Kornimate/medical-research-clean huggingface dataset:
study of the safety and efficacy of opc-34712 as adjunctive therapy in the treatment of patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: primary: to compare the efficacy of opc-34712 to placebo as adjunctive treatment to an assigned open-label marketed antidepressant treatment (adt)in patients who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed adt.

a comparison of the fixed dose arm (opc-31712, 0.15 mg) verses placebo was included as a general secondary efficacy variable and results for this dose group comparison are included under each of the outcome measures.

Eligibility criteria:
inclusion criteria: * male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by dsm-iv-tr criteria * the current depressive episode must be equal to or greater than 8 weeks in duration * subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than three adequate antidepressant treatments. exclusion criteria: * females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug. * subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration. * subjects with a current axis i (dsm-iv-tr) diagnosis of: * delirium, dementia,amnestic or other cognitive disorder * schizophrenia, schizoaffective disorder, or other psychotic disorder * bipolar i or ii disorder * subjects with a clinically significant current axis ii (dsm-iv-tr) * diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.

Keywords: opc-34712, major depressive disorder, adjunctive treatment
comparison of efficacy of methotrexate and azathioprine in patients with chronic actinic dermatitis: a randomized controlled trial

Conditions: Chronic Actinic Dermatitis

Summary: the aim of this study is to evaluate the efficacy and safety of azt and mtx in patients with chronic actinic dermatitis (cad). these drugs have been used successfully as steroid-sparing alternatives in a variety of related dermatoses and this trial may help in paving the path towards the ubiquitous use of these cost-effective and relatively safer drugs in cad patients of our population. the researchers will try to answer the following questions: 1. is methotrexate safe and efficacious in treating cad? 2. is there a difference in efficacy of methotrexate and azathioprine in the treatment of this disease? after the enrollment of patients and taking consent, participants will be divided in two treatment groups via lottery method. group a will be administered oral methotrexate 10mg/week after a test dose while group b will be administered tablet azathioprine at a dose of 0.3mg/kg daily after. both group of patients will be advised regarding strict sun protection measures (sunblock, hats, sunglasses etc.). the baseline investigations for both groups will include complete blood picture (cbc), liver function tests (lfts), renal function tests (rfts), electrocardiogram, chest x-ray and urine analysis while thiopurine methyltransferase (tpmt) levels will be assessed specifically for group b patients. the patients will be followed up at week 4, 12 and 24. cbc, rfts and lfts will be done at each follow-up and easi score will be calculated,


Eligibility criteria:
inclusion criteria: * all newly diagnosed as well as patients with an established diagnosis of cad presenting to the outpatient department or the emergency department of pemh or cmh will be included in the study. exclusion criteria: * patients with coexisting conditions requiring immunosuppressants will be excluded from the study. patients with dementia or any other neuropsychiatric disorder will also be excluded.
impact of immunosuppressive regimens on polyomavirus-related transplant nephropathy

Conditions: Polyomavirus Infections

Summary: the aim of this study is to characterize and evaluate risk factors of polyomavirus nephropathy (pvn) including the impact of three immunosuppressive regimens.

polyomavirus nephropathy (pvn) is an emerging cause of renal transplant loss. until now the risk factors of pvn are poorly understood. tacrolimus (tacr) and mycophenolate mofetil (mmf) are thought to be associated with a higher risk of developing pvn. however, the way in which tacr or mmf might enhance the susceptibility for pvn remains largely unknown. in this prospective study we will analyze whether differences in immune-reactivity patterns (th1, th2, b cell and monocyte responses, scd30, immunoregulatory antibodies) of renal transplant patients induced by different immunosuppressive regimens (cyclosporine a \[csa\]/mmf, tacr/mmf, tacr/mmf with conversion to tacr/everolimus \[erl\]) or by cytokine promoter gene polymorphisms may account for the different risks of developing pvn. comparison(s): renal transplant recipients stratified according to their relative immunological risk (group 1: low risk (primary recipients without pre-immunization \[pra \ 20%\]) randomized to be treated with one of three immunosuppressive regimens (csa/mmf, tacr/mmf, tacr/mmf with subsequent conversion to tacr/erl).

Eligibility criteria:
inclusion criteria: * cadaver kidney and living donor kidney transplant recipients * primary, secondary, and tertiary transplant recipients * pre-immunized and not pre-immunized transplant recipients * age \> 18 years exclusion criteria: * contraindications against administration of one of the four study drugs * history of severe gastrointestinal morbidity * age \< 18 years * pregnant or breast feeding women * rejection of effective contraceptive methods with young women * combined kidney and islet cell transplantation

Keywords: kidney transplantation polyoma virus associated transplant nephropathy tacrolimus mycophenolate mofetil everolimus cyclosporin a bk virus pcr viruria screening bk polyomavirus immunosuppression
behavioral interventions to increase parent adherence with behavior plans

Conditions: Family Accommodation; Nonadherence; Behavior Problem

Summary: many children with autism demonstrate severe problem behavior (spb) in the form of self-injury, aggression, and disruptive behavior. conducting a functional analysis and implementing derived treatments can produce effective behavior plans. nonetheless, skills training and an effective plan may not be sufficient to produce parent adherence. this applied research proposal describes an approach to target the negative maintaining contingencies supporting parent reinforcement of problem behavior (accommodation) and nonadherence. the intervention, borrowed from acceptance and commitment therapy and behavioral activation strategies, is matched specifically to the hypothesized function of the problematic caregiver responses (negative reinforcement). parents who participate in the proposed investigation will be assigned to either the defuse experience accept live intervention (deal) protocol group or treatment as usual. five 45-min deal sessions will 1) introduce caregivers to behavior change strategies that maximize contact with positive-maintaining contingencies related to adherence, while undermining the contingencies that maintain accommodation, and 2) provide caregivers with new treatment-related committed actions that are sensitive to positive changes in parent-child interactions. within and between participant analyses will be conducted to determine the effectiveness of the deal protocol.


Eligibility criteria:
inclusion criteria: * child under the age of 18 years, * child is diagnosed with asd, as confirmed by the gilliam autism rating scale-3, * child problem behavior is socially-maintained as identified via functional analysis, * parent is english-speaking, and * parent attendance of at least 80% of appointments at entry into the study. exclusion criteria: * child is older than 18 years of age, * child does not have asd, * child's problem behavior is not socially-maintained, * parent does not speak english, and * parent attendance at time of study entry is less than 80%.

Keywords: family accommodation nonadherence
long-term follow-up of subjects who were treated with st-920

Conditions: Fabry Disease; Fabry Disease, Cardiac Variant

Summary: long-term follow-up of subjects who received st-920 in a previous trial (st-920-201) and completed at least 52 weeks post-infusion follow-up in their primary protocol. enrolled subjects will be followed for a total of up to 5 years following st-920 infusion.

non-interventional, multi-center, long-term follow-up (ltfu) study of subjects dosed with st-920 in the clinical study st-920-201. all subjects dosed in the study who completed at least 52 weeks post-infusion follow-up in their primary protocol will be offered to participate. subjects who enroll will be monitored for a total of up to 5 years following st-920 infusion.

Eligibility criteria:
inclusion criteria: * subjects who received st-920 therapy in a separate parent trial * subjects who have consented to participate in this ltfu study. exclusion criteria: -this study has no exclusion criteria

Keywords: fabry disease gene therapy st-920 rare genetic dna sangamo long term
pilot study for noninvasive spectroscopic detection of adipose tissue inflammation in obesity

Conditions: Obesity

Summary: this study will test the potential of two techniques using light properties of adipose tissue to diagnose crown-like structures and inflammation to be compared with pathologic examination of adipose tissue biopsies from ongoing clinical studies.

adipose tissue (fat) inflammation is emerging as an important harbinger of disease development including type 2 diabetes, heart disease and potentially cancer. the hallmark feature of adipose tissue inflammation is the crown-like structure, a dying fat cell surrounded by immune cells attempting to clear the damage. current methods for detecting adipose tissue inflammation rely on invasive procedures such as fat biopsies. we propose developing methods that use the light reflection properties of inflamed adipose tissue as a potential non-invasive method to detect adipose tissue inflammation.

Eligibility criteria:
inclusion criteria: -subjects currently enrolled in a current rockefeller university study who will be undergoing adipose tissue biopsies as part of the study protocol exclusion criteria: -history of any skin disease

Keywords: obesity healthy volunteers
effect of nutritional supplementation on pediatric burn patients

Conditions: Burns

Summary: this study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.


Eligibility criteria:
inclusion criteria: 1. 1-10 years of age 2. hospital admission within 24 hours post-burn 3. at least 15% tbsa burned to at least 2nd degree and no more than 5% tbsa 4th degree or higher 4. capable of exclusive oral feeding within 3 days of hospitalization 5. expected to be hospitalized at least 14 days exclusion criteria: 1. history diabetes or stress-induced hyperglycemia 2. artificial ventilation 3. requires parenteral or enteral feeding 4. iv albumin 5. drug that affects metabolism 6. receiving dialysis 7. acutely impacted or constipated 8. consumes non-study nutritional supplement 9. allergy or intolerance to any study product ingredient 10. participating in non-abbott approved concomitant trial
swiss national iodine survey 2015

Conditions: Healthy Subjects

Summary: the aim of this study is to monitor iodine nutrition in switzerland in order to inform the authorities regarding iodine content in iodized salt. as a proxy for the entire population the investigators will study school aged children, pregnant women and women of reproduction age.

in a national sample of school aged children (n=990), pregnant women (n=700) and women of reproductive age (n=700) urinary iodine will be determined in order to assess iodine nutrition in switzerland. in addition, in both groups of women a blood sample will be taken for the determination of thyroid hormones, iron- and folate status. questionnaires will be used for the determination of dietary iodine and salt intake as well as sociodemographic parameters.

Eligibility criteria:
inclusion criteria: * healthy * living in switzerland for at least 1 year * for pregnant women: singleton pregnancy exclusion criteria: * major known medical illness: thyroid dysfunction, gastrointestinal or metabolic disorders and taking chronic medications * for women of reproductive age: pregnancy, breastfeeding * use of x-ray or ct contrast agent or iodine containing medication within the past year
effects of brandt daroff exercises in older adults with vertigo

Conditions: Vertigo

Summary: vertigo is among the most prevalent disorder in older adults around the world leads to dizziness and balance problems resulting in decreased quality of life. brandt daroff exercises can accelerate vertigo recovery and prevent recurrence without taking drugs. cawthorne cooksey first presented vestibular exercises to improve neurophysiological habituation, improves balance in the elderly. this study aims to determine the effects of brandt daroff exercises with cawthorne cooksey exercises on balance, dizziness and functional parameters in older adults with vertigo.

this is a randomized controlled trial. participants will be selected by non-probability convenience sampling technique, thirty two vertigo patients meeting the inclusion criteria will be randomly allocated into two equal groups (experimental and control) by online randomizer tool. the experimental group will receive brandt daroff exercises with cawthorne cooksey exercises and the control group will receive brandt daroff exercises alone. treatment session of 60 min will be given 3 times a week for 6 weeks. the following assessment tool will be used visual analogue scale and dizziness handicap inventory for vertigo symptom severity, berg balance scale and tinetti poma for assessment of balance, functional independence measure and iadl tool for assessment of functional parameters. assessment will be done at baseline and after 6 week. the data will be analyzed using spps software version. 25.

Eligibility criteria:
inclusion criteria: * older adults 65or above. * both male and female. * symptoms suggested vertigo, confirmed by neurologist. * accepted to participate in study. * dhi scale: 36-42 (moderate handicap). exclusion criteria: * patients having balance issues other than dizziness and vertigo. * middle or external ear diseases. * cerebrovascular diseases. * feet injuries including severe bruises, ulcers, open wounds or recent burns. * neck pain and cervical spine disease. * history of serious musculoskeletal disease (arthritis, alzheimer's disease, intervertebral disc degeneration).

Keywords: vertigo, balance functional parameters dizziness,
a multiple dose trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of nnc0123-0000-0338 in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of nnc0123-0000-0338 (insulin 338) in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * male subject, or female subject of no childbearing potential, if surgically sterilized (i.e. tubal ligation, bilateral oopherectomies (removal of both ovaries and both fallopian tubes) or hysterectomised) for at least 3 months or if postmenopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by follicle stimulating hormone (fsh) levels above 40 u/l) * body mass index (bmi) between 20.0 and 35.0 kg/m\^2 (both inclusive) * type 2 diabetes mellitus (as diagnosed clinically) for 12 months or more exclusion criteria: * known or suspected hypersensitivity to trial products or related products * presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator * any chronic disorder or severe disease which in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
effector and regulatory t cell receptor repertoire analyses in patients affected by covid-19

Conditions: COVID-19

Summary: the specificity of the adaptive immune response (air), and its balance between effector t cells (teffs) and regulatory t cells (tregs), is most likely a major determinant of the outcome of a covid-19 infection. we aim to analyze (i) the cellular components and (ii) the specificity of the air to covid-19 in 60 patients with moderate and severe form of the disease. this should have important implications for (i) understanding the pathophysiology of the disease, (ii) discovering biomarkers of severity and (iii) designing treatments and vaccines.

the quality of the adaptive immune response (air) to covid-19 probably determines the course of the disease. therefore, a comprehensive knowledge of the immune response to covid-19 is required to better anticipate its outcome and identify vaccine targets. in particular, the quality of an air can be investigated by immunophenotyping (enumerating immune cells and assessing their fitness) and by analyzing the t cell receptor (tcr) repertoire. the cellular components of the air will be analyzed by a deep immunophenotyping generating \>800 measures assessing immune cells quantitatively and qualitatively (pitoiset et al.,2018). combined with supervised and unsupervised analyses, it has the power to detect subtle/hidden abnormalities. the specificity will be analyzed by studying the global t cell receptor (tcr) repertoire of separated tregs and teffs from peripheral blood, as well as by single cell sequencing of cells from bronchoalveolar lavages. these combined approaches should uncover parameters/abnormalities of the air linked to the infection severity and outcome, and lead to a better understanding of the nature of the tregs and teffs repertoires against covid-19. this will have important implications for (i) understanding the pathophysiology of the disease, (ii) discovering biomarkers of severity and (iii) designing treatments and vaccines.

Eligibility criteria:
inclusion criteria : * age≥18 and ≤75 years * presenting a confirmed diagnosis of covid-19 disease in accordance with who diagnostic criteria; * good venous capital ; * affiliation to a social security system; * having declared his/her non-opposition to participation in research (for patients hospitalized in intensive care units who are not able to communicate, the non-opposition of a trusted person will be sought.) exclusion criteria : * still under the exclusion period from another biomedical study * psychiatric illness or addiction that could interfere with the ability to comply with the requirements of the protocol or to give consent to participate in the study; * patient benefiting from a legal protection measure

Keywords: covid-19 t cell receptor effector t cells regulatory t cells single cell sequencing modelisation pathophysiology biomarkers
dual epicardial endocardial persistent atrial fibrillation (af) study

Conditions: Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation

Summary: the purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the atricure bipolar system combined with a catheter ablation procedure in treating af, and how effective this combined procedure is using the atricure system in treating af. the atricure bipolar system will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. this surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent af persistent 3. patient is willing and able to provide written informed consent. 4. patient has a life expectancy of at least 2 years. 5. patient is willing and able to attend the scheduled follow-up visits. exclusion criteria: 1. prior cardiothoracic surgery. 2. patient has nyha class iv heart failure. 3. evidence of underlying structural heart disease requiring surgical treatment. 4. ejection fraction \< 30% 5. measured left atrial diameter \> 6.0 cm 6. renal failure 7. stroke within previous 6 months. 8. known carotid artery stenosis greater than 80%. 9. evidence of significant active infection or endocarditis. 10. pregnant woman or women desiring to become pregnant in the next 24 months. 11. presence of thrombus in the left atrium determined by echocardiography. 12. history of blood dyscrasia. 13. contraindication to anticoagulation, based on investigator's opinion. 14. mural thrombus or tumor. 15. moderate to severe copd

Keywords: persistent atrial fibrillation longstanding persistent atrial fibrillation ablation catheter ablation
appropriate - rate adaptive pacing sensor

Conditions: Heart Diseases

Summary: the appropriate study will compare differences in functional capacity (peak vo2) between chronotropically incompetent patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or an accelerometer (motion-based).


Eligibility criteria:
inclusion criteria: * meets or met current pacemaker implantation indications * willing and capable of providing informed consent for participation * receiving a dual-chamber pacemaker or previously received a dual-chamber pacemaker with active atrial and ventricular leads * plans to remain in the long-term care of his/her enrolling physician and is available for study follow-up for three months post-enrollment exclusion criteria: * mobitz ii second degree heart block * third degree heart block * chronic atrial fibrillation or uncontrolled atrial arrhythmias within the past 90 days prior to consent * neuromuscular, orthopedic, or vascular disability that prevents normal walking or weight carrying (e.g., intermittent claudication, arthritis, residual stroke weakness, need for a wheelchair or walker) * a symptom-limited exercise protocol is thought to be dangerous or contra-indicated, including but not limited to changing pattern of chest discomfort or uncontrolled arrhythmias * pulmonary disease as defined by any one of the following: * forced vital capacity (fvc) or forced expiratory volume in one second (fev1) \< 60% of predicted values * use of two or more pulmonary inhalers * use of supplemental oxygen * chronic use of oral steroids for pulmonary disease treatment * life expectancy is less than 12 months due to other medical conditions, per physician discretion * has or indicated for an implantable cardioverter defibrillator (icd) or cardiac resynchronization therapy-defibrillator (crt-d) * currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study. * younger than 18 years of age * pregnant or planning to become pregnant during the study (method of assessment upon physician's discretion) * unable or unwilling to comply with the protocol requirements

Keywords: pacemaker