Kornimate/medical-research-clean huggingface dataset:
pelvic ultrasound pessary study: changes in pelvic anatomy after placing a pessary

Conditions: Pelvic Organ Prolapse

Summary: in the past, the impact of pessaries was mostly assessed by questionnaires on quality of life (qol) and sexual dysfunction. this research project primarily aims to objectify the effects of the currently available pessaries in a different way. to accomplish this, the investigators choose transperineal ultrasound and uroflowmetry. additionally, this project aims to describe the impact of pessaries on the symptoms and qol.

first, the investigators will carry out a small feasibility study with inclusion of 20 patients with pelvic organ prolapse (pop) already using a pessary to check if it is possible to perform adequate measurements of the pelvic floor on transperineal ultrasound with the pessary in situ. by doing this cross-sectional study, the investigators want to refine our technique to optimize data collection. the study will be designed as a monocentric prospective longitudinal study. patients presenting to our gynecology outpatient department with symptomatic pop, who choose to try a pessary after thorough counseling, will be recruited. the follow-up will continue for 1 year after the insertion of the pessary. regular check-ups at 2 weeks, 3, 6, and 12 months will be performed to document patient-reported outcome measures (proms), perform a clinical examination. transperineal ultrasound (tpus) and uroflowmetry will be added to the examinations at the check-up at 3 and 12 months.

Eligibility criteria:
inclusion criteria: * symptomatic pop * start of pessary therapy * patient must master dutch, french or english exclusion criteria: * active pelvic infection * severe vaginal ulceration * vaginitis * allergy to silicone and/or latex * non compliant patients * pregnancy

Keywords: pessaries, pop, transperineal ultrasound
comparing mobilization techniques for the hemiplegic shoulder

Conditions: Hemiplegic Shoulder; Mobility Limitation

Summary: one of the main complications after stroke is hemiplegic shoulder pain. it is known that one of the most frequent causes of hemiplegic shoulder pain is a restricted range of motion in the shoulder joint. therefore, it is necessary to preserve the passive range of motion by using the most optimal mobilization technique. the aim of this study is to compare 2 different techniques in order to document their influence on shoulder range of motion and shoulder pain in stroke patients.


Eligibility criteria:
inclusion criteria: * first stroke * upper limb impairment exclusion criteria: * shoulder pain on the hemiplegic side with onset before the stroke * surgery at the hemiplegic shoulder * active movement possible within the whole range of motion
study of a cell-phone system to improve health of youth with diabetes

Conditions: Type 1 Diabetes

Summary: fl3x is an integrated diabetes self-management system that incorporates modern cell phone technology with behavioral modification approaches to improve diabetes self-management in high-risk youth. utilizing such approaches will increase adherence to diabetes management behaviors and improve glucose control by providing increased autonomy over diabetes care.

fl3x utilizes diabetes care providers (diabetes educators) as health coaches to employ behavioral modification techniques including motivational interviewing and problem solving skills training. coaches help adolescents and their families learn these techniques to improve diabetes self management behaviors and diabetes care.

Eligibility criteria:
inclusion criteria: * type 1 diabetes with duration at least 12 months * between ages 12-16 years at registration * poor glycemic control (a1c 8.0-13.0%) * parent/guardian willing to also participate * minority race/ethnicity * low income exclusion criteria: * pregnant (if female) * diabetes type 2 or gestational * no health insurance * pre-existing systemic chronic disease (drug abuse, cancer, psychiatric conditions)

Keywords: motivational interviewing problem solving skills family communication technology support cell phone system
response of metabolic syndrome severity score to high intenisty interval training in women with central obesity.

Conditions: Metabolic Syndrom

Summary: this study will be conducted to investigate any significant effect of high intensity interval training on metabolic syndrome severity score in women with central obesity.

response of metabolic syndrome severity score to high intenisty interval training in women with central obesity forty eight women with age ranges from 25 to 45 years old will be selected from nutrition-outpatient clinic; they will participate in the study for 6 weeks, and randomly be assigned into two equal groups. study group a (n =24) will receive low volume high-intensity interval training (hiit) three times /week for 6 weeks , study group b (n =24) will receive caloric restriction diet for evaluation physical efficiency index using modified harvard step test it is a powerful indicator for aerobic fitness. the fitness index score is determined according to the following equation fitness index (long form) = (100 x test duration in seconds) divided by (2 x sum of heart beats in the recovery periods). metabolic syndrome severity score metabolic syndrome severity score will be calculated through mets calculator (metscalc). -3laboratory investigation before \& after treatment: for fasting blood glucose level and lipid profile (total cholesterol, ldl, hdl, tags). 4- the 45-item diet satisfaction questionnaire (dsat-45) b) for treatment 1- grand ii treadmill: (ac999- for maximum weight 150 kg-

Eligibility criteria:
inclusion criteria: - 1. 48 women subjects with age ranges from 25to 45 years. 2. waist height ratio ranges from 49-58 (overweight and seriously overweight). exclusion criteria: * 1. uncontrolled diabetes 2. uncontrolled hypertension 3. cognitive impaired patients 4. severe anemic women 5. subjects with physical or musculoskeletal disabilities 6. pregnancy 7. recent cardiothoracic surgery

Keywords: metabolic syndrom severity score metabolic syndrom central obesity
multimodal ultrasound and focal liver lesions (flls)

Conditions: Liver Neoplasms

Summary: background and aim: flls are common findings in abdominal ultrasound and differential diagnosis between benign and malignant lesions is often challenging, especially in patients with chronic liver diseases. the diagnostic role of ceus has already been defined by international guidelines when lesions show a typical pattern for hepatocellular carcinoma whereas in case of non-typical contrast enhanced patterns radiologic imaging or liver biopsy are still needed. however, these techniques are more invasive and expensive than ultrasound. therefore, the aim of this study is to identify d-ceus and swe quantitative parameters useful for characterizing flls. study design: prospective, observational, single-center study methods: 50 consecutive adult patients with focal liver lesions detectable with b-mode ultrasound will be enrolled in the unit of internal medicine and gastroenterology of the policlinico gemelli. exclusion criteria will be liver failure, hearth failure, previous locoregional or systemic treatments for flls (e.g. ablation, chemoembolization, alcoholization, chemotherapy), known allergy to ultrasound contrast agents. after obtaining informed consent and identifying the target lesion in b-mode ultrasound, patients will undergo ceus and swe and, subsequently, to computed tomography/magnetic resonance/biopsy according to international guidelines and current clinical practice. the average, maximum, minimum and standard deviation value of lesion elasticity in kpa will be calculated using swe. three consecutive swe acquisitions will be performed both for the lesion and for the liver parenchyma and the average value of the three measurements will be considered. the ceus will allow the construction of signal intensity curves as a function of time in a specific area of interest drawn manually. from these curves a series of quantitative parameters related to the flow and volume of blood will be extrapolated and in particular: peak intensity, pi (in arbitrary units, au); time to peak, tp ( in seconds); area under the time curve, auc (in au); slope of the wash-in curve, pw (in au per second); average transit time, mtt (in seconds). in addition, the personal, clinical and laboratory data necessary to determine the hepatological scores of disease severity such as meld and child-pugh will be collected. the study has an expected duration of one year.


Eligibility criteria:
inclusion criteria: * written informed consent * adult patients (more than 18 years old) * focal liver lesions detectable with b-mode ultrasound exclusion criteria: * liver failure, * hearth failure, * previous locoregional or systemic treatments for flls (e.g. ablation, chemoembolization, alcoholization, chemotherapy), * known allergy to ultrasound contrast agents * pregnancy * lactation
to study the effectiveness and safety of niacin and a topical steroid eye drop to treat retinal vein occlusions

Conditions: Retinal Vein Occlusion

Summary: the purpose of this study is to determine whether niacin, a b vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye. the topical steroid eye drops are aimed at reducing swelling in the retina, until the collateral vessels have a chance to develop.

the aim of this study is to develop a less risky, yet effective and more sustainable treatment for retinal vein occlusions than the current commonly used approach of repeated intravitreal triamcinolone acetonide (kenalog) injections. the types of retinal vein occlusion that are being studied include central (crvo), hemi-retinal (hrvo), and branch (brvo) retinal vein occlusion. niacin, (nicotinic acid, not nicotinamide)a b-vitamin, has lipid lowering and vasodilating properties. the combination of niacin and prednisolone acetate steroid eye drops as a non-invasive treatment approach was developed by the principal investigator. the niacin dilates the retinal vessels, hopefully encouraging earlier collateral vessel formation aimed at bypassing the venous obstruction, thus restoring venous outflow. the prednisolone acetate steroid eye drops are aimed at reducing vascular leakage and therefore the macular edema in the eye while the niacin is taking effect.

Eligibility criteria:
inclusion criteria: * patients must be able to understand the study procedures, agree to participate, and give written consent. * patient must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusion. * patients must be able to follow the study medication regimen. * patients must agree to return for the once monthly eye exams. * patients must agree to have liver function tests performed on a regular basis. * patients must agree to have regular appointments with their internist on an established basis. exclusion criteria: * patients with active gout, or high levels of uric * patients may not be pregnant or lactating. * the principal investigator reserves the right to exclude any patient who he feels will not make a good candidate.
efficacy and safety study of bepotastine besilate ophthalmic solution in allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: efficacy and safety study of bepotastine besilate ophthalmic solution in allergic conjunctivitis


Eligibility criteria:
inclusion criteria: * subjects must be at least 10 years of age exclusion criteria: * no active ocular disease
evaluation of ultrasonic scissors and diathermy for axillary clearance in breast cancer patients

Conditions: Seroma

Summary: breast surgery plays an important role in the treatment of breast cancer. this study investigates if the use of harmonic focus has advantages than the use of conventional diathermy in axillary clearance due to metastatic breast cancer.

breast surgery plays an important role in the treatment of breast cancer. sometimes cancer cells can spread to lymph nodes in the axill. the first lymph node affected in the armpit is called the sentinel node. surgery to remove this node can answer the question of whether the cancer has spread to the axill. if the node is affected, further surgery is performed to remove most of the lymph nodes in the armpit, a so-called axillary clereance. the breast unit at linköping university hospital performs about 60 axillary clereance per year. axillary clereance is associated with a number of complications, such as infections, bleeding, pain, loss of sensation and limited mobility in the arm. accumulation of wound fluid in the surgical area is common, affecting about a quarter of patients undergoing surgery. small amounts of wound fluid usually do not require treatment, but larger accumulations usually require drainage. patients who have symptoms from armpit wound fluid have to make repeated return visits so that a nurse drains the fluid using a needle. this poses several risks to the patient such as infection and/or bleeding. this, in turn, can delay the start of additional treatment and can put a financial burden on both the patient and the healthcare system. today, the investigators use a device with a weak electric current (diathermy) to remove lymph nodes from the armpit. harmonic focus ® is a pair of scissors that instead uses ultrasound waves to divide the tissue. there are scientific studies showing that the use of ultrasonic scissors reduces the risk of fluid accumulation and thus the risk of complications after surgery\[1, 2\]. the investigators want to conduct a prospective study, an economic analysis comparing the costs of using diathermy versus harmonic focus®. in addition, patients will complete a quality of life questionnaire before surgery, approximately 4-6 weeks after and one year after surgery. the results of the questionnaires will be compared between the harmonic focus® and the diathermy group.

Eligibility criteria:
inclusion criteria: * 18 years or older * all patients who will undergo axillary evacuation * informed consent exclusion criteria: * patients who have previously undergone axillary evacuation.

Keywords: seroma axillary dissection complications
single dose safety, tolerability, pharmacokinetics and pharmacodynamics study of pf-06291874 in healthy adult subjects

Conditions: Healthy

Summary: the primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of pf-06291874 in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects of non childbearing potential. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Keywords: t2dm diabetes mellitus type 2
repetitive transcranial magnetic stimulation for the treatment of focal hand dystonia

Conditions: Dystonia, Focal, Task-specific

Summary: this study investigated the short term effects of repeated administrations of repetitive-transcranial magnetic stimulation (rtms) on clinical changes and investigate neurophysiologic responses to rtms of the activated motor system in patients with fhd.

purpose: the ability of low-frequency repetitive transcranial magnetic stimulation (rtms) to enhance intracortical inhibition has motivated its use as a potential therapeutic intervention in focal hand dystonia (fhd). in this preliminary investigation, we assessed the physiologic and behavioral effects of multiple sessions of rtms in fhd. methods: 12 patients with fhd underwent five daily-sessions of 1 hz rtms to contralateral dorsal premotor cortex (dpmc). patients held a pencil and made movements that did not elicit dystonic symptoms during rtms. we hypothesized that an active but non-dystonic motor state would increase beneficial effects of rtms. five additional patients received sham-rtms protocol. the area under curve (auc) of the motor evoked potentials and the cortical silent period (csp) were measured to assess changes in corticospinal excitability and intracortical inhibition, respectively. behavioral measures included pen force and velocity during handwriting and subjective report.

Eligibility criteria:
inclusion criteria: * task specific focal hand dystonia exclusion criteria: * any neurologic condition other than fhd * medication for dystonia * botulinum toxin within the past three months * seizure history * pregnancy * implanted medical devices

Keywords: focal hand dystonia rehabilitation rtms writer's cramp clinical
a study in patients with erectile dysfunction

Conditions: Erectile Dysfunction

Summary: the purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (sildenafil citrate) taken as needed.


Eligibility criteria:
inclusion criteria: * history of erectile dysfunction (ed) of at least 3 months duration. * anticipate having the same adult female sexual partner during the study. * agree not to use any other treatment for ed and to participate in recording responses to questionnaires and other instruments used in this study. exclusion criteria: * previous or current treatment with tadalafil or any other phosphodiesterase type 5 (pde5) inhibitor. * ed caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity. * ed caused by untreated or inadequately treated endocrine disease. * current treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens. * severe renal or hepatic impairment, history of malignant hypertension. * presence or history of specific heart conditions.

Keywords: erectile dysfunction
registry to evaluate long-term outcomes in patients who undergo 68-ga-psma-11 pet/ct imaging evaluations

Conditions: Prostate Cancer (Adenocarcinoma)

Summary: the purpose of this observational research registry is to understand the real-world use of illuccix pet/ct in prostate cancer, and how results from this testing impact patient's treatment and prostate cancer journey over time. it will follow subjects and the diagnostic testing and therapy they receive for their prostate cancer. subjects will not be administered any medical diagnostic testing or therapy that they would not have normally undergone outside of participation in the registry.


Eligibility criteria:
inclusion criteria: participants will qualify for inclusion into cohort 1, 2, or 3 only if they meet all the following criteria. 1. be a biological male at birth who is ≥ 21 years of age at the time of informed consent. 2. have undergone a 68ga-psma-11 (illuccix or gozellix) pet/ct imaging evaluation within 60 days before enrolling in the study. (prior imaging with alternate radioactive imaging agents are allowed, but enrollment imaging must be with 68ga-psma-11(illuccix or gozellix). 3. have histopathologically confirmed prostate adenocarcinoma. 4. have a life expectancy of ≥ 6 months as determined by the investigator. 5. participants intended for enrollment in cohort 1: patients who have been newly diagnosed with prostate cancer and have not received any prior treatment for prostate cancer and have undergone a 68ga-psma-11 pet/ct imaging evaluation to evaluate potential spread of the disease. 6. participants intended for enrollment in cohort 2: patients who have received previous treatment for prostate cancer and have and have undergone 68ga-psma-11 pet/ct imaging evaluation for suspected recurrence (demonstrated by elevated psa levels). participants intended for enrollment in cohort 3: patients who have metastatic prostate cancer and undergone a 68ga-psma-11 pet/ct imaging evaluation for the initiation of rlt. 7. be willing and able to provide informed consent and comply with the protocol requirements. exclusion criteria: participants are excluded from the study if any of the following criteria apply. all participants must not: 1. have any medical condition or other circumstances that, in the opinion of the investigator, compromises the safety of the participant, the ability of the participant to comply with protocol requirements, the ability of the participant to complete the study, or confound study outcomes by being unable to produce reliable data over the course of the study.

Keywords: psma prostate cancer
application of miglustat in patients with niemann-pick type c

Conditions: Niemann-Pick Disease Type C

Summary: to evaluate the changes in cognitive function after miglustat treatment in niemann-pick type c patients.

patients with niemann-pick c disease will be treated with miglutat 200mg tid. neurologic evaluation and safety will be monitored periodically.

Eligibility criteria:
inclusion criteria: * confirm diagnosis of niemann-pick c disease * symptomatic including motor or mental symptoms exclusion criteria: * unknown severe diarrhea for more than 7 day * allergy to miglustat

Keywords: niemann-pick disease type c miglustat
3d ultra sound for resection of brain tumors

Conditions: Patients With Resectable Brain Tumors

Summary: phase 3 randomized open labeled trials will evaluate the 3 d navigable ultrasound (sonowand) in improving the extent of resection in intra-axial brain tumors. all patients will undergo resective surgery. in the experimental arm, a navigable 3 d ultrasound will be used. in the standard arm, only navigation will be used. this study will help in assessing the usefulness sononavigation in improving radicality of resection in malignant gliomas and also to access the accuracy of sonowand in predicting residue (histopathological correlation).

routine presurgical evaluation of all patients will be conducted. the preoperative use of steroids, antiepileptics and other medications would be as per standard procedure and would be documented. in addition detailed mri evaluation will be performed (including contrast enhanced mri study, diffusion mri, perfusion mr, mr spectroscopy, dynamic-contrast-enhanced mri for permeability studies, as well as functional mri, and tractography if required) not more than 1 week prior to the date of surgery. navigation specific mr sequences would be performed in all patients (both arms).

Eligibility criteria:
inclusion criteria: 1. all radiologically-suspected, previously untreated, supratentorial malignant gliomas being considered for debulking surgery. 2. adults (above 18 years) 3. eligible for surgical therapy (craniotomy not stereotactic biopsy ) 4. resectability : a lesion would be considered "resectable" if the surgeons feel that all the radiologically imaged lesion can be removed (with reasonable certainty). only deemed resectable lesions will be included exclusion criteria: 1. unfit for ga 2. unwilling for the study 3. unresectable lesion

Keywords: malignant gliomas sono rct