Kornimate/medical-research-clean huggingface dataset:
trigeminal nerve stimulation in treatment-resistant generalized anxiety disorder: a feasibility study

Conditions: Generalized Anxiety Disorder

Summary: this is a feasibility study for trigeminal nerve stimulation (tns) in patients with treatment-resistant generalized anxiety disorder (tr-gad). ten participants will receive tns for 8 weeks as an augmentation strategy to pharmacological treatment for generalized anxiety disorder (gad). * the primary objective is to ascertain if tns is a safe and well-tolerated treatment for patients with tr-gad. * the secondary objective will be to monitor changes in gad symptom severity throughout the study. results from this study will inform a randomized controlled trial to be conducted in the future.


Eligibility criteria:
inclusion criteria: * meet the diagnostic and statistical manual of mental disorders, fifth edition (dsm5) criteria for generalized anxiety disorder. * subjects on a stable dose of an selective serotonin reuptake inhibitor (ssri) or serotonin and noradrenaline reuptake inhibitor (snri) for at least 8 weeks. * treatment-resistant - treatment resistance will be defined as lack of response to at least two drugs, from two different classes of drugs considered first-line or second-line for gad. only trials lasting at least 8 weeks, and with at least the minimum effective dose of the given medication will be considered failed trials. exclusion criteria: * moderate to severe major depressive disorder * moderate to high suicidality * diagnosis of obsessive compulsive disorder (ocd), ptsd, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities and dementia or other neurological diseases including trigeminal neuralgia * pregnant or breastfeeding women * participants who are experiencing seizures * implanted vagal nerve stimulation (vns) or other electrical devices * participants who are already undergoing transcutaneous electrical nerve stimulation * consumption of cannabis, any cannabis by-products, illicit drugs, or alcohol above 3 drinks per week * consumption of natural health products that may affect anxiety or depression symptoms
the effect of correction of metabolic acidosis in ckd on intrarenal ras activity

Conditions: Chronic Kidney Disease

Summary: this study evaluates the effect of oral sodium bicarbonate treatment on the intrarenal renin-angiotensin-system in adult patients with a metabolic acidosis and chronic kidney disease. this treatment is compared to sodium chloride treatment, which serves as control for increased sodium-intake and no treatment, which serves as time-control.

in chronic kidney disease (ckd), as glomerular filtration rate decreases, excretion of hydrogen ions fails, leading to progressive metabolic acidosis (arterial ph \< 7.35 and a serum bicarbonate concentration \< 22 meq/l). metabolic acidosis enhances further progression of ckd. it is known that the intrarenal renin-angiotensin system (ras) is stimulated during metabolic acidosis, but it's specific role in the renal response on changes in the acid-base balance is unknown. correction of metabolic acidosis by administration of bicarbonate is a common intervention in patients with metabolic acidosis due to chronic kidney disease. it is proven to slow down progression of ckd. there is no knowledge on the effect this therapy has on the intrarenal ras. since acidosis does not change serum renin levels, and bicarbonate therapy has no effect on blood pressure, it seems to have no effect on the systemic ras. the investigators hypothesize that bicarbonate therapy diminishes intrarenal ras activity without affecting the systemic ras.

Eligibility criteria:
inclusion criteria: * male or female adult (≥18 years) * chronic kidney disease stage 4, i.e. estimated glomerular filtration rate (mdrd) 15-30 ml/min * plasma bicarbonate concentration of 15-24 meq/l exclusion criteria: * bicarbonate level \>24 meq/l or \<15 meq/l, the latter because in that case it seems highly recommended to start sodium bicarbonate suppletion and not to postpone this * sodium bicarbonate use in the 1 month preceding the study * heart failure * liver cirrhosis * blood pressure \>140/90 mmhg despite the use of 3 different antihypertensives * a kidney transplant in situ * a history of nonadherence to medication * use of calcineurin inhibitors (these immunosuppressive drugs are known to induce metabolic acidosis and influence electrolytes and acid-base balance)
the effects of sapropterin dihydrochloride supplementation on in vivo redox status in patients with classical pku

Conditions: Classical Phenylketonuria(PKU)

Summary: this study is an independent sub-study of the protocol titled pku-016: a double-blind, placebo-controlled, randomized study to evaluate the safety and therapeutic effects of sapropterin dihydrochloride on neuro-psychiatric symptoms in subjects with phenylketonuria (pku ascend). the primary objective of this study is to determine oxidative stress in patients with classical phenylketonuria (pku) enrolled in pku-016, using a brain scan (called an hmpao spect) at baseline and 26 weeks, and blood redox biomarkers.


Eligibility criteria:
inclusion criteria:sub-study inclusion criteria same as main study: * ≥ 8 years of age * confirmed diagnosis of pku * willing to continue current diet (typical diet for the 3 months prior to study entry)unchanged while participating in the study * willing and able to provide written, signed informed consent or in the case of subjects under the age of 18, provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures * sexually active subjects must be willing to use an acceptable method of contraception while participating in the study and for at least 30 days following the last dose of sapropterin dihydrochloride * females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study. females considered not of childbearing potential include those who have been in menopause at least 2 years, or had tubal ligation at least 1 year prior to screening, or have had total hysterectomy * willing and able to comply with all study procedures exclusion criteria:all other sub-study exclusion criteria same as main study: * has known hypersensitivity to sapropterin dihydrochloride or its excipients * subject breastfeeding at screening or planning to become pregnant (subject or partner) at any time during the study * use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to the completion of all scheduled study assessments * received sapropterin dihydrochloride within 16 weeks of randomization • have initiated or adjusted medication for treatment of adhd, depression, or anxiety ≤ 8 weeks prior to randomization * taking medication known to inhibit folate synthesis (eg, methotrexate) * any condition requiring treatment with levodopa or any pde-5 inhibitor * concurrent disease or condition that would interfere with study participation, compliance or safety as determined by the investigator * any condition that, in the view of the investigator, places the subject at high risk of poor treatment compliance or not completing the study
bio-adm as a biomarker of refilling in chronic hemodialysis patient

Conditions: Chronic Kidney Disease 5D

Summary: aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (stage 5d) the predictive value of bio-adrenomedullin (bio-adm) level on vascular refilling rate.


Eligibility criteria:
inclusion criteria: * chronic kidney disease patient on dialysis (stage 5d) for more than 1 month * anuric patient exclusion criteria: * patient protected by law * patient under guardianship ou curatorship * patient deprived of liberty

Keywords: chronic kidney disease extracorporeal purification bio-adm vascular refilling rate
prednisone plus ivig vs. prednisone for itp during pregnancy

Conditions: Immune Thrombocytopenia

Summary: this is a prospective, randomized, open-label, multicenter clinical trial study to compare the efficacy and safety of prednisone plus ivig to prednisone monotherapy in the treatment of immune thrombocytopenia (itp) in pregnancy.

the investigators are undertaking a prospective, parallel group, multicenter, randomized controlled trial in pregnant patients with treat-naive itp. a total of 100 participants are randomized to two groups with the 1:1 ratio: prednisone plus ivig group versus prednisone monotherapy group. participants will receive prednisone 20mg per day for 4 weeks plus ivig 400mg/kg (total dose ≤20g per day) for 5 days or prednisone 20mg monotherapy per day for 4 weeks. platelet count, bleeding and other symptoms were evaluated before and after treatment. time to response and platelet counts of newborns are investigated. adverse events including participants and their newborns are also recorded throughout and after the study.

Eligibility criteria:
inclusion criteria: 1. age 18-50 years old; 2. meet the diagnostic criteria for immune thrombocytopenia; 3. pregnant women with itp without itp-specific treatments during pregnancy; 4. gestational weeks ≥12 weeks; 5. platelet count \<30×10\^9/l, accompanied with or without bleeding symptoms. 6. willing and able to sign written informed consent. exclusion criteria: 1. have a known diagnosis of other autoimmune diseases, confirmed medical history or laboratory findings within positive anti-nuclear antibodies (\>1:80), anti-cardiolipin antibodies, lupus anticoagulant factors or direct coombs' test. 2. thrombocytopenia caused by pregnancy-specific conditions, such as gestational thrombocytopenia, preeclampsia, the hellp syndrome and acute fatty liver of pregnancy. 3. secondary thrombocytopenia such as drug-related thrombocytopenia, vaccine-related thrombocytopenia, lymphoproliferative disorders, severe infection, hepatic cirrhosis and so on. 4. with other underlying diseases that may cause thrombocytopenia, such as: malignant disease, megaloblastic anemia, aplastic anemia, myelodysplasia syndrome, myeloid fibrosis, disseminated intravascular coagulation, thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, disseminated intravascular coagulation and so on; 5. current hiv infection or hepatitis b virus or hepatitis c virus infections; 6. with severe heart, kidney, liver or respiratory dysfunction; 7. with the medical history of mental illness; 8. have allergic reaction to prednisone or ivig;

Keywords: immune thrombocytopenia pregnancy therapy
information visualizations to enhance hiv-related communication

Conditions: HIV; Communication Research

Summary: hiv disproportionately affects latinos who have more infections, faster disease progression, more hiv-related deaths, and slower diagnosis and treatment than their white/majority counterparts. this is a concern across the united states (us) and in developing countries, such as the dominican republic (dr). the hiv-related health disparities experienced by latinos are made worse when those living with hiv have low health literacy and difficulty understanding the information they need to manage their health. the pi developed a set of images to assist clinicians in providing information to latino people living with hiv (plwh). these images have been put into a mobile health app so clinicians can easily access them during clinic visits. the pi has tested her with plwh in the dr and in new york city. so, the next steps in this research are to ensure the images are relevant and useful to latinos across the united states (us) and to further assess if, and to what extent, the images can improve health outcomes among plwh in the us and in the dr. we will therefore, adapt images to latinos of mexican origin/descent and then test them to determine if these images help clinicians provide information to patients by conducting a study at clinical sites in the us and in the dr.


Eligibility criteria:
inclusion criteria: - participants must self-identify as latino, be english or spanish-speaking, living with hiv with a detectable viral load (\>200 copies/ml) at any point in the past year or have an indication of adherence risk, and planning to receive care at the study site for the next year. exclusion criteria: * not meeting inclusion criteria or not having the mental capacity to understand the study or provide informed consent.

Keywords: health literacy hiv infographic information-visualization clinician-patient communication health education
an open-label safety study of pimavanserin in parkinson's disease patients

Conditions: Parkinson's Disease Psychosis

Summary: this is an open-label extension study to assess the long-term safety and tolerability of pimavanserin (acp-103) in subjects with parkinson's disease psychosis (pdp).


Eligibility criteria:
inclusion criteria- * patients of any age, male or female with a clinical diagnosis of idiopathic parkinson's disease, who participated in a previous (phase ii) clinical trial that evaluated pimavanserin * patients who may, in the opinion of the treating physician, benefit from continued therapy with pimavanserin * patient is willing and able to provide consent exclusion criteria- * female patient of childbearing potential * patient has a clinically significant concurrent medical illness * patient is judged by the treating physician to be inappropriate for the study.
flacs vs phaco in shallow anterior chamber

Conditions: Cataract Surgery; Shallow Anterior Chamber; Phacoemulsification

Summary: phacoemulsification in eyes with a shallow anterior chamber (acd \< 2.2mm) presents with problems of safe access to the cataract and increased vulnerability of the endothelium and a higher tendency of complications such as descemet's detachment and iris prolapse. a shallow anterior chamber is also responsible for the high incidence of glaucoma and postoperative complications after cataract surgery. femtosecond assisted cataract surgery has made cataract surgery safer and more predictable. the effective phacoemulsification time and intra-operative manipulation is greatly reduced in flacs. however phacoemulsification still remains the most widely performed cataract surgery around the world. post-operative outcomes after phacoemulsification in patients having shallow anterior chamber have been extensively reported in literature over the years. there is no head to head comparison in terms of intraoperative performance and post-operative outcomes between flacs and phacoemulsification in eyes with shallow anterior chamber. the aim is to compare the intra-operative performance and post-operative outcomes in eyes undergoing femtosecond laser assisted cataract surgery versus eyes undergoing phacoemulsification in eyes having shallow anterior chamber. the study will bring an understanding on the question: do patients undergoing femtosecond laser assisted cataract surgery behave differently from those undergoing phacoemulsification?

inclusion criteria: * age-related cataract * shallow anterior chamber (\<2.5mm) exclusion criteria: -ocular co-morbidity - corneal disorders, glaucoma, uveitis, previous ocular surgery surgical technique : * standardized, single surgeon * 2.2 mm clear corneal temporal incision * flacs group : capsulorhexis, lens fragmentation with femto laser the investigators will be evaluating the following parameters: 1. primary outcome measure corneal thickness on day 1, week 1 and 1 month (change in corneal thickness of 15% from preop. will be considered significant). 2. secondary outcome measures * corneal clarity -on day 1, week 1 and 1 month postoperatively * anterior chamber cells and flare (hogan's criteria) * percentage change in endothelial cell density from preoperatively to 3 months postoperatively * unaided visual acuity (distance) on day 1 and 1 month. * best corrected distance visual acuity 1 month postoperatively 3. other observations : 1) cumulative dissipated energy (cde) 2) surgical time 3) fluid used 4) descemets membrane detachment during surgery 5) incidence of iris trauma 6) any other intra-operative complications

Eligibility criteria:
inclusion criteria: * uncomplicated, age related cataracts * shallow anterior chamber (measured as \</=2.5mm ) exclusion criteria: * coexisting ocular morbidity, * inability to come for followup

Keywords: flacs phaco shallow anterior chamber
family-centered mental health promotion intervention

Conditions: Stress, Psychological; Stress, Physiological; Anxiety; Depression

Summary: goal: the long-term goal of the proposed research program is to test the effectiveness of a preventative behavioral intervention and to scale it up for use with broader immigrant populations to reduce stress and mental health disorders. intervention: this study plan to adapt the world health organization developed problem management plus (pmp), an evidence based, multi-component, behavioral intervention including breathing, problem solving, behavioral activation, and social support for immigrants. hypothesis: immigrants in the problem management plus for immigrants (pmp-i) will have significantly lower levels of stress and anxious/depressive symptoms as compared to immigrants in the talk program with community support service pamphlets (css). objective: the current study aims to pilot test the feasibility and acceptability of pmp-i among bhutanese immigrants 18 years and older living in the massachusetts.

problem management plus (pmp) is a low-intensity evidence-based psychological intervention developed by world health organization that can be delivered by trained lay people. pmp systematically teaches four strategies: stress management through breathing exercises, problem solving, behavioral activation, and skills to strengthen social support at individual level. the current study plans to adapt pmp to develop the pmp for immigrants (pmp-i) for a family setting to address immigrant's multiple social and emotional stressors while adjusting into the new multi-cultural environment of the united states. the rationale to adapt pmp is based on our intervention model that demands integration of social and emotional stressors; promising results of pmp; strong evidence of family and community ties in health care process; and growing consensus among community, scientists, and policymakers on the need for family-based care models that are sustainable. pmp-i is a 5-week, peer-led, culturally tailored mental health promotion program that includes psychoeducation, behavioral activation, and problem solving (90 minutes/session/weekly), and breathing exercises and yoga (90 minutes/session/weekly) in a family setting. participating families will be randomly allocated into two groups (n=116 families (232 participants: two eligible members per family); 58 families per intervention (pmp-i) and control (css)) with assessments at baseline, post-intervention, and 3-month post-intervention with trained community facilitators in collaboration with church leaders.

Eligibility criteria:
inclusion criteria: * bhutanese adult 18 years or older resettled in massachusetts * have a score of 14 or below on the patient health questionnaire (phq-9) exclusion criteria: * have a phq-9 score of 15 or above * clinically diagnosed mental health disorders * taking psychiatric medications for any mental health problems

Keywords: stress anxiety depression preventative intervention
a 2-year clinical performance of two different ion-releasing bulk-fill restorative materials posterior cavities

Conditions: Secondary Caries

Summary: the aim of this study is to evaluate and compare the clinical performance of 2 ion-releasing bulk-fill restorative materials in comparison with a bulk-fill resin composite restoration in posterior cavities.


Eligibility criteria:
inclusion criteria: * criteria for patient's inclusion in the study will be the presence of at least 3 occlusal or proximal carious lesion in posterior teeth, favourable and stable occlusion between the remaining teeth, the patients must be older than 18 years old with permanent dentition, moderate oral hygiene, asymptomatic vital teeth with no sensitivity to percussion, and the presence of contact with adjacent teeth exclusion criteria: * exclusion criteria will be, sever bruxism, patients with known unavailability to attend recall visits, patients with known allergy to any component of the study materials, pulp exposure during caries excavation, patients with unstable medical conditions and pregnant or lactating individuals.
eco-leak technique: early detection of colorectal anastomotic leakage by transvaginal ultrasound

Conditions: Gynecologic Cancer; Anastomotic Leak; Cytoreductive Surgery

Summary: the main hypothesis is that anastomotic leakage can be predicted peri- and postoperatively.to this end, the aim is to establish the accuracy of transvaginal ultrasound with transrectal enema (ecoenema-tv) for the diagnosis of anastomotic leakage in patients undergoing colorectal anastomosis. diagnosis of anastomotic leakage in patients undergoing colorectal anastomosis.

cytoreductive surgery is the cornerstone of advanced ovarian cancer treatment and often requires the performance of a modified posterior pelvic exenteration (mpe) or colorectal resection (crr), ideally followed by an end-to-end colorectal anastomosis with the goal of achieving optimal cytoreduction. one of the most challenging complications of this procedure is anastomotic leakage (al) which is considered a life-threatening situation with a reported incidence between 1.24% and 9% in patients with ovarian cancer making any adjuvant postoperative treatment challenging and therefore having a negative impact on the overall prognosis. in order to diagnose the presence of anastomotic leakage in female patients after colorectal anastomosis we devised this diagnostic test during the postoperative period. the eco-leak test is performed in the following sequence, after informing the patient and obtaining her consent. the patient is placed in gynaecological position/ lithotomy. then basal transvaginal ultrasound is performed with the aim of describing the presence or absence of free fluid or other ultrasound findings (sagittal and transverse scan). simultaneously transanal foley catheter is introduced and filled the balloon of the probe by direct visualization. then transvaginal ultrasound with enema is performed with insertion of 180cc of serum under ultrasound vision with probe in vagina and sagittal and mid-sagittal cut. if no new free peri-anastomotic/pelvic fluid appears, the test is considered negative. if there is an appearance of pelvic free fluid (previously absent) or an increase in free fluid with respect to the baseline examination (fluid present at the beginning of the examination) peri anastomosis/pelvic, the test is considered positive. in conclusions, anastomotic leak can occur despite a normal intraoperative anastomosis check-up. transvaginal ultrasound associated with a transrectal enema (eco-leak) performed during post operative period might represent an useful tool for anastomotic leak diagnosis. a prospective study is needed in order to determine its accuracy

Eligibility criteria:
inclusion criteria: * woman sex * age between 21-99 years old * colorectal resection and anastomosis * anastomosis upper from 5 cm from anal verge * signed informed consent exclusion criteria: * no colorectal anastomosis after resection * ultralow colorectal anastomosis (\< 5 cm) * insufficient vaginal cuff for tv-us examination

Keywords: transvaginal ultrasound enema anastomotic leakage computed tomography scan (ct-scan)