can be treated with any market released catheter for ablation and diagnostic examination. the decision to perform the ablation will be made based on clinical evaluation of the investigators according to their clinical practice. the study does not require specific surgical techniques. the study has been designed to describe the italian clinical practice in relation to the ablation approach of different kind of arrhythmias. in particular, the investigators will analyze the percentage of acute and long-term success in clinical practice, predictors of arrhythmias recurrence and they will describe the methods for the validation of ablation success, the techniques adopted, and the patient management approaches in the participating centers


Eligibility criteria:
inclusion criteria: * patients who are eligible for ablation procedure of atrial and ventricular arrhythmia; * patients who are able to sign an authorization to use and disclose health information and capable of providing informed consent. * patients who are willing and capable to attend scheduled follow-up visits at the clinical investigational center for at least 12 months exclusion criteria: * patients who are currently enrolled in another clinical study that would directly interfere with the clinical practice of the investigational center

Keywords: cardiac catheter ablation cardiac arrhythmias mapping system
spinal-induced hypotension in geriatric patients

Conditions: Spinal Induced Hypotension; Geriatric Population; Intravascular Volume

Summary: the study will be conducted to asses preoperative condition of venous system by vexus score and it's relation with the incidence of spinal induced hypotension in geriatric patients undergoing surgery with spinal anaesthesia.

an assessment of the intravascular volume deficit prior to the spinal anaesthesia conduction may help to predict the occurrence of a critical decrease in blood pressure, so several indices have been proposed to assess it's status depending on either a fluid challenge or an assessment of heart-lung interaction. heart rate variability, passive leg raise test, and peripheral perfusion index have revealed good abilities to predict spinal induced hypotension. the inferior vena cava (ivc) collapsibility index provides high diagnostic accuracy in predicting spinal induced hypotension the vexus score is a four-staged validated protocol which evaluates the presence and severity of systemic venous congestion in the inferior vena cava (ivc) and organs (liver, gut, and kidneys) by evaluating the (ivc) diameter, venous waveforms of the hepatic vein (hv), portal vein (pv), and interlobar renal veins using colour doppler (cd) and pulsed wave doppler (pwd)

Eligibility criteria:
inclusion criteria: * . patients aging 65 or older * lower body surgeries to be done with spinal anaesthesia * bmi less than 30 kg/m2. * patients with asa i-iii exclusion criteria: * patient refusal * major bloody surgeries (class c surgeries) * patients with a history of cardiovascular disorders including arrhythmias, heart failure, tricuspid or mitral regurgitation, dilated right atrium or ventricle, af * patients with a history of respiratory disorders * patients with cirrhotic liver * patients with pulmonary hypertension * patients with renal diseases
evaluation of sleep pattern and mood profile in hypertensive patients

Conditions: Sleep

Summary: introduction: sleep disturbances may contribute to impairments in mood, occupational and intellectual performance, and social relationships, as well as being associated with cardiovascular diseases, such as arterial hypertension. sedentary lifestyle has often been associated with poor sleep quality and hypertension; regular exercise has been studied as a coadjuvant therapy for hypertension and/or for some sleep disorders. objective: to compare sleep pattern of active and inactive patients with arterial hypertension, as well as to evaluate complaints of depression and anxiety, and the mood profile. material and methods: polysomnography, pittsburgh sleep quality index and epworth sleepiness scale will be used to assess the sleep pattern. depression will be assessed by the beck depression inventory (bdi), beck anxiety inventory (bai) anxiety, and mood pattern by the state of mood profile (poms). the level of physical activity will be recorded by the number of steps taken (pedometer). participating in the study will be 60 hypertension patients (active, n=30; inactive, n=30). hypothesis: active hypertensive patients better quality of sleep, better mood profile, and fewer complaints of depression and anxiety when compared to physically inactive hypertensive patients.


Eligibility criteria:
inclusion criteria: * diagnosis of systemic arterial hypertension, according to the vii brazilian guidelines for hypertension; * male; * bmi \<30; * age between 30 and 60 years; * minimum level of education: elementary school exclusion criteria: * present pathologies in the musculoskeletal and neurological systems, or incapacitating complaints in these systems; * diagnosis of psychiatric disorder; * being under medical treatment for insomnia or other psychiatric treatment.

Keywords: hypertension exercise sleep
tips vs. nsbb plus endotherapy for the prevention of variceal rebleeding in nsbb non-responders of primary prophylaxis

Conditions: Variceal Hemorrhage; TIPS; NSBB; Liver Cirrhosis

Summary: variceal bleeding (vb) is a life-threatening complication of cirrhosis with a 6-week mortality of approximately 15%-20%. the 1-year rate of recurrent vb is approximately 60% in patients without prophylaxis treatment. therefore, all patients who survive vb must receive active treatments to prevent rebleeding. usually, these patients are submitted to rebleeding prophylaxis with endoscopic band ligation (ebl) combined with non-selective beta-blockers (nsbb). transjugular intrahepatic portosystemic shunts (tips) are reserved for those who failed endoscopic plus medical treatment. a recent meta-analysis comparing combination therapy to monotherapy with ebl or drug therapy has demonstrated that combination therapy is only marginally more effective than nsbb alone. this suggests that nsbb is the cornerstone of combination therapy. the lowest rebleeding rates are observed in patients on secondary prophylaxis who are hepatic venous pressure gradient (hvpg) responders (defined as a reduction in hvpg below 12 mm hg or \> 20% from baseline). a recent study demonstrated that patients who have their first episode of variceal bleeding while on primary prophylaxis with nsbb have an increased risk of further bleeding and death, despite adding ebl. these patients possibly require alternative treatment approaches, such as tips. the aim of the present study was to compare the effect of tips vs. ebl + nsbb for the prevention of rebleeding in nsbb non-responder for primary prophylaxis.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of liver cirrhosis * standard nsbb therapy was used for primary prophylaxis * at least 5 days after index variceal bleeding * child-pugh score \<13, model for end-stage liver disease score \< 19 exclusion criteria: * gastric variceal bleeding (gov2，igv1，igv2) * history of shunt surgery * degree of portal vein thrombosis \> 50% * refractory ascites * budd-chiari syndrome * hepatocellular carcinoma or other malignant tumors * uncontrolled infection * hiv * pregnant or breast-feeding woman * poor compliance
comparing the clinical outcomes of dermacell® with integra® bilayer wound matrix

Conditions: Wounds; Chronic Wounds; Nonmalignant Condition

Summary: both dermacell® and integra® bilayer wound matrix are indicated for deep soft tissue coverage and serve as a biological matrix for cellular migration. the current thinking about the utility of these products is to apply over the wound surface and wait until the graft is well vascularized (granular bed/neodermis). at that point a split thickness skin graft can be applied over this area to cover and heal the wound. this study will determine whether human allograft or xenograft will create a durable neodermis that is more supportive of accepting of a split thickness skin graft. patients who do not receive split thickness skin grafts will be assigned to the second cohort for observation of healing rates.

this is a prospective, randomized, single site, clinical research trial comparing the clinical outcomes of dermacell® compared with integra® bilayer wound matrix in dermal regeneration. a total of 100 subjects will be randomized into either the dermacell® (n=50) or integra® bilayer wound matrix (n=50) treatment group. an interim analysis will be performed when both groups have enrolled 25 subjects. subjects will receive either dermacell® or integra® bilayer wound matrix in the operating room for coverage of deep soft tissue defects in the lower extremity. subjects will then be followed in the outpatient clinic. once the neodermis has been sufficiently generated, a split thickness skin graft (autograft or allograft) will be applied in the operating room. the split thickness skin graft application site will be then followed to observe viability.

Eligibility criteria:
inclusion criteria: 1. male or female 18-90 2. who have a complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone) 3. wounds that are either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 2 years in duration) 4. wounds not amendable to primary closure as deemed by the surgeon 5. wounds that have been deemed by the surgeon that any residual infection has been or is being treated upon entry into the clinical trial 6. requiring operative application of a dermoconductive agent 7. extremity wounds have adequate perfusion determined by: palpable pedal pulses, dopplerable pulses, ankle brachial index of \>0.7, or transcutaneous oximetry of \>0.5 8. renally stable (i.e. cr\ 9.0, egfr \>60) 9. is able to comply to clinical trial requirements exclusion criteria: 1. with a contraindication for the application of a xenograft or allograft 2. untreated infection of soft tissue or bone 3. untreated autoimmune connective tissue disorders 4. body mass index of ≥ 50 5. undergoing chemotherapy/radiation therapy 6. malignancy 7. active liver disease (e.g. hepatitis a-g), 8. previous wound care therapy that included any bioengineered alternative tissue or stsg 30 days prior to enrollment 9. pregnancy 10. enrolled in any other interventional clinical research trial 11. unable or unwilling to comply with study requirements
changes in vaginal, cervical and uterine microflora with levonorgestrel intrauterine device placement

Conditions: Human Microbiome; Metagenome; Contraception; Cytokine

Summary: the goal of this study is to examine changes in the bacterial ecology and inflammatory markers of the female genital tract with levonorgestrel intrauterine device placement. the specific research objectives of this project include: 1. characterization of vaginal, cervical and uterine bacterial species and communities prior to and after lng iud placement using bacterial dna microarray analysis. samples will be collected up to 1 week before and 2 months after iud insertion. 2. characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after lng iud placement using human rna microarray analysis. samples will be analyzed from up to one day before and three weeks after iud insertion. 3. establish a tissue bank of vaginal, cervical and uterine specimens for future research.


Eligibility criteria:
inclusion criteria: * not currently pregnant * no use of hormonal birth control for at least three months prior to enrollment * desiring levonorgestrel iud for birth control * greater than 6 months postpartum * greater than 6 weeks after miscarriage * no antibiotic use in the past 6 weeks exclusion criteria: * uterine abnormalities * current use of hormonal contraceptives or use less than 3 months ago * unexplained vaginal bleeding * irregular menses * cervical dysplasia * cervical or vaginal infection in the last 6 weeks * douching within the week prior to sample collection * use of vaginal lubricants within the week prior to sample collection

Keywords: microflora vaginal cervical uterine inflammation cytokine intrauterine device levonorgestrel
use of platelet rich plasma after arthroscopic debridement for triangular fibrocartilage complex tears

Conditions: Arthroscopic Surgery; Triangular Fibrocartilage Complex Injury

Summary: the objective of this study is to compare outcomes and functionality measures of subjects treated with platelet rich plasma (prp) after arthroscopic debridement of triangular fibrocartilage complex (tfcc) tears to subjects treated with arthroscopic debridement alone.

patients with triangular fibrocartilage complex (tfcc) tears will undergo treatment with arthroscopic debridement, as is standard of care, followed by treatment with platelet rich plasma (prp) (24 subjects) versus no treatment with prp (24 subjects). outcome measures will include modified mayo wrist scores (pain scale scores, grip strength, wrist range of motion, functional status) and patient-rated wrist evaluation (prwe) scores.

Eligibility criteria:
inclusion criteria: * male or female \>18 years of age * triangular fibrocartilage complex (tfcc) tear requiring surgical intervention * be willing to undergo arthroscopic debridement and injection with platelet-rich plasma (prp) * be in good health other than the tfcc tear * have realistic expectations of surgical results * understand and be willing to follow all aspects of the study protocol and have signed and dated the irb-approved informed consent form and the authorization for use and release of health and research study information (hipaa) form prior to any study-related procedures being performed exclusion criteria: * have collagen-vascular, connective tissue, or bleeding disorders * be a smoker or have smoked in last 2 months * have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability * have regional sympathetic dystrophy * be pregnant, lactating or expecting to be within the next 24 months * currently have an alcohol/substance abuse problem or have had a relapse within one year to screening visit * have an abscess or infection at the time of surgery * have a condition or be in a situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Keywords: platelet-rich plasma
comparing surgical to conservative management in the treatment of type ii odontoid fractures among the elderly

Conditions: Odontoid Fractures Type II

Summary: the purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type ii odontoid fractures among patients \>/= 65 years of age. of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.


Eligibility criteria:
inclusion criteria: * all new type ii odontoid fractures including \< those in which the fracture line crosses into the body of c2 \< as long as it doesn't enter the superior articular process of c2 * age 65+ * stable and unstable fractures * \< 3 months postinjury * no previous treatment for an odontoid fracture exclusion criteria: * pathologic fractures unrelated to osteoporosis * severe dementia or other severe mental health problem if there is no consentable surrogate available * participating in other trials or unlikely to attend follow-ups

Keywords: odontoid type ii fractures elderly patients surgical vs. conservative treatment
the effect of somatropin treatment in adult patients on chronic dialysis

Conditions: Chronic Kidney Disease; End-Stage Renal Disease

Summary: this trial is conducted in africa, asia, europe, north and south america and oceania. the aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; "time to death" and health related quality of life in adult patients on chronic haemodialysis.

the decision to discontinue the trial is not due to safety concerns. the discontinuation is based on an analysis of the significant delay in recruitment of patients which is expected to have a negative impact on the outcome of the trial.

Eligibility criteria:
inclusion criteria: * serum albumin as specified in protocol * malnourished (based on serum albumin value below 40 g/l, assessed centrally) * stable (for 3 months or more) and adequate haemodialysis treatment three months prior to enrolment as defined by kt/v of more than 1.2 exclusion criteria: * active malignant disease * critical illness requiring treatment in an intensive care unit (icu) * uncontrolled treated/untreated hypertension * patients on chronic (more than 3 months) treatment with steroids in doses of more than 10 mg/day prednisolone (or equivalent) * patients treated with immunosuppressive agents * known growth hormone deficiency * patients suffering from any clinically significant disease history in the opinion of the investigator * severe illness as defined in the protocol (as judged by the investigator)
common allergens in skin tests for adult atopic dermatitis

Conditions: Atopic Dermatitis

Summary: to analyze the common allergens revealed by skin tests in adult atopic dermatitis patients.

the allergens involved in atopic patients are widely existed in our environment. traditionally, we use serum specific ige, skin prick test or intradermal test to verify the possible causative allergens in patients with atopic dermatitis. this study will evaluate the correlation between serum specific ige, skin prick test, intradermal test, and patch test for common allergens in adult patients with atopic dermatitis.

Eligibility criteria:
inclusion criteria: * patients with atopic dermatitis (according to hanifin and rajka criteria) * age older than 16 years old exclusion criteria: * pregnancy

Keywords: atopic dermatitis, skin test
preventing recurrent urinary tract infections with α-d-mannose

Conditions: Urinary Tract Infections

Summary: in this trial, women with history of recurrent urinary tract infections (utis) will be followed over the course of 6 months. the women will be randomized either to d- mannose or placebo. the primary objective of this study is to investigate if treatment with d-mannose reduces the risk for a uti recurrence compared to treatment with placebo. h0: women with history of recurrent utis treated with d-mannose on average have the same number of recurrent utis over the course of 6 months compared to women treated with placebo. h1: women with history of recurrent utis treated with d-mannose on average have fewer recurrent utis over the course of 6 months compared to women treated with placebo.


Eligibility criteria:
inclusion criteria: * women * ≥ 3 utis within the last 12 months or ≥ 2 utis within the last 6 months; * laboratory urine culture: \<103 cfus * age \> 18 years exclusion criteria: * utis ≥ 12 within 1 year * pregnancy or lactation * immune disease * lactose intolerance * urinary tract anomaly * systemic infection * newly started hormone therapy within the last 6 months * antibiotic prophylaxis within the last 6 months * α-d-mannose intake within the last month * use of catheters * diabetes mellitus * participation to other studies

Keywords: d-mannose
pelvic floor muscle training and hypopressive exercises for pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: to verify if pelvic floor muscle training program and/or a hypopressive exercise program could improve women with stage ii of pelvic organ prolapse, their symptoms or pelvic floor muscle strength.

to verify if three months of an exercise program could improve stage ii of pelvic organ prolapse, as a conservative treatment.

Eligibility criteria:
inclusion criteria: * women with stage ii of pelvic organ prolapse, preferably symptomatic and not to be submitted to surgery to correct pelvic organ prolapse during the study exclusion criteria: * neuromuscular diseases and use of hormonal therapy

Keywords: pelvic floor pelvic organ prolapse