Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of vivaglobin® in previously untreated patients with primary immunodeficiency

Conditions: Common Variable Immunodeficiency; Agammaglobulinemia

Summary: the objective of this study is to assess the efficacy and safety of vivaglobin in previously untreated patients (pups) with primary immunodeficiency (pid) over a 25-week observation period. the purpose is to investigate whether pups will respond to subcutaneous immunoglobulin (scig) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin g/kg body weight (igg/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg igg/kg bw) results in an igg increase to ≥ 5 g/l on day 12 after initiation of scig therapy.


Eligibility criteria:
key inclusion criteria: * written informed consent, age-adapted * male or female aged 1 to 70 years * diagnosis of primary humoral immunodeficiency * no prior immunoglobulin substitution therapy * igg level of \<5 g/l at screening * women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening key exclusion criteria: * evidence of serious infection between screening and first treatment * bleeding disorders that require medical treatments * any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity * any condition likely to interfere with evaluation of the study drug or satisfactory conduct of the trial

Keywords: previously untreated patient (pup) primary immunodeficiency (pid) cvid xla subcutaneous immunoglobulin (scig) igg trough level quality of life common variable immunodeficiency (cvid) x-linked agammaglobulinemia (xla)
sterile water injections for pain relief i̇n labor

Conditions: Labour Pain; Back Pain

Summary: abstract introduction: in addition to pain caused by uterine contractions in labour, in 33% of women, continuous and severe back pain is observed. in management of this pain, sterile water injection is considered to be an effective method. aim of this study is assessment of effectiveness and satisfaction of this method among turkish women in which analgesic methods are not extensively used in labour and rates of cesarean section exponentially increases. material and methods: 168 termed, healthy women who admitted to istanbul gaziosmanpaşa-taksim training and research hospital with labour pain and had severe back pain were randomized into 4x0.1 ml sterile water and 4xdry injection groups. injections were applied to michaelis rhomboid region in sacral region. pain scores were assessed at 10th, 30th, 60th, 120th and 180th minutes with visual analog scale (vas). additionally, need for epidural analgesia, apgar score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding scores were assessed.


Eligibility criteria:
inclusion criteria: * aged between 18-35 * 37-42 weeks of gestation * expecting vaginal delivery * cephalic presentation * single, healthy fetus * spontaneous onset of labor * active phase of first stage of labor (3-7 cm cervical dilatation) * severe low back pain (vas\>7cm) * required pain relief exclusion criteria: * gestation \<37 weeks * multiple pregnancy * malpresentation * second stage labour * pharmacological analgesia prior to swi * back pain assessed by vas \<7 * women whose labour would be considered high risk

Keywords: sterile water injection midwifery
safety and efficacy of idp-123 lotion to tazorac® cream, in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: safety and efficacy of idp-123 lotion (0.045% tazarotene) to tazorac® (tazarotene) cream, 0.1%, in the treatment of acne vulgaris

a phase 2, multi-center, double-blind, randomized, vehicle-controlled, study to compare the safety and efficacy of idp-123 lotion (0.045% tazarotene) to tazorac® (tazarotene) cream, 0.1%, in the treatment of acne vulgaris

Eligibility criteria:
key inclusion criteria: * male or female at least 12 years of age and older. * written and verbal informed consent must be obtained. subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit). * women of childbearing potential and females that are pre-menses must be willing to practice effective contraception for the duration of the study. (effective contraception is defined as stabilized on oral contraceptive for at least 3 months, iud, condom with spermicidal, diaphragm with spermicidal, implant, nuvaring, injection, transdermal patch or abstinence.) females on birth control pills must have taken the same type pill for at least three months prior to entering the study and must not change type during the study. those who have used birth control pills in the past must have discontinued usage at least three months prior to the start of the study. women who use birth control for acne control only should be excluded. * pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits. key exclusion criteria: * use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study; * any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis, dermatitis, eczema. * any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive. * subjects with a facial beard or mustache that could interfere with the study assessments. * evidence or history of cosmetic-related acne. * subject has a history of experiencing significant burning or stinging when applying any facial treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their face.
empowering rural african american women and communities to improve diabetes outcomes

Conditions: Type 2 Diabetes Mellitus

Summary: the empower diabetes program is a year-long, community-based program designed to enhance diabetes management in rural african american women with uncontrolled diabetes. the treatment is delivered by community peers and follows a relative small changes approach.

east carolina university, along with established community partners, is implementing a community-based and culturally-tailored intervention to reduce diabetes disparities in 200 rural african american women with uncontrolled diabetes using our unique behaviorally-centered small changes approach to diabetes self-management, delivered by community health workers. the focus is on moderation and patient-selected small changes in eating, activity, and care management that decrease feelings of deprivation and failure and increase feelings of confidence and success. the intervention is specifically tailored to overcome psychosocial and environmental barriers to behavioral change through a strong focus on emotional, cultural, and social factors related to eating, activity, and medications. objectives for the proposed project are to: 1) implement and evaluate the effectiveness of this tailored small changes intervention; 2) examine the impact of this approach on psychological mediators of behavioral choices in diabetes; 3) implement and evaluate public policy and built environment advocacy strategies; and 4) build, sustain, and disseminate a business-sustainable care model. the study will be a randomized prospective trial comparing the small changes intervention, delivered in 16 sessions by community health workers, to a control group receiving 16 mailings of diabetes educational materials. we hypothesize that there will be a greater improvement in behavioral choices and glycemic control in the intervention group compared to the control group.

Eligibility criteria:
inclusion criteria: * african american female, * age 19 - 75yr., * with type 2 diabetes mellitus and * living in or near bertie, edgecombe, and pitt counties in eastern nc exclusion criteria: -
smart pilot trial of glycemic screening outreach

Conditions: Overweight (BMI &gt; 25); Obesity

Summary: approximately 130 million americans have prediabetes or type 2 diabetes (t2d) but remain unscreened and/or unaware of their diagnosis. while prediabetes/t2d screening, also known as glycemic screening, is endorsed in national guidelines, there is almost no research on how to increase screening rates, or evaluations of interventions testing the effectiveness of screening promotion strategies. the american medical association has published prediabetes quality measures that apply to ucla health as well as all other health systems, specifically tracking the percentage of adult patients with risk factors for t2d due for glycemic screening for whom the screening process was initiated. however, there is no current systemic effort underway at ucla, or most other health systems, to encourage glycemic screening. we are proposing a pilot trial of the first smart (sequential multiple assignment randomized trial) for glycemic screening. our smart experiment will provide preliminary feasibility and acceptability data for a larger, multisite trial that will provide vital guidance to optimize screening approaches for a growing number of screening-eligible patients so that they may seek earlier detection, treatment, and/or access to lifestyle programs and interventions for t2d or prediabetes.


Eligibility criteria:
inclusion criteria: * overweight or obese exclusion criteria: * existing type 2 diabetes, a1c drawn within past 3 years

Keywords: diabetes screening
non-automatic control of gait and posture in obstructive sleep apnea syndrome (cih-gait)

Conditions: Obstructive Sleep Apnea Syndrome

Summary: the purpose of this randomised controlled study is to determine the impact of continuous positive airway pressure (cpap) versus sub-therapeutic cpap (placebo) on the control of gait upon severe sleep apnea patients, based on stride time variability.

as severe sleep apnea patients exhibit gait abnormalities, this is the first randomised controlled trial to our knowledge to assess the impact of cpap upon gait and postural control in severe sleep apnea patients. based on a dual-task paradigm, posture and gait analysis will be perform before and after 8 week of intervention. beside gait parameters, the cerebral metabolism will be assessed using a near infrared spectroscopy (fnirs) device during normal walking and during walking while dual-tasking, using a visual and a verbal task.

Eligibility criteria:
inclusion criteria: * normally weighted or over-weighted patients (bmi \< 30 kilograms/m²) * newly diagnosed obstructive sleep apnea syndrome (osas) (i.e. no previous treatment) * severe osas as defined by the american academy of sleep medicine (ahi ≥ 30) * to speak and understand french * to be affiliated to social welfare exclusion criteria: * age criteria : \ 70 year old * obesity (bmi ≥ 30 kilograms/m²) * pathological conditions thought to be responsible of gait unsteadiness and postural sway or requiring an walking device : nervous system disease (parkinson disease, chronic stroke), cerebellum syndrome, vestibular syndrome, orthopaedic and rheumatic diseases, * lower limb sensitivity impairment, * cognitive disorder (folstein test score \< 24), * ophthalmology disorder : uncorrected refractive disorder, disturbance of color vision, * psychotropic treatment intake, * alcoholism, * member of an at-risk occupation (car, bus, truck drivers...) mandating effective continuous positive airway pressure introduction.

Keywords: obstructive sleep apnea syndrome gait posture continuous positive airway pressure
a study of intra-operative imaging in women with ovarian cancer

Conditions: Ovarian Cancer; Ovarian Carcinoma

Summary: the purpose of this study is to find out whether using the pinpoint imaging system intra-operatively can reduce the risk of anastomotic leaks and other complications after surgery for ovarian cancer, compared with standard intra-operative assessments alone. the pinpoint endoscopic fluorescence imaging system uses a special camera and a fluorescent (glowing) dye that can evaluate the blood flow of the bowel in real-time. if there is an area that appears concerning, the surgeon can correct the problem during the procedure.


Eligibility criteria:
participant inclusion criteria part 1 (pre-operative): * 18 years or older * diagnosed with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer * scheduled to undergo debulking or cytoreductive surgery * suspected need for a low anterior rectosigmoid resection at the time of a debulking procedure * enrolled and consented before the operation part 2 (intra-operative): * completed rectosigmoid resection * surgeon plans to perform colorectal anastomosis participant exclusion criteria part 1 (pre-operative): * documented history of allergic reaction to icg * not approached for study enrollment before undergoing an unexpected low anterior rectosigmoid resection part 2 (intra-operative): * did not undergo rectosigmoid resection intraoperatively * surgical procedure with rectosigmoid resection for any other type of gynecologic malignancy * patient requires permanent colostomy

Keywords: ovarian cancer pinpoint rectosigmoid resection anastomosis 21-202 memorial sloan kettering cancer center
postpartum uterine curettage in the recovery from preeclampsia/eclampsia

Conditions: Pre-Eclampsia; Eclampsia

Summary: use of postpartum uterine curettage in reducing hospitalization time or in improving the clinical evolution of the patient with preeclampsia/eclampsia.

to evaluate if postpartum uterine curettage improved the clinical and laboratory parameters in patients with preeclampsia or eclampsia. a total of 442 patients with preeclampsia/eclampsia were randomized to postpartum curettage (223) or no procedure (219). systolic and diastolic blood pressure were recorded and analyzed at hours 6, 12, 24 and 48. also, several laboratory values and diuresis were evaluated.

Eligibility criteria:
inclusion criteria: * gestational age 24 weeks or more. * preeclampsia/eclampsia exclusion criteria: * epilepsy or seizures previous to pregnancy. * renal disease * heart disease * liver disease

Keywords: pre-eclampsia eclampsia postpartum uterine curettage
comparison of primary repair versus gastrocnemius turn-down flaps of acute achilles tendon rupture

Conditions: Acute Rupture of Achilles Tendon (Disorder)

Summary: this retrospective study includes 74 patients with acute achilles tendon rupture from march 2012 to september 2018, aiming to compare the mid-term curative effect of primary repair and gastrocnemius turn-down flaps and guide clinical decision.

objective: to explore the surgical methods and observe the med-term curative effect of primary repair and gastrocnemius turn-down flaps for acute achilles tendon rupture, so as to guide clinical decision. methods: this retrospective study includes 74 patients with acute achilles tendon rupture from march 2012 to september 2018, whose surgeries was completed by the sponsor with either primary repair or gastrocnemius turn-down flaps. the recovery and motor function of the patients were followed up by outpatient clinic and telephone at 3 months, 6 months, 12 months and 24 months after operation, respectively, so as to statistically analyze the med-term curative effects of two surgeries. specific indicators include: visual analogue scale, american orthopaedic foot and ankle society ankle-hindfoot score, the victorian institute of sport assessment-achilles, the achilles tendon total rupture score, the tegner activity score, biodex isokinetic dynamometer system, postoperative rehabilitation index and complications.

Eligibility criteria:
inclusion criteria: * history of achilles tendon injury * within two weeks of injury * inability to single heel rise * more than one year of follow-up * age under 65 exclusion criteria: * open achilles tendon rupture * achilles tendon terminal disease * rerupture of achilles tendon * history of local corticosteroid injection around the achilles tendon * accompanied by fracture, vascular or nerve damage * not available for regular follow-up

Keywords: achilles tendon acute injury primary repair gastrocnemius turn-down flaps
using immersive virtual reality for cognitive therapy in elderly with mild cognitive impairment

Conditions: Mild Cognitive Impairment (MCI)

Summary: the proposed study aims to investigate the potential of ivr-cst in improving cognition of people with mci, and as well the association of eye movement during therapy and treatment outcomes of ivr-cst. four research questions have been proposed and listed as follows: 1. is ivr-cst a feasible treatment for elderly with mci? 2. is ivr-cst an efficacious treatment for improving cognition of elderly with mci? 3. is ivr-cst more efficacious than conventional cst (i.e., without ivr) in improving the cognition of elderly with mci? 4. is eye-tracking data collected during therapy associated with treatment outcomes of ivr cst?


Eligibility criteria:
inclusion criteria: 1. elderly aged 60 years or above, 2. a diagnosis of mci made by a psychiatrist, or a score of 16-21 out of 30 in the hong kong brief cognitive test (hkbc, 31), with upper and lower cutoff scores for mci as suggested by the test. hkbc has been validated in hong kong with satisfactory sensitivity (0.88) and specificity ((0.81) in differentiating subjects with mci and healthy individuals, 3. ability to speak and comprehend cantonese, 4. normal or corrected-to-normal binocular vision and hearing, 5. absence of physical illness/disability to prevent them from ivr-cst participation, 6, compatible with ivr exposure in the 10-minute ivr trial without major signs of cybersickness, based on the symptoms given in the simulator sickness questionnaire exclusion criteria: 1. concurrent participation in other clinical therapy trials, 2. incompatibility with ivr exposure such as complaints of nausea, headache, or other severe discomforts during trial use, 3. a diagnosis of dementia or other psychiatric/neurological diseases such as depression, stroke, brain trauma, parkinson's disease 4. hearing/visual/upper limb impairments that hinder cst/ivr-cst participation, 5. prior cst treatment, 6. use of medication for mci/dementia, e.g., aducanumab

Keywords: mild cognitive impairment (mci) cognitive stimulation therapy immersive reality eye-tracking
360 degree expanded diaphragm breathing pattern training in individuals with urinary incontinence

Conditions: Urinary Incontinence

Summary: the aim of this study is to investigate the effect of transferring the healthy intra-abdominal pressure created by 360 degree expanded diaphragm breathing taught to the patient to the pelvic cavity on incontinence problems.

66 people with a score of 3 or higher on the incontinence severity index will be included in the study. all participants will complete the king health questionnaire and incontinence quality of life questionnaires. the control group will consist of 33 people and will apply only kegel exercises 2 sets a day, 3 days a week for 8 weeks. the experimental group will consist of 33 people and the participants will apply kegel exercises for 8 weeks, 3 days a week, 2 sets a day. in addition to this, 360 degree expanded diaphragm breathing training will be given to the experimental group. practices for using this breathing pattern will be done 2 sets per day, each set for 10 minutes. at the end of 8 weeks, all 3 questionnaires will be asked to be filled again. the variation between the initial results and the final results, as well as the differences between the final changes, will also be compared.

Eligibility criteria:
inclusion criteria: * getting a score of 3 and above in the incontinence severity index. * be in the age range of 12-65 years. * no neurological problems. exclusion criteria: • having a history of surgery or childbirth in the last 3 months.

Keywords: kegel exercises urinary incontinence diaphragmatic breathing
an evaluation of a new nonverbal treatment for global aphasia

Conditions: Stroke

Summary: people with global aphasia (pwga) post stroke have little to no meaningful communication abilities (ie limited comprehension, spoken language, reading and writing abilities).a proportion of pwga will also have limited abilities to use any alternative means of communication e.g. gesture, pictures or computer devices. there is a suggestion in the literature that this is because of co-occurring cognitive deficits. the consequence is that these clients are unable to reliably communicate even their basic needs.this is commonly known as having no functional communication abilities. such pwga tend not to respond to standard speech and language therapy interventions. this research will investigate the effect of a new cognitive intervention designed to improve basic functional communication abilities. the treatment will be nonverbal and involve computer and paperbased tasks ordered hierarchically from basic to more complex tasks. six to eight participants will take part. all their sessions will take place in their own home. for some this may be a care home. they will first complete a diagnostic communication assessment in order for baseline abilities to be established. further formal language and cognitive assessments will be conducted over a period of 6 weeks. a relative/friend will complete a questionnaires about mood/communication. the pwga will also be videoed interacting with the research student e.g. looking at a magazine, completing a jigsaw, answering questions and making choices non-verbally. the participants then receive the new intervention 3 times a week for 6 consecutive weeks. all intervention sessions will be videoed. then participants will be reassessed over 2 weeks using the same assessments as prior to the intervention. the questionnaire with their relative/friend and videoed activity session will also be repeated. after a twelve week break the participant will be videoed interacting with the research student complete some of the assessments again and their relative will re-complete the questionnaires.


Eligibility criteria:
inclusion criteria: * have global aphasia as diagnosed by an slt * have little or no verbal output * inconsistent single word comprehension * little or no ability to read or write * little or no ability to use alternative modes of communication * little or no ability to make choices in function * no diagnosis/history of a progressive neurological condition * no diagnosis of hearing loss * no diagnosis/history of a mental health condition * english as a first language exclusion criteria: * has another form of aphasia * is able to consistently express basic needs non-verbally or verbally. * is able to participate in communicative interaction with a familiar other * has a history of a progressive neurological condition * has hearing loss * has a diagnosis/history of a mental health condition * does not have english as a first language.