Kornimate/medical-research-clean huggingface dataset:
a phase iv, open-label, randomised, pilot clinical trial designed to evaluate the potential neurotoxicity of dolutegravir/lamivudine/abacavir in neurosymptomatic hiv patients and its reversibility after switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. dream study

Conditions: HIV Infections

Summary: a phase iv, multicentre, randomised, open-label, pilot clinical trial designed to evaluate hiv-infected, aviremic patients who receive treatment with the combination of dtg/3tc/abc and who have neuropsychiatric adverse effects that, in the opinion of the investigators, may be related to taking dtg/3tc/abc, if they improve after switching antiretroviral therapy to the combination of elv/cobi/ftc/taf.

we estimate that 64 participants will need to be enrolled in the study to demonstrate symptomatic improvement after switching antiretroviral therapy from dtg/3tc/abc to elv/cobi/ftc/taf.

Eligibility criteria:
inclusion criteria: * patient \> 18 years of age diagnosed with hiv using normal serology techniques. * current antiretroviral therapy with dtg/3tc/abc. * hiv viral load \< 50 copies/ml for at least 12 weeks prior to signing the consent form \[(\]confirmed by two assays at least 12 weeks apart with viremia \< 50 copies/ml between both). if the patient has a recent routine blood test available (≤ 4 weeks) that includes determining hiv viral load, these results may be used for the screening visit. if this test is not available, or the test is more than four weeks old, viral load will be determined on the day of screening in order to confirm that the patient meets this criterion. * appearance or worsening of the following symptoms compared to when dtg/3tc/abc was started: * symptoms of anxiety or depression * insomnia or other sleep disturbances * headache * cognitive complaints (attention, concentration or memory) * alterations in behaviour (irritability, aggressiveness or agitation) * dizziness of neurological or neurologically-mediated origin exclusion criteria: * determination of at least one hiv viral load ≥ 50 copies/ml in the last 12 weeks. * allergy, intolerance or existence of resistance mutations to any of the components of elv/cobi/ftc/taf * history of active cns infections * active psychosis, major depression with psychotic symptoms or autolytic ideation * dementia or mental retardation * drug use with a diagnosis of abuse or dependence according to dsm-5 criteria * illnesses that may interfere with the study procedures * claustrophobia * presence of magnetisable devices in the body * inability to complete any of the study procedures * pregnant or nursing women, as well as women of childbearing age who do not agree to use an adequate birth control method.
safety study of the hypo-fractionated (large doses) radiation therapy in post-menopausal women with breast cancers

Conditions: Breast Cancer

Summary: the purpose of this study is to determine whether high dose of radiation therapy (rt) are effective over standard 6-week radiation treatment in patients with breast cancer

hypo-fractionation (several large fractions as the only radiation treatment) for breast cancer irradiation was common in the forties and 50s and, while very successful in achieving tumor control, was found to leave significantly inferior cosmetic results due to severe fibrosis and telangiectasia compared to those obtained with multiple fraction regimens (38-40). these complications were due to the use of very large fields, with the inclusion of a large proportion of uninvolved skin and tissue surrounding the tumor. based on these assumptions, a few large fractions can be safely delivered to breast cancers provided that 1) the target volume is sufficiently small and 2) the radiation technique assures maximum sparing of the surrounding normal tissue. conformal rt to the tumor bed of t1 breast cancers satisfies both requirements.

Eligibility criteria:
inclusion criteria: * post-menopausal women (at least 2 years without menstrual period): hysterectomized patients need follicle-stimulating hormone (fsh) confirmation of post-menopausal status. * original tumor non-palpable (mammographically detected). * small primary tumor (pt1) breast cancer, excised with negative margins (defined as at least a 5 mm margin). * n0 or sentinel node negative or n0 clinically if the tumor is \<1 cm in size. * patient offered six weeks of post-segmental mastectomy conventional radiation therapy and declined. * prescribed antihormonal therapy as part of their management. exclusion criteria: * previous radiation therapy to the ipsilateral breast. * presence of a proportion of ductal carcinoma in situ (dcis) in the pathology specimen which is compatible with extensive intraductal component (eic). * women incapable of providing their own consent. mental status will be assessed by the principal investigator using the radiation therapy oncology group (rtog) mini-mental status examination. * women with a diagnosis of multifocal breast cancer.
antibiotic prophylaxis before percutaneous gastrostomy

Conditions: Infection

Summary: the purpose of this study is to evaluate the use of antibiotics (i.e. kefzol) before percutaneous gastrostomy performed in interventional radiology. patient will be randomized to receive antibiotics or placebo before the procedure, and the rates of skin infection after the procedure will be determined between the two groups. this has never been studied in our population of patients undergoing the procedure. however, antibiotics are routinely given despite the lack of evidence. the investigators hypothesize that patient receiving prophylactic antibiotics will have a decreased number of infections compared to placebo.


Eligibility criteria:
inclusion criteria: * anyone over the age of 18 years who is not currently on antibiotics for other reasons exclusion criteria: * anyone on antibiotics for the treatment of other infections. * anyone under the age of 18 years * pregnant patients
effectiveness comparison between continuous cryotherapy and ice pack therapy after anterior cruciate ligament reconstruction surgery

Conditions: Postoperative Pain, Acute; Anterior Cruciate Ligament Injuries; Cryotherapy Effect

Summary: a randomized controlled trial study conducted by comparing the vas score, swelling condition, knee rom and patient's satisfactory score between applying ice pack cold therapy and applying continuous compressive cryotherapy in a postoperative three-day period of anterior cruciate ligament reconstruction surgery patients.


Eligibility criteria:
inclusion criteria: * having anterior cruciate ligament reconstruction * agree to be enrolled in study exclusion criteria: * complex knee injury * raynard's disease * sensitive to low temperature * do not want to use cryotherapy * have vascular disease
the effect of dynamic balance exercises on balance in patients with ankylosing spondylitis.

Conditions: Ankylosing Spondylitis

Summary: the aim of the study is to investigate the effect of dynamic balance exercises added to current medical treatment on balance in patients with ankylosing spondylitis.

the study was planned as a randomized controlled study. forty participants with a clinically confirmed diagnosis of as according to asas criteria will be recruited from the pau department of physical medicine and rehabilitation (pmr). these participants who meet the inclusion and exclusion criteria will be randomly divided into 2 groups. the trial will be carried out at pamukkale university department of physical medicine and rehabilitation between january 2024 and july 2025. the local ethics committee approved the study. all participants will be informed about the purpose and content of the study and will sign written consent to participate in the study. participant's age, gender, body mass index, education, occupation, medications, duration of diagnosis, comorbidity, functional status and pain will be questioned and recorded. group1: group receiving dynamic balance exercise with tecnobody prokin 252 balance device added to current medical treatment (intervention group) the first group will be given dynamic balance exercises with the tecnobody prokin 252 device and participants will continue their current medical treatment. these dynamic balance exercises will be performed in 3 days a week for 6 weeks. each exercise will last 30 minutes. it will take 18 sessions in total. these exercises include 14 balance exercise movements performed on tecnobody prokin 252 balance device (manufactured in italy). group 2: group receiving current medical treatment (control group) participants in this group will receive only current medical treatment. care will be taken not to change the medical treatments of the participants during the study. all participants will be evaluated with the following evaluation parameters before the treatment and at the end of 6 weeks.

Eligibility criteria:
inclusion criteria: * participants aged 18 to 65 years with a clinical diagnosis of ankylosing spondylitis according to asas criteria * to have the ability to give written informed consent * having the ability to understand procedures exclusion criteria: * visual and vestibular system diseases that may affect balance * neurological or orthopedic diseases that may affect balance (parkinson's disease, history of stroke, presence of knee or hip prosthesis, previous fracture sequelae, foot problems, etc.) * individuals with severe mental and sensory problems * history of balance exercise and/or spine surgery in the last 6 months * pregnancy or breastfeeding * over 150 kg

Keywords: tecnobody ankylosing spondylitis balance
effect of topical lidocaine on warm and cold sensation in healthy individuals

Conditions: Neuropathy;Peripheral; Thermal Hypesthesia

Summary: the purpose of the present study is to systematically test the occurrence of paradoxical and illusory responses to cold and warm stimuli in healthy volunteers with artificial sensory loss.

efficient thermal sensation is important for adequate behavioral response to cold or warm stimuli and early signs of neuropathy can be changes in the thermal sensation. alterations in thermal perception can results in paradoxical heat sensation (a warm perception when the skin is cooled) or a peculiar/burning sensation when the skin is stiumlated with simultaneous warm and cold (a "thermal grill"). clarifying the occurrence of these paradoxical and illusory sensations, may help understanding early signs of peripheral neuropathy as well as thermal sensory perception. the investigators plan to conduct a study on thermal sensory perception using a model of sensory loss in healthy volunteers and systematically test the occurrence of paradoxical heat sensations and responses to the thermal grill.

Eligibility criteria:
inclusion criteria: * healthy subjects * age between 18 and 40 years * participant is able and willing to give informed consent. exclusion criteria: * unable to understand and speak danish * non-cooperative * chronic pain or acute pain the past week lasting more than 4 hours or pain on the day of investigation * pain medication within the last week * medication within the last week that can affect assessment * psychiatric or neurological disease and diseases that may affect the assessment * sensory disturbances * history or symptoms of significant diseases (e.g. psychiatric or neurological disease, diseases that may affect the assessment, sensory disturbances, cancer, diabetes mellitus, liver diseases, kidney diseases, cardiovascular diseases) * pregnancy or lactation * jetlag or sleep deprivation * alcohol or drug abuse * consumption of cannabis the last 4 weeks and consumption of alcohol in the last 48 hours * any abnormality of the skin or of vascular origin at application site * history of hypersensitivity to lidocaine, other amide-type anesthetics, or other contents of the lidocaine or vehicle

Keywords: paradoxical heat sensations thermal grill illusion lidocaine
bms - safety, pharmacokinetics (pk) and pharmacodynamics (pd) of dapagliflozin in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: to obtain safety and tolerability information in patients with type 1 diabetes where dapagliflozin is added on to insulin (for 14 days)

study classification : safety, pharmacokinetics and pharmacodynamics

Eligibility criteria:
inclusion criteria: * type 1 diabetes with central lab glycosylated hemoglobin (a1c) ≥ 7.0% and ≤ 10.0% * insulin use for at least 12 months and initiation immediately after diagnosis of diabetes * method of insulin administration \[multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii)\] stable ≥ 3 months * stable basal insulin dose ≥ 2 weeks * ages 18 to 65 years * central laboratory c-peptide value of \< 0.7 ng/ml * body mass index (bmi) 18.5 to 35.0 kg/m2 exclusion criteria: * history of type 2 diabetes mellitus (t2dm), maturity onset diabetes of young (mody), pancreatic surgery or chronic pancreatitis * oral hypoglycemic agents * history of diabetes ketoacidosis (dka) within 24 weeks * history of hospital admission for glycemic control within 6 months * frequent episodes of hypoglycemia (2 unexplained within 3 months) or hypoglycemic unawareness * aspartate aminotransferase (ast), alanine aminotransferase (alt) or serum total bilirubin \> 2x upper limit of normal (uln) * abnormal free t4 \[if screening thyroid stimulating hormone (tsh) abnormal\] * estimated glomerular filtration rate (egfr) modification of diet in renal disease (mdrd) formula ≤ 60 ml/min/1.73m2 * cardiovascular (cv)/vascular diseases within 6 months
edwards lifesciences self-expanding stent peripheral vascular disease study

Conditions: Intermittent Claudication; Atherosclerotic Disease; Arterial Occlusive Disease

Summary: the main objective of this study is to assess the safety and effectiveness of the edwards lifesciences lifestent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (sfa) disease by reducing the re-intervention rate as compared to percutaneous transluminal angioplasty (pta) alone

the resilient trial is a dual stage clinical investigation designed to evaluate the safety and effectiveness of the edwards lifesciences self-expanding stent system. phase 1 consists of a prospective, multi-center, non-randomized study with a peri-procedure endpoint. phase 2 consists of a prospective, multi-center, randomized study with a 30-day primary safety endpoint and a 6-month primary effectiveness endpoint.

Eligibility criteria:
inclusion criteria: * written informed consent approved by the irb. * ≥ 18 years old. * lifestyle-limiting claudication defined as: rutherford cat. 1-3. * target lesion(s) is de-novo or restenotic and located within the native sfa and/or proximal popliteal artery * angiographic evidence of ≥ 50% stenosis or occlusion * target rvd is ≥ 4.0 mm and ≤ 7.0 mm * target total length of the lesion or series of lesions is ≤ 150 mm. * angiographic evidence of at least one vessel runoff to the foot. exclusion criteria: * unable to conform to the study protocol procedures and visits. * lifestyle-limiting claudication/cli (rutherford cat. 4-6) * patients who are pregnant or planning to become pregnant during the clinical investigation * contraindication to study related medications, ni, ti, ta, or other media that is not amenable to pretreatment. * history of bleeding diatheses or coagulopathy. * concomitant renal failure with a creatinine of \> 2.0 mg/dl. * concomitant hepatic insufficiency, thrombophlebitis, uremia, sle, or dvt at the time of the study procedure. * receiving dialysis or immunosuppressive therapy. * suffered a hemorrhagic stroke ≤ 6 mo prior to the study procedure. * prior peripheral vascular bypass surgery involving the target limb. * target vessel has been previously stented. * target lesion(s) received angioplasty intervention ≤ 6 mo. prior * any non-iliac percutaneous intervention(s) \< 7 days prior. * currently participating in an investigational drug/device study. * limited life expectancy of less than two years. * extensive pvd that precludes safe insertion of an sheath. * target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s). * unresolved thrombus within the target vessel. * poor inflow which would not support a vascular bypass graft. * diagnosed with septicemia at the time of the study procedure. * additional percutaneous interventional procedures (cardiac/peripheral) planned ≤ 30 days following procedure.

Keywords: sfa, edwards, popliteal, lifestent, pta, nitinol
toripalimab plus neoadjuvant chemotherapy combined with chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this phase ii non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.

this phase ii non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma. all patients were planned to receive 2 cycle of toripalimab plus paclitaxel/nedaplatin as neoadjuvant therapy. then they all receive radical dose of chest radiation and concurrent chemotherapy of capecitabine (po 1000 mg/m2, bid, d1-d14, q3w).

Eligibility criteria:
inclusion criteria: * histologically confirmed esophageal squamous cell carcinoma * patients have measurable or evaluable lesions based on the response evaluation criteria in solid tumors (recist) criteria * unresectable t1-4 n0-3 m0-1 confirmed by ct or mri (m1 only includes patients with lymph node metastasis in the supraclavicular region) * ecog performance status 0-1 * no previous chest radiotherapy, immunotherapy or biotherapy. * hemoglobin≥10 mg/dl, platelet≥100000/μl,absolute neutrophil count ≥1500/μl * serum creatinine ≤1.25 times the upper normal limit(unl), or creatinine clearance≥60 ml/min * bilirubin ≤1.5 times unl, ast（sgot）≤2.5 times unl ,alt（sgpt）≤2.5 times unl,alkaline phosphatase ≤5 times unl * fev1 \>0.8 l * cb6 within normal limits * patients and their family signed the informed consents exclusion criteria: * previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ * contraindication for chemotherapy * women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose * women who has the probability of pregnancy without contraception * tendency of hemorrhage * in other clinical trials within 30 days * addicted in drugs or alcohol, aids patients * uncontrollable seizure or psychotic patients without self-control ability * severe allergy or idiosyncrasy * not suitable for this study judged by researchers

Keywords: toripalimab, neoadjuvant, concurrent chemoradiotherapy, esophageal squamous cell carcinoma
relationship of skeletal muscle thickness, strength, and diaphragm function in adults with cf

Conditions: Cystic Fibrosis

Summary: 31 cf patients and 23 healthy sex and age-matched volunteers were enrolled. all subjects underwent pulmonary function tests, 6-minute walking tests. body mass index and fat free mass index were measured via a body composition analyser. diaphragm ultrasonography (to measure thickening fraction), quadriceps femoris muscle ultrasonography were performed. a dynamometer was used to measure each subjects handgrip strength.


Eligibility criteria:
inclusion criteria: * cf diagnosed * age 18 and above exclusion criteria: * having a pulmonary flare up within the previous month * pregnancy

Keywords: cf, nutritional status, peripheral muscle thickness, peripheral muscle strength, diaphragm thickening fraction
repeatability and reproducibility of the arcscan insight 100 vhf digital ultrasound

Conditions: Corneal Thickness Measurement; Epithelial Thickness Measurement; Anterior Eye Segment Measurements

Summary: the purpose of this study is to evaluate the repeatability and reproducibility of corneal (including corneal, epithelial, stromal, and lasik flap thickness) and anterior segment measurements using the arcscan insight 100 very high-frequency digital ultrasound arc-scanner.

very high-frequency (vhf) digital ultrasound was first used in 1993 to obtain images of the cornea (the window at the front of the eye) and anterior segment (the space behind the cornea including the iris and the lens). a commercially available instrument, called the artemis 2, has been used in routine clinical practice since 2001. the artemis 2 was ce approved as well as having fda approval (the us equivalent of the ce mark). the arcscan insight 100 vhf digital ultrasound scanner is a new instrument so does not yet have a ce mark. however, the arcscan insight 100 is an upgraded version of the artemis 2, so any differences are improvements to components, but the measurement method remains essentially the same. the aim of the study is to establish the repeatability (i.e. the variability in measurements taken by a single examiner during a single visit) and reproducibility (i.e. the variability in measurements taken in the same conditions between two examiners) of the arcscan insight 100 device for measuring corneal and anterior segment parameters.

Eligibility criteria:
inclusion criteria only patients who are medically suitable for corneal refractive surgery can be included in the study. as general inclusion criteria the following aspects are defined: * subjects should be 21 years of age or older. * contact lens wearers must stop wearing their contact lenses at least four weeks per decade of wear before baseline measurements in case of hard contact lenses and one week before baseline measurements in case of soft contact lenses. * patient will be able to understand the patient information and willing to sign an informed consent. for the repeatability and reproducibility phase using normal eyes of the study: * eyes with no ocular pathology * eyes with no previous ocular or corneal surgery for the repeatability and reproducibility phase using post-lasik eyes of the study: • eyes between 3 and 9 months after lasik or smile for the comparison of arcscan insight 100 vhf digital ultrasound with rtvue oct • either eyes before or after corneal refractive surgery exclusion criteria * previous ocular or corneal surgery (for normal eyes) * patient not being able to tolerate local or topical anesthesia * patient has active conjunctivitis or any active ocular infection or inflammation * patient has a corneal ulcer * patient has an open wound on the corneal epithelium * patient has compromised epithelium (e.g. ≥grade 3 superficial punctate keratitis) * pregnancy

Keywords: vhf digital ultrasound corneal thickness epithelial thickness angle diameter sulcus diameter anterior chamber depth repeatability reproducibility