Kornimate/medical-research-clean huggingface dataset:
the use of lymph node biopsies to support hiv pathogenesis studies

Conditions: HIV

Summary: hiv medicines have led to dramatic improvements in health. however, there remains a concern for potential drug toxicities, cost of drugs, and need for life-long treatment. in addition, research has found that health is not completely restored in hiv-infected patients, even if they have been taking effective hiv medicines for a long time. this may be due to direct drug-toxicity, continued replication of the virus, and/or inflammation of the body in response to the virus. therefore, a more complete understanding of how hiv stays in the body is necessary. recent research has shown that one of the places that hiv can stay in the body is in lymphatic tissues such as lymph nodes (even in patients who have been taking hiv medicines for a long time). in addition, the amount of damage to the lymphatic tissues can predict how the immune system (cd4+ t cell count) will respond to therapy. the investigators therefore propose a study in which lymph nodes from the groin area will be removed, with the goals of: 1) seeing how much hiv is in lymph nodes and 2) seeing how much damage has happened to the lymph node architecture.


Eligibility criteria:
inclusion criteria: 1. able to give informed consent 2. no contraindication to surgical procedures 3. palpable inguinal adenopathy at study entry 4. for hiv seropositive subjects, meeting one of the following criteria: (1) on stable highly active antiretroviral therapy (haart) with a recent undetectable viral load (\ 1000 copies/ml) ("non-controllers") exclusion criteria: 1. known anemia (hiv+ males hct\<34; females hct\<32) or contraindication to donating blood 2. blood coagulation disorder (including bleeding tendency or problems in past with blood clots) 3. platelets \< 50,000/mm3 4. ptt \> 2x uln 5. inr \> 1.5 6. pregnant

Keywords: hiv hiv persistence lymph node fibrosis
mindfulness-based intervention in police officers - the police study

Conditions: Mindfulness; Police; Quality of Life; Burnout Syndrome

Summary: the physical, emotional, economic and social damage of stress in the police corporation indicates an urgent call for preventive programs to approach stress reduction, burnout symptoms and promotion of quality of life and well-being. the aim of the police study is to evaluate the effectiveness of a mindfulness-based intervention (mbi), compare to a waiting list (wl), in promoting quality of life and mental health in police officers.

police officers are submitted to a high burden of chronic stress. it is no surprise to find that this occupation ranks highest on diseases and accidents rates among all professions. these professionals presents a very high incidence of depression, anxiety disorders, alcohol dependence and suicidal behavior. in addition to mental health suffering, evidence suggests an increase risk of sudden cardiac death, diabetes, obesity and metabolic syndrome. mindfulness-based interventions have been tested and incorporated for several clinical and non-clinical conditions for more than three decades, with emphasis on stress reduction, promotion of quality of life, chronic pain, anxiety, depression and eating disorders. the main hypothesis is that mindfulness training will improve their quality of life and reduce burnout symptoms. the investigators expect that individuals allocated in the mbi group will report, besides showing a better quality of life, mental health and less burnout, lower levels of stress, anxiety and depression symptoms. with regard to the working mechanism of the mbi, investigators will examine if the changes in mindfulness trait, self-compassion, spirituality, decentering and resilience skills will mediate the main hypothesis. the study will be conducted in porto alegre-rs and são paulo-sp.

Eligibility criteria:
inclusion criteria: * active police officers * availability to attend 8 sessions * willingness to voluntarily participation exclusion criteria: * manic or hypomanic episode (current) * psychotic syndrome (current or past) * substance use disorder (past 12 months, except tobacco) * risk of suicide * previously completed mindfulness-based intervention
evaluation of psychological impact of group therapy for patients who have been hospitalized in intensive care during covid-19 pandemic: exploratory study

Conditions: Intensive Care Unit Syndrome; Covid19; Anxiety; Depression

Summary: psychological impact of intensive care hospitalization for patients has been demonstrated during the last few years: anxiety, depression and post traumatic stress disorder. hospitalizations during covid-19 pandemic have been marked by factors such as confinement forbidding family members visits, stress on intensive care unit ...those factors may have a psychological impact added to factors of long hospitalization and prolonged mechanical ventilation. for all these reasons the investigators fear that patients hospitalized in intensive care during covid-19 pandemic develop psychological trouble with an increased risk for those who experienced covid-19 infection. the hypothesis therapy group added to standard care might have a positive impact on psychological troubles such as anxiety, depression and post traumatic stress disorder for patients who have been hospitalized in intensive care during covid-19 pandemic. the investigators will compare two groups: * group receiving standard of care * group receiving standard of care and therapy group


Eligibility criteria:
inclusion criteria: * 18 years old and older * hospitalized at least 72h in intensive care during covid-19 pandemic crisis * out of intensive care for at least 2 months and maximum 6 months * psychological evaluation done according to local practice and standard of care * speaking french * patient coming alone to the therapy group * patient agree to respect confidentiality rules and demonstrating goodwill with others participants * patient comite to respecting barriers rules against covid-19 * affiliated to social security system * no juridic protection engaged exclusion criteria: * presenting psychological disease * drug addiction * participation to other interventional clinical trial
combination of preoperative gabapentin and tap blocks in decreasing postoperative pain

Conditions: Postoperative Pain

Summary: there is an increasing trend on decreasing narcotic use and maximizing efficiency in the perioperative care. there are no studies that have compared a tap block versus a tap block plus gabapentin for laparoscopic procures.this study will investigate if taking gabapentin and receiving a tap block decrease post-operative morphine consumption. it will be a randomized controlled, double blind study, with 130 patients between 18-60 years; that will undergo laparoscopic gyn procedures. secondary outcomes will look at the incidence of nausea, vomiting, and vas (verbal analog scale) scores. this combination may be helpful because gabapentin will be used to decrease visceral and central pain, and tap block will decrease somatic pain. performing a multimodal approach may decrease narcotic consumption, adverse effects and improve pain management.


Eligibility criteria:
inclusion criteria: * female * receiving laparoscopic gyn procedure * between 18-60 exclusion criteria: * are already taking gabapentin * have diabetic neuropathy * have a chronic pain syndrome * take opioids at home * are pregnant * have kidney disease * have an allergy to morphine

Keywords: gabapentin tap block
the enterprise study - study of the enterprise self-expanding stent system

Conditions: Aneurysms

Summary: to evaluate the safety and feasibility of the cordis neurovascular self-expanding stent system to facilitate endovascular coil embolization of wide neck saccular intracranial aneurysms. cordis self expanding stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel

this is a multi-center, prospective, non-randomized feasibility study including 30 subjects. subjects will receive a safety follow-up evaluation at 30 days (+ two weeks) and an efficacy follow-up evaluation at 6 months (+ four weeks).

Eligibility criteria:
inclusion criteria: * patients with intracranial, wide-neck, saccular aneurysms exclusion criteria: * subject with hunt and hess grade iv or v subarachnoid hemorrhage

Keywords: intracranial wide-neck saccular aneurysms
tumor absorbed dose-response relationship in patients treated with 177lu-dotatate for meningioma

Conditions: Meningioma of Brain

Summary: the hypothesis for this study is that there is a dose-response relationship in patients treated with 177lu-dotatate for meningiomas.

dosimetry is essential for peptide receptor radionuclide therapy (prrt) of meningiomas, to predict efficacy and dose-effect relationships at the individual level, and to move towards personalized medicine. due to the increasing therapeutic applications of lutathera, the european association of nuclear medicine (eanm) recently issued recommendations on the dosimetry of 177lu-labeled somatostatin analogues. nevertheless, despite these recommendations, the evaluation of meningioma tumor dosimetry in peptide receptor radionuclide therapy studies is not systematic, which has not enabled us to clearly determine the dose delivered to the meningioma lesion in these treatments and the possible dose-response relationship in this type of treatment.

Eligibility criteria:
inclusion criteria: * patients treated for menigioma at nancy hospital * patients who performed 3 scintigraphics exams during there treatment exclusion criteria: * patients deprived of liberty * patient who refused to collect data retrospectively

Keywords: meningioma theragnostic dosimetry
my diabetes care: a scalability and usability study

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to conduct a prospective, longitudinal study on the my diabetes care (mdc) mobile intervention to assess usage patterns, user experience, and to uncover errors in functionality prior to a larger interventional trial.

up to 90 adult patients with type 2 diabetes mellitus will be enrolled and given access to my diabetes care (mdc). my diabetes care (mdc) is a multi-faceted patient portal intervention for mobile devices that is designed to help patients better understand their diabetes health data as well as promote and support self-management. mdc uses infographics to facilitate patients' understanding of their diabetes health data (e.g., hba1c, ldl) and provides literacy level-appropriate and tailored diabetes selfcare information. patients will be invited by mail to be screened for enrollment in the study. interested patients will be able to complete an electronic consent form and enroll online via research electronic data capture (redcap) version 5.0.8. study participants will complete questionnaires electronically via email using redcap at two time points: baseline (t0) and one-month follow-up (t1). participants will complete a baseline questionnaire (t0) including basic demographic questions, items about computer usage and internet access, and validated measures of health literacy and ehealth literacy. each participant will have access to mdc for 1 month.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * age 18-75 years old * currently taking at least one medication for diabetes * patient at a participating clinic within vanderbilt medical center or brigham and women's hospital * able to speak and read in english or spanish * reliable access to a smartphone or tablet with internet access * active patient web portal account (for example, my health at vanderbilt or patient gateway) exclusion criteria: * have a medical condition that affects your memory or ability to think * have severe difficulty seeing or hearing * have a medical condition that makes it hard for people to understand what you are saying

Keywords: diabetes mellitus self-efficacy patient web portals
safety and maximum tolerated dose (mtd) study of inno-206 in subjects with advanced solid tumors

Conditions: Malignant Solid Tumour

Summary: this is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated dose of a new formulation of inno-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450 mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous infusion on day 1 every 21 days for up to 6 cycles.


Eligibility criteria:
inclusion criteria: * age between 18 and 70 years, male or female. * histologically or cytologically confirmed malignant solid tumor that has relapsed or is refractory to standard therapy. * subjects who have received prior radiation therapy with stable cns metastasis with no progression of brain metastasis by ct/mri scan in last 4 weeks. * capable of providing informed consent and complying with trial procedures. * ecog performance status 0-2. * life expectancy \>12 weeks. * measurable or evaluable disease according to recist 1.1 criteria. * women must not be able to become pregnant (e.g. post menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. * women of child bearing potential must have a negative serum or urine pregnancy test at the screening visit and be non-lactating. * geographic accessibility to the site. exclusion criteria: * palliative surgery, chemotherapy, immunotherapy and/or radiation less than 4 weeks prior to the screening visit. * exposure to any investigational agent within 30 days of the screening visit. * laboratory values: screening serum creatinine greater than or equal to 1.5 mg/dl, alanine aminotransferase (alt) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (wbc) count \ 1.5 times the upper limit or normal. * clinically evident congestive heart failure \> class ii of the new york heart association (nyha) guidelines. * serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as lown iii, iv or v. * history or signs of active coronary artery disease with or without angina pectoris. * serious myocardial dysfunction defined scintigraphically (muga, myocardial scintigram)or ultrasound determined absolute left ventricular ejection fraction (lvef) \< 45% of predicted. * history of hiv infection. * active, clinically significant serious infection requiring treatment with antibiotics, antivirals or antifungals. * major surgery within 3 weeks prior to treatment. * substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results. * any condition that is unstable and could jeopardize the subject's participation in the study.

Keywords: inno-206 phase 1 doxo-emch advanced solid tumors
diagnostic values of lung ultrasound for perioperative atelectasis

Conditions: Postoperative Pulmonary Atelectasis

Summary: lung ultrasound offers a novel, reliable and radiation-free tool for diagnosing perioperative atelectasis and evaluating its severity in adult patients undergoing general anesthesia in the operating room.

atelectases occur in up to 90% of patients undergoing general anesthesia and intubation. the aim of the present observational study was designed to further to evaluate the diagnostic performance of lung ultrasound (lus) in detection of postoperative atelectasis in adult patients undergoing general anesthesia. results of lus as the experimental method will be compared to the results of computed tomography (ct) as the reference technique for the detection of atelectasis. the investigators want to confirm former findings of the appearance of perioperative atelectases and to prove that ultrasound is a valid tool for detection of atelectases.

Eligibility criteria:
inclusion criteria: 1. aged 18 years and older; 2. american society of anesthesiologists (asa) physical status within class i-iii; 3. scheduled for selective neurosurgical operation with general anesthesia; 4. need of mechanical ventilation more than 2 hours; exclusion criteria: 1. patients decline to participate; 2. pregnancy; 3. previous thoracic procedures (thoracic drain, thoracotomy, thoracoscopy); 4. a history of pulmonary diseases within last two weeks with abnormal manifestation of lung ct (pulmonary parenchyma or/and interstitial lesions ); 5. pneumothorax or subcutaneous emphysema during peri-operation; 6. patients with a body mass index (bmi) more than 30 kg/m2; 7. emergency operation.

Keywords: lung ultrasound atelectasis thoracic computed tomography
the effect of cognitive behavioral therapy on the outcome of spinal surgery

Conditions: Back Pain

Summary: this study is designed to examine the efficacy of cognitive behavioral therapy (cbt) on the outcome of spinal surgery. the goal of this treatment is to change the coping style, thoughts, behavior and adaptive perception of the patient, and to replace them with an adaptive style. the patients in this study will be randomly divided into two groups. one group will undergo cognitive behavioral therapy (cbt) before having spinal surgery. the other group will be a control group, and will not have any psychological intervention.


Eligibility criteria:
inclusion criteria: * patients who intended to undergo spinal surgery exclusion criteria: * patients who does not speak hebrew language
pre- and post-treatment investigation of b12 and folic acid (folate) levels in patients receiving antiepileptic (anticonvulsant) treatment for fibromyalgia: retrospective study

Conditions: Fibromyalgia (FM); Vitamin B 12 Deficiency; Folic Acid Deficiency

Summary: fibromyalgia is a rheumatological disorder characterised by chronic widespread body pain, second most common after osteoarthritis. the overall prevalence is 2-8% and it is more common in women. diffuse body pain, fatigue, sleep and cognitive dysfunction occur. the etiology of fibromyalgia is multifactorial and occurs due to central and peripheral pain mechanisms that occur with neuroendocrine imbalance due to psychological and physical stress in people with genetic predisposition. the diagnostic criteria for fibromyalgia were updated by the american college of rheumatology in 2016 to include a widespread body pain scale and a symptom severity scale. fibromyalgia treatment consists of drug (antidepressants and antiepileptics) and non-drug treatments. pregabalin is also used in the treatment of epilepsy by blocking and modulating the α2 δ subunit of voltage-dependent calcium channels. there are studies showing that antiepileptics cause folate and vitamin b12 deficiency in epilepsy patients. in our study, we aimed to retrospectively investigate vitamin b12 and folic acid levels before and after treatment in patients with fibromyalgia using antiepileptics (anticonvulsants).

after the acceptance of the study (after obtaining ethics committee approval), patients who have been followed up for at least 6 months in the physical medicine and rehabilitation outpatient clinic with a diagnosis of fibromyalgia and who use pregabalin will be evaluated retrospectively (1-year records). blood vitamin b12 and folate (folic acid) levels of the patients before and after antiepileptics (anticonvulsants). use will be determined. patients will be evaluated whether there is a change in vitamin b12 and folic acid levels due to antiepileptics (anticonvulsants) drug use.

Eligibility criteria:
inclusion criteria: * patients aged 18-75 years who have been diagnosed with fibromyalgia, whose vitamin b12 and folic acid levels have been analysed, who do not receive vitamin b12 and folic acid treatment, and who do not have diabetes mellitus, liver and kidney failure exclusion criteria: * patients receiving vitamin b12 and folic acid therapy at the time of antiepileptic (anticonvulsant) drugs initiation, patients with hepatic and renal insufficiency

Keywords: antiepileptic (anticonvulsant) drugs vitamin d deficiency
a safety study of dapivirine (tmc120) vaginal microbicide gel in belgium

Conditions: HIV Infections; HIV-1

Summary: approximately 36 hiv-negative women, aged \>18 and \< 50, will be enrolled in this study. each volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. the volunteers will receive investigational product for a total of 42 days.


Eligibility criteria:
inclusion criteria: * hiv-negative * willing to participate and sign an informed consent form * willing to be tested for hiv, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group. * willing to use two forms of contraception during the study * willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study. * have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses exclusion criteria: * currently pregnant or breast-feeding * clinically detectable genital abnormality on the vulva, vaginal walls or cervix * laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed gud or active hsv-2 lesion * breakthrough bleeding or gynecologic surgery within 60 days prior to randomization * symptomatic bacterial vaginosis at screening and unwilling to undergo treatment. * women who require treatment for tuberculosis (tb) within 21 days prior to randomization.

Keywords: hiv seronegativity
cognitive behavior therapy (cbt) for children with functional gastrointestinal disorders

Conditions: Functional Gastrointestinal Disorders (FGID); FGID According to the Rome III Criteria; Irritable Bowel Syndrome (IBS); Functional Abdominal Pain; Functional Dyspepsia

Summary: the purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered cbt for children with functional gastrointestinal disorders (fgid). the study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. this study will include 20-30 children with fgid and their parents who will be treated individually (face-to-face). the treatment consists of 10 weekly sessions of exposure-based cbt. the study uses a pre- post-design with no control group.


Eligibility criteria:
inclusion criteria: * age between 8-12 years * a diagnosis of a functional gastrointestinal disorder by a treating physician exclusion criteria: * concurrent serious medical condition or gastrointestinal symptoms likely caused by an organic disorder. * psychiatric disorder more urgent to treat than the abdominal pain. * on-going psychological treatment. * absence from school more than 40 %. * ongoing maltreatment, violence or severe parental psychiatric illness. * pronounced language or learning difficulties that hinder the child to benefit from the treatment.

Keywords: functional gastrointestinal disorders fgid recurrent abdominal pain abdominal pain pain-predominant functional gastrointestinal disorders pediatric pain