Kornimate/medical-research-clean huggingface dataset:
use of plantar flexion resistant ankle-foot orthosis in stroke patients with genurecurvatum gait

Conditions: Chronic Stroke

Summary: hypothesis 1: ho: ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has no effect on knee hyperextension control in stroke patients with genurecurvatum gait. h1: ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has an effect on knee hyperextension control in stroke patients with genurecurvatum gait. hypothesis 2: ho: ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has no effect on pelvic movements in stroke patients with genurecurvatum gait. h1: ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has an effect on pelvic movements in stroke patients with genurecurvatum gait.

kinematic evaluation of the gaits of stroke patients in 3 different situations will be made in the motion analysis system. patients will be asked to walk at a normal walking pace for a distance of only 5 meters. patients will walk the 5-meter distance first without the ankle-foot orthosis, then with the ankle-foot orthosis adjusted at 3 degrees of dorsiflexion, and then with the ankle-foot orthosis adjusted at 5 degrees of dorsiflexion.

Eligibility criteria:
inclusion criteria: * at least 6 months have passed since the stroke incident * ambulating with or without a walking aid (walker, cane or tripod) * being between 0-3 points according to the modified rankin scoring * getting a score of 24 or above from the mini mental test * presence of hyperextension in the stance phase of gait * volunteering to participate in the study exclusion criteria: * having a history of more than one stroke * known presence of dementia * having a known orthopedic, psychiatric or other neurological disease * there is a situation that prevents communication * having a history of surgery involving the lower extremities and gait
post-marketing safety study of gsk biological's pediarix™ vaccine

Conditions: Hepatitis B; Poliomyelitis; Diphtheria; Tetanus; Acellular Pertussis

Summary: pre-licensure studies of gsk biologicals' pediarix vaccine have shown it to be generally safe and unlikely to result in vaccine-associated serious adverse events. this post-licensure study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort.

* the outcomes to be assessed include the occurrence of all seizures (with or without fever), medically-attended fever, seizures associated with fever, allergic reactions, outpatient visits and hospitalizations for any cause, and all deaths. * data collection through utilization of automated databases at the study site with subset medical record review. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

Eligibility criteria:
inclusion criteria: primary study cohort the primary study cohort will include all infants from sckp who have begun their primary course of vaccine with pediarix co-administered with prevnar and for whom at least one dose of pediarix was administered prior to the infant's 9-month birthday and safety follow-up information is available. control cohorts three control cohorts will be evaluated. 1. the historical cohort will include age-, gender- and area-matched infants from sckp who received at least one dose of dtap vaccine co-administered with prevnar prior to the infant's 9-month birthday and for whom safety follow-up information is available. this cohort will include infants vaccinated between january, 2002 and march, 2003. 2. the self-control cohort is defined for the study subject as the 20-day post-vaccination period from day 21 to day 41 for each infant in the primary cohort (pediarix co-administered with prevnar as the primary vaccination course). 3. the "delayed pediarix use clinic" cohort will include all infants from sckp who, during the enrollment period for the primary cohort, began their primary course of vaccination with dtap vaccine and for whom at least one dose of dtap vaccine was co-administered with prevnar prior to the infant's 9-month birthday and safety follow-up information is available. the size of this cohort will depend on how quickly individual sckp clinics and medical centers use pediarix once it is made available. the size of this cohort, therefore, is not immediately predictable. exclusion criteria: none
supervised versus home based exercises neck and low back pain among students due to quarantine during covid-19

Conditions: Musculoskeletal Pain

Summary: this study investigates whether or not the stretching and strengthening exercises are effective both at home and under supervision for people suffering from neck pain from using equipment for online courses due to quarantine during covid-19.

the aim of this study is to investigate which regime is best to follow a recommendation, be it under the supervision of the therapist or at home with stretching and strengthening exercises. there was no study that could explain the effect of stretching and strengthening exercises as a comparison between a supervised and a home treatment plan for neck pain in students during quarantine due to covid-19.this study examines whether or not the recommendations given are effective both at home and under supervision.

Eligibility criteria:
inclusion criteria * participants using gadget like computer, mobile or laptop for online education during quarantine * participants having musculoskeletal pain during covid-19 quarantine * prolonged sitting and low physical activity during quarantine * prolonged exposure of screen more than 6 hours per day due online classes during the quarantine exclusion criteria: * participants having musculoskeletal pain before the quarantine * participants doing any type of physical activity during quarantine * participants taking online classes or any online educational program before quarantine * participants with known congenital, inflammatory and infectious conditions of spine * participants following any ergonomic recommendations or any postural awareness during and after quarantine

Keywords: musculoskeletal pain covid-19 strengthening exercises stretching exercises
the effects of cetyl tranexamate mesylate on the appearance of acne-related hyperpigmentation

Conditions: Hyperpigmentation; Post-inflammatory Hyperpigmentation; Acne

Summary: the purpose of this study is to assess the effects of cetyl tranexamate mesylate on acne-related hyperpigmentation through a specific delivery form known as teraceutic txvector.

hyperpigmentation is characterized as an increase in pigment on the skin and is a common skin condition in individuals with skin types iii to vi on the fitzpatrick skin classification scale. hyperpigmentation can be localized to an area in the form of post-inflammatory hyperpigmentation or diffused in the form of melasma. one of the treatments that are used to treat hyperpigmentation is tranexamic acid (txa) which is a third-generation bioactive and is formally known to work as a plasmin inhibitor. since txa is hydrophilic in nature and has a strong hydrogen-bonding capacity, it has an insufficient skin permeability. similar to txa esters, cetyl tranexamate mesylate (ctm) is hypothesized to have greater permeability and this study will evaluate the effects of ctm on the appearance of post-inflammatory hyperpigmentation.

Eligibility criteria:
inclusion criteria: * males and females between the ages of 14 years of age until 55 years of age * individuals experiencing 3 different areas minimum of facial post-inflammatory hyperpigmentation in those with acne exclusion criteria: * individuals who are pregnant or breastfeeding. * prisoners. * adults unable to consent. * those who are unwilling to discontinue hydroquinone, vitamin a/c/e, azelaic acid, kojic acid, bakuchiol, licorice root, retinol, niacinamide, alpha arbutin, and oral or topical tranexamic acid for two weeks to meet the washout criteria prior to enrolling and for the duration of the study. * subjects with any of the following facial cosmetic treatments within the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including microdermabrasion, intense pulsed light (ipl), peels, laser treatments, acid treatments, or any other medical treatment administered by a physician or skin care professional which is designed to improve skin pigmentation. * individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study. * current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
a study of smt19969 compared with vancomycin for the treatment of clostridium difficile-associated diarrhoea (cdad)

Conditions: Clostridium Difficile Infection

Summary: the purpose of this research study is to evaluate the safety and effectiveness of a new oral antibiotic called smt19969 in treating c. difficile infection (cdi).


Eligibility criteria:
inclusion criteria: * informed consent * clinical diagnosis of cdad plus laboratory diagnostic test * no more than 24 hrs antimicrobial treatment for current cdad episode * no more than 3 episodes of cdad in prior 12 months * no previous episode of cdad within 30 days of study enrollment * female subjects of childbearing potential must use adequate contraception exclusion criteria: * life-threatening or fulminant colitis * concurrent use of antibiotics or any other treatments for cdad * history of inflammatory bowel disease (ulcerative colitis, crohn's disease) * participation in other clinical research studies within one month of screening

Keywords: cdad clostridium difficile
study of tg-1801 alone or in combination with ublituximab in subjects with b-cell lymphoma or chronic lymphocytic leukemia

Conditions: CLL; SLL; Richter's Transformation; Indolent Lymphoma; Follicular Lymphoma; Marginal Zone Lymphoma; Aggressive Lymphoma; DLBCL; Mediastinal Large B-cell Lymphoma; MCL

Summary: the primary objective of this study is to determine the recommended phase 2 dose (rp2d) and characterize the safety profile of tg-1801. as per protocol v3.0, ublituximab will be discontinued.


Eligibility criteria:
inclusion criteria: * b-cell non-hodgkin lymphoma (nhl) including richter's transformation (rt) and transformed follicular lymphoma (fl), that warrants systemic therapy * chronic lymphocytic leukemia (cll), that warrants systemic therapy as defined by international workshop on chronic lymphocytic leukemia (iwcll) (hallek 2018) * treatment status: 1. nhl subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics) 2. rt subjects: relapsed or refractory after at least two prior lines of therapy for cll/ small lymphocytic lymphoma (sll) or rt 3. cll subjects: relapsed to or refractory after at least two prior standard therapies * measurable disease defined as: 1. nhl (including sll): at least 1 measurable disease lesion \> 1.5 centimeters (cm) 2. cll: at least 1 measurable disease lesion exclusion criteria: * prior therapy with any agent blocking the cd47/sirpα pathway or any previous cd19 targeting therapy, * subjects receiving cancer therapy (i.e. chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of cycle 1 day 1. * prior autologous stem cell transplant (sct) within 6 months.
mucopolysaccharidosis vii disease monitoring program

Conditions: Mucopolysaccharidosis VII; MPS VII; MPS 7; Sly Syndrome

Summary: the objectives of this study are to characterize mps vii disease presentation and progression and assess long-term effectiveness and safety, including hypersensitivity reactions and immunogenicity of vestronidase alfa.

the mucopolysaccharidosis vii disease monitoring program (mps vii dmp) is a global, prospective, multicenter, longitudinal protocol designed to characterize mps vii disease presentation and progression, assess long-term effectiveness and safety of vestronidase alfa, including hypersensitivity reactions and immunogenicity , as well as prospectively investigate longitudinal change across biomarker(s), clinical assessments, and patient/ caregiver-reported outcome measures in a representative population. the aim of this dmp is to collect data on patients with mps vii to provide a comprehensive dataset on the clinical presentation, heterogeneity, and disease progression, and meaningful standardized ich gcp-quality data collected in-clinic across multiple sites globally. the dmp is not a randomized study and both treated and untreated patients will be enrolled.

Eligibility criteria:
inclusion criteria: * diagnosis of mps vii based on laboratory diagnosis, including either enzymatic or mutation analysis. * willing and able to provide written informed consent or, in the case of patients under the age of 18 (or below adult ages as defined by local laws and regulations) or patients \>18 years of age who have cognitive deficiencies, provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the dmp has been explained, and prior to any research-related procedures. * willing to comply with dmp visit schedule. exclusion criteria: * concurrent participation in other pharmaceutical company-sponsored interventional clinical trial unless approved by ultragenyx.

Keywords: ux003 mepsevii vestronidase alfa-vjbk vestronidase alfa recombinant human beta-glucuronidase
effects of cholecalciferol on osteoprotegerin levels in patients on peritoneal dialysis

Conditions: Vitamin D Deficiency; Vascular Calcification; Renal Insufficiency; End Stage Renal Failure on Dialysis

Summary: aim: to investigate whether cholecalciferol (4800 u/daily) or placebo for 16 weeks reduces proteins levels associated with vascular calcification (osteoprotegerin, osteopontin, osteocalcin) in patients treated with peritoneal dialysis and 25(oh) vitamin d deficiency.

patients with chronic kidney disease on peritoneal dialysis have very low 25-(oh) vitamin d levels. vitamin d deficiency may be involved in generalized atherosclerosis, vascular calcification and cardiovascular mortality. among others, osteoprotegerin (opg) has been implicated in the pathogenesis leading up vessel calcification in this patients. furthermore, very low levels of 25-(oh) vitamin d in peritoneal dialysis patients are associated with increased levels of opg and high values of vascular calcification scores in x-rays. it is unknown whether cholecalciferol supplementation in patients on peritoneal dialysis with low levels of 25-(oh) vitamin d could change the proteins associated with vascular calcification. the objective is to conduct a randomized, double-blind, placebo-controlled study focusing on the impact of cholecalciferol substitution in 25-oh vitamin d deficient peritoneal dialysis patients on circulating opg and other osteogenic biomarkers levels during 16 weeks of intervention. moreover, the impact of cholecalciferol on serum calcium and phosphorus levels, kidney disease quality of life short form, and ultrasound characteristics of carotid arterial will be performed during the first four weeks after inclusion, and after 28 weeks postintervention. peritoneal dialysis patients found to have 25-(oh) vitamin d levels \<20 ng/ml will be included and will be randomized to receive either oral cholecalciferol therapy or placebo. cholecalciferol will be administered at a daily dose of 4800 iu over a time period of 16 weeks. all in all, 58 subjects will be included in this study.

Eligibility criteria:
inclusion criteria: * peritoneal dialysis treatment for at least 3 months. * concentrations of 25-oh vitamin d \<20 ng / ml * corrected calcium \<10.5 mg / dl * serum phosphorus \<7.0 mg / dl * intact parathyroid hormone \> 50 pg / ml and \<1500 pg/ml exclusion criteria: * active participation in another protocol. * vitamin d deficiency due to a hereditary disease or liver disease. * use of cholecalciferol ≥ 2000 iu per day within 6 months prior * new prescription of calcitriol or paricalcitol at any dose within three months prior to the intervention (the subjects may be taking calcitriol or paricalcitol only if these drugs are taken at least three months before and no substantial changes in dosage have been made). * use of bisphosphonates. * treatment with anticonvulsants or other drugs that affect the metabolism of vitamin d. * pregnancy and lactation. * active cancer or other active inflammatory disease. * hiv or aids

Keywords: cholecalciferol peritoneal dialysis fgf23 calcium phosphorus
tbe (tick-borne encephalitis) vaccination in allergic patients

Conditions: Vaccine Responsiveness in Allergy; Vaccine Responsiveness During Allergy De-sensitization Treatment

Summary: allergic patients especially those undergoing de-sensitization treatment have an altered immune responsiveness. the investigators aim to find out whether this influences immune responses to primary and booster vaccinations.

allergic patients generally have an altered immunologic profile (th2 bias), and allergic individuals undergoing de-sensitization treatment display an increased production of immune suppressive cytokines. the investigators measure humoral and cellular immune responses to routine vaccination (tick-borne encephalitis \[tbe\] booster) in allergic patients with and without de-sensitization treatment to determine whether allergy negatively influences vaccine induced immune responses and protection.

Eligibility criteria:
inclusion criteria: * completed primary tbe immunization + at least one booster immunization * adults of both sexes between 18 and 60 years of age * willingness to sign written informed consent form exclusion criteria: * age \ 60 years * prior tbe infection * hepatitis a vaccination * pregnancy and breast feeding * acute infection on day of inclusion (day 0), body temperature \>37,9°c * concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive therapy 4 weeks prior to or during study * administration of other vaccines 4 weeks before/after tbe vaccination * planned surgery within 2 weeks before/after tbe vaccination * start of de-sensitization and the first 4 weeks of allergen dose escalation * any contraindication to administration of fsme-immun® vaccine according to manufacturer's instructions * history of malignant disease within the last 5 years * autoimmune diseases * drug addictions * plasma donors * receipt of blood transfusions or immuno globulins within 3 month before study entry
total parenteral nutrition-associated liver disease

Conditions: Liver Diseases

Summary: this is a study to determine whether choline, when added to total parenteral nutrition (tpn), can help prevent the development of hepatic steatosis, a liver disease, in patients on tpn.

choline deficiency-induced hepatic steatosis occurs in patients that require long-term tpn and may progress to significant hepatic disease and death. initial studies indicate choline-supplemented tpn may reverse tpn-associated hepatic steatosis. choline chloride or placebo will be added to each patient's tpn for 16 weeks by the hospital or pharmacy providing their usual tpn. patients will receive their tpn in the hospital until they are medically stable for discharge. if patients are discharged before study completion, the pharmacy will deliver the tpn supply to them. evaluation of hepatic steatosis is done by ct scans and blood analyses. blood will be drawn on a biweekly basis during the first 4 weeks and at week 8, 12, 16 or withdrawal. ct scans will be done at week 4, 8, 16, or withdrawal. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
inclusion criteria: * underlying pathology may include, but is not limited to: short bowel syndrome, chronic pancreatitis, pancreatic pseudocysts, pseudo-obstruction, enterocutaneous fistula, entero-enteric fistula, or malabsorption syndrome. * requirement for tpn to supply greater than 85 percent of nutritional needs for at least 16 weeks. exclusion criteria: * not receiving lipid emulsion with tpn regimen * albumin less than 2.5 g/l * renal failure requiring hemo- or peritoneal dialysis * hepatic failure (pt greater than 2 times control) * diabetes * hepatitis c * aids * concurrent hospitalization for organ transplantation or rejection treatment * concurrent cholinergic medication * positive pregnancy test * refusal to use an acceptable method of birth control * ethanol abuse * more than 40 kcal/kg/day ideal body weight * obesity with ensuing weight loss * use of iv tetracycline, valproic acid, corticosteroids, methotrexate, or amiodarone

Keywords: parenteral nutrition, total lipotropic agents choline
the effect of light on scar appearance

Conditions: Cutaneous Scars

Summary: the goal of this project is to examine the ability of light exposure to improve the appearance of cutaneous scars.

light would be efficacious in improving scar appearance due to its known effects on wound healing, acne, and its use for skin rejuvenation. light interacts with cells and stimulates the production of new collagen and elastin. this same energy can be used to inhibit collagen formation and help improve scars.

Eligibility criteria:
inclusion criteria: * have two lesions that have been selected for excision * have two cutaneous scars from previous excisions as part of a standard of care * subjects are in good health * subject has a willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator exclusion criteria: * pregnancy or lactation * subjects who are unable to understand the protocol or to give informed consent * subjects with mental illness
roadmap to parenthood: testing the efficacy of a decision aid and planning tool for family building after cancer

Conditions: Quality of Life; Parenthood Status

Summary: this study will test a decision support intervention that consists of a web-based 'decision aid and planning tool' for family building after cancer in a randomized controlled trial.


Eligibility criteria:
inclusion criteria: * assigned female at birth * aged 18 to 45 years old * understands verbal and written english * history of a cancer diagnosis. * completed cancer treatment(s) with known or uncertain gonadotoxic effects (e.g., systemic chemotherapy, surgery or radiation affecting reproductive organs or hormone regulation, stem cell or bone marrow transplant, and/or immunotherapy) * interested in having a future child (or more children) or uncertain about family building plans * access to the internet and use of a computer, tablet, or smartphone * ability to understand and the willingness to personally sign the written irb-approved informed consent document exclusion criteria: * currently undergoing cancer treatment excluding long term adjuvant or maintenance therapies, such as tamoxifen * significant physical or mental disability that prevents completion of study activities

Keywords: roadmap to parenthood decision aid planning tool