Kornimate/medical-research-clean huggingface dataset:
treatment of geriatric bipolar mood disorders: a pilot study

Conditions: Bipolar Disorder

Summary: the purpose of this study is to collect pilot data on the feasibility of recruiting, eliciting informed consent, assessing, treating, and following patients aged 60 and older with bipolar mood disorders.

study specific aims are: * to establish a recruitment, referral, and collaborative network for elderly bipolar patients, in collaboration with the nimh funded step-bd * to establish an outpatient treatment clinic at the bellefield towers site of the nimh funded intervention research center for late life mood disorders * to implement standardized care pathways compatible with step-bd treatment algorithms for mood stabilizing pharmacotherapy. * to document short- and long-term treatment response with respect to affective symptoms, sleep, general life functioning, cognition, treatment-emergent side effects * to establish the clinical infrastructure necessary for randomized controlled clinical trials and for clinical research training in bipolar mood disorders of late-life.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of bipolar disorder * folstein mini-mental status exam score of 18 or higher exclusion criteria: * medical condition that precludes the use of both lithium and depakote * if mood disturbance is deemed an organic mood disorder (i.e., iatrogenic, secondary to medication) * if refuse to designate someone who the study staff can contact about bipolar symptoms, concerns about the subject's health, in an emergency, and/or inability to reach the subject.

Keywords: bipolar disorder manic depression elderly late-life
the "notijoves" randomised controlled

Conditions: Sexually Transmitted Diseases

Summary: background: increase of sexually transmitted infections (stis) as well as increased use of new information and communication technologies (icts) among young people in catalonia triggers the idea of designing a mobile phone application to promote partner notification. objective: design a web based tool adapted to mobile phones for partner notification of sti among youngsters 16 to 24 years old and evaluate its role in increasing the "patient referral" partner notification. methods: this is a multicentre randomised controlled trial with a proportional stratification of the sample by centre and random allocation of participants to the three arms of the study (simple web based intervention, game web based intervention and control). this study is conducted by midwives, gynaecologists and physicians in the sexual and reproductive areas of the primary health care centres. the study population is: 1- all youngsters 16 to 24 years old diagnosed with one of the three curable stis, (syphilis, gonococcus and chlamydia). 2- all partners of those diagnosed with the previous stis, independently of their state of infection.


Eligibility criteria:
inclusion criteria: * 16 to 24 years old diagnosed with one of the three curable stis, (syphilis, gonococcus and chlamydia). * all partners of those diagnosed with the previous stis, independently of their state of infection. exclusion criteria: * already participated in the study within its length

Keywords: mobile applications contact tracing game theory adolescent
the effect of intravenous lidocaine on trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: the aim of this randomized double blind, placebo controlled, crossover study is to investigate in a prospective way the effect of lidocaine in patients with trigeminal neuralgia. included patients will undergo four weekly sessions, two of which with lidocaine (5mgs/kg) and two with placebo infusions administered over 60 minutes. effect will be measured with pain diaries and visual analogue scales.


Eligibility criteria:
inclusion criteria: (1) confirmed diagnosis of tn according to iasp definition, (2) age equal to or greater than 18 years, (3) visual analogue scale (vas) score equal to or greater than 3 (out of a maximum 10), (4) dn4 score equal to or greater than 4 (out of a maximum 10), (5) having received the recommended medications for tn (antiepileptics, spasmolytics, opioids, anti-inflammatory and simple analgesic drugs) for an adequate period without therapeutic results, (6) tn duration of at least 12 months, (8) no history of allergy to lidocaine, (9) no history of substance abuse, (10) absence of severe psychiatric diseases, (11) not being pregnant, (12) not lactating, (13) absence of severe cardiac, hepatic and renal decease, and (14) be willing to provide a written informed consent to undergo the experimental procedures.

Keywords: effect lidocaine
breast reconstruction and body map : assessment by functional mri (remasco)

Conditions: Breast Cancer

Summary: breast reconstruction is an integral part of the management of patients with breast cancer and treated by total mastectomy. the aim of breast reconstruction is to get a satisfying aesthetic and functional result (sensitivity) and that would enable the patient to appropriate the reconstructed breast. patient satisfaction assessed subjectively by questionnaires would be better in autologous reconstructions than in reconstructions by prosthesis. the aim of our trial is to use functional mri (fmri) as an objective evaluation tool to describe the brain functional changes of sensory projections after immediate or secondary breast reconstruction.

patients responding criteria for selection and not objecting to participate in this trial will address a quality of life questionnaire at baseline. then the study procedures differ depending on which group the patient belongs to. immediate breast reconstruction group : six months after surgery (or six months after the implantation of the definitive prosthesis in case of use of a tissue expander), a postoperative fmri will be performed and patients will be asked to complete a quality of life form and a satisfaction form. secondary breast reconstruction group : * in the two months preceding the surgery, a preoperative fmri will be performed. * six months after surgery (or six months after the implantation of the definitive prosthesis in case of use of a tissue expander), a postoperative fmri will be performed and patients will be asked to complete a quality of life form and a satisfaction form.

Eligibility criteria:
inclusion criteria: 1. patient with an indication of unilateral total mastectomy with immediate breast reconstruction for initial breast cancer or recurrence, or patient undergoing a unilateral secondary breast reconstruction 2. who performance status less than or equal to 2 3. age ≥ 18 years 4. for patients of childbearing age, use of an effective contraceptive method for the duration of the study 5. patient having been informed and having signed an informed consent form for the study. exclusion criteria: 1. patient undergoing a breast reconstruction by exclusive lipomodelling 2. contraindication to mri : claustrophobia, intra-orbital metallic fragment, pregnancy, cochlear implants, incompatible metallic foreign body such as certain pacemaker and mechanical valves 3. patient with an indication of preoperative radiotherapy or adjuvant chemotherapy according to regional and/or national standards 4. history of brain surgery 5. history of contralateral breast surgery 6. history of prophylactic total mastectomy 7. reconstruction techniques using a mixed procedure (autologous + prosthesis) 8. patient on medication that may alter the bold signal in mri 9. pregnant or breastfeeding women 10. patient under tutorship or guardianship

Keywords: functional magnetic resonance imaging (fmri) breast reconstructive surgery breast q questionnaire
risk and clinical consequences of low count monoclonal b-cell lymphocytosis (lc mbl)

Conditions: Monoclonal B-Cell Lymphocytosis; Chronic Lymphocytic Leukemia; Infections; Cancers; Cardiovascular Diseases; Alzheimer Disease; Dementia; Autoimmune Diseases; Parkinson Disease

Summary: the aim of this proposal is to identify immune biomarkers, genetic risk, and the clinical consequences of low count monoclonal b-cell lymphocytosis (lc mbl), a common premalignant condition affecting up to 17% of european adults age\&gt;40. lc mbl is a precursor to chronic lymphocytic leukemia (cll), characterized by a circulating population of clonal b-cells. it is relatively understudied, despite emerging evidence of clinical consequences such as increased risk for life-threatening infections and lymphoid malignancies. studies reported that male sex, age, family history of cll, and cll-susceptibility genetic loci were associated with lc mbl risk. these findings were reported in european ancestry individuals and have not been generalized to other thnicities. this study will provide this missing knowledge using a unique multi-ethnic israeli population of jews and arabs that have one of the highest and lowest age-standardized incidence rates of cll in the world, respectively, and characterized with different genetic backgrounds.


Eligibility criteria:
inclusion criteria: * individuals over the age pf 40 exclusion criteria: * individuals with lymphoproliferative disorder

Keywords: monoclonal b cell lymphocytosis genetic risk outcomes infections cancers cll
medico-economical assessment of telemedicine during chronic diabetes-related foot wound management

Conditions: Diabetes; Diabetic Foot Ulcer

Summary: the aim of the study is to assess the cost-effectiveness of telemedicine in the care of chronic diabetic foot ulcers. patients will be randomized into 2 groups: 1/conventional care group with iterative visits to diabetes specialist or 2/innovative care (telemedicine group). the health insurance system perspective is adopted.


Eligibility criteria:
inclusion criteria: * patients with type 1 or 2 diabetes, at least 18 years old * patient with a diabetic foot wound : * acute or chronic (evolving for at least 30 days) * size ≤ to 3 cm² * level i, ii or iii, stage a or b, excluding stages c and d from the university of texas wound classification systems * person affiliated to french health insurance or equivalent * person having signed freely the consent form after receiving sufficient information * treatment compliance and 6 months follow-up feasible exclusion criteria: * patient with a ischemic wound: ankle-brachial index (abi) \<0.9 or transcutaneous oxygen pressure (tcpo2) \< 30 mmhg (stage c and d from the university of texas wound classification systems) * patient with emergency hospitalization indication whatever the reasons. * person deprived of liberty by a legal or administrative decision, patients in emergency and people hospitalised without consent and who are not protected by law. * pregnant or breastfeeding women * patient currently participating in another telemedicine research protocol (such as : study on the impact of telemedicine on the management of patients with type 1 diabetes (telediab-3))

Keywords: innovative care telemedicine cost effectiveness diabetes
pd-l1 expression in japanese renal cell carcinoma patients

Conditions: Renal Cell Carcinoma

Summary: this is a multicenter retrospective study designed to compare overall survival (os) by pd-l1 expression status in patients with rcc who have received systemic chemotherapy for recurrent or metastatic rcc, to determine whether the prognosis is worse in pd-l1-positive than in pd-l1-negative rcc. total 600 rcc surgical specimens will be collected from patients who started systemic chemotherapy for recurrent or metastatic rcc between january 1, 2010 and december 31, 2015 at about 30 participating study sites in japan. pd-l1 expression status (ic; immune cell) on tumor-infiltrating immune cells will be evaluated by ihc, and classified by score: ic0 (pd-l1-negative) and ic1, ic2, ic3 (pd-l1-positive). unless otherwise specified, between-group comparisons will be performed between ic0 and ic1/2/3.


Eligibility criteria:
inclusion criteria: * 1. written informed consent for this study. in the case obtaining written informed consent is difficult due to death, change of address, and so on, the opt-out consent is accepted by giving patients or their relatives notification regarding the usage of their clinical information and surgical samples for the research. * 2. age at nephrectomy≧20 years * 3.patients with recurrent or metastatic rcc who have initiated first line treatment between 1 january 2010 and 31 december 2015, with representative ffpe of nephrectomy surgical specimen which are suitable for assessment of pd-l1 expression exclusion criteria: * 1. malignancies other than rcc is co-existed from the time of nephrectomy and death. * 2. treatment with anti-ctla-4 antibody, anti-pd-1/pd-l1 antibodies as first-line therapy for recurrent or metastatic rcc.
am-125 in the treatment of acute peripheral vertigo following neurosurgery

Conditions: Vestibular Vertigo

Summary: treatment of vertigo after removal of a tumor of the balance and hearing nerve after neurosurgery, which damages or cuts the vestibular nerve (balance). this trial explores the efficacy and safety of am-125 in the treatment of acute vertigo. in this proof of concept trial patients experiencing vertigo after neurosurgery (vestibular schwannoma labyrinthectomy and vestibular neurectomy) will receive am-125 or placebo. it evaluates the potential of am-125 versus placebo in reducing the symptoms of vestibular dysfunction and accelerating vestibular compensation following neurosurgery.


Eligibility criteria:
main inclusion criteria: 1. scheduled for neurosurgery (vestibular schwannoma resection, labyrinthectomy or vestibular neurectomy). 2. small to moderately large vestibular schwannoma (koos grade i-iii; samii grade t1-t3b; ≤ 30 mm in diameter in cerebellopontine angle) that does not displace the brainstem, documented by magnetic resonance imaging not older than six months or indication for labyrinthectomy or vestibular neurectomy. 3. confirmed vestibular function on both sides. main exclusion criteria: 1. prior radiotherapy (gammaknife, intensity modulated radiation therapy) irradiating the brain-stem with more than 4 gy. 2. any ongoing other peripheral vestibular disorder (e.g. meniere's disease, benign paroxysmal vertigo, vestibular neuritis) or central vestibular disorder (e.g. vestibular migraine, central vertigo). 3. vestibular rehabilitation therapy or presurgical gentamicin therapy (i.e. "pre-habilitation therapy") within the past three months prior neurosurgery. 4. any clinically relevant nasal obstruction or pathology precluding effective and/or safe intranasal delivery.

Keywords: vertigo balance
functional outcomes and quality of life in hip, knee and shoulder arthroplasty

Conditions: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Shoulder

Summary: paris-ior is a prospective observational study that aims to collect and analyze functional outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder arthroplasty at the irccs rizzoli orthopedic institute (ior).

paris-ior is a prospective observational study that aims to collect and analyze functional outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder arthroplasty at the irccs rizzoli orthopedic institute (ior). ior was selected as a pilot center for the launch of the oecd's paris initiative in italy, whose purpose is to accelerate the adoption and reporting of validated, standardised, internationally-comparable patient-reported indicators, particularly within patient registries. paris-ior's study population will consist of consecutive patients undergoing hip, knee and shoulder arthroplasty performed at 6 operative units of the ior. the study will last 30 months and will include a 12-month recruitment period, a 12-month follow-up and 6 months for data analysis and reporting. functional outcomes and quality of life will be detected through the administration of validated questionnaires (eq-5d, hoos, koos, ases). the questionnaires will be administered in the month preceding the surgical procedure in the clinic or in the ward, while the 2 follow-up questionnaires will be send by mail at patients' home. the collected data will be combined with those routinely collected by the registry of orthopedic prosthetic implantology (ripo), already active at the ior since year 1990.

Eligibility criteria:
inclusion criteria: 1. males and females aged 18-95 years 2. be on the list for an elective primary arthroplasty of hip, knee or shoulder 3. availability to sign the informed consent exclusion criteria: 1. severe cognitive impairment 2. to be listed for arthroplasty for musculoskeletal cancer 3. not eligible for the surgical intervention
safety of colorectal assessment and tumor evaluation by colon capsule endoscopy

Conditions: Colorectal Cancer; Colorectal Polyp

Summary: following european guidelines patients undergoing colonoscopy in one of odense university hospitals units will now be offered a colon capsule endoscopy (cce) in case of incomplete examinations. patients formerly referred to colonoscopy in general anesthesia or patients who decline colonoscopy after having completed bowel preparation will also be offered a cce. in our department we have conducted a comparison study documenting that the sensitivity of cce is superior to ct colonography in both polyps \>9 mm and polyps \>5 mm, which is also supported by an italian study. the safety and completion rate of cce following incomplete colonoscopy is confirmed by several studies including one multicenter study and the completion rate is not significantly lower compared to other patient groups. in an incomplete colonoscopy it is always the most oral part of the colon which is not visualized, whereas in cce, an incomplete investigation will most often have visualized the oral part. by combining incomplete colonoscopy results and incomplete cce results we can identify patients who have had a complete colon investigation although both investigations were incomplete. aim: to investigate the quality of cce and the completion rate in patients who have undergone an incomplete colonoscopy, have completed bowel preparation but declines colonoscopy or have been referred to colonoscopy in general anesthesia.


Eligibility criteria:
inclusion criteria: * incomplete colonoscopy, referral for colonoscopy under general anesthesia or declining colonoscopy after completion of bowel preparation. exclusion criteria: * chrohn's disease with symptoms of stenosis and/or pacemaker

Keywords: colon capsule endoscopy ct colonography colonoscopy endoscopy
cardiac output pulmonary arterial catheter compared to flowave™ 1000

Conditions: Congestive Heart Failure; Ischemic Cardiomyopathy; Mitral Valve Prolapse; Mitral Regurgitation; Aortic Valve Disease; Tricuspid Regurgitation

Summary: the purpose of this study is to compare cardiac output results obtained using the thermodilution push technique with the pulmonary arterial catheter (pac) to the predicted cardiac output results obtained from the non-invasive flowave™ 1000 device.


Eligibility criteria:
inclusion criteria: * adults only: the flowave device is intended for use on adult patients only. all subjects will be 18 years or older. * existing placement of a pulmonary arterial catheter placed for medical reasons other than our study. exclusion criteria: * patients with aortic balloon pumps and cardiac mechanical assist devices will be excluded from study enrollment if the devices are present during the screening process. if patients have cardiac assist devices inserted after enrollment in the study, cardiac output data will be collected with both the pac and flowave device and will be evaluated as a subset analysis population at the conclusion of the study. * patients with intracardiac shunts will be excluded from this study. * flowave cardiac output determinations are dependent on detection of a pulse. if no peripheral pulse can be detected the device will not be able to perform a measurement and this will be indicated to the user. * patients who are not in a steady hemodynamic state shall be excluded from the study. * presence of arrhythmias: patients with arrhythmias are excluded from the study when not in a steady hemodynamic state. if a patient has a history of arrhythmia or is currently experiencing an arrhythmia but is in a maintained hemodynamic state, they will not be excluded from enrollment into the study. their clinical symptoms and cardiac rhythm will be evaluated and noted in the patient data record. * inability or unwillingness of subject or the subject's legally authorized representative to give informed consent.

Keywords: non-invasive cardiac output
a clinical study of sotatercept (mk-7962) in people with pulmonary arterial hypertension (pah) (mk-7962-024)

Conditions: Pulmonary Arterial Hypertension

Summary: researchers are looking for other ways to treat people with pah. in pah, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. the goal of the study is to learn: * what happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. there may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial. * about the safety of sotatercept and if people tolerate it


Eligibility criteria:
inclusion criteria: * has documented diagnostic right heart catheterization, with the diagnosis of world health organization (who) pulmonary atrial hypertension (pah) group 1 in any of the following subtypes: idiopathic pah, heritable pah, drug/toxin-induced pah, pah associated with connective tissue disease, pah associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair * has symptomatic pah classified as who functional class ii or iii exclusion criteria: * has a weight of \<35 kg * has a diagnosis of ph who groups 2, 3, 4, or 5 * has a diagnosis of the following pah group 1 subtypes: hiv-associated pah, pah associated with portal hypertension, exclusion in pah group 1 should also include schistosomiasis-associated pah, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis * has uncontrolled systemic hypertension * has a history of pneumonectomy * has a history of known pericardial constriction * has a history of restrictive cardiomyopathy * has history of atrial septostomy (within 180 days prior to study start) * has personal or family history of long qt syndrome * has history of coronary artery disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass, graft surgery, or cardiac anginal chest pain) (within 6 months prior to study start) * has a cerebrovascular accident (within 3 months prior to study start) * has significant (\>2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease * has untreated more than mild obstructive sleep apnea * has known malignancy that is progressing or has required active treatment within the past 5 years * has recently started (within 12 months prior to study start) or has plans to start weight loss medication or enter a weight loss program during the study period * has a previous (within 3 years) or planned (during the study) obesity treatment with surgery or a weight-loss device
oral nadolol for the treatment of adults with mild asthma

Conditions: Asthma

Summary: the purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.


Eligibility criteria:
inclusion criteria: * pre-bronchodilator fev1 80% or greater than the predicted value. * pc20 fev1 ≤4 mg/ml on methacholine challenge test. * blood pressure ≥ 100/65mm hg. * pulse rate ≥ 60 beats/min. * no significant health issues. * non-smoker or x-smoker \< 10 pack/year. exclusion criteria: * history of upper/lower respiratory tract infection or asthma exacerbation within 6 weeks of first baseline visit. * currently diagnosed with chronic obstructive pulmonary disease (copd). * used any oral or inhaled corticosteroids within 4 weeks of the first baseline visit.

Keywords: asthma hyperresponsiveness