Kornimate/medical-research-clean huggingface dataset:
botox injections for patients with persistent facial pain

Conditions: Facial Pain

Summary: the main objective of this study is to investigate efficacy and safety of injecting botulinum toxin towards the sphenopalatine ganglion using multiguide in patients with persistent idiopathic facial pain


Eligibility criteria:
inclusion criteria: * persistent idiopathic facial pain fulfilling diagnostic criteria as classified in the international classification of headache disorders, 3rd edition (ichd-3 beta version) as modified by the authors of this trial. see below. * unsatisfactory effect of available treatment methods as evaluated by a neurologist, ent specialist or maxillofacial surgeon. the patient should have failed treatment with both anticonvulsant as carbamazepine (tegretol, carbatrol) and antidepressant as tricyclic antidepressants * average pain intensity ≥4 (0-10) in numeric pain rating scale (nrs) on the affected side during the 4-week baseline period * written informed consent from the patient modified diagnostic criteria for pifp according to the international classification of headache disorders, 3rd edition (ichd-3 beta version): a. facial and/or oral pain fulfilling criteria b and c. b. recurring daily for \>2 hr per day for \>3 months c. pain has both of the following characteristics: 1. poorly localized and may radiate beyond the trigeminal nerve distribution 2. dull, aching or nagging quality d. clinical neurological examination is normal, however patient may denote paresthesia e. a dental cause has been excluded by appropriate investigations; signs of structural pathology or other specific causes of pain are not identified. minor operation and injury (insignificant trauma e.g. tooth extraction) to the face, maxilla, teeth and gums without a direct causal relationship with the pain regarding both time and site is accepted. f. not better accounted for by another ichd-3 diagnosis. exclusion criteria: * bilateral symmetrically affected * neurological disorders or other related systemic diseases that can explain the pain * mri/ct examination confirming intracranial pathology. * systemic or local disease or condition that can give a significantly increased risk of complications to the particular procedure * not competent to asses informed consent based on neurological assessment * psychiatric disorder that prevents the completion of the study * pregnancy * inappropriate use of contraception * breastfeeding * abuse or unauthorized use of medication, drugs or alcohol * allergy or other hypersensitivity reactions to marcaine, lidocaine, xylocaine, or adrenaline, possibly similar related drugs * anatomical factors that prevent or impede the injection * known hypersensitivity to botulinum toxin type a or to any of the excipients * treatment with drugs that can interact with botulinum toxin type a: aminoglycoside antibiotics, spectinomycin, neuromuscular blockers, both depolarizing (succinylcholine) and non-depolarizing (tubocurarine derivatives), lincosamides, polymyxins, quinidine, magnesium sulfate, anticholinesterases.

Keywords: botulinum toxins, type a injections sphenopalatine ganglion block
statin in hip fracture

Conditions: Hip Fracture

Summary: statins (or hmg-coa reductase inhibitors) have largely proven their efficacy in the primary and secondary prevention of cardiovascular events. many clinical and experimental studies support also a potential beneficial effect of statin therapy on venous thromboembolism (vte). patients with hip fracture are at high risk of vte and cardiovascular events. the aim of this study is to evaluate the efficacy and the tolerance of a statin (rosuvastatin) in hip fracture surgery on the occurrence of venous and atherothrombotic events and the global mortality at six months. subjects aged 60 years or over who are scheduled to undergo surgery for fracture of the upper portion of the femur (hip fracture) are eligible to participate to this multicentre, randomized, double-blind placebo controlled trial. they will receive either rosuvastatin (5 or 20 mg) or placebo for 6 months. the primary efficacy outcome is the incidence of an adjudicated composite of non fatal vte, acute coronary syndrome, non fatal stroke, other acute ischemic arterial event, or all-cause death. assuming a endpoint frequency of 20% in the control group, we calculated that 1200 patients will be required for the study to have 80% power to detect a 30% reduction in the relative risk with rosuvastatin (with a two-sided alpha level of 5%). the investigators assumed that rosuvastatin could have a positive benefit-risk ratio in patients undergoing orthopaedic surgery for hip fracture, by reducing vascular events and global mortality at six months.


Eligibility criteria:
inclusion criteria: * 60 years old or older. * fracture of the femoral neck or of the trochanteric mass * undergoing surgery within 5 days for this fracture * signed written informed consent exclusion criteria: * contraindication to rosuvastatin: * active liver disease including unexplained and prolonged elevations of serum transaminases and any increase of serum transaminases beyond 3 times the upper limit of normal * severe renal impairment (creatinine clearance calculated by the formula mdrd \<30 ml / min) * myopathy * use of cyclosporine * statin therapy ongoing at the admission for fracture * curative anticoagulant therapy ongoing at the admission and expected to be maintained after the intervention * patients considered by the investigator to be unable to participate to the study * refuse to participate

Keywords: venous thromboembolism hip fracture cardiovascular events statin
omega-3 fatty acid deficiency replacement in early schizophrenia

Conditions: Schizophrenia; Fatty Acid Deficiency

Summary: the purpose of this research study is to find out what effects (good and bad) that omega-3 fatty acids has on schizophrenia.

the two aims of the study test the hypotheses that correcting omega-3 fatty acid deficiency in the early stages of schizophrenia improves positive symptom treatment response, negative symptom treatment response, and cognition symptom response.

Eligibility criteria:
inclusion criteria: * between the ages of 8-25 years. * diagnosis of mdd and not exhibited symptom remission cdrs-r (\> 28 but \< 40) despite being administered a standard therapeutic dose of an ssri continuously for a minimum of 6 weeks. * ability and willingness to provide assent and informed, written consent from at least one biological parent. * present with biological parent or legal guardian. * willingness to maintain current dietary habits. * permission from treating physician * able to perform fmri/mrs. exclusion criteria: * inability or unwillingness to provide consent. * antecedent or concurrent serious medical illness. * clinically unstable medical disease, including cardiovascular, hepatic insufficiency, severe renal impairment, gastrointestinal, pulmonary, metabolic, endocrine, obesity or other systemic disease. * history of seizures, excluding febrile seizures in childhood. * patients requiring treatment with any drug which might obscure the action of the study treatment. * female patients who are either pregnant or lactating. * clinically significant laboratory abnormalities in the last year on cbc or tsh tests. * judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within the past 6 months, or a baseline cdrs-r suicide score of \>3). * hospitalized within the last 3 months * greater than 1 year outside appropriate age/grade level * pacemaker * cerebral aneurysm clip * cochlear implant * metal fragments lodged within the eye or braces * claustrophobia * necessity of sedation (no sedation will be given). * history of loss of consciousness \> 10 minutes in duration * allergy to seafood.
analysis of vital, facial and muscular responses front to music or message in coma, vegetative state or sedated patients

Conditions: Consciousness Disorders; Communication; Intensive Care

Summary: objectives: (1) to check music or voice message influence on vital signs, facial expressions or muscular tonus of coma, vegetative or sedated patients; (2) to connect the existence of patient's responsiveness with the glasgow coma scale or with the ramsay sedation scale; (3)to evaluate the relation between the response and the score of glasgow outcome scale.


Eligibility criteria:
inclusion criteria: * to be in disorder of consciousness; * to be evaluated according to one of the scales and to have a score in the study range: in physiological comas, score between 3 to 8 glasgow coma scale (gcs); in induced coma, one of the last two scores of ramsay sedation scale (rss), r5 or r6; * to have hearing function preserved according to family; * to have written consent from the family or responsible party for the patient's participation exclusion criteria: * score between 9 to 15 in gcs or scores r1, r2, r3 or r4 in rss

Keywords: glasgow coma scale glasgow outcome scale ethics
general use-results surveillance with awiqli in patients with diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of the study is to investigate the safety and effectiveness of awiqli in participants with diabetes mellitus under real world clinical practice in japan. participants will get awiqli as prescribed by the study doctor. the study will last for about 1 year.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * the decision to initiate treatment with commercially available awiqli has been made by the patient/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the patient in this study. * male or female with no age limitation. * diagnosis of diabetes mellitus. there is no limitation for type of diabetes mellitus and prior treatment for diabetes mellitus. exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study. * treatment with any investigational drug within 30 days prior to enrolment into the study. * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * contraindication described in japanese package insert. * participants showing hypoglycaemic symptoms. * participants with a history of hypersensitivity to any ingredients of this drug.
standard follow-up program (sfp) for patients with esophageal cancer

Conditions: Esophageal Cancer

Summary: motive: in order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from esophageal cancer patients. goal: to set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life. a standard database of patients receiving photon treatment will be created. these data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.


Eligibility criteria:
inclusion criteria: * patients with esophageal cancer * patients receiving a radiotherapy dose \> 40 gy exclusion criteria: * failure to comply with any of the inclusion criteria

Keywords: acute toxicity late toxicity prediction models
a problem-solving intervention for family caregivers in palliative oncology

Conditions: Palliative Care; Caregivers; Medical Oncology

Summary: in congruence with the national cancer institute's commitment to supporting families of individuals with cancer across the full disease trajectory, the investigators seek to examine the feasibility of a technologically-mediated problem-solving intervention designed to improve the quality of life and decrease the psychological distress of family caregivers of cancer patients receiving outpatient palliative care. investigators involved in this mixed methods pilot study will collect and analyze both quantitative and qualitative data, which will subsequently inform a large-scale randomized clinical trial of the problem-solving intervention.

palliative oncology providers are ideally situated to improve the cancer journey for the millions of family members and friends who are vital to the care of seriously ill patients. in recent decades, the primary setting for cancer care has shifted from the hospital inpatient unit to the outpatient clinic, leaving family caregivers responsible for providing the majority of patient care in the home, often with little support or preparation. the numerous stressors associated with family caregiving often give rise to caregiver anxiety, depression, fatigue, neglect of self-care and, for particularly strained caregivers, psychological symptoms that mirror those experienced by trauma survivors. in congruence with the national cancer institute's commitment to supporting families of individuals with cancer across the full disease trajectory, the investigators seek to examine the feasibility of a technologically-mediated problem-solving intervention designed to improve the quality of life and decrease the psychological distress of family caregivers of cancer patients receiving outpatient palliative care. specifically, the investigators aim to 1) examine the feasibility of the intervention relative to recruitment, randomization, retention, and fidelity to core intervention components; 2) investigate the impact of the intervention on family caregiver anxiety, depression, and quality of life; and 3) explore the benefits and challenges associated with the intervention from the perspective of participants. to accomplish these aims, investigators will recruit and randomly assign 82 family caregivers of cancer patients receiving outpatient palliative care into two groups (usual care and intervention) and collect quantitative and qualitative data, which will be analyzed to inform a future large-scale randomized clinical trial of the problem-solving intervention.

Eligibility criteria:
inclusion criteria: * 18 years of age or older, * access to an internet-connected device that will support videoconferencing software exclusion criteria: * younger than 18 years of age, * lack of access to an internet-connected device that will support videoconferencing software

Keywords: palliative care caregivers medical oncology
group- versus individual-mindfulness-based cognitive therapy: a randomized trial

Conditions: Depressive Symptoms

Summary: the purpose of this study is to determine whether both group and individual mindfulness-based cognitive therapy (mbct) are effective in reducing depressive symptoms in patients with a chronic somatic disease.

depression is a common co-morbidity in patients with a chronic somatic disease which has a negative impact on patients' physical and mental health. in recent years, mindfulness-based cognitive therapy (mbct) has gained interest and popularity as a treatment not only for preventing recurrence of depression, but also to treat current symptoms. usually, the training is delivered in group format, thus little is known about the feasibility and effectiveness of mbct as an individual training. this pilot study aims to compare the effectiveness and feasibility of group and individual mbct in reducing depressive symptoms in patients with a chronic somatic disease.

Eligibility criteria:
inclusion criteria: * chronic somatic disease * age ≥ 18 and ≤ 70 * depressive symptoms as assessed by bdi-ii score ≥ 14 (cut-off score indicating the presence of at least mild symptoms of depression) exclusion criteria: * not being able to read and write dutch * severe (psychiatric) co-morbidity * acute suicidal ideations or behavior * receiving an alternative psychological treatment during or less than two months prior to starting the participation in the study using an antidepressant drug during participation in the present study is allowed, on condition that a patient has been on stable medication regimen for at least two months prior to inclusion in the study, and that no new treatment with an antidepressant is initiated during the course of the study

Keywords: depression mindfulness mbct
impact of multiple electrolytes injection ⅱ and saline on hyperchloremia in patients with aneurysmal subarachnoid hemorrhage:a pilot study

Conditions: Aneurysmal Subarachnoid Hemorrhage; Hyperchloremia

Summary: the goal of this pilot randomized trial is to compare the effect of multiple electrolytes injection ⅱand saline on the occurrence of hyperchloremia within 72h of randomization in patients with aneurysmal subarachnoid hemorrhage(asah). a secondary aim was to provide data for the design and power of a large-scale, multicenter, randomized controlled trial.

background: the isotonic solutions commonly used in icus are saline (0.9% sodium chloride) and balanced crystalloid solutions (ringer's solution, multiple electrolytes injection, etc.). studies have shown that the lower chloride in balanced crystalloids compared to saline may result in lower risks of hyperchloremia, acute kidney injury and poor clinical outcome in critical ill patients. as a balanced crystalloid, few evidence was found on multiple electrolytes solution ii in patients with aneurysmal subarachnoid hemorrhage (asah). purpose this study aimed to evaluate the security and feasibility of the study. moreover, compare the impact of multiple electrolytes injection and saline solution on hyperchloremia in asah patients. method as a pilot trial of a prospective randomized controlled study, patients with aneurysmal subarachnoid hemorrhage randomly assigned to receive saline or multiple electrolytes injection ii as maintenance fluid for 3 days during icu stay.

Eligibility criteria:
inclusion criteria: * patients with aneurysmal subarachnoid hemorrhage; * expected icu stay \> 24 hours. exclusion criteria: * under 18 years of age; * pregnancy; * patients at imminent risk for death within 24 hours; * patients with a known history of serious cardiovascular, respiratory, kidney, liver, blood, or immune disease; * azotemia (bun \> 200μmol/l), hypokalemia (blood potassium \< 2.5mmol/l), hypocalcemia (blood calcium \< 1.8mmol/l); * patients routinely receiving renal replacement therapy (rrt); * declined to participate in the study.

Keywords: saline balanced crystalloids
compare efficacy and safety of raltitrexed-based and 5fu-based neoadjuvant chemotherapy for colorectal liver metastasis

Conditions: Colorectal Cancer; Liver Metastasis

Summary: this study is a multicenter ,randomization, open control study to evaluate the efficacy and safety of raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in the peri-operative treatment of patients with liver metastasis from colorectal cancer (crc).

the contrast analysis is separately done on raltitrexed plus oxaliplatin and 5-fluorouracil plus oxaliplatin;raltitrexed plus irinotecan and 5-fluorouracil plus irinotecan.to investigate the objective response rate,the r0 resection rate, the early tumor shrinkage （ets）and depth of response(dpr) and the safety profile.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed chinese colorectal cancer patients and imaging detection confirmed liver metastasis 2. previously no treatment for liver metastasis or primary tumor had been removed and last additional chemotherapy over one year 3. age of≥18 and ≤75 4. adequate organ functions, as determined by normal bone marrow function (absolute neutrophil count2 x 109/l, platelets 100 x 109/l, white blood cells 4 x 109/l), liver function (serum bilirubin ≤ 2.5 x uln, serum transaminases ≤2. 5x uln) 5. ecog≤1 6. life expectancy\>6months 7. signed written informed consent 8. expected adequacy of follow-up exclusion criteria: 1. lesion is too small to assess by imaging 2. extrahepatic metastases 3. any anticancer chemotherapy in development within 4 weeks prior to study entry 4. concurrent uncontrolled illness such as infection 5. be allergic to medicines in the study 6. pregnant or nursing patients 7. fertile women (\< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception. 8. not willing or incapable to comply with all study visits and assessments 9. evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications.

Keywords: colorectal cancer liver metastasis neoadjuvant chemotherapy
efficacy of peginterferon alfa-2b in previously untreated subjects with chronic hepatitis b and d co-infection (study p04603)

Conditions: Hepatitis D, Chronic; Hepatitis B, Chronic

Summary: the objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected with hepatitis virus b and d. after 52-week treatment and 52-week follow-up, the virologic, biochemical, and histological response will be evaluated.


Eligibility criteria:
inclusion criteria: * participants must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. * age 18-65 years old. * hbsag positive \>6 months. * alt \>= 2 uln \>6 months. * hdv rna positive serology. * serum antibody to hepatitis delta antigen of igg and igm class. * knodell score hai \>= 6 and f \>= 0; positive test for intrahepatic delta antigen in liver biopsy. * women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed iud, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation). * participants must be free of any clinically significant disease (other than chronic hepatitis b and d), that would interfere with study evaluations. * participants must understand and be able to adhere to the dosing and visit schedules, and agree to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary. exclusion criteria: * age \ 65. * concomitant hcv and/or hiv infection. * actual liver failure (total serum bilirubin \>2.5 x normal, prolonged prothrombin time \>3 sec, serum albumin \<3 g/dl, history of ascites, variceal bleeding, or hepatic encephalopathy). * toxic or autoimmune hepatitis (ana titers \> 1:160), metabolic liver diseases (wilson disease, hemochromatosis, α-1 antitrypsin deficiency) * women who are pregnant or nursing. * leukopenia (\<2500/mm\^3), neutropenia (\<1000/mm\^3), hemoglobin \<10 g/dl, presence of other severe diseases (myocardiopathy, diabetes mellitus, arterial hypertension, neoplasia, neurologic diseases, malnutrition). * antiviral, immunomodulatory, corticosteroid, or chemotherapeutical treatment within 6 months of the participation in the study. * depression and/or psychiatric disorders.

Keywords: hepatitis d hepatitis b