Kornimate/medical-research-clean huggingface dataset:
an insulin sensitivity study in healthy subjects

Conditions: Healthy Volunteers

Summary: this study will characterize insulin sensitivity in response to treatment with alks 3831, olanzapine, and placebo.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.0 and \< 25.0 kg/m\^2 at screening and randomization * no prior history of regular smoking or nicotine use * women of child-bearing potential should be on stable regimens of oral contraceptives for at least 2 months prior to screening * subjects must be willing to avoid a regular exercise regimen from screening through the end of the treatment period * additional criteria may apply exclusion criteria: * has current evidence or history of any clinically significant medical or psychiatric condition or observed abnormality * is currently pregnant or breastfeeding, or is planning to become pregnant during the study * has a lifetime history of diabetes * has a known risk of narrow-angle glaucoma * has a clinically significant illness within 30 days prior to screening or admission to the clinic * has a history of dependence on any substance other than caffeine * has a current or anticipated need for prescribed opioid medication (eg, planned surgery) during the study period * has a positive urine drug screen for drugs of abuse at screening or admission to the study site * has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to screening or admission to the clinic * has had any vaccinations in the 4 weeks prior to screening or admission to the clinic * chronic use of non-steroid anti-inflammatory drugs (nsaids) and acetaminophen, except for low-dose aspirin is not allowed * use of new prescription and non-prescription drugs, as well as dietary/nutritional supplements within 3 weeks preceding the first dosing of study drugs, unless approved by investigator * has prior use of any antipsychotic medication, including on and off label uses * additional criteria may apply

Keywords: alks 3831 samidorphan olanzapine
influence of perfluorohexyloctane (novatears) on tear film thickness in patients with mild to moderate dry eye disease

Conditions: Dry Eye Disease

Summary: patients with mild to moderate dry eye disease will be randomized to receive either novatears® or hydrabak® eye drops as control.


Eligibility criteria:
inclusion criteria: * men and women aged over 18 years * history of dry eye disease for at least 3 months before the screening visit * be able and willing to follow instructions, including participation in all study assessments and visits * signed and dated written informed consent exclusion criteria: * have any clinically significant slit-lamp findings at the screening visit that may include trauma, steven johnson syndrome, and/or in the opinion of the investigator may interfere with study parameters * participation in a clinical trial in the 4 weeks preceding the before the screening visit * active ocular allergies or ocular allergies that are expected to be active during the study period * pregnancy, planned pregnancy or lactating * known hypersensitivity to any component of the study medication * any medical or surgical history, disorder or disease such as acute or chronic severe organic disease
effect of enhanced interactive text messages and phone instruction on the quality of bowel preparation for colonoscopy.

Conditions: Colon Polyp; Colon Neoplasm

Summary: efficacy evaluation of enhanced bowel preparation instructions in elective colonoscopy.

this is a prospective, randomized, controlled clinical investigation designed to evaluate the efficacy of enhanced bowel preparation instructions (automated sms, information website, and pre-recorded phone call) in improving bowel preparation quality in elective colonoscopy. subjects from the interventional and control group will receive standard of care bowel preparation instruction. the interventional group will receive enhanced instructions delivered by automated sms, information website and pre-recorded phone calls in the 48 hours leading up to the colonoscopy day. the intention is to provide a reminder, to reiterate instruction on clear fluid diet and timing of bowel preparation medication, and to provide additional graphical illustration on the information website. subjects in the interventional group must reply "ok" to each automated sms or press "1" on the keypad at the end of the automated phone call to acknowledge understanding and receipt of instruction. failure to acknowledge trigger an alert for a booking office staff member to directly call the patient and confirm compliance. the clinical investigation will be conducted at one hospital in the state of new south wales, australia. subjects will be randomized to the interventional group (enhanced instruction) versus the control group (standard instruction). the proceduralist assessing outcome measures at the time of colonoscopy is blinded to the intervention.

Eligibility criteria:
inclusion criteria: * elective colonoscopy booking at griffith base hospital. exclusion criteria: * emergency colonoscopy * patients who are unable to understand bowel preparation instructions in the following languages: english, italian, punjabi, gujarati, samoan, mandarin.

Keywords: colonoscopy boston bowel preparation scale bowel preparation quality enhanced bowel preparation instruction
a non-invasive intervention (breestim) for management of phantom limb pain (plp) after limb amputation (experiment 3)

Conditions: Pain Management

Summary: the purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (breestim) and conventional electrical stimulation (estim) in management of neuropathic phantom limb pain in patients after limb amputation after multiple sessions of treatment.

subjects will receive 10-session breestim and 10-session estim treatment in a random order. the interval between breestim and estim is at least 2 weeks. the following assessment will be made before and after 1. visual analogue scale (vas). 2. quantitative sensory testing (qst). it includes non-invasive assessment of tactile sensation threshold (tst), electrical sensation threshold (est), electrical pain threshold (ept), and thermal thresholds. 3. hear rate variability (hrv). it consists of 5-minute electrocardiogram (ecg) recording before and after a treatment session.

Eligibility criteria:
inclusion criteria: * has phantom limb pain (plp) after amputation of one limb, upper or lower limb; * has chronic pain, \>3 months; * is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.) exclusion criteria: * currently adjusting oral pain medications for their plp; * has pain, but not plp (e.g., from inflammation at the incision wound of the residual limb); * has a pacemaker, or other metal and/or implanted devices; * has cognitive impairment from brain injury or are not able to follow commands, or to give consent; * has amputation in multiple limbs; * have asthma or other pulmonary diseases; * are not medically stable; * have preexisting psychiatric disorders; * alcohol or drug abuse; * have a history of seizures/epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.

Keywords: phantom limb pain breestim
a meditation program in high-burden informal caregivers

Conditions: Caregivers Burnout

Summary: the aim of the present study was to investigate in high burden caregivers the effects of a face-to-face meditation program during four weeks (16 hours) on physiological parameters, psychological state and vagal nerve activity comparing with a control group.

a non-randomized repeated-measures controlled clinical trial was conducted with convenience allocation of participants into intervention (n = 18) or control group (n = 17). due to ethical reasons, it was not possible to randomize the patients. the investigators invited from different associations in granada city and its province through word and mouth or by telephone to 45 volunteer informal caregivers. 40 of them enrolled in this study but only 37 finalized the program, 24.3% male and 75.7% female with a mean (sd) age of 44.03 (7.30) years. the people that have previous experience in mind body practices or cardiovascular diseases were excluded. all the caregivers received information about the study and informed consent was obtained from all participants. this study was approved by the cei-gr (c-9) ethics committee and followed the principles of the declaration of helsinki. convenience sampling was used to assign caregivers to the control or experimental groups.

Eligibility criteria:
inclusion criteria: * people who care for a dependent family member or close relative and live with him/her in the same home for at least two years with a caregiver burden of more than 55 points in zarit burden scale. exclusion criteria: * people that have previous experience in mind body practices or cardiovascular diseases.
efficacy study of cardizem in pulmonary arterial hypertension

Conditions: Idiopathic Pulmonary Arterial Hypertension; Primary Pulmonary Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension

Summary: the purpose of this study is to determine if cardizem is effective in the treatment of nitric oxide non-responder pulmonary arterial hypertension.


Eligibility criteria:
inclusion criteria: * adult participants * confirmed who class i pulmonary arterial hypertension * nitric oxide non-responders on right heart catheterization * experience dyspnea, nyha iii-iv with poor oxygenation and quality of life despite standard treatments * must be able to swallow medications exclusion criteria: * pulmonary hypertension secondary to 1) elevations in pulmonary venous pressures (i.e. left heart disease), 2) chronic hypoxemic states from lung diseases such as copd, sleep-disordered breathing, alveolar hypoventilation disorders, chronic exposure to high altitude and developmental abnormalities 3) chronic thromboembolic disease, 4) sarcoidosis, 5) lymphangiomyomatosis, 5) pulmonary langerhans cell histiocytosis * already on a calcium channel blocker * systolic blood pressure less than 90 * heart rate less than 55 * pregnant * cannot sign informed consent * right heart failure * pulmonary veno-occlusive disease
an observational study on human epidermal growth factor receptor (her) 2 status of breast invasive carcinoma in latin american participants

Conditions: Breast Cancer

Summary: this is a descriptive, prospective, observational and epidemiological study on participants recently diagnosed with breast cancer to evaluate the her2 status by ihc and sish procedures.


Eligibility criteria:
inclusion criteria: - anatomopathological samples (surgical specimens or when a surgical sample is not possible, a core needle biopsy may be used) from female participants with a histopathological diagnosis of invasive breast cancer exclusion criteria: * samples whose residual material in the paraffin block(s) is insufficient for neoplasm representation in the procedures in this study * cancer samples that have received previous chemotherapy treatment
peng block versus fascia iliaca block for pre- and post-operative analgesia in elderly patients with hip fracture

Conditions: Hip Fractures

Summary: clinical controled trial to compare between pericapsular nerve group block and fascia iliaca block to find the best way to provide analgesia for elderly patients with hip fracture in the pre- and post-operative periods.

pain is a major problem that has to be dealt with in case of hip fracture, as it resembles an obstacle for examination, positioning for receiving neuroaxial anesthesia and postoperative mobility and physiotherapy. with the introduction of ultrasound in regional anesthesia and peripheral nerve blocks, regional analgesia float to the surface as a substitute for opioids with less side effects. of the many techniques to provide regional analgesia for hip fractures; fascia iliaca block was widely used with good results. in 2018 pericapsular nerve group block was introduced to provide regional analgesia for hip fractures with interesting results. in this study the investigators are going to compare pericapsular nerve group block and fascia iliaca block to find the best way to provide analgesia for elderly patients with hip fracture in the pre- and post-operative periods.

Eligibility criteria:
inclusion criteria: 1. patient acceptance. 2. accepted mental state of the patient. 3. gender: both sexes. 4. age above 65 years old. 5. body mass index 18.5-35 kg/m2. 6. asa physical status ii and iii. 7. unilateral hip fracture assigned for surgical fixation. 8. expected duration of surgery ≤ 3 hours. exclusion criteria: 1. associated trauma or multiple fractures. 2. peripheral neuropathy. 3. coagulopathy. 4. infection at site of injection. 5. allergy to the drugs used in the study. 6. advanced kidney, liver or heart disease.

Keywords: peng block hip fracture analgesia fascia iliaca block ultrasound fentanyl
isolated thoracic perfusion (itp-f) for mpm

Conditions: Mesothelioma

Summary: this is an observational study of isolated thoracic perfusion with subsequent hemofiltration to lower the concentration of the cytotoxic drugs as a locoregional therapeutic strategy in malignant pleural mesothelioma.

treatment of patients with progressive malignant pleural mesothelioma (mpm) after multimodal therapy is a therapeutic challenge. survival of the patients is low and the treatment options are sparse. this is an observational study of isolated thoracic perfusion with subsequent hemofiltration as a locoregional therapeutic strategy in this situation. 23 pts. with epithelioid mpm were included in this phase ii study after informed consent. all patients had progressive disease after multiple therapies and were recommended bsc of a mdt. following insertion of a venous and arterial 21 ch. stop flow catheter via a femoral access, the inferior vena cava was blocked beneath the right atrium, the arterial catheter was blocked in the aorta at the diaphragm. the upper arms were blocked by pneumatic cuffs. chemotherapy was given via the arterial catheter. chemotherapy consisted of 60mg/m2 cisplatinum and 15mg/m2 mitoxantrone q for 3 weeks until progress. after administration of chemotherapy, thoracic perfusion with blocked stop-flow catheters was maintained for 15 minutes. after de-blocking of the catheters, hemofiltration was performed for 45 min. with 5l filtrate. the endpoint of the study was overall survival.secondary endpoint was toxicity.

Eligibility criteria:
inclusion criteria: * history of pre-treated malignant pleural mesothelioma, progress after staging exclusion criteria: * drug abuse, distant metastases, no bone marrow function

Keywords: mesothelioma, malignant chemotherapy
effects of cranberry extractive on the lipid profiles in subjects with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: cranberry, containing flavonoids, is effective on improvement of lipid profiles in non-diabetic subjects. the hypothesis of is to assess the effect of cranberry on lipid profiles in type 2 diabetic patients using oral antidiabetic drugs.

hypercholesterolemia is a notorious risk factor for cardiovascular disease. it had been reported cranberry consumption increased nearly 8% of circulating high-density lipoprotein (hdl) cholesterol levels in non-diabetic subjects. although characteristics of diabetic dyslipidemia are low hdl and high triglyceride, the benefits of concentrated powder of cranberry juice on lipid profiles were not evident in type 2 diabetic subjects with diet control alone. to the best of our knowledge, the effect of cranberry on lipid profiles in type 2 diabetic subjects using oral anti-diabetic drugs have never been studied, especially total to hdl cholesterol ratio which is important in predicting cardiovascular diseases in asian and/or diabetic population. furthermore, cranberry has anti-oxidative effect which is associated with reduction of oxidized low-density lipoprotein (ox-ldl) cholesterol in non-diabetes. therefore, we conducted a placebo-controlled, double-blind, randomized study to assess the effect of cranberry on lipid profiles in type 2 diabetes.

Eligibility criteria:
inclusion criteria: * type 2 diabetic subjects * age between 50 and 75 years exclusion criteria: * glycosylated hemoglobin (hba1c) less than 7% or more than 10%; * triglyceride more than 4.5 mmol/l; * current insulin treatment; * change of the medications for anti-diabetes, hypertension, hyperlipidemia and anti-platelet in recent four weeks; * abnormal renal function (serum creatinine \> 177 μmol/l; * abnormal liver function test results (more than two-fold upper limit of normal range); * severe systemic disease such as immune disorder, cancer, acute or chronic inflammation disease; * smoking in recent 1 year; * alcoholism (more than two drinks daily); * using steroid or drugs with unknown components; * pregnancy or breast-feeding.

Keywords: cranberry total to hdl cholesterol ratio type 2 diabetes
vigadexa gel compared to vigadexa solution following cataract surgery

Conditions: Cataracts

Summary: the purpose of this study is to compare vigadexa (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to vigadexa (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * diagnosis of cataract with intention to undergo routine, uncomplicated cataract surgery. * able to understand and sign an informed consent form. * other protocol-defined inclusion criteria may apply. exclusion criteria: * glaucoma or ocular hypertension. * use of topical or systemic non-steroidal anti-inflammatory drugs (nsaids) within 14 days prior to surgery or planned use during the study. low-dose acetylsalicylic acid (up to 100 mg/day) is allowed. * use of anti-bacterial, anti-viral, or anti-fungal agents or ocular medications within 30 days prior to enrollment in the study or during study, as specified by protocol. * secondary implantation or replacement of the intra-ocular lens (iol) in the study eye. * planned use of contact lenses in the study eye during the study period. * cataract surgery in the contralateral eye within 30 days prior to the screening visit, or planned for the 3 weeks after the cataract surgery in the study eye. * history of clinically significant trauma to the study eye within the past 12 months. * other protocol-defined exclusion criteria may apply.

Keywords: cataract surgery topical therapy prevention of inflammation inflammation of infection
a study to investigate the food effect on the pharmacokinetics of ym178 in healthy, non-elderly volunteers

Conditions: Healthy Volunteer; Pharmacokinetics of YM178

Summary: the purpose of the study is to evaluate the effect of food intake on the pharmacokinetics of ym178 in healthy, non-elderly adult subjects.


Eligibility criteria:
inclusion criteria: * healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests * body weight (at screening); female ≥40.0 kg, \<70.0 kg, male ≥50.0 kg, \<80.0 kg * bmi (at screening): ≥17.6, \<26.4 * written informed consent has been obtained exclusion criteria: * received any investigational drugs within 120 days before the screening test * donated 400 ml of whole blood within 90 days, 200 ml of whole blood within 30 days, or blood components within 14 days before the screening test * received medication within 7 days before hospital admission or is scheduled to receive medication * females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period * history of drug allergies * upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before hospital admission

Keywords: overactive bladder urinary incontinence ym178 mirabegron
sedation during noninvasive ventilation (niv)

Conditions: Acute Hypercapnic Respiratory Failure

Summary: in patients undergoing niv for acute respiratory, lack of tolerance is one of the main reason of failure. this may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing. the investigators aim to investigate whether in these patients poorly responding to niv the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to niv.

in patients undergoing niv for acute respiratory, lack of tolerance is one of the main reason of failure. this may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing. the investigators aim to investigate whether in these patients poorly responding to niv the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to niv. in this physiological study the investigators will study 15 patients at risk of failing niv because of scarce tolerance and showing clinical signs of poor interaction with the ventilator. once the patient will be enrolled the investigators will record using the balloon-catheter technique the online measurement of respiratory mechanics, to assess the inspiratory muscle effort and the matching between the patient breathing pattern and that of the ventilator the investigators will also record the clinical success of sedation (i.e. need or not for endotracheal intubation)

Eligibility criteria:
inclusion criteria: * ph\ 50 mmhg with acute respiratory failure * signs of respiratory distress and poor synchrony with the ventilator as assessed on the ventilator screen and by looking patient own rate and ventilator recorded rate exclusion criteria: * patients responding well to niv and not showing signs of poor synchrony

Keywords: acute respiratory failure noninvasive ventilation sedation patient/ventilator interaction
transdiagnostic internet-delivered rebt intervention for adolescents' internalizing problems

Conditions: Anxiety Disorders; Social Anxiety Disorder; Generalized Anxiety Disorder; Panic Disorder; Persistent Depressive Disorder; Major Depressive Disorder

Summary: to investigate the efficacy and mechanisms of change of an internet-delivered transdiagnostic rebt intervention for adolescents with internalizing problems.

the main objectives of this study are to evaluate the efficacy and mechanisms of change of an internet-delivered rational emotive behavior therapy for adolescents (12-15 years) diagnosed with a principal anxiety or depressive disorder according to dsm-5 criteria. participants will be randomly allocated to one of the two groups: experimental (rebtonad) and waitlist control. the intervention is structured in 8 modules and will be delivered over six weeks. assessments will be conducted at four time points: baseline, post-treatment, 3-month follow-up, and 6-month follow-up.

Eligibility criteria:
inclusion criteria: * age between 12 and 15 years * a principal diagnosis of social anxiety disorder, generalized anxiety disorder, panic disorder, persistent depressive disorder, or major depressive disorder as defined by dsm-5 (apa, 2013) * not currently following another treatment (psychotherapy, pharmacological treatment); * internet access * ability to read and write romanian exclusion criteria: * suicidal ideation * severe depression * any physical and mental health acute problem that requires hospitalization * diagnosed with autism spectrum disorder, psychosis, bipolar disorder or mental disability

Keywords: transdiagnostic anxiety depression rebt adolescents internet intervention