Kornimate/medical-research-clean huggingface dataset:
international validation of two non-motor scales in pd (nfs and spark)

Conditions: Parkinson's Disease; Non-motor Symptoms

Summary: the goal of this project is to develop the international validation of two new rating scales, the neuropsychiatric fluctuations scale (nfs) and the shame in parkinson's disease (spark) scale, in order to improve the understanding of the extent and severity of non-motor symptoms in parkinson's disease (pd).

this project is a prospective international multicentre study to validate two new rating scales in different languages: the neuropsychiatric fluctuations scale (nfs) and the shame in parkinson's disease (spark) scale. the project population consists a minimum of 300 pd patients with and without fluctuations in the participant countries: spain, germany, france, switzerland, romania and greece. the nfs is specifically designed to detect neuropsychiatric fluctuations between off- and on-medication condition in pd. it is composed of 20 items, 10 items measuring the on-neuropsychological symptoms and 10 items for the off-neuropsychological manifestations. the validation of this scale, based on the most frequently experienced symptoms by the patients, would allow a crucial breakthrough in the improvement of management of pd patients. shame and embarrassment are poorly recognized by physicians in pd. pd-related shame and embarrassment may emerge from motor and non-motor symptoms, from self-perception of inadequacy due to loss of autonomy and need for help, or from perceived deterioration of body image. the current available scales are not specific for pd. based on reports of persons affected with pd and a literature review about shame and stigmatization in pd a 25-items self-questionnaire for shame and embarrassment in pd was created. the scale includes 6 different subscales (1. shame arising from pd symptoms; 2. shame arising from the increasing physical dependence and need for help induced by pd; 3. shame arising from the patient's assumption of breaking certain social rules; 4. shame arising from the deteriorated body image; 5. consequence of related shame and embarrassment on patients' health-related quality of life; 6. stigmatization). the validation of this scale will give a tool for physicians and researchers to better understand the impact of pd on patient's quality of life.

Eligibility criteria:
inclusion criteria: 1. written informed consent; 2. pd, according to the mds criteria; 3. age of participants \> 30 and \< 75 years; 4. being fluent in the language in which the scales are applied. exclusion criteria: 1. presence of pd dementia (defined as moca score \< 24).

Keywords: parkinson's disease non-motor symptoms scales for non-motor symptoms validation
efficacy and safety of alirocumab in patients with hypercholesterolemia not adequately controlled with non-statin lipid modifying therapy or the lowest strength of statin

Conditions: Hypercholesterolemia

Summary: primary objective: to demonstrate the reduction of low-density lipoprotein cholesterol (ldl-c) by alirocumab administration as add-on therapy to non-statin lipid modifying therapy (lmt) including diet therapy alone or the lowest strength of statin in comparison with placebo after 12 weeks of treatment in participants with hypercholesterolemia. secondary objective: * to evaluate the effect of two treatment regimens of alirocumab on other lipid parameters: apolipoprotein b (apo-b), non-high-density lipoprotein cholesterol (non hdl-c), total cholesterol (tc), lipoprotein (a) (lp\[a\]), high-density lipoprotein cholesterol (hdl-c), triglyceride (tg), and apolipoprotein a-1 (apo a-1). * to evaluate the safety and tolerability of alirocumab administration. * to evaluate the development of anti-alirocumab antibodies. * to evaluate the pharmacokinetic and pharmacodynamic profiles of alirocumab administration. * to evaluate the long-term safety in participants receiving open-label alirocumab administration.

the duration of study per participant was approximately 71 weeks consisting of a run-in period (4 weeks), a screening period (3 weeks), a double-blind treatment period (12 weeks), and an open-label treatment period (52 weeks).

Eligibility criteria:
inclusion criteria : participants with hypercholesterolemia (hefh or non-fh) receiving non statin lmts or the lowest strength of statin. exclusion criteria: * ldl-c \<100 mg/dl (\<2.59 mmol/l) at the screening visit (week -3) in participants with hefh or in participants with non-fh who have a history of documented coronary heart disease. * ldl-c \<120 mg/dl (\<3.10 mmol/l) at the screening visit (week -3) in participants with non-fh participants who had a history of documented diseases or other risk factors classified as primary prevention category iii as defined in jas guidelines for prevention of atherosclerotic cardiovascular diseases 2012. * not on a stable dose of lmt (including diet therapy alone) in the run-in period or the screening period. * fasting serum tgs \>400 mg/dl (\>4.52 mmol/l) at the screening period. * systolic blood pressure (bp) \>160 mmhg or diastolic bp \>100 mmhg at the run-in visit (week -7) or the screening visit (week -3) or the randomization visit (week 0). the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: non-statin lmt low dose statin
a phase 2 open label study of ba3021 in patients with recurrent or metastatic squamous cell carcinoma of the head and neck

Conditions: Head and Neck Cancer; Squamous Cell Carcinoma of Head and Neck; Recurrent Squamous Cell Carcinoma of the Head and Neck; Metastatic Cancer; Metastatic Squamous Cell Carcinoma of the Head and Neck

Summary: this is a multi-center, open-label phase 2 study designed to evaluate the efficacy and safety of ba3021 as monotherapy and combination therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.


Eligibility criteria:
inclusion criteria: * the eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. patients may not have a primary tumor site of nasopharynx (any histology). * neoadjuvant/induction setting (cohort n1): patient with newly diagnosed stage iii scchn who are eligible for induction therapy with resectable tumors. no prior treatments, including surgery, radiation, or systemic treatment, for scchn are allowed. * recurrent or metastatic setting: histologically or cytologically confirmed recurrent or metastatic scchn stage iii/iv and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). * first-line - combination cohorts (c1 and c2): patients must have no prior systemic therapy administered in the locally recurrent or metastatic setting. previous treatments with pd-1/l1 inhibitor or anti-ctla-4 treatment are not allowed. * second-line (combination cohort c3) and second-line+ (monotherapy cohorts m1 and m2): patients must have documented treatment failure of no more than one approved pd-1/l1 inhibitor either administered alone or in combination. patients must have measurable disease. * age ≥ 18 years * adequate renal function * adequate liver function * adequate hematological function * have an eastern cooperative oncology group (ecog) performance status of 0 or 1. exclusion criteria: * patients must not have a history of ≥ grade 3 allergic reactions to mab therapy as well as known or suspected allergy or intolerance to any agent given during this study. * patients must not have known human immunodeficiency virus (hiv) infection, active hepatitis b and/or hepatitis c. * patients must not be women who are pregnant or are breast feeding.

Keywords: cancer
safety and efficacy of gabapen for pediatric (regulatory post marketing commitment plan)

Conditions: Epilepsies, Partial

Summary: this investigation aims to understand the following issues in pediatric patients, as well as to assess the need of a special investigation and a post-marketing clinical study: * the frequency of treatment related adverse events. * the frequency of efficacy assessment. * treatment related unlisted adverse events in japanese package insert. * risk factors likely to affect the frequency of treatment related adverse event.

all the patients whom an investigator prescribes the first gabapentin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria:
inclusion criteria: * all the pediatric subjects (aged 3-15 years) whom an investigator prescribes the first gabapentin (tablets, syrup, and switch to syrup from tablet) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random. exclusion criteria: * patients who have been enrolled in the drug use investigation of gabapen tablets in adults (protocol no. a9451163). * patients who receive gabapen tablets or syrup before, except for switched from tablets to syrup.

Keywords: gabapentin epilepsies safety
a study of sk-1405 in hemodialysis patients with uremic pruritus

Conditions: Uremic Pruritus in Hemodialysis Patients

Summary: the purpose of this study is to evaluate the efficacy, safety and dose response of sk-1405 for the treatment of subjects with uremic pruritus receiving hemodialysis, during 2 weeks of treatment.


Eligibility criteria:
inclusion criteria: * receiving hemodialysis three times a week for at least 12 weeks * worst itching vas in a day is 30 mm or more at least 5 days during the first observation period * mean worst itching vas is 50 mm or more in both the first and second observation periods exclusion criteria: * complications that may affect the assessment of uremic pruritus * started or changed pruritus treatment within 13 days prior to starting observations * received ultraviolet treatment within 27 days prior to starting observations * uncontrollable hypertension, serious liver disease, serious heart disease, stroke, or malignant tumor * depression, schizophrenia, dementia, epilepsia, convulsive seizure, drug addiction, or alcoholism * pregnancy, or breastfeeding

Keywords: uremic pruritus
transitional case management for patients suffering from substance use disorders

Conditions: Substance Use Disorders

Summary: according to the world health organization the population suffering from addiction problems is increasing. this population is characterized by multiple needs at the medico-psychosocial level. however, some of these patients, a particular subgroup that we are going to be interested in the so-called "high need" user group, find it difficult to access and stay in outpatient treatment programs. they often present a chaotic use of the health system, including a high number of hospitalizations in times of crisis. they also show very low utilization of health care services, accompanied by social marginalization. this can be related to relapses and poor social functioning. a high number of relapses occur particularly at the end of hospitalization. interventions in the field of addiction, such as transitional case management (tcm) should increase the adherence of these patients to treatment by accompanying them in the sensitive period following hospitalization. one of the objectives of the study is to evaluate the impact of tcm on the number, duration and type of hospitalizations, as well as the number of emergency room visits. the investigators will also measure the duration until the possible future hospitalization, after the tcm. the secondary objectives of this study will be to see the effect of tcm on adherence to outpatient treatment. the investigators will focus on the impact of follow-up on the participant's medico-psycho-social network, substance use and other psychological variables. the investigators will also evaluate his or her psychiatric symptoms and global and social functioning. life satisfaction and satisfaction with the care received will also be measured. the investigators will compare the population treated by the tcm with the other users of the addiction service who are hospitalized. the study will investigate this through questionnaires at the beginning of care, at one month, three months, six months and 12 months after the start of tcm management.


Eligibility criteria:
inclusion criteria: * substance use disorder * hospitalisation at recruitment * substance use disorder according to the dsm-5 and one of the following criteria: * no preexisting outpatient follow-up care or regular follow-up care * more than three emergency room visits during the last 12 months * more than three hospitalizations in psychiatric hospital during the last 12 months * more than 40 hospitalization's days during the last 12 months * first hospitalization for a sud exclusion criteria: * evidence of organic brain disease or learning disability based on the chart review.

Keywords: substance use disorders case management community treatment hospital discharge
investigating cardiac health of adults with trauma

Conditions: Posttraumatic Stress Disorder

Summary: this project examines the impact of a healthy lifestyle intervention, specifically designed for adults with posttraumatic stress and identified cardiovascular risks.

considerable research has indicated strong associations between posttraumatic stress and cardiovascular disease (cvd) risk. individuals with posttraumatic stress disorder (ptsd) tend to show patterns of elevated cvd risk earlier in life than in the general population. the need for developing effective interventions for cvd risk-reduction in ptsd is increasingly evident. in comparison to the cumulative evidence concerning elevated cvd risk in ptsd, relatively little research has addressed cvd risk-reduction in this population. adjunctive treatments, such as health behavior interventions, may be necessary as supplements to traditional psychotherapy for ptsd in order to reduce cvd risks. the objective of the proposed project is to examine the effects of a healthy lifestyle intervention that addresses multiple cvd-related heath behaviors among civilian adults across genders (ages 18+), who evidence ptsd and cvd risk at baseline. the investigators will assess the intervention impact on both subjective and objective indices of health behaviors, cardiovascular risks and cvd markers over a one-year timeframe. the healthy lifestyle intervention addresses unique aspects of ptsd symptom presentation that serve as barriers to healthy behaviors (e.g., nightmares/sleep disruption, and cognitive responses to stress), while encouraging healthy lifestyle changes. the primary goal of the present study is to examine whether, compared to a usual care psychotherapy control condition, utilizing the healthy lifestyle intervention as an adjunct to psychotherapy will result in significantly reduced cvd risks and improved cvd markers among civilian adults with ptsd and elevated cvd risks. therefore, participants will be randomly assigned to either a usual care psychotherapy-only control condition or a usual care psychotherapy plus healthy lifestyle intervention condition. outcomes will be assessed at post-intervention (12 weeks), as well as 6-month and 12-month time points for follow-up evaluation.

Eligibility criteria:
inclusion criteria: * ptsd symptoms * overweight or less than 30 min. of moderate physical activity 5 times per week exclusion criteria: * cannot exercise at a low-moderate level (walking)

Keywords: posttraumatic stress cardiovascular health intervention ptsd lifestyle behavior
post-thyroidectomy dysphagia: an international multicentric consort - compatible rct

Conditions: Dysphagia, Esophageal; Dysphagia, Oral Phase; Dysphagia Comes and Goes; Thyroiditis; Thyroid Cancer; Thyroid Neoplasms; Thyroid Goiter; Thyroid Nodule (Benign)

Summary: the most common and feared complications of total thyroidectomy are vocal cord paralyses and hypocalcemia. however, post-thyroidectomy dysphagia is not uncommon and has important consequences on the quality of life (qol). it should be taken seriously by all clinicians.

dysphagia is a possible complication that can be observed in patients undergoing thyroidectomy, and can be related to superior and inferior laryngeal nerves dysfunction, but it usually appears after an uncomplicated surgical procedure. aerodigestive symptoms, such as discomfort, tightness, lump, foreign body, difficulty or pain during swallowin, can also present before operation. if it appears or aggrevates after surgery, laryngeal nerve damage (superior laryngeal nerve - sln, or inferior laryngeal nerve - recurrent, rln), tracheo-malacia and postoperative fibrotic changes should be interrogated. however, in most of the cases, an anatomic and/or physiologic defect in the oro-pharngeal region is not easy to be detected. therefore, a subjective feeling of dysphagia is more common. dysphagia has important consequences on the qol in postoperative period, and should be addressed by the primary surgeon/clinician, regardless of whether it is objective or subjective. the goal of the present study is to better understand the incidence of postoperative dysphagia symptoms among patients who have undergone total thyroidectomy for benign or malign thyroid disease. besides, all possible risk factors (pre-intra-post-operative) are also going to be evaluated in detail, and the efficacy of a 6-week dysphagia-rehabilitation programme will also be employed and results will be shared.

Eligibility criteria:
inclusion criteria: * patients with benign or malignant thyroid disorder (multinodular goitre, toxic goitre, thyroid carcinoma) * patients with total thyroidectomy (tt) indication * patients over 17 year-old exclusion criteria: * patients without thyroid disease * patients with thyroid disorder, but prepared for surgery other than tt * healthy volunteers * patients below 17 y/o

Keywords: thyroidectomy total thyroidectomy post-thyroidectomy post-thyroidectomy dysphagia international multi-centric
exploratory clinical study for techniques associated with the fluid accommodating iol

Conditions: Aphakia; Presbyopia

Summary: the purpose of this clinical study is to assess the repeatability of objective refraction using auto refraction on subjects bilaterally implanted (implanted in both eyes) with the fluid accommodating iol (faiol).

subjects will be expected to attend 10 office visits from screening to exit. the total expected duration of participation for each subject in this study is approximately 12 months. the second eye surgery will take place within 7-15 days from the date of the first implanted eye. the primary endpoint will be collected at month 1, following the 2nd eye implant date.

Eligibility criteria:
inclusion criteria: * willing and able to attend all scheduled study visits as required per protocol * 22 years of age or older * bilateral cataracts * corneal astigmatism ≤ 1.25 d * clear intraocular media other than cataract * other protocol-specified inclusion criteria may apply. exclusion criteria: * women of childbearing potential, defined as all women who are physiologically capable of becoming pregnant and who are not postmenopausal for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply: 1. are currently pregnant, 2. have a positive urine pregnancy test result at v0, 3. intend to become pregnant during the study period, 4. are breast-feeding. * subjects taking medications that may affect accommodation, confound the outcome, or as per the investigator's opinion may increase the risk to the subject * glaucoma * significant corneal or retinal abnormalities, per the investigator's opinion, or other disease or pathology other than cataract expected to reduce postoperative vision * monocular patient, significant permanent visual function loss, or binocular vision anomalies as evaluated by specific testing * previous corneal procedure (such as lasik, keratotomy, lri) or plans to have additional corneal procedures during the study * systemic disease that could increase the operative risk or confound the outcome * other protocol-specified exclusion criteria may apply

Keywords: iol cataract accommodation
clinical outcomes of newborns born to pregnant women with and without covid-19

Conditions: Covid19; Vertical Transmission of Infectious Disease; Neonatal Infection; Pregnancy Related

Summary: a case-control trial was conducted to test the early postpartum period clinical outcomes of newborns born to pregnant women with and without covid-19.


Eligibility criteria:
inclusion criteria: pregnant women on labor or preterm labor. pregnant women who underwent programmed or emergence cesarean exclusion criteria: those who were transferred to another hospital without or within a short period of delivery

Keywords: childbirth covid-19 neonatal outcomes newborn pregnant women vertical transmission
enhancing uptake of family planning services by hiv-infected women attending the pmtct program

Conditions: Contraception

Summary: a specific organized program utilizing peers in the pmtct clinic who provide family planning information and support to hiv infected mothers was compared to providing standard family planning messages currently used in the clinic.

a planned group education structural intervention utilizing peers in the pmtct clinic who provide family planning information and support to hiv infected mothers was compared to the standard of care which consisted of providing standard family planning messages to women attending the pmtct clinic. the study had two phases. the formative phase consisted of six focus group discussions and six in depth interviews. in the implementation phase, patient attendance and family planning uptake summaries for during implementation were monitored and summarized daily. weekly average summaries were considered as time points.

Eligibility criteria:
inclusion criteria: * this being a program based intervention, all hiv positive mothers who utilize the pmtct and post natal clinic during the study period will be enrolled. exclusion criteria: * none

Keywords: hiv pmtct
stress inoculation through virtual reality in the pediatric electrophysiology laboratory

Conditions: Stress, Psychological; Stress, Physiological; Anxiety; Pain Perception

Summary: the goal of this study is to assess the utility of virtual reality technology to aid in the mental health of patients with cardiac disease, specifically looking at decreasing anxiety and perceptions of pain from stressful procedures in the pediatric electrophysiology laboratory.

the investigators will perform a pilot study of 40 patients who are randomized to either standard of care preparation for an electrophysiology procedure (control arm) vs. virtual reality preparation (vr arm). participants in control arm will have standard preparation for a procedure including discussion of the procedure with the provider the day before the procedure with all questions answered at that time. vr arm participants will have access to the virtual reality tour and gear 1 week prior to the procedure. vr arm participants will be instructed to watch the virtual reality tour at least three times prior to the procedure but will be encouraged to watch as often as the participants would like. the virtual reality equipment will measure how often participants complete the tour. all participants will undergo anxiety measures a total of four times: once at time of recruitment, day of procedure and then 1 week and 4 weeks post procedure. participants will have cortisol salivary swabs performed 1 week before procedure (before vr use), pre-op visit, day of procedure, and immediately following procedure. heart rate and blood pressure will be measured on day of procedure.

Eligibility criteria:
inclusion criteria: * pediatric cardiology patients between the age of 10 and 20 years old * undergoing cardiac electrophysiology procedure exclusion criteria: * inability to wear virtual reality glasses * patients under 10 years old * prior psychiatric illness

Keywords: virtual reality stress inoculation procedure