Kornimate/medical-research-clean huggingface dataset:
sad/mad study to assess safety, tolerability, pk & pd of medi1814 in subjects with mild-moderate alzheimer's disease.

Conditions: Mild-Moderate Alzheimer's Disease; Healthy Elderly

Summary: the purpose of this study is to assess the safety, drug levels and effects on the body of 1 or 3 injections of medi1814, in people with mild to moderate alzhiemer's disease or healthy elderly people.


Eligibility criteria:
inclusion criteria male and female (non child bearing potential) subjects mild-moderate alzheimer's disease exclusion criteria history or evidence of significant autoimmune disease presence of psychiatric disorder which would affect completion of the study current serious or unstable clinically important illness
optimizing tdcs protocol for clinical use in major depressive disorder

Conditions: Depressive Disorder; Cognitive Impairment; Psychiatric Disorder

Summary: in this project, the efficacy of different tdcs protocols in major depression will be investigated. the tdcs protocols have already been investigated in humans, and results showed that stimulation intensity has a different effect on tdcs long-term aftereffects based on the human motor cortex model. the project has three major goals: first, we want to see if the differential outcome of tdcs dosage, as present in healthy populations, can be translated to patients with major depression. second, we want to compare the efficacy of a multi-channel novel protocol with conventional tdcs modules. lastly, we are interested in the safety and tolerability of optimized multi-channel. the project output will be an optimized tdcs protocol for major depression treatment.


Eligibility criteria:
inclusion criteria: * meet dsm-5 criteria for a moderate-to-severe major depression, primarily by a dsm-5-based structured interview by a licensed psychiatrist, confirmed by score on hamilton rating scale for depression (hamd) * being 18-60 years old * providing written informed consent * if female, negative urine pregnancy test * treatment naïve or on a stable standard antidepressant regimen (including selective serotonin reuptake inhibitors (ssris), serotonin-noradrenaline reuptake inhibitors (snris), monoamine oxidase inhibitors (moais) or tricyclics (tcas)) with no change in treatment 6-weeks prior to and during the tdcs intervention exclusion criteria: * smoker * pregnancy * alcohol or substance dependence * history of seizure * history of neurological disorder * comorbid schizophrenia axis i disorder, bipolar disorder, substance abuse or dependence, dementia, personality disorder * history of head injury * currently receiving any form of cognitive behavioral therapy, dialectical behavioral therapy, or acceptance and commitment therapy * presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments)

Keywords: major depressive disorder tdcs
prophylactic amnioinfusion for prevention of postpartum hemorrhage

Conditions: Postpartum Hemorrhage

Summary: the purpose of this study is to decrease the likelihood of composite postpartum hemorrhage (pph) morbidity, which consists of i) estimated or quantified blood loss of 1,500 ml or more, ii) transfusion of any blood products or iii) hysterectomy


Eligibility criteria:
inclusion criteria: * singletons with a gestational age of 34.0 weeks or more * labor (spontaneous or medical induction) * medium- or high-risk for pph, as described by american college of obstetricians and gynecologists (acog) exclusion criteria: * scheduled cesarean delivery * multiple gestations * delivery at \< 34.0 weeks * contraindication to place intrauterine pressure catheter (e.g. hiv) * incarcerated subjects * major fetal anomalies requiring neonatal surgical intervention * stillbirth on admission
interleukin-2 in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. purpose: phase ii trial to study the effectiveness of interleukin-2 in treating patients who have metastatic melanoma.

objectives: i. evaluate the response and survival rates of patients with metastatic melanoma following induction with high-dose and maintenance with low-dose interleukin-2. ii. assess the toxicity of this regimen. outline: all patients receive high-dose interleukin-2 over 24 hours, followed by low-dose interleukin-2 for 4 days in the absence of toxicity. patients receive a second cycle beginning 9-13 days after completion of the first cycle, with response assessed approximately 2 months after initiating therapy. patients with stable or responding disease receive a second course as above; those with a continued response may receive additional courses provided toxicity is limited. patients are followed for survival. projected accrual: 20 patients will be entered.

Eligibility criteria:
disease characteristics: histologically proven melanoma that is metastatic no tumor replacement of 25% or more of liver on ct or mri no involvement of the cns or a major nerve measurable disease required patient characteristics: age: 18 and over performance status: karnofsky 80%-100% life expectancy: more than 3 months hematopoietic: no coagulopathy (i.e., platelets less than 80,000) hepatic: bilirubin normal renal: creatinine normal cardiovascular: no abnormal cardiac stress test in patients over 50 years of age or with possible cardiac disease suggested by history, physical exam, or ekg pulmonary: fev1 or vc greater than 65% of predicted in patients with significant smoking history or with suspected pulmonary disease by history, physical exam, or x-ray other: no site of ongoing bleeding no systemic infection no hiv antibody no hbsag no requirement for steroids no psychiatric disease that precludes informed consent or protocol treatment no second malignancy except: basal cell skin carcinoma carcinoma in situ of the cervix no pregnant or nursing women negative pregnancy test required of fertile women effective contraception required of fertile women prior concurrent therapy: no prior interleukin-2 at least 28 days since treatment for melanoma

Keywords: stage iv melanoma recurrent melanoma
influenza vaccine randomized educational trial: adult

Conditions: Vaccination; Influenza

Summary: influenza vaccine is recommended as routine care for all individuals who are at least 6 months of age and older. recently, questions about vaccine safety and concerns for side effects have increased, contributing to both influenza vaccine hesitancy and refusal. in an effort to educate patients, public health entities and physicians give informational handouts in various forms. however, recent publications have found that pro-vaccine messages can have paradoxical effects on vaccine intentions, therefore further studies on vaccine related public health communication is needed. the purpose of this study is to compare the effectiveness of pro-vaccine messages of local data, pro-vaccine messages of national data, and no educational message on patient's receipt of the influenza vaccine. these results will help to understand the relationship between patient education and the intent to vaccinate and receipt of the influenza vaccine as well as to optimize educational information given to patients regarding the influenza vaccine.


Eligibility criteria:
inclusion criteria: * visit to study site at time of intervention exclusion criteria: * prior receipt of influenza vaccine that season
effect of all-trans retinoic acid with chemotherapy based in paclitaxel and cisplatin as first line treatment of patients with advanced non-small cell lung cancer

Conditions: Non-Small-Cell Lung Carcinoma

Summary: purpose: this randomized phase ii trial evaluated whether the combination of cisplatin and paclitaxel plus all-trans retinoic acid (atra) increases response rate (rr) and progression-free survival (pfs) in patients with advanced non-small cell lung cancer (nsclc) with an acceptable toxicity profile and its association with the expression of retinoic acid receptor beta 2 (rar-beta2) as a response biomarker. patients and methods: patients with stage iiib and iv nsclc were included to receive paclitaxel and cisplatin (pc). patients were randomized to receive atra 20 mg/m2/day (ra/pc) or placebo (p/pc) 1 week prior to treatment until completing two cycles. rar-beta2 expression was analyzed by immunohistochemistry (ihc) and rt-pcr in tumor and adjacent lung tissue.

purpose: this randomized phase ii trial evaluated whether the combination of cisplatin and paclitaxel plus all-trans retinoic acid (atra) increases response rate (rr) and progression-free survival (pfs) in patients with advanced non-small cell lung cancer (nsclc) with an acceptable toxicity profile and its association with the expression of retinoic acid receptor beta 2 (rar-beta2 ) as a response biomarker. patients and methods: patients with stage iiib and iv nsclc were included to receive paclitaxel and cisplatin (pc). patients were randomized to receive atra 20 mg/m2/day (ra/pc) or placebo (p/pc) 1 week prior to treatment until completing two cycles. rar-beta2 expression was analyzed by immunohistochemistry (ihc) and rt-pcr in tumor and adjacent lung tissue.

Eligibility criteria:
inclusion criteria: * stage iii b and iv nsclc * eastern cooperative oncology group (ecog) performance status of 0-2 * no prior cytotoxic chemotherapy for nsclc * age ≥18 years, adequate laboratory measurements * measurable disease according to response evaluation criteria in solid tumors (recist) * life expectancy of \>12 weeks. exclusion criteria: * patients who had received prior chemotherapy * patients with other comorbid conditions

Keywords: all-trans retinoic acid non-small cell lung cancer retinoic acid receptor beta chemotherapy
emdr in the treatment of specific phobia.

Conditions: Specific Phobia

Summary: the purpose for this study is to determine whether emdr is effective in the treatment of specific (animal) phobia.

aims: to test the hypothesis that one session emdr is more effective for the treatment of specific (animal) phobia than relaxation immediately after treatment and at follow-up. secondly to test whether an additional one-session exposure therapy offered to both treatment groups (emdr patients and relaxation patients) improves outcome in the emdr-group and results in equal outcome for both treatment groups.

Eligibility criteria:
inclusion criteria: * patients with specific (animal) phobia exclusion criteria: * current or past psychotic disorder * current substance dependence or abuse * serious physical illness * active suicidal behavior * bipolar affective disorder * pregnancy

Keywords: specific (animal) phobia emdr exposure therapy
clinical features, outcomes, and therapeutics of pregnancy-related aortic dissection

Conditions: Aortic Dissection; Pregnancy Related

Summary: aortic dissection in pregnancy represents a lethal risk to both the mother and fetus, it has yet to yield the optimal therapeutic strategy. the aim of this study was to characterize the clinical features and outcomes in women with pregnancy-related acute aortic dissection, and to suggest therapeutic guidelines.


Eligibility criteria:
inclusion criteria: * women who presented with aortic dissection during pregnancy or post partum ≤12 weeks. exclusion criteria: * loss of surgical information.
patient's telemonitoring with amyotrophic lateral sclerosis treated by non invasive ventilation at home.

Conditions: Amyotrophic Lateral Sclerosis; Noninvasive Ventilation

Summary: single-center, prospective pilot study on patients with amyotrophic lateral sclerosis fitted with noninvasive ventilation. the objective is to assess the satisfaction of remote monitoring of patients on non-invasive ventilation after 12 months.

the non invasive ventilation is one of treatments used during the amyotrophic lateral sclerosis when patients have a chronic respiratory failure with alveolar hypoventilation signs. it is demonstrated to improve quality of life and prognosis of the disease. these patients, often severely disabled, generally have a negative experience of repeated hospitalizations. despite everything, medical and paramedical monitoring is necessary, especially when they are fitted with non invasive ventilation (niv). a quarterly reassessment is recommended . the possibilities of telemonitoring at home have grown considerably in recent years. in addition, the fans are currently able to remotely transfer a certain amount of data to the service provider, making remote monitoring feasible.our project therefore aims to assess the feasibility of remote monitoring of patients with amyotrophic lateral sclerosis (als) fitted with non invasive ventilation (niv) through the assessment of their satisfaction, using both medical data and data provided by the ventilator. it is a single-center, prospective pilot study on 30 patients with amyotrophic lateral sclerosis fitted with noninvasive ventilation. patients will benefit from a quarterly teleconsultation to assess the study criteria through questionnaires during 12 months. ventilation machines make it possible to carry out remote monitoring, with the help of healthcare providers.

Eligibility criteria:
o inclusion criteria: * patient over 18 years, * patient with amyotrophic lateral sclerosis (als), * already fitted by non invasive ventilation (niv), * patient having signed the informed consent * patient affiliated to a social security scheme, * patient with a correct understanding of the french language, * patient with access to an internet connection at home. for the caregiver: * adult person * be the patient's primary caregiver * have signed the informed consent intended for the caregiver o exclusion criteria: * patient with another cause of chronic respiratory failure: other neuromuscular diseases, chronic obstructive pulmonary disease (copd), diffuse interstitial lung disease, * patient under guardianship or under judicial protection, * patient dependent at least 20 hours out of 24 of the non invasive ventilation (niv).

Keywords: telemonitoring amyotrophic lateral sclerosis noninvasive ventilation feasibility
efficacy and safety of dapagliflozin in combination with glimepiride (a sulphonylurea) in type 2 diabetes patients

Conditions: Type 2 Diabetes

Summary: this study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study * inadequate glycaemic control, defined as a1c ≥ 7.0 % and ≤ 10% exclusion criteria: * type 1 diabetes * hepatic (liver) impairment * renal (kidney) failure or dysfunction

Keywords: dapagliflozin efficacy safety sulphonylurea type 2 diabetes
bispectral index throughout esophageal cancer operation

Conditions: Esophageal Cancer

Summary: the investigators try to conduct a study to assess the impact of changing patients' lateral decubitus position on bis readings during esophageal cancer operation. also, the investigators evaluate the effects of one-lung ventilation and total lung ventilation on bis value with inhalation agent.

bispectral index (bis) was developed to monitor a patient's level of consciousness under general anesthesia. several factors have been found to alter bis readings without affecting the depth of anesthesia.changing a patient's position (head up and head down) significantly affects the bis values, which might affect the interpretation of anesthetic depth. during esophageal cancer surgery, there were several factors which could affect to bis values.first, the surgical positions are consisted with supine and lateral decubitus position more than 1 h. thus, the investigators compare the bis value of both side on supine and lateral decubitus position by both side approach. second, the one lung ventilation was applied for surgical filed. it alters the oxygenation and the cerebral flow. because of these effects, the bis monitoring can differ by the period of surgery. thus, in this study, the bis value of both side monitor throughout the surgery.

Eligibility criteria:
inclusion criteria: the patients who are planned the esophageal cancer operation exclusion criteria: * patient who has dermatitis * patient who refuse to participate in this study

Keywords: bispectral index lateral decubitus position one lung ventilation
a study of guselkumab in participants with moderately to severely active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * documented diagnosis of ulcerative colitis (uc) * moderately to severely active uc, defined by modified mayo score * demonstrated inadequate response or intolerance to medical therapies specified in the protocol * screening laboratory test results within the parameters specified in the protocol exclusion criteria: * diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohn's disease or clinical findings suggestive of crohn's disease * uc limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon * presence of a stoma * presence or history of a fistula * receiving prohibited medications and/or treatment
betaplus survey - observational study to assess drug adherence in patients with multiple sclerosis after conversion to betaferon® by using elements of the betaplus program

Conditions: Relapsing Remitting MS (RRMS); Secondary Progressive MS (SPMS)

Summary: this is an observational survey to assess the factors that influence adherence to betaferon therapy in multiple sclerosis patients using elements of the betaplus support program, including the nurse support and auto-injectors. the patients were evaluated under normal clinical practice and were asked to fill out the quality of life fams questionnaire, coping processes (wcq - ways of coping questionnaire) and depression questionnaire ces-d.


Eligibility criteria:
inclusion criteria: * relapsing-remitting ms (rrms) or secondary-progressive ms (spms) * previous treatment with disease modifying drugs * adjustment of disease modifying treatment necessary at the discretion of the investigator * switch to betaferon at least 1 month but not longer than 3 months prior to inclusion exclusion criteria: * patients not fulfilling the indications in the local prescribing information * refusal to sign inform consent

Keywords: multiple sclerosis adherence interferon beta-1b coping styles
mapping of the epileptic brain

Conditions: Epilepsy

Summary: this study aims improving the outcome after brain resective surgery of epileptic patients by improving presurgical evaluations. in particular the specific goal is to evaluate the ability of non invasive neuroimaging (functional magnetic resonance imaging and electroencephalography) to provide presurgical maps of the functional areas of the brain and of the epileptogenic networks.


Eligibility criteria:
inclusion criteria: * epilepsy exclusion criteria: * mri incompatible * pregnancy

Keywords: epilepsy mri eeg neuroimaging
miniject implantation combined with cataract surgery in patients with poag and cataract

Conditions: Primary Open-angle Glaucoma; Cataract

Summary: the study will assess safety and performance of miniject implant in patients with open-angle glaucoma uncontrolled by topical hypotensive medications in conjunction with cataract surgery.

the study aims to evaluate the safety and efficacy of the miniject in the reduction of intraocular pressure (iop) in patients with primary open-angle glaucoma (poag) in conjunction with cataract surgery. the cataract surgery will be performed first and if successful, only then will the miniject be placed. patients will be followed for 2 years after the date of their implantation. standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.

Eligibility criteria:
inclusion criteria: * diagnosis of primary open angle glaucoma (poag) in the study eye * operable age-related cataract eligible for phacoemulsification surgery with intraocular lens (iol) implantation * glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the patient has an allergy / intolerance to a medication * patient must provide written informed consent to participate exclusion criteria: * known or suspected allergy or hypersensitivity to medical silicone * allergy to fluorescein * presence of silicone oil in the study eye * individuals under tutorship or trusteeship * patient has a condition such that his / her ability to provide personal informed consent is compromised

Keywords: primary open-angle glaucoma (poag) cataract intra ocular pressure (iop) reduction glaucoma drainage device minimally invasive glaucoma surgery (migs) supraciliary space combined procedure (poag and phacoemulsification)
vegan diet, amla fruits and uric acid

Conditions: Hyperuricemia; Diet, Healthy; Cardiometabolic Syndrome

Summary: this is an intervention study aiming to test the effectiveness of a vegan diet, my plate with low purine choices, and amla fruits on uric acid and other cardiometabolic risk factors in individuals with high serum uric acid levels.

ninety-two participants with hyperuricemia will be randomly assigned to one of these 4 diet interventions: (1) vegan, (2) vegan with amla fruits, (3) my plate-low purine, (4) my plate-low purine with amla fruits. during the 3 months intervention phase, participants will attend group lessons and individual nutrition counseling sessions to assist adherence to the diet. at baseline, end of 3 months, and 1 year, participants will be measured on uric acid and other cardiometabolic risk factors, and some nutritional markers. amla fruits powder, and some foods encouraged in each dietary arm will be provided to enhance adherence during the 3 months intervention phase.

Eligibility criteria:
inclusion criteria: * men with serum uric acid \> 7mg/dl * women with serum uric acid \> 6mg/dl * willing to make diet changes according to dietary interventions exclusion criteria: * age \<19 * with cancer diagnosis * with diseases that require special dietary needs * on urate-lowering medication within 3 months

Keywords: vegan diet uric acid cardiometabolic risk factors amla fruits
safety and efficacy of sufentanil nanotab for management of acute pain following bunionectomy

Conditions: Acute Pain

Summary: this is a dose-finding study to determine if the sublingual administration of the sufentanil nanotab is safe and effective in the treatment of post-operative pain.


Eligibility criteria:
inclusion criteria: * patients scheduled for bunion surgery exclusion criteria: * daily opioid use * drug or alcohol abuse * pregnant or breastfeeding women