Kornimate/medical-research-clean huggingface dataset:
evaluation of effects of estetrol on testosterone suppression and quality of life in prostate cancer patients treated with an lhrh agonist.

Conditions: Prostatic Neoplasm

Summary: this is a phase iia, double-blind, randomised, placebo-controlled, multi-center study to evaluate the effects of estetrol on testosterone suppression and quality of life in prostate cancer patients treated with an lhrh agonist. patients will be treated with estetrol or placebo for 6 months.


Eligibility criteria:
inclusion criteria: * male patients with prostate cancer, qualifying for treatment with a lhrh agonist; * age ≥ 18 years; * body mass index (bmi) between ≥ 18.0 and ≤ 35.0 kg/m2 (inclusive); * reasonable physical and mental health as judged by the investigator determined by physical examination, clinical laboratory assessments and vital signs; * eastern cooperative oncology group (ecog) performance status 0-1; * life expectancy of at least 2 years. exclusion criteria: * current or prior (during the last 12 months) hormonal therapy, immunotherapy or chemotherapy for prostate cancer. allowed are 14 days concomitant treatment with an anti-androgen to prevent the flare-up, radiotherapy and low dose radiation to prevent gynecomastia; * history of deep vein thrombosis, pulmonary embolism, or cerebrovascular accident. however, patients with such history using anticoagulants for ≥ 6 months are eligible for the study provided anticoagulant treatment is continued throughout the whole study; * history of myocardial infarction or a coronary vascular procedure (e.g. percutaneous coronary intervention, coronary artery bypass graft). however, patients with such history using anticoagulants for ≥ 6 months are eligible for the study provided anticoagulant treatment is continued throughout the whole study; * patients who have unstable angina or clinical congestive heart failure; * a defect in the blood coagulation system, assessed at screening: deficiencies in at-iii, protein c and protein s and elevated factor viii; * mutation in coagulation factor ii and/or positive for factor v leiden, assessed at screening; * diabetes mellitus with poor glycaemic control in the past 6 months (haemoglobin a1c (hba1c) above 7.5%); * known primary hyperlipidaemias (fredrickson); * disturbance of liver function: cholestatic jaundice, a history of jaundice due to previous estrogen use, rotor syndrome and dubin-johnson syndrome; * known porphyria; * uncontrolled hypertension, i.e. systolic blood pressure 160 mmhg and/or diastolic blood pressure 100 mmhg in the last 6 months with or without medication.

Keywords: quality of life hot flushes prostate cancer testosterone
a study of raludotatug deruxtecan (r-dxd) in people with gastrointestinal cancers (mk-5909-005)

Conditions: Gastrointestinal Cancer

Summary: researchers are looking for new ways to treat certain types of advanced gastrointestinal (gi) cancers. the study medicine raludotatug deruxtecan (also called mk-5909, r-dxd, or ds-6000a) is a type of medicine called an antibody-drug conjugate (adc). an adc attaches to a protein on cancer cells and delivers treatment to destroy those cells. the main goal of this study is to learn if the cancer responds to treatment (gets smaller or goes away).


Eligibility criteria:
inclusion criteria: the main inclusion criteria include but are not limited to the following: * has one of the following cancers: * unresectable or metastatic pancreatic ductal adenocarcinoma (pdac) * unresectable or metastatic adenocarcinoma of the biliary tract \[intra- or extrahepatic holangiocarcinoma (cca) or gallbladder cancer (gbc)\] * unresectable or metastatic colorectal adenocarcinoma * unresectable or metastatic gastric adenocarcinoma * gastroesophageal junction adenocarcinoma (gejac) * esophageal adenocarcinoma (eac) * has received prior therapy for the cancer * has a life expectancy of at least 3 months * if human immunodeficiency virus (hiv) infected, must have well controlled hiv on antiretroviral therapy (art) exclusion criteria: the main exclusion criteria include but are not limited to the following: * has a history of (noninfectious) interstitial lung disease (ild)/pneumonitis that required steroids or has current ild/pneumonitis, and/or suspected ild/pneumonitis * has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * has uncontrolled or significant cardiovascular disease * has a known additional malignancy that is progressing or has required active treatment within the past 3 years * has known active central nervous system (cns) metastases and/or carcinomatous meningitis * active autoimmune disease that has required systemic treatment in the past 2 years * has not adequately recovered from major surgery or has ongoing surgical complications * hiv-infected participants with a history of kaposi's sarcoma and/or multicentric castleman's disease
trial comparing cisplatin with or without gemcitabine in patients with carcinoma of unknown primary

Conditions: Carcinoma

Summary: this is a randomized phase iii trial comparing cisplatin with or without gemcitabine in patients with carcinoma of unknown primary and a predicted favorable prognosis. the purpose of this trial is to compare the overall survival rates of patients with carcinoma of unknown primary (cup) and a predicted favorable prognosis according to the french classification treated with cisplatin with or without gemcitabine.


Eligibility criteria:
inclusion criteria: * patients older than 18 years * evidence of cup based on histologic examination * negative search for the primary tumor site using recommended guidelines * disease classified as good prognosis according to the french classification criteria: \*performance status \>2 and \*normal serum ldh * no prior chemotherapy * no previous carcinoma, except basal-cell carcinoma of the skin * adequate renal function: measured or calculated creatinine clearance \> 60 ml/min * absolute granulocyte count ≥ 1,500/mm3; platelets ≥ 100,000 mm3; bilirubin ≤ 1.5 fold the upper normal value * signed informed consent exclusion criteria: * patients infected by the human immunodeficiency virus (hiv) * cup belonging to one of the following subgroups: 1) axillary lymph node of an adenocarcinoma in a woman; 2) serous adenocarcinoma of the peritoneum in a woman; 3) undifferentiated carcinoma of the middle line in a young man; 4)squamous-cell carcinoma; 5) neuroendocrine carcinoma; 6) bone metastases with elevated serum prostate specific antigen (psa) in a man * patients who do not fit inclusion criteria.

Keywords: patients with carcinoma of unknown primary and a predicted favorable prognosis
adjunctive use of salvadora persica in chronic periodontitis

Conditions: Chronic Periodontitis

Summary: a randomized controlled triple blinded study to evaluate the effectiveness of salvadora persic (sp) as an adjunct to scaling and root planing (srp) in chronic periodontitis by comparing the basic parameters of periodontitis, radiographs and bacterial levels with a controlled group (srp only).

sixty-six subjects with untreated, moderate-to-severe chronic periodontitis will be selected by convenience sampling. the participants will be randomly divided into 2 groups: 1. test group: srp + sp gel 2. control group: srp only each participant will undergo treatment in the following steps: 1. questionnaire: all participants will complete a structured baseline questionnaire provided by one trained interviewer that will include the data regarding; (a) age; (2) gender; (3) education status; (4) occupation; (5) medical status 2. informed consent: all eligible subjects will be thoroughly informed of the nature, potential risks and benefits of their participation in the study. 3. assessment of parameters: 1. clinical periodontal parameters full-mouth plaque index (pi), bleeding on probing (bop), probing depth (pd), and clinical attachment loss (cal) will be recorded on baseline, 6th week and 12th week for all the patients that pass the inclusion criteria. 2. radiographic analysis the depth of bony defects (bd) will be evaluated at baseline, 6 and 12 weeks using image analysis software (scion image analyzer, scion, frederick, md, usa). 3. analysis of plaque microorganism subgingival plaque will be collected at baseline and 12 weeks from the deepest pd (\>4mm) of each patient. 4. scaling and root planing after baseline recordings, thorough srp will be performed by a single clinician. the srp procedure will be carried out in two sittings, comprising of ultrasonic scaling in the first, and manual instrumentation and root debridement in the second. 5. application of sp gel in the test group, areas with ppd greater than 4 mm will be marked on the periodontal chart. in these areas sp gel will be placed following root planing procedure.

Eligibility criteria:
inclusion criteria: 1. subjects who are \>30 years old 2. minimum of 20 teeth , excluding third molars 3. systemically healthy patients with moderate (pd of 5 to 6 mm or clinical attachment loss cal of 4 to 6 mm) or deep pockets (pd ≥7mm or cal of 6 to 9 mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs (armitage 1999) exclusion criteria: 1. presence of systemic conditions that could modify the progression of periodontitis such as diabetes mellitus, metabolic syndrome, cardiovascular disease or immunologic disorders 2. systemic antimicrobials in the previous 6 months 3. aggressive periodontitis 4. pregnancy or lactation 5. inability to provide informed consent
effect of remote ischemic preconditioning on postoperative complications in visceral surgery

Conditions: Postoperative Complication

Summary: remote ischemic preconditioning (ripc) is mediated by intermittent brief episodes (5-10 minutes) of short ischemia in a limb (i.e. arm), followed by reperfusion. for this purpose in 3-4 cycles, a tourniquet is insufflated to suprasystolic pressure levels for 5 minutes and deflated for 5 minutes afterwards. the ischemic episodes are known to stimulate platelets and factors platelet dependent factors such as serotonin and vegf. these humoral factors have a systemic effect and have the potential to protect target organs (i.e. heart, kidney, liver) remote to the ischemic limb. the purpose of this randomized controlled study is to investigate the influence and impact of ripc on postoperative complications in patients undergoing visceral surgery


Eligibility criteria:
inclusion criteria: * \> 18 years * undergoing major visceral surgery exclusion criteria: * \< 18 years * pregnancy * signs of infection/inflammation on upper limb * shunt * medical history of axillary lymph node dissection * signs of malperfusion of upper limb (i.e. allen test) * missing informed consent

Keywords: visceral surgery comprehensive complication index patient undergoing abdominal surgery
participative rehabilitation in stroke patients

Conditions: Stroke

Summary: primary objective of this study is to determine whether a case management of stroke patients after discharge to home or to nursing home results in improving physical and cognitive capacity one year after discharge.

in a randomized trial, the project participative rehabilitation process management "stroke in saxony-anhalt" (paresis) implements a case management trial, explicitly including all providers in the course of illness, treatment and rehabilitation. to achieve this, patients in the intervention group have the opportunity to choose, specifically and according to their own needs, from the offers of a web portal and a telephone hotline, from individual counselling and info sessions as well as from home visits. patients in the control group receive patient-information-notes beyond primary care. there will be qualitative interviews with the persons concerned and/or their relatives in both groups in order to validate the instruments.

Eligibility criteria:
inclusion criteria: * acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding) with signs and symptoms of an acute stroke according to the diagnosis i61 and i63 of the icd-10-gm 2008 * differentiation between ischemic or haemorrhagic stroke by the use of ct or mrt * resident in saxony-anhalt or saxony or thuringia * able to understand german language exclusion criteria: * reinfarction * alcoholism * death in acute care * nihhs \> 25 * homelessness

Keywords: stroke rehabilitation patient care management patient participation
incorporating mind-body skills with diabetes education in adolescents with type 1 diabetes

Conditions: Type 1 Diabetes; Adolescent Behavior

Summary: adolescence presents a challenging time for type 1 diabetes management, and despite a multitude of studies aimed at increasing disease compliance in this age group, none have been deemed superior. the purpose of this study is to incorporate mindfulness skills in with diabetes education sessions for adolescents with type 1 diabetes and study if this translates to improved outcomes in glycemic control, patient satisfaction, and mental wellness.

this is a pilot study to learn if adding mind-body skills to diabetes education is useful in helping adolescents manage their type 1 diabetes. specifically, the investigators will be studying adolescents aged 15-17 years old with uncontrolled diabetes defined by an a1c \>9.0% who have also had the diagnosis of diabetes for at least 12 months. this study combines the teaching of mind-body skills with short virtual diabetes education sessions, in order to address both the direct needs of good diabetes management and the indirect needs of coping with diabetes-related stress and other external factors. the investigators will have two arms of the study - one receiving diabetes education with the addition of mind-body skills, and the other arm receiving only diabetes education. sessions will be conducted virtually with 20-30 minutes of diabetes education, followed by 20-30 minutes of mind-body skills teaching in the respective arm. the study will consist of 10-12 weekly group sessions, with pre- and post-study questionnaires to evaluate mental and physical health. participants will continue to attend their regular diabetes clinic appointments every three months. at the end of the study, participants will also partake in a short interview to gather feedback about their experience. the goals of this study are to evaluate the effect of mind-body skills as well as pilot test the feasibility and acceptability of such a project.

Eligibility criteria:
inclusion criteria: * age 15-17 years * diagnosis of type 1 diabetes for at least 12 months * uncontrolled diabetes with a1c at least 9.0% * parent or guardian agrees for adolescent to participate exclusion criteria: * diagnosed cognitive disabilities * other uncontrolled chronic diseases as assessed by pi * inability to attend visits due to individual schedules

Keywords: type 1 diabetes adolescents mind-body skills
a trial of vitamins and haart in hiv disease progression

Conditions: HIV Infections

Summary: this study is a double-blind randomized clinical trial, conducted to examine the effects of multivitamins (including b, c, and e) on hiv disease progression among hiv-positive tanzanian adult men and women taking highly active anti-retroviral therapy (haart).

access to highly active anti-retroviral therapy (haart) for the treatment of hiv in developing regions is limited, but gradually becoming standard of care in some countries. multivitamin supplements have demonstrated immune-enhancing effects among individuals in pre-haart hiv disease stages. however, the efficacy and safety of micronutrient supplements need to be documented in the context of haart. this study is a double-blind randomized clinical trial, conducted to examine the effect of multivitamins (including b, c, and e) on hiv disease progression among individuals taking haart. participants are hiv-positive tanzanian men and women aged 18 years and older, who are initiating haart at the time of randomization. eligible individuals are randomized to receive daily oral supplements in one of two intervention groups: a) multivitamins at the single recommended dietary allowance (rda) level; and b) multivitamins at multiples of the rda at the same doses used in our previous study "a trial of vitamins in hiv progression and transmission".

Eligibility criteria:
inclusion criteria: * hiv-positive * men or women * 18 years of age or older * initiating haart at time of randomization exclusion criteria: * pregnant or lactating women * individuals at pre-haart disease stages * bmi less than 16

Keywords: hiv aids disease progression multivitamins anti-retroviral therapy haart tanzania africa
oximeters and skin pigment: impact of skin pigmentation on accuracy of pulse oximetry

Conditions: Hypoxemia; Hyperoxia; Pigment Skin

Summary: finger pulse oximetry spo2 is widely used to estimate arterial oxygen saturation sao2. current spo2 targets do not take into consideration the many variables that affect that correlation in particular skin pigmentation. this study aims to evaluate different fda approved pulse oximeters (nonin co-pilot, massimo radical 7, philips-standard of care monitor, innovo premium ip900bp, nellcor pm1000n, nano100) with sao2 reference values obtained by an arterial blood gas in subjects with different skin pigments measured by a skin color scale as well as self-identification of race.

the oximeters that will be evaluated are nonin co-pilot, massimo radical 7, philips (standard care), innovo premium ip900bp, nellcor pm1000n and usa medical supply nano100. the sensors used will be reusable digital sensors for all oximeters. oximeters will have been placed on patients' fingers (3 fingers on each hand) during an initial phase of clinical stability. due to the impact of the fingers used for spo2 measurement and bias that might be caused by right hand versus left hand, oximeters will be randomized to different fingers and hands for each patient. measurements will be made when the spo2 with the usual oximeter is \<97% as recommended and in the absence of changes of the respiratory parameters in the last 10 minutes. a set of measures that will include all the oximeters tested will be used. once the oximeters are installed, at least 2 minutes will run out to let the oximeters reach steady state. then when a standard of care blood gas is obtained, measurements will be taken simultaneously to the drawing of a standard care arterial blood gas by a clinician in the icu. while the clinician takes the arterial blood gas, a picture will be simultaneously taken of the spo2 readings shown by each oximeter, in addition to taking vital signs, o2 flow or fio2.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * patients admitted to the intensive care unit * patient has arterial line exclusion criteria: * no signal with the oximeter * missing digits preventing application of all probes simultaneously * no requirement for arterial blood gases * pigmented nails, fake nails, or nail polish * methemoglobinemia * patient in isolation (multi-resistant bacteria, c-difficile, covid-19)

Keywords: spo2, sao2,hypoxemia
the effect of internet- and mobile-based group treatment in menopausal women

Conditions: Menopausal Syndrome

Summary: background: menopause syndrome generally occurs with and is related to psychological problems. however, internet- and mobile-based group treatment (imgt) may improve women's physiological and psychological conditions. objective: to investigate the efficacy of group treatment with or without internet- and mobile-based treatment of menopause, mood swings and quality of life status. methods: this protocol is for a randomized controlled clinical trial with a sample of 144 menopausal women divided into 2 groups: imgt and face-to-face group treatment (ffgt). the primary outcome will be the menopausal symptom improvement of the two groups, as assessed by greene climacteric scale. the secondary outcomes will be quality of life, assessed by the short form 36 health survey questionnaire; insomnia, assessed by the pittsburgh sleep quality inventory; anxiety, assessed by the hamilton anxiety rating scale; and therapeutic alliance, assessed by the working alliance inventory-short revised. imgt will be performed once a week for 1.5 hours for 10 weeks with a daily punched-in on the wechat app; ffgt will be performed once a week for 1.5 hours for 10 weeks. all outcomes will be assessed at baseline, at a post-intervention evaluation (week 10), and at a follow-up evaluation (week 22). discussion: this study will be the first clinical trial to examine the effects of imgt on menopausal women in china. if imgt is found to be equivalent to or superior to ffgt, it will facilitate easier access to menopausal health services, which may be feasible to offer to other medical institution.


Eligibility criteria:
inclusion criteria: * aged 40\~60, in menopausal transition or post-menopause, according to the straw +10 definition * have internet access * have mobile phone access * have sufficient knowledge of the chinese language * have scored in the clinical range for menopause syndrome from the psychiatric interview * have signed a consent form that will be provided to eligible participants. exclusion criteria: * not completing informed consent * presence of any of the following diseases: hyperthyroidism, coronary atherosclerotic heart disease, hypertension (bp≥140/90 mmhg), pheochromocytoma, neurasthenia, psychosis, or other diseases closely related to the main disease * troublesome drinking * drug use (hypnotics or hormone therapy) in the past 14 days, which might affect mood.

Keywords: menopause group treatment mood swing quality of life
third ventricle echographic study for neuro-intensive care unit patients

Conditions: Neuro-intensive Care Unit Patients; Brain Injuries

Summary: transcranial doppler ultrasonography is usually used in the evaluation and management of patients with brain injury. this noninvasive method measures local blood flow velocity and direction in the proximal portions of large intracranial arteries. the operator requires a short training and experience to perform. the third ventricle diameter measurement by transcranial duplex flow sonography was performed in healthy volunteers . this studies show similar results in those obtained with the mri or computer tomography (ct). currently the third ventricle diameter measurements by transcranial doppler ultrasonography was not validated for neuro-intensive care unit patients. the investigators propose to used recent ultrasound system to validate the third ventricle diameter measurements in comparison with the standard method (ct).

transcranial doppler ultrasonography is usually used in the evaluation and management of patients with brain injury. this noninvasive method measures local blood flow velocity and direction in the proximal portions of large intracranial arteries. the operator requires a short training and experience to perform. the third ventricle diameter measurement by transcranial duplex flow sonography was performed in healthy volunteers . this studies show similar results in those obtained with the mri or computer tomography (ct). currently the third ventricle diameter measurements by transcranial doppler

Eligibility criteria:
inclusion criteria: * adult, \> or equal to 18-yr * admission to neuro-intensive care unit with brain injury * evaluation by computer tomography * indication for transcranial doppler ultrasonography exclusion criteria: * opposition to participate by the patient or a next of kin

Keywords: neuro-icu third ventricle computer tomography transcranial doppler ultrasonography