Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy of docetaxel and carboplatin in metastatic malignant melanoma failed first-line dacabazine or temozolomide contained therapy

Conditions: Malignant Melanoma

Summary: this is the phase ii, single-arm, single-center study assessing the efficacy of weekly docetaxel plus carboplatin in second-line treatment of malignant melanoma (unresectable or metastatic) who has failed dacarbazine or temozolomide contained therapy. the primary end point is overall response rate according to recist 1.1 criteria assessed using ct or mri and secondary end point includes disease control rate, progression free survival, overall survival and safety.


Eligibility criteria:
inclusion criteria: * patients with histologically proven malignant melanoma (recurred or metastatic) that had progressed during or after receiving at least one cycle of a regimen containing dacarbazine or temozolomide in the advanced setting * measurable disease (recist) * ecog performance 0-2 * adequate organ function * total bilirubin \<1.5n ; asat and alat \<2.5n * serum creatinin \< 1.5n * anc ≥ 1,500/mm³ (g-csf allowed) * platelets ≥ 100,000/mm³ * hb ≥ 9.0 g/dl * life expectancy of at least 12 weeks * signed written informed consent exclusion criteria: * symptomatic brain metastasis * previous history of treatment with taxane or platinum agent containing chemotherapy * previous major surgery within 2 weeks before the start of the trial, or a failure to recover from the surgery * previous history of other malignancies within 5 years except for cured skin basal cell carcinoma or cured in-situ cervix cancer * other severe medical conditions (infection, uncontrolled hypertension, heart failure, mi history within 6 months) * sensitivity to platinum agents or docetaxel * uncontrolled seizure * women pregnant or nursing * alcohol or drug abuser

Keywords: malignant melanoma, second-line treatment, docetaxel, carboplatin
examining the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women

Conditions: Chronotype; Pregnancy Complications

Summary: purpose: the aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women. methods: eighty-five pregnant women in the second trimester were included in the study. the chronotypes of pregnant women were determined using the morningness-eveningness questionnaire (meq). then, oral glucose tolerance tests were performed on the participants between 24-28 weeks. also, pregnant women's nausea and vomiting conditions with the pregnancy-unique quantification of emesis and nausea (puqe) and sleep quality with pittsburgh sleep quality index (psqi) were evaluated.

purpose: the aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women. methods: this study is a single-blind (participants), parallel trial. it was performed in line with the principles of the declaration of helsinki. the followings were the study's inclusion requirements: being between the ages of 18-40, having a singleton pregnancy, being in the second trimester, and not having any known chronic disease. exclusion criteria are working night shifts, having a high-risk pregnancy, and having a neurological or orthopedic disease. eighty-five pregnant women in the second trimester were included in the study. the chronotypes of pregnant women were determined using the morningness-eveningness questionnaire (meq). then, oral glucose tolerance tests were performed on the participants between 24-28 weeks. also, pregnant women's nausea and vomiting conditions with the pregnancy-unique quantification of emesis and nausea (puqe) and sleep quality with pittsburgh sleep quality index (psqi) were evaluated.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-40, * having a singleton pregnancy, being in the second trimester, * not having any known chronic disease. exclusion criteria: * working night shifts, * having a high-risk pregnancy, * having a neurological or orthopedic disease.
a study assessing the safety and efficacy of de-117 ophthalmic solution in patients with poag or oht

Conditions: Glaucoma and Ocular Hypertension

Summary: the purpose of this study is to investigate the safety and efficacy of up to three concentrations of de-117 ophthalmic solution (low dose, medium dose, and high dose) as monotherapy and as adjunctive therapy (de-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular hypertension.

this is a two stage study. stage one will explore the dose response of three concentrations of de-117 as monotherapy compared with 0.0015% tafluprost and placebo. the safety and efficacy of de-117 as adjunctive therapy (with 0.0015% tafluprost) compared with 0.0015% tafluprost and placebo will also be evaluated. in addition, the additive effect of adjunctive therapy of each concentration will be compared with the corresponding monotherapy concentration. stage two will assess the safety and efficacy of the optimal de-117 concentration as monotherapy compared with 0.0015% tafluprost. the safety and efficacy of the optimal de-117 concentration as adjunctive therapy (with 0.0015% tafluprost) compared with de-117 monotherapy and 0.0015% tafluprost will also be evaluated.

Eligibility criteria:
inclusion criteria: 1. male or female, 18 years of age or older 2. current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes 3. qualifying intraocular pressure (iop) in at least one eye at baseline exclusion criteria: 1. closed/barely open anterior chamber angle or a history of acute angle closure in either eye 2. anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (iop) during the study period 3. females who are pregnant, nursing or planning a pregnancy 4. presence of any abnormality or significant illness that could be expected to interfere with the study.
safety and efficacy of herbal tea in type 2 diabetics

Conditions: Type 2 Diabetes; Herbal Medicine Adverse Reaction

Summary: nearly 25% of the world's population relies on traditional medicinal systems but for professionals their effectiveness and even more safety are the main concern. therefore, the aim of this preliminary study is to assess safety and effectiveness of herbal tea mixture on the control of glycaemia in type 2 diabetics.the mixture consists of nine plants which have well-documented traditional use for the control of glycaemia.

the study will include type 2 diabetics who are taking only oral hypoglycemic medications (without insulin). their therapy has to be stable for at least 3 months prior enrollment. besides anthropometric measures, patient's glycaemia, renal and liver function will be monitored. safety and adverse events will be closely monitored and these are the primary outcomes of the study. the main outcome measure of the effectiveness is hba1c (glycated hemoglobin). patients will be given detailed instructions on how to prepare the tea and the dosing. the intervention will last 3 months and during that time patients will be asked not to change their dietary or lifestyle habits.

Eligibility criteria:
inclusion criteria: * signed informed consent * croatian-speaking * stable therapy for at least 3 months prior enrollment * not taking any dietary supplements, especially herbal-based * not taking any other herbal medicine (as a tea or a supplement) * stable dietary and lifestyle patterns for at least 3 months prior enrollment exclusion criteria: * type 1 diabetes * severe somatic disorder (oncological disease, hepatic, renal or autoimmune disease) * pregnancy * inability to fill in questionnaires in croatian * cognitive impairment * psychiatric disorder * undergoing current treatment for a major medical illness such as malignancy, autoimmune or immune deficiency disorder * clotting disorders * having nutritional deficiency (e.g. iron deficiency) * current or history of eating disorder (anorexia, bulimia or ednos) * current use of weight loss interventions (drugs; exercise interventions) * regular use of dietary supplements, especially herbal-based * regular use of herbal medicine (as a tea or a supplement) * significant changes in diet or lifestyle patterns (e.g. increased physical activity) in the last 3 months prior the enrollment

Keywords: type 2 diabetes herbal medicine safety glycaemia control alternative therapy
rct of an integrative intervention for non-treatment-seeking meth users

Conditions: HIV/AIDS; Stimulant Use Disorders

Summary: in the era of hiv treatment as prevention (tasp), efforts are needed to identify evidence-based combination prevention approaches that achieve greater decreases hiv viral load among populations that are more likely to engage in hiv transmission risk behavior. because methamphetamine-using men who have sex with men (msm) are at greater risk for acquiring and transmitting hiv, interventions targeting stimulant use in this population of high-risk men could boost the effectiveness of tasp. at present, only conditional cash transfer approaches such as contingency management (cm) have demonstrated short- term efficacy in reducing stimulant use among substance-using msm who are not actively seeking formal treatment. the proposed rct will examine the efficacy of a positive affect intervention that is designed to optimize the effectiveness of cm to achieve long-term reductions in stimulant use and hiv viral load in this population. the team will examine the efficacy of this integrative intervention in a randomized controlled trial (rct) with 110 hiv-positive, methamphetamine-using msm. after enrolling in cm, participants will be randomized to receive either: 1) the positive affect intervention; or 2) a attention-matched control condition. follow-up data will be collected at 3, 6, 12, and 15 months post-randomization. this rct will provide an opportunity to examine the efficacy of an integrative intervention designed to promote long-term reductions in hiv viral load as the primary outcome. secondary outcomes that will be examined include: increases positive affect, reductions in stimulant use, improvements in t-helper (cd4+) count, unsuppressed viral load, and decreases hiv transmission risk behavior. identifying an efficacious intervention approach to decrease hiv viral load among methamphetamine-using msm would substantially support the goals of the national hiv/aids strategy to reduce hiv incidence and mitigate hiv-related health disparities.


Eligibility criteria:
inclusion criteria: * at least 18 years old * documentation of hiv-positive serostatus * speak english * biological verification of recent methamphetamine use * completion of at least three contingency management (cm) visits * self reported anal sex with a man (msm) in the past 12 months exclusion criteria: * inability to provide informed consent, evidenced by cognitive impairment * hiv negative serostatus

Keywords: hiv/aids treatment as prevention methamphetamine cocaine hiv viral load
endmetriosis and reserve ovarienne

Conditions: Deep Endometriosis Stage III; Deep Endometriosis Stage IV

Summary: endometriosis is the ectopic implantation of endometrial glands and stroma, and can be ovarian and peritoneal (superficial or deep). there are 4 stages in endometriosis according to severity, and the stage is established on the basis of intra-operative observations. the afsr classification is currently most used (i-iv,minimal, mild, moderate, severe). most associated with endometriosis are subfertility and pelvic pain. in the surgical management of deep endometriosis, the issue of fertility is pivotal. there is a higher rate of infertility in a population of women with endometriosis as compared to the general population, even though the mechanisms are not yet elucidated. patients with deep endometriosis can be referred to the surgeon for subfertility, but even when they are referred for chronic pain, future fertility considerations are taken into account in the planning of the surgery, as the patients are often young. it is now well documented that ovarian cystectomy is deleterious with regards to the ovarian reserve, and more so in endometriomas than in any other type of benign cysts. the ovarian reserve is the functional potential of the ovaries, reflecting the quantity and quality of remaining follicles. studies have also relied greatly on the measure of serum anti-mullerian hormone (amh) to evaluate the effect of cystectomy on ovarian reserve, as amh is currently the most reliable marker to assess ovarian reserve. a significant difference was found between amh before and following cystectomy in several studies. the deleterious effect of deep endometriosis surgery which comprises a wide dissection and adhesiolysis of the pelvis in many cases, even when no cystectomy has been performed, is therefore not entirely ruled out. to the best of our knowledge, there are no studies on the effect of deep endometriosis surgery, apart from ovarian surgery, on ovarian reserve. our center is very active in the laparoscopic surgical treatment of deep endometriosis, with more than 200 cases every year. the objective of this trial is to assess the effect of deep endometriosis surgery on the ovarian reserve, whether a cystectomy is performed or not, by measuring serum amh before and after surgery, at 6 months and 1 year post-operatively.


Eligibility criteria:
inclusion criteria: * female patient between 18 and 38 years * endometriosis stage iii or iv in the afsr classification * laparoscopy included deep endometriosis procedures (adhesiolysis, ureterolysis, cystectomy, resection of bowel, urinary or deep peritoneal endometriosis) * written informed consent exclusion criteria: * previous adnexectomy or adnexectomy during surgery

Keywords: afsr classification laparoscopy
optimized mri of patients with hip arthroplasty

Conditions: Hip Arthropathy

Summary: this is a single-center single-arm clinical trial with a paired design which compares the effectiveness of 3t mri with (modified) and without (standard) radiofrequency pulse polarization optimization in reducing metal-related artifacts in patients with hip arthroplasty implants.

twenty participants with symptomatic primary total hip arthroplasty will be imaged with both methods. the results of the two methods will be compared in reference to the size of the artifact-degraded regions, visibility of the normal structures and the rate of abnormality detection.primary objective: to assess the size of the artifact-degraded regions, defined as regions of the image where underlying anatomic structure are obscured, between modified and standard mri protocols. secondary objectives: (1) to assess the visibility of normal structures between modified and standard mri protocols. (2) to assess the abnormality detection rate using modified and standard mri protocols.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 with unilateral symptomatic (e.g. pain) total hip arthroplasty * referred for mri examination at the discretion of the treating physician * provision of signed and dated informed consent form * no metal hardware in the body including contralateral hip arthroplasty * no contraindication to mri: defined as claustrophobia or presence of other mri-incompatible devices exclusion criteria: * history of revision hip arthroplasty * pregnancy (self-reported, or self-suspected) * hip arthroplasty surgery within one year of enrollment * clinical indication to administer intravenous contrast material during mri
evaluating the safety of bonebridge implants in children under five years old: this study looks at children under five who got bonebridge bci 602 implants. it collects information on any problems with the device or the surgery to see if it is safe within the first year after the operation.

Conditions: Hearing Loss, Conductive; Hearing Loss, Mixed; Children Under 5 Years

Summary: this study, titled "the bonebridge in children under five: premarket clinical investigation" (study id 2023bb006), looks at kids under five who have received the bonebridge bci 602 hearing implant. this observational study, which is both retrospective (looking back) and prospective (looking forward), will take place at multiple hospitals. the main goal is to see if the bonebridge implant is safe for young children within 12 months after surgery. primary goal: the study's main aim is to collect all information about any bad experiences or issues related to the device and the surgery to check its safety. secondary goals: hearing improvement: using tests like the göttinger speech intelligibility test (word recognition scores) to see how much the hearing improves with the implant. treatment history: surgeons will fill out questionnaires about how the treatment went. quality of life: parents will answer questions about their child's quality of life using the gcbi questionnaire at least 12 months after the implant. the study will last up to 12 months, including enrolling participants and performing all necessary procedures. the target number of participants includes at least 12 sets of data for safety checks and at least 5 sets of hearing performance data. by collecting detailed information on any problems and assessing the performance of the bonebridge implant, this study aims to determine if it is safe and effective for young children.


Eligibility criteria:
inclusion criteria: children who received the bonebridge bci 602 implant before the age of five and have had the implant for at least 12 months. ability to perform the german language test. willingness and ability to undergo all tests required by the study. signed and dated informed consent obtained before any study-specific procedure and collection of retrospective data. exclusion criteria: inability to perform audiological tests due to psychological, emotional, or related physical disorders. failure to meet any inclusion criteria. any condition that, in the investigator's opinion, poses an increased risk to the patient or prevents full compliance or completion of the study.
magnetic resonance imaging and acute low back pain

Conditions: Acute Low Back Pain

Summary: this is a behavioral observational study aimed at understanding the limit of tolerance (in days) of ideally performing a magnetic resonance imaging (mri) by people with acute low back pain. it consists of a short self-administered questionnaire. relationships between low back pain intensity, maladaptive thoughts and awaited days before ideally requesting a mri will be evaluated.

this is a behavioral observational study aimed at understanding the limit of tolerance (in days) of ideally performing a magnetic resonance imaging (mri) by people with acute low back pain (lbp) and by general practitioners (gp). literature pointed out that lbp is a common occurrence in people, with high rates of self-resolution in the absence of red flags (i.e. possible indicators of serious spinal pathology). in italy there is an over-prescription of mri despite international guidelines go the opposite way. the study consists of a short self-administered questionnaire which will be given to people and gp to complete. in more details, the survey is made of 3 questions collecting information on the limit of tolerance (in days) before requesting (people) and prescribing (gp) a mri for the lumbar tract of the spinal column. further, participants will have to complete a self-administered pain intensity numerical rating scale, along with catastrophizing and anxiety self-administered questionnaires. descriptive statistics will be presented by taking into account the socio-demographic characteristics of the sample being investigated. statistical correlations between participants' answers and the scores from the questionnaires will be also evaluated. this study investigates the relationships among acute low back pain, the intention of persons/gp to request/prescribe a mri despite the absence of red flags, mood disorders and maladaptive thoughts.

Eligibility criteria:
inclusion criteria: * having acute low back pain (i.e., a pain lasting no more than 6 weeks) * adult age * ability to understand the italian language exclusion criteria: * mental deficits * refuse to adhere to the study.

Keywords: low back pain magnetic resonance imaging catastrophizing anxiety red flags
radx-up- impact of community health worker deployment

Conditions: Diabetes; COVID-19; Community Health Workers; Health Behavior; Health Knowledge, Attitudes, Practice

Summary: the proposed project will implement and evaluate a brief community health worker (chw) intervention through the albany area primary health care, a rural federally qualified health center (fqhc). the primary goal of this study is to maximize effective outreach, education, and communication through chws in order to facilitate improved covid-19 vaccine confidence and uptake in underserved and vulnerable communities. chws will be deployed to the homes of adults with increased risk of morbidity and mortality (i.e., african americans or latinos with uncontrolled diabetes or prediabetes, age \<50 years, and non-covid-19 vaccinated) in order to educate them about diabetes, covid-19 and related vaccines. health assessments, including blood glucose measurement, will be conducted on the indexed patient and offered to all other adult family members in the household (i.e., "bubble"). adults with type 2 diabetes likely live in households with other adults who have or are at increased risk for diabetes (i.e., prediabetes and obesity).1 it is expected that they will also share similar covid-19 exposure risk. the specific aims are to: 1) evaluate a community-driven education program to increase and enhance covid-19 vaccine confidence and uptake in individuals with uncontrolled diabetes and their families (i.e., their "bubble") and 2) evaluate a community-driven education program to improve diabetes self-management behaviors and related outcomes (e.g., blood glucose) in individuals with uncontrolled diabetes in rural, southwest georgia.


Eligibility criteria:
inclusion criteria: * participants must be between18 and 50 years * self-identify as african american/black or latino * english speaking * have received care for uncontrolled diabetes (hba1c \> 9%) or prediabetes diagnosis within one of the aaphc 27 community sites * unvaccinated for phase 1 (vaccinated for phase 2) exclusion criteria: * not meeting the inclusion criteria * enrolled in the parent radx-up project peach study * unable or unwilling to provide informed consent to participate in the study (ie: incarcerated individuals and children) * individuals with a terminal cancer diagnosis, have chronic kidney disease (stage 4-5), pregnant women, and people with severe psychological disorders (i.e., dementia,suicide ideation)

Keywords: diabetes covid-19 rural communities rural health center rural population community health workers