Kornimate/medical-research-clean huggingface dataset:
efficacy of peroperative suction drain usage in arthroscopic knee surgery

Conditions: Chondropathy; Knee Effusion; Knee Hemarthrosis

Summary: the study was designed to investigate efficacy of suction drains in arthroscopic knee surgery, rather than anterior cruciate ligament (acl) reconstruction. two groups were randomised, and suction drain was applied to one group, and the other group as the control group without a suction drain.

the groups were compared in terms of patellar shock, knee effusion, knee scoring systems, range of motion, loss of labour, hospitalization time. also different arthroscopic procedures such as meniscectomy, meniscus repair, synovectomy and microfracture were evaluated in terms of need for a suction drain. the controls was at 1st and 15th day, 6th week and 3rd month.

Eligibility criteria:
inclusion criteria: * patients with knee derangement and accepted to enroll to the study exclusion criteria: * intraarticular fracture, acl surgery, arthrotomy, bleeding disorder,

Keywords: suction drain knee arthroscopy knee pain
study of a cohort of children with molluscum contagiosum (mc) treated with a 5% solution of potassium hydroxide (molutrex®) applied locally to the skin

Conditions: Molluscum Contagiosum

Summary: molutrex® a 5% potassium hydroxide solution for topical application to the skin. molutrex® is intended for the superficial treatment of certain types of warts, molluscum contagiosum and is composed of potassium hydroxide (5%) purified water. with regard to the 2017/745 rdm, he is a class iia medical device. in accordance with regulation (eu) 2017/745 of the european parliament and of the council of april 5, 2017 relating to medical devices, as part of the molutrex® post-marketing monitoring plan, the objective of this study is to have data on the performance , safety and suitability for real-life use of molutrex® in a prospective cohort of patients with molluscum contagiosum. since molluscum contagiosum is most prevalent in children, and potassium hydroxide is used very little in adults (because most often they are immunocompromised patients requiring other antiviral treatments), the study will be conducted in children aged 2 to 10 years. this population represents the majority of patients treated with molutrex®, although the product can be used in adults. the study includes 2 visits, the objective of the study being to evaluate the percentage of children healed at 45 days, healing defined by a reduction of more than 90% in the number of lesions present at inclusion in the study.


Eligibility criteria:
inclusion criteria: child aged 2 to 10 years old : * ambulatory * seen in dermatology consultation for molluscum contagiosum * for which a treatment with a 5% solution of potassium hydroxide (molutrex®) in local cutaneous application has been decided by the dermatologist as monotherapy * not treated for their molluscum contagiosum in the previous month * for which one of the parents gives their written consent to participate exclusion criteria: doubt about the diagnosis of molluscum contagiosum molluscum contagiosum surge already treated immunocompromised child atopic eczema in outbreak lesions around the eye

Keywords: molluscum contagiosum observational study medical device
validation of a non-invasive diagnostic method for sarcoidosis using exhaled breath

Conditions: Sarcoidosis

Summary: sarcoidosis is a chronic lung disease that is characterized by fatigue, shortness of breath, chest pain and reduced lung function. suffering from these diseases has a very negative effect on the quality of life. when people are suspected of having sarcoidosis various markers in the blood are measured. ultimate diagnosis, however, always requires invasive techniques such as bronchoscopy and lung biopsy. consequently, there is an urgent need for a new diagnostic tool that is easy, quick and most of all non-invasive and thus friendly for the patient. such a new diagnostic tool might be found in examining the exhaled air of patients, which contains a complex mixture of so-called volatile organic compounds (vocs) that are the result of damaging processes that occur in the lung. determining the voc profile in the breath can be used as a biomarker, or biological indicator, of those damaging processes. in other words, searching for unique voc profiles in the breath of sarcoidosis patients might lead to the development of a diagnostic tool that only uses their exhaled breath. the current study involves 25 sarcoidosis patients and 25 healthy volunteers. the aim of this study is find vocs in exhaled air that can be used to diagnose sarcoidosis. in a previous study, sarcoidosis-specific vocs were found, which we intend to validate using the current study.


Eligibility criteria:
inclusion criteria: * patients with confirmed sarcoidosis exclusion criteria: * (ex-) smokers * for healthy controls: controls with pulmonary disease excluded
a study to determine the effect of montelukast sodium as an episode modifier in the treatment of infrequent episodic asthma in children (0476-165)

Conditions: Asthma

Summary: a 53-week study to determine the effect of montelukast sodium when given to children (with infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.


Eligibility criteria:
inclusion criteria: * males or females between the ages of 2 and 14 who have infrequent episodic asthma.
cost effectiveness of combined contingency management and cognitive behavioral therapy for alcohol use disorder

Conditions: Alcohol Drinking; Veterans

Summary: alcohol contributes to 88,000 deaths and costs an estimated $223 billion annually in the united states. alcohol use disorder (aud) is highly prevalent in veterans. the positive public health impact of reducing heavy drinking among veterans with aud would prevent significant medical morbidity and mortality. contingency management (cm) is an intensive behavioral therapy that provides incentives to individuals for reducing substance use. monitoring alcohol abstinence usually requires daily monitoring. because of this difficulty, cm approaches for treatment of aud are not currently available to people with aud. our group has developed a mobile smart-phone application that allows patients to video themselves using an alcohol breath monitor and transmit the encrypted data to a secure server. this innovation has made the use of cm for outpatient aud treatment feasible. the aim of the current study is to evaluate the effectiveness and cost effectiveness of cm as an add-on to cognitive behavioral therapy for aud. the trial will also explore the potential usefulness of a long-term abstinence incentive ontreatment utilization and alcohol outcomes. proposed is a trial in which 140 veterans with aud will be randomized to receive either cm as an add-on to evidence-based cbt or cbt alone. veterans will also be randomized to one of two long-term incentive conditions (i.e., receipt of a monetary incentive for abstinence/low-risk drinking at 6- months vs. no incentive). this project aims to advance aud treatment by 1) testing the effectiveness of a mobile health approach that makes cm for aud feasible, and 2) providing highly needed cost-effectiveness data on the use of behavioral incentives as an adjunct to cbt for the treatment of aud. these aims are designed to address two significant barriers to the implementation of cm for aud.


Eligibility criteria:
inclusion criteria: * are an enrolled veteran at the dvahcs for primary care, * have current aud (meeting past month dsm-5 criteria), and * are willing to make a quit attempt and/or reduce alcohol use to low risk levels. exclusion criteria: * have fewer than 3 days of abstinence, * have a history of clinically significant alcohol withdrawal, as indicated by a score of 10 or more on the clinical institute withdrawal assessment of alcohol (ciwa), or * are currently receiving professional behavioral treatment for aud.
non-contact measurement of aortic compliance

Conditions: Vascular Disease

Summary: reduced aortic stiffness is a powerful way to predict the outcome of cardiovascular (cv) disease. there are several non invasive methods for its estimation, most of which are based on the measurement of speed of the arterial pulse wave. (the stiffer the artery, the faster the pulse wave travels.) they rely on detecting the arterial pulse with 2 sensors placed on the skin a known distance apart and measuring the time for the pulse to travel between them. however all current methods require skilled operators and are of limited accuracy. thus, there is a need for an easy to use and reliable device to measure pulse speed. the aim of this project is to develop a non contact device to detect the aortic pulse as it moves into the small arteries following the ribs, using the principle of thermal imaging, by means of a high sensitivity infra red camera, directed towards the subjects back. the investigators plan to validate the device and conduct a small feasibility study in patients undergoing elective angiography, by simultaneously measuring pulse speed using established methods. these are doppler ultrasound (non-invasive) and direct intra-arterial measurement (the gold standard).


Eligibility criteria:
inclusion criteria: * age 18 years and above * patients eligible for coronary angiography * informed consent obtained * able to complete experimental protocol exclusion criteria: * refusal of consent * age below 18 years * breast feeding * known or suspected pregnancy * patient participating in another study at time of study entry or previous participation in this registry * diagnosed but untreated hypertension

Keywords: pulse wave velocity non contact non-invasive photoplethysmography doppler flow velocimetry
stent omission after ureteroscopy and lithotripsy in the michigan urological surgery improvement collaborative

Conditions: Stone, Kidney; Stone Ureter

Summary: this is a multicenter prospective trial with randomized and observational cohorts assessing patient-reported outcomes and unplanned healthcare utilization following ureteroscopic treatment of renal and ureteral stones, with placement versus omission of a ureteral stent. eligible participants in the randomization trial will be randomized to ureteroscopy with stent placement or stent omission. eligible participants that consent to the observational only cohort will complete surveys and the treating physicians will decide the treatment options for the participants. the study team hypothesizes that: * pain interference change from pre-surgery to day 7-10 will differ between the two treatment arms. this hypothesis will be evaluated separately in the randomized and observational cohorts. * unplanned healthcare utilization in the treatment arms will have different unplanned healthcare utilization ranks leading to a win proportion significantly higher or lower than 0.5 in the stent omission arm compared to the stent placement arm. this hypothesis will be evaluated separately in the randomized and observational cohorts.

the coordinating center for this study is the michigan urological surgery improvement collaborative (music), which is a physician-led quality improvement (qi) collaborative comprised of 44 urology practices and 260 urologists across the state of michigan. as sites are activated the registration will be updated.

Eligibility criteria:
inclusion criteria: * undergoing unilateral ureteroscopy and lithotripsy for stone disease (participants may have contralateral stones, as long as these are asymptomatic and not being treated concurrently) * largest stone less or equal to 10 millimeter in size as measured on abdominal x-ray, ultrasound, or computed tomography scan * access to means of communication with the study team (email, text messaging, and/or telephone) * adequate independent cognitive function and english language proficiency to complete study surveys * written informed consent exclusion criteria: * planned bilateral ureteroscopy * indwelling ureteral stent or percutaneous nephrostomy tube preoperatively in either kidney * anatomic abnormalities of the ipsilateral upper urinary tract (for example, horseshoe kidney, crossed fused ectopia, pelvic kidney, urinary diversion) * anatomic or functional solitary kidney * planned secondary or staged ureteroscopy * planned use of ureteral access sheath * pregnancy * patients who use opiate medication daily for greater than 3 months to manage a painful condition second stage exclusion criteria: * ureteral perforation * unanticipated anatomic abnormality * greater than expected bleeding * ureteral dilation greater than 12 french * ureteral access sheath utilized * failed ureteroscopy * no or incomplete lithotripsy performed * unable to complete case due to medical or anesthetic event.

Keywords: unilateral ureteroscopy and lithotripsy ureteral stent pain assessment quality of life
fractional photothermolysis for treating melasma

Conditions: Melasma

Summary: in several observational studies, non-ablative fractional photothermolysis (fp) has been reported to bridge the gap between efficacy and tolerability in the treatment of melasma. while some beneficial effects have been attributed to non-ablative fp in treating melasma, methodological constraints (e.g., a limited number of patients; no control group assignment) impair efficacy assessment; currently published results neither allow researchers and clinicians to draw valid conclusions nor warrant recommendations for therapy. in particular, bias resulting from poorly designed trials may mislead clinicians into making a wrong decision and generate not only unnecessary treatment (i.e., costs), but also a risk of side effects for patients. therefore, the purpose of this trial was to clarify the efficacy and safety of fp in the treatment of melasma as compared to the lone application of a sun-blocking lotion (spf \>50).


Eligibility criteria:
inclusion criteria: * adults (female/male) with clinical evidence of melasma; * fitzpatrick skin phototype i-iii; * ability and willingness to comply with the requirements of the protocol. exclusion criteria: * pregnancy or nursing; * inability to avoid sun exposure for occupational reasons (e.g., gardeners); * known history or clinically relevant allergy to components of the sunscreen or topical anaesthetic; * use of topical retinoids within 3 months prior to study enrolment; * use of topical hydroquinone within 6 months prior to study enrolment; * use of topical corticosteroids within 1 month prior to study enrolment; * use of topical cosmetic depigmenting agents within 2 weeks prior to study enrolment; * laser surgery procedures within the treatment region during the last 12 weeks prior to enrolment; * coagulation disorders or anticoagulant treatment; * photo-sensitizing medication (e.g., tetracyclines, gold).

Keywords: controlled trial fractional photothermolysis laser surgery melasma pigment disorder
intralesional treatment with interleukin-2 (proleukin) in soft tissue melanoma metastases

Conditions: Melanoma

Summary: the intra-/perilesional application of interleukin-2 seems to be a safe and effective treatment of skin and soft tissue metastases in malignant melanoma. especially in case of intransit metastases the overall survival rate is still 20-30%. however, the management of intransit metastases is sometimes difficult because of frequent recurrences. il-2 intralesionally seems to be an non-invasive option as pilot studies indicate. in this study the safety and efficacy of il-2 are evaluated.


Eligibility criteria:
inclusion criteria: * age 18+ * informed consent * histologically proven melanoma * have confirmed stage iiib or stage iv disease (ajcc 2002) with skin or soft-tissue metastases exclusion criteria: * pregnant or lactating women * patients with severe cardiac disease (e.g. nyha functional class iii or iv, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina) * patients with severe liver disease or severe renal disease * simultaneous immunosuppressive treatment (e.g. steroids) * simultaneous chemotherapy * pretreated soft-tissue or skin metastases (e.g. cryo-, radiotherapy)

Keywords: melanoma soft tissue metastases interleukin-2
a study to characterize profile of participant with psoriatic arthritis depending on whether their disease is managed by a dermatologist or by a rheumatologist, and starting ustekinumab

Conditions: Psoriatic Arthritis

Summary: the primary purpose of this study is to describe the psoriatic arthritis (psa) participant profiles depending on whether their disease is managed by a dermatologist or by a rheumatologist in routine practice.


Eligibility criteria:
inclusion criteria: * participant with a confirmed diagnosis of psoriatic arthritis (psa) according to the dermatological and/or rheumatologic routine practice, using different diagnosis tools, example, the classification criteria for psoriatic arthritis (caspar), or others * participant must be starting ustekinumab for psa according to the local labelling, as a first (biological naïve participant), or second line (biological experienced participants) of bdmard therapy: first line bdmard therapy: the first line therapy includes all bio-naïve participants who start their ustekinumab as their first biologic treatment at the study start (within a maximum 1-month window after the baseline visit); second line bdmard therapy: the second line therapy includes participants who initiated ustekinumab as their second biologic therapy at the study start (within a maximum 1-month window after the baseline visit) * participant for which the ustekinumab treatment has been decided by the investigator prior to and independently of the participant's inclusion into the study * participant for which the first administration of the ustekinumab treatment will occur within the 4-week period from inclusion assessment * participant has signed an informed consent form exclusion criteria: * participant starting ustekinumab as a third or further line of bdmard therapy * already ustekinumab-experienced participants * participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within at least 30 days before the start of the study or more according to the half-life of the investigational drug * participant has refused to participate in the study or unable to give his consent
study of rad001 and bevacizumab in recurrent ovarian, peritoneal, and fallopian tube cancer

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Summary: this study will investigate the efficacy as well as the safety of rad001 in combination with bevacizumab for recurrent ovarian, peritoneal, and fallopian tube cancer. rad001 will be taken orally once daily and bevacizumab will be administered once every 14 days. the study will be conducted over a period of about 3 to 4 years.

in this trial, approximately 50 patients will receive the study drug, rad001 in combination with bevacizumab (avastin)chemotherapy. rad001 will be taken orally once daily and bevacizumab will be administered intravenously once every 14 days. in addition to study treatment, a few blood samples and a sample of the patients tumor from a previous surgery if available will be collected for research.

Eligibility criteria:
inclusion criteria: * patients may or may not have measurable disease. measurable disease is defined according to recist criteria. if the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation was completed. * minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy) * fasting serum cholesterol ≤300 mg/dl or ≤7.75 mmol/l and fasting triglycerides ≤ 2.5 x uln. * performance status £ 2 * signed informed consent. exclusion criteria: * prior treatment with any investigational drug within the preceding 4 weeks * chronic treatment with systemic steroids or another immunosuppressive agent * patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period * uncontrolled brain or leptomeningeal metastases * other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin. * patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation * uncontrolled diabetes mellitus * a known history of hiv seropositivity * impairment of gastrointestinal function or gastrointestinal disease * patients with an active bleeding diathesis or on oral anti-vitamin k medication (except low dose coumadin) * women who are pregnant or breast feeding, or women able to conceive and unwilling to practice an effective method of birth control. * patients who have received prior treatment with an mtor inhibitor (sirolimus, temsirolimus, everolimus). * patients with a known hypersensitivity to rad001 (everolimus), other rapamycins (sirolimus, temsirolimus) or excipients, or bevacizumab * patients with serious non-healing wound, ulcer, or bone fracture. * patients with known hypersensitivity to chinese hamster ovary cell products or other recombinant human or humanized antibodies

Keywords: recurrent ovarian fallopian tube primary peritoneal cancer recurrent ovarian, fallopian tube, primary peritoneal cancer
lumbosciatic syndrome: vojta therapy vs. tens

Conditions: Lumbosciatic Syndrome; Pain; Functional Limitation; Vojta Therapy; Transcutaneous Electrical Nerve Stimulation

Summary: this pilot "pre-post" quasi-experimental study evaluates for the first time the effectiveness of vojta therapy in treating lumbosciatic and compares it with the transcutaneous electrical nerve stimulation (tens) procedure. patients who agree will be distributed alternately in order of arrival to a physiotherapy unit, in such a way that half of the sample will be treated using tens and the other half with vojta.

lumbago/lumbosciatic (with or without radicular implication) is the second most frequent cause of primary medical care and the highest cause of disability in the entire world. this pathology is normally slight to moderate in the majority of cases, meaning that the therapeutical treatment tends to be conservative and thus the interest in increasing the range of non-invasive therapeutic possibilities is available. reflex locomotion or vojta therapy began being used in 1959 for the rehabilitation of children with motor alterations and infants with a risk of cerebral palsy. years later it was successfully applied to adults with neurological and motor alteration problems. until now, there have been no studies on its use in pathologies of the spine and, in particular at a lumbar level. a pre-/ post-intervention examination will be performed to obtain an objective clinical analysis (measurements of pain, disability, functionality and joint movement), by means of simple questionnaires completed by the patient (vas scale, oswestry and roland-morris questionnaires) and exploration techniques (lasègue manoeuvre, schöber test, fingertips to floor test and walking on heels and toes).

Eligibility criteria:
inclusion criteria: * patients diagnosed with acute, sub-acute or chronic lumbosciatic by a rehabilitation doctor were referred by said doctor to the physiotherapy unit, as candidates for either of the therapeutical procedures. exclusion criteria: * patients with lumbosciatic resulting from a specific pathology (infection, metastasis, neoplasia, osteoporosis, fracture or inflammatory arthropathy).