Kornimate/medical-research-clean huggingface dataset:
descriptive study of drug compliance in uncontrolled hypertensive patients

Conditions: Uncontrolled Hypertension

Summary: therapeutic compliance is defined as the degree of coincidence between a person's behavior and prescribing advice given by his or her physician. according to the world health organization (who), "insufficient adherence is the main reason why patients do not get all the benefits they could expect from their medicines. it causes medical and psychosocial complications, diminishes the quality of life of patients, increases the likelihood of drug resistance, and waste of resources. " in the case of certain conditions such as high blood pressure (hypertension), poor adherence increases the risk of stroke, acute coronary syndrome, and heart failure. in patients with uncontrolled hypertension under treatment, the issue of therapeutic non-compliance should always be considered before considering the dose (supplemental drug) of antihypertensive therapy. for each patient participating in the study, medication adherence (for one of the antihypertensive treatments) will be assessed for 2 months using an electronic pill. the antihypertensive treatments considered for the study belong to the following classes: diuretics, beta-blockers, calcium-blockers, ace (angiotensin-converting enzyme) inhibitors, sartans. main objective: care objective: to provide physicians and patients with assistance in case of ineffectiveness or therapeutic escape in a chronic disease such as hypertension, by assessing the compliance profile of each patient. secondary objectives: to carry out a quantitative typology of drug adherence in patients with unbalanced hta under treatment.


Eligibility criteria:
inclusion criteria: * patient treated with diuretics and / or beta-blockers and / or calcium-blockers and / or ace inhibitors and / or sartans * holter blood pressure total average of 24h greater than 135/85 mmhg or a daytime average greater than 140/90 mmhg or a nighttime average greater than 125/75 mmhg. * informed consent given exclusion criteria: * adults with severe hypertension (bp ≥ 180/110 mmhg) with or without organ failure requiring therapeutic adaptation * adults unable to comply with study procedures * patients who do not wish to receive generic drugs.

Keywords: drug compliance hypertension anti-hypertensive agents
registry for severe rop and treatment on visual outcomes

Conditions: Retinopathy of Prematurity

Summary: the purpose of this study is to determine what factors influence the visual outcomes of infants with severe retinopathy of prematurity (rop) and to monitor the outcomes.


Eligibility criteria:
inclusion criteria: * documentation of informed consent and authorization * inborn and those admitted within 7 days of birth * infant with a diagnosis of stage 2 rop or higher * site ability to plan close ophthalmological follow-up due to significant and persistent rop * parents must agree to report outcomes following each ophthalmological visit and overall outcomes for up to five (5) years of age * ability to obtain follow-up data on outcomes if the child is transferred to another facility * no known major congenital anomalies exclusion criteria: * rop stage 1 or less * parents unwilling to participate in follow-up * major congenital anomalies

Keywords: retinopathy of prematurity
the association between tau & gfap and postoperative neurological impairment in patients undergoing cardiac surgery

Conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass; Brain Injury; Congenital Heart Defect

Summary: patients born with heart defects often undergo surgical procedures on a heart lung machine. with improvements in medical and surgical management, their survival has significantly improved, but their brain insult has not been paid much attention. this study is to determine the relationship between specific proteins in the blood and brain injury in patients less than 18-year-old undergoing heart surgery.


Eligibility criteria:
inclusion criteria: * less than 18 years old * undergoing cardiac surgery with cardiopulmonary bypass at boston children's hospital exclusion criteria: * undergoing an emergent procedure and do not have more than 1 hour ahead of time to review the consent * patient in a moribund condition american society of anesthesiology (asa 5) * patient with a hematological and/or oncological disease * jehovah witnesses * patient on preoperative mechanical ventilation
the relationship between social anxiety and anxious thinking styles

Conditions: Social Anxiety

Summary: this study aims to investigate whether reductions in negative interpretation biases, induced via an experimental manipulation (cognitive bias modification for interpretation; cbm-i), lead to reductions in symptoms of social anxiety amongst individuals experiencing high levels of social anxiety. the study further aims to investigate the relationship between multifaceted measures of interpretation bias, psychopathological symptoms, neurophysiological indices, behavioral indices of stress reactivity, and sad symptoms. to achieve these aims a sample of individuals experiencing high levels of social anxiety will be recruited. after completing multi-faceted measures of interpretation bias, including neurophysiological indices, participants will be randomized to complete an online one-week daily cbm-i or sham training control condition training schedule. following the one week training, individuals will return to the lab to complete further multi-faceted measures of interpretation bias and social anxiety symptoms. one week after this (i.e. 2 weeks post-basline), participants will complete a final set of symptom and bias measures online.


Eligibility criteria:
inclusion criteria: * provides informed consent * sufficient german language skills to complete the experimental tasks and questionnaires * aged between 18 and 65 years * scoring ≥ 52 on the spai-g (turner et al., 1989; fydrich, 2016), indicating elevated levels of social anxiety * lives within reasonable travelling distance of the research centre exclusion criteria: * current psychotherapeutic treatment or psychotherapeutic treatment completed within the last 6 months prior to study enrolment. * current substance misuse or dependency (apart from nicotine) * acute suicidality or self-harm * symptoms of a psychotic or bipolar disorder * presence of a somatic condition that could systematically affect cortisol levels (in particular: pregnancy and lactation, adrenal dysfunction, thyroid dysfunction, pituitary dysfunction) * presence of a somatic condition that could systematically affect brain physiology (current or anamnestic neurological disorders, in particular: anamnestic traumatic brain injury, epilepsy, multiple sclerosis, brain tumors) * presence of a somatic condition that could systematically affect peripheral physiological measures (in particular: cardiovascular diseases (e.g., cardiac arrhythmias, circulatory diseases \[e.g., hypertension\])) * sensitivity or alteration of skin surface providing contraindication for eeg or periphysiological measures (in particular: baldness, dreadlocks, open wounds on the head or facial surface, skin conditions that cause particular sensitivity to gels and creams) * intake of psychotropic medication that cannot be interrupted during study duration or change in psychotropic medication within the 8 weeks before starting the study (except: antidepressants in unaltered dosage) * left handedness

Keywords: social anxiety interpretation bias cognitive bias modification
polyp recognition assisted by a device interactive characterization tool - the predict study

Conditions: Artificial Intelligence

Summary: diminutive colorectal polyps (≤ 5 mm) represent most of the polyps detected during colonoscopy, especially in the rectum-sigmoid tract. the characterization of these polyps by virtual chromoendoscopy is recognized as a key element for innovative imaging techniques. as a matter of facts diminutive colorectal polyps are very frequent and, if located in the rectosigmoid colon, they present a very low malignant risk (0.3% of evolution towards advanced adenoma and up to 0.08% of evolution towards invasive carcinoma). the real-time characterization would allow to identify the lowest risk polyps (hyperplastic subtype), to leave them in situ or, if resected, not to send them for histological examination, allowing a huge saving in healthcare associated costs. recently, the american society for gastrointestinal endoscopy (asge) technology committee established the preservation and incorporation of valuable endoscopic innovations (pivi) document, specific for real-time histological assessment for tiny colorectal polyps, to establish reference quality thresholds. two performance standards have been developed to guide the use of advanced imaging: 1. for diminutive polyps to be resected and discarded without pathologic assessment, endoscopic technology (when used with high confidence) used to determine histology of polyps ≤ 5mm in size, when combined with the histopathology assessment of polyps \> 5 mm in size, should provide a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps; 2. in order for a technology to be used to guide the decision to leave suspected rectosigmoid hyperplastic polyps ≤ 5 mm in size in place (without resection), the technology should provide ≥ 90% negative predictive value (when used with high confidence) for adenomatous histology. computer-aided-diagnosis (cad) is an artificial intelligence-based tool that would allow rapid and objective characterization of these lesions. the gi genius cadx was developed to help endoscopists in their clinical practices for polyps characterization.


Eligibility criteria:
inclusion criteria: * patients aged 40-80 undergoing screening colonoscopy for crc * ability to provide written, informed consent (approved by ec) and understand the responsibilities of trial participation. exclusion criteria: * subjects positive to fecal immunochemical test or fecal occult blood test; * subjects undergoing crc surveillance colonoscopy * subject at high risk for crc * subjects with a personal history of crc, ibd or hereditary polyposic or non-polyposic syndromes; * patients with previous resection of the sigmoid rectum; * patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings; * patients who perform an emergency colonoscopy.
a study to assess the efficacy and safety of tc-5214 as an adjunct therapy in patients with major depressive disorder (mdd)

Conditions: Major Depressive Disorder; Depression

Summary: the purpose of this study is to determine if tc-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

a multicenter, randomized, double-blind, parallel group, placebo-controlled, phase iii efficacy and safety study of tc-5214 (s-mecamylamine) in flexible doses as an adjunct to an antidepressant in patients with major depressive disorder with an inadequate response to antidepressant therapy.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent before initiation of any study-related procedures. * the patient must have a clinical diagnosis of major depressive disorder (mdd) with inadequate response to no more than one antidepressant. * out-patient status at enrollment and randomization. exclusion criteria: * patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder. * patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide. * history of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population

Keywords: major depressive disorder mdd depression safety add-on therapy
pain evaluation after anterior cruciate ligament (acl) ligamentoplasty

Conditions: Arthroscopic Anterior Cruciate Ligament Reconstruction

Summary: the "all-inside" method is a new minimally invasive procedure for anterior cruciate ligament reconstruction (acl). it consists of incomplete bone tunnels drilling and cortical fixation. in the so-called "classical" method, the fixation is achieved with interference screws. the hypothesis of this study was that the "all-inside" technique causes less pain than the conventional technique. the main objective was to evaluate the immediate postoperative pain for the first ten days and at one month from the intervention.


Eligibility criteria:
inclusion criteria: * total or partial tear of the anterior cruciate ligament exclusion criteria: * patient refusal

Keywords: anterior cruciate ligament arthroscopy incomplete bone tunnels anterior cruciate ligament reconstruction
a six-week study evaluating the efficacy and safety of geodon in patients with a diagnosis of bipolar i depression

Conditions: Bipolar Disorder

Summary: this is a 6-week trial that evaluates the efficacy and safety of geodon (ziprasidone) in outpatient subjects ages 18 and older with bipolar disorder type i, depressed. subjects are required to undergo a washout period of at least 7 days of any prior med.


Eligibility criteria:
inclusion criteria: * subjects must have a primary diagnosis of bipolar i disorder, most recent episode depressed, with or without rapid cycling, without psychotic features, as defined in diagnostic and statistical manual (of mental disorders) - fourth edition - text revision (dsm-iv-tr) (296.5x) and confirmed by a structured mini international neuropsychiatric interview (mini) exclusion criteria: * subjects with a dsm-iv tr diagnosis of schizophrenia (295.xx), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder not otherwise specified (298.9). * subjects with other dsm-iv tr axis i or axis ii disorder (in addition to bipolar i disorder) are ineligible if the comorbid condition is clinically unstable, requires treatment, or has been a primary focus of treatment within the 6 month period prior to screening.

Keywords: bipolar i disorder
melody transcatheter pulmonary valve (tpv) post-market surveillance study

Conditions: Heart Valve Diseases

Summary: this non-randomized, prospective, interventional observational multi-center study is designed to assess the long-term clinical performance of the medtronic melody™ transcatheter pulmonary valve (tpv) in the post market environment over a period of five years after transcatheter implantation in patients with dysfunctional rvot conduits. in addition, the quality of life of implanted subjects will be assessed over five years.


Eligibility criteria:
prospective subjects have complex congenital heart defects that have been palliated with rvot conduits that have become dysfunctional and have a clinical indication for invasive intervention. prospective subjects must meet all of following inclusion and exclusion criteria: inclusion criteria: * age greater than or equal to 5 years of age * weight greater than or equal to 30 kilograms * existence of a full (circumferential) rvot conduit that was equal to or greater than 16 mm in diameter when originally implanted * any of the following by transthoracic echocardiography for patients in nyha classification ii, iii, or iv: * moderate (3+) or severe (4+) pulmonary regurgitation, or * mean rvot gradient greater than or equal to 35 mmhg. for patients in nyha classification i: * severe (4+) pulmonary regurgitation with rv dilatation or dysfunction, or * mean rvot gradient greater than or equal to 40 mmhg. exclusion criteria: * active endocarditis * a major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year * patient or - for patients who cannot legally give consent themselves- the guardian unwilling or unable to provide written informed consent or comply with follow-up requirements * obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein * known intravenous drug abuse

Keywords: pulmonary valve congenital heart disease
comparison of stacked-pulses vs. double-pass treatments of facial acne with a 1450 nm laser

Conditions: Acne; Acne Scars

Summary: acne can be treated with a mid-infrared laser. we demonstrated safety and efficacy using lower energy settings in order to make the treatments less painful

numerous light based therapies are currently being used for the treatment of acne. non-ablative mid-infrared lasers have the advantage of decreasing inflammatory acne and improving acne scars. specifically, the 1450 nm laser has been shown to be quite effective. however, it is associated with considerable pain at higher fluences despite topical anesthetics, especially when treating inflammatory acne. the goal of this study was to determine the possibility of using low fluence settings to treat moderate to severe acne at a more tolerable pain level without compromising treatment effectiveness.

Eligibility criteria:
inclusion criteria: * acne lesion count of at least 10 inflammatory papules on each side of the face and a severity grade consistent with color photographs in the allen \& smith grading scale of greater than or equal to grade 3 and no worse than grade 5 exclusion criteria: * exclusion criteria included the use of oral retinoids or systemic corticosteroids within the past 6 months and the use of all prescription topical or systemic anti-acne medications 4 weeks prior to the initiation of the study

Keywords: diode laser acne acne scar
cytomegalovirus-specific response measured by quantiferon® and overall immunologic response measured by immuknow® in lung transplant patients cmv-positive

Conditions: Cytomegalovirus Infections

Summary: the purpose of this study is to determine the sensitivity and specificity of quantiferon® and immuknow® in combination for early detection of patients who will develop cmv infection in lung transplant patients with cmv-positive serology (r+) prior to transplant.

the secondary objectives of the study are: * to evaluate cytomegalovirus (cmv)-specific immune response measured by quantiferon®. * to evaluate overall immune response measured by immuknow®. * to study the course of quantiferon® and immuknow®over the follow-up period. * to correlate levels of immuknow® and quantiferon®. * to evaluate the relationship between levels and doses of immunosuppressants and their relationship to degree of overall immunosuppression (immuknow®). * to evaluate the relationship between infections, immunological complications and degree of overall immunosuppression (immuknow®).

Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years. * men or women who have received a lung transplant. * cmv-seropositive patients (r+). * patients who have been informed of the study procedures and have signed the informed consent form. * over 3 months posttransplant. exclusion criteria: * patients who are not expected to be able to be followed during the first 12 months posttransplant. * patient participation in another clinical trial or study will not be a criterion for exclusion.

Keywords: lung transplant quantiferon immuknow
green tea extract for endometriosis treatment

Conditions: Endometriosis

Summary: the purpose of the study is to evaluate the efficacy and safety of green tea in endometriosis.

women with endometrioma will be randomised into either the experimental group or the placebo comparator group in a 1:1 ratio. the subjects will be given sunphenon egcg or placebo for 3 months prior to their planned surgery.

Eligibility criteria:
inclusion criteria: * complaints of pelvic pain, dysmenorrhoea and/or dyspareunia ≥ 6 months; and * verbal pain rating scale \> 4/10 and visual analogue pain scale \> 4cm; and * ultrasound confirmed endometrioma with or without fibroid and adenomyoma; and * planned surgery treatment within 4-6 months exclusion criteria: * age \ 40 year behind the active reproductive age; or * bmi \ 25 kg/m2 as overweight; or * chronic pelvic pain or low back pain due to other medical conditions, e.g. urological disorders and orthopaedic disorders; or * secondary dysmenorrhoea due to gynaecological conditions other than endometriosis, e.g. pelvic inflammatory diseases, genitourinary infections, gynaecological tumours, etc.; or * primary dysmenorrhoea without any underlying disease identified; or * ultrasound suggested polycystic ovary, haemorrhagic ovarian cyst, ovarian dermoid cyst, cystic neoplasm, tubo-ovarian abscess or other ovarian pathologies in the same ovary; or * chronic medical conditions under long-term medications; or * endometriosis under active medication in past 1 month; or * history of herbal medicine intake in past 1 month
g1t38, a cdk 4/6 inhibitor, in combination with fulvestrant in hormone receptor-positive, her2-negative locally advanced or metastatic breast cancer

Conditions: Carcinoma, Ductal, Breast; Breast Cancer; Breast Neoplasm

Summary: this is a study to investigate the potential clinical benefit of g1t38 as an oral therapy in combination with fulvestrant in patients with hormone receptor-positive, her2-negative metastatic breast cancer. the study is an open-label design, consists of 2 parts: dose-finding portion (part 1), and expansion portion (part 2). both parts include 3 study phases: screening phase, treatment phase, and survival follow-up phase. the treatment phase begins on the day of first dose with study treatment and completes at the post-treatment visit. approximately, 102 patients will be enrolled in the study.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of hr-positive, her2-negative breast cancer, not amenable to curative therapy * pre- or perimenopausal women can be enrolled if amenable to be treated with goserelin * patients must satisfy 1 of the following criteria for prior therapy: * progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor or tamoxifen * progressed during treatment or within 2 months after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer, or prior endocrine therapy for advanced/metastatic breast cancer * received ≤ 2 chemotherapy regimens (part 1) or ≤ 1 chemotherapy regimen (part 2) for advanced/metastatic disease * for part 1, evaluable or measurable disease (bone only disease eligible for part 1 only) * for part 2, measurable disease as defined by recist, version 1.1 * ecog performance status 0 to 1 * adequate organ function exclusion criteria: * for part 1, prior treatment with fulvestrant * for part 2, prior treatment with any cdk inhibitor or fulvestrant * active uncontrolled/symptomatic cns metastases, carcinomatous meningitis, or leptomeningeal disease * chemotherapy within 21 days of first g1t38 dose * investigational drug within 28 days of first g1t38 dose * concurrent radiotherapy, radiotherapy within 14 days of first g1t38 dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to \> 25% of bone marrow * prior hematopoietic stem cell or bone marrow transplantation

Keywords: breast cancer cdk 4/6 inhibitor her2-negative hr-positive hr+ her2- her2 -ve her2 +ve
the efficacy of paracetamol in reducing pain during ophthalmological examination for retinopathy of prematurity: a prospective randomised trial

Conditions: Retinopathy of Prematurity

Summary: retinopathy of prematurity (rop) is one of the major morbidity among preterm infants. although, local anesthetics reduce pain to some extent, eye examination still remains as a painful procedure. the investigators aimed to evaluate the effect of oral paracetamol combined with local anesthetics for pain relief during ophthalmological examination.


Eligibility criteria:
inclusion criteria: * gestational age below 32 weeks or birth weight below 1500 grams exclusion criteria: * congenital anomalies, necrotising enterocolitis, surgical problems