Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of ach24 in the treatment of vitiligo

Conditions: Vitiligo

Summary: this is a multicenter clinical trial, phase iii, randomized, placebo-controlled, parallel group, enroll 94 patients, to assess the efficacy of ach24 in the repigmentation of achromatic areas in patients with vitiligo.

to evaluate the efficacy and safety of ach24 compared to placebo in the treatment of vitiligo.the present study aims to register a new product in the country, the ach24 for the treatment of vitiligo.

Eligibility criteria:
inclusion criteria: * patients of both sexes, aged between 18 and 65 years, remaining the feasibility of a legal guardian in accordance with need, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol; * presence of generalized vitiligo; * able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines. exclusion criteria: * patients with: * inflammatory diseases; * alopecia areata; * diabetes type i; * asthma; * collagen disease; * atopic dermatitis; * psoriasis; * autoimmune thyroid disease (self reported). ¬ thyroid problems (represents 15% of people with vitiligo), exclude only those who need to do treatment with corticosteroid or immunosuppressive. * women of childbearing age who had tested positive for pregnancy, or who do not use acceptable contraceptive method, or do not agree to practice reliable contraception during the study; * woman in pregnancy or lactation period; * known allergic reaction against the phytomedicine as assessed by medical history; * patient that is taking any prohibited medication (item 9.3); * participation in last one year of clinical protocols, unless it can be direct benefit to subject; * any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the subject or interfere with the endpoints of study.

Keywords: vitiligo macular depigmentation stachytarpheta cayensensis
multifunctional magnetic resonance (mr) for radiotherapy planning in prostate cancer

Conditions: Prostate Cancer

Summary: to determine if functional mri methods will aid planning of a radiation dose boost within the prostate in patients with prostate cancer potentially improving safety and efficacy.


Eligibility criteria:
inclusion criteria: * hormone therapy naive patients planned to be treated by radical radiotherapy after 3-6 months of androgen suppression * patients with low-high risk histologically confirmed localised disease are eligible, with who performance status 0-1. exclusion criteria: * patients unsuitable for functional mri of the prostate or gold seed fiducial marker insertion (e.g. patients unable to tolerate endorectal mri examination). * no prior pelvic radiotherapy or radical prostatectomy, previous androgen therapy, patients unsuitable for radical radiotherapy, life expectancy \<10 years, previous active malignancy within last 5 years, co-morbid conditions likely to impact on the advisability of radical radiotherapy, full anticoagulation, other exclusions to mri (e.g. hip prosthesis or fixation, claustrophobia, ferromagnetic implants).

Keywords: magnetic resonance imaging prostate cancer magnetic resonance spectroscopy radiotherapy planning
bone marrow-derived stem cell transplantation for the treatment of cerebral palsy

Conditions: Cerebral Palsy

Summary: this study is a single arm, single center trial to study the safety and efficacy of purified autologous bone marrow derived stem cells and mesenchymal stem cells for the treatment of children with cerebral palsy.

cerebral palsy (cp) is a chronic childhood disorder defined by a range of motor and cognitive impairments and results in a substantial suffering to the patient and a tremendous socio-economic burden to the individual, family, and healthcare system. with no effective treatments or interventions, therapies for cp are currently focused on supportive and management strategies. stem cell transplantation has been suggested as a putative intervention for neural pathology, as mesenchymal and neural stem cells, as well as olfactory ensheathing glia and schwann cells, which have shown some regenerative and functional efficacy in experimental central nervous system disorders. in this trial, the investigators study the safety and efficacy of the intrathecal transplantation of specific populations of purified autologous bone marrow-derived stem cells and mesenchymal stem cells in patients with cerebral palsy.

Eligibility criteria:
inclusion criteria: * must be more than 2 year of age and less than 12 years of age at the time of screening for inclusion in the study. * clinical evidence of a non-progressive motor disability due to brain dysfunction. * willing to comply with all study procedures. * gross motor function classification score level ii-v exclusion criteria: known history of: * intractable seizures * traumatic brain injury * genetic disorder * current infection * renal insufficiency * hepatic disease * hiv+ (as demonstrated by positive blood test) * immunosuppression * infectious related neurological injury * other etiologies such as degenerative, mitochondrial, and metabolic disorders * normal brain mri * evidence of acute illness such as fever (temperature \> 37.5 c), vomiting, diarrhea, wheezing or crackles * progressing neurological disease (batten disease, leukodystrophies, neurotransmitter disorders) * microcephaly, macrocephaly, cortical malformations, or genetic disorders of dysgenesis * pulmonary disease requiring ventilator support * unwillingness to return for follow-up visits * contraindications to mri

Keywords: stem cells
early diagnosis of active tuberculosis using ultra low-dose chest ct

Conditions: Tuberculosis, Pulmonary; Latent Tuberculosis

Summary: the aim of this study is to evaluate ultra low dose chest computed tomography (uldct) for early diagnosis of active tuberculosis in cohort of close contacts of active pulmonary tuberculosis for 1 year follow up

the early diagnosis of active tuberculosis in close contacts have not yet been established. to evaluate the early detection of active pulmonary tuberculosis using uldct, the investigators will establish the observational cohort of close contacts living in the same space with active pulmonary tuberculosis. participants will visit our center at enrollment, after 3 months, and 12 months and will be received uldct, chest x-ray and interferon-gamma assays at each visit. one chest radiologist will interpret findings of uldct and chest x-ray. patients diagnosed with active tuberculosis will be excluded from the study and treated based on world health organization guidelines.

Eligibility criteria:
inclusion criteria: * close contacts of active pulmonary tuberculosis * family members of active tb patient who has lived together for more than one month, or work colleagues of active tb patient who has been working in the same office for more than 8 months * participants who received explanation of the research plan, understands and writes agreement. exclusion criteria: * vulnerable subjects with mental retardation or severe mental illness * patients who could not receive chest ct * pregnancy * close contacts who diagnosed active pulmonary tuberculosis
study of high-dose oral vitamin d for the prevention of liver cancer

Conditions: Cirrhosis; Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the safety and tolerability of a high dose of vitamin d (vd) in patients with cirrhosis. the investigator hypothesizes that high dose vd will be safe and well-tolerated in adults with cirrhosis, and will inhibit the inflammatory and proliferative events that cause progression of cirrhosis to hepatocellular carcinoma.

this study will be done in two phases. the first phase is being done to find the highest dose of vd that can be tolerated, in other words taken without causing severe side effects. the second phase is a 6 month treatment with the dose determined to be safe in the first phase, to investigate general health benefits and the potential to reduce the development of hepatocellular carcinoma (hcc), also known as liver cancer. improvement of general health will be determined by interviews with patients, markers in the blood for response to vd, bone remodeling, inflammation, and evidence of hcc on routine imaging.

Eligibility criteria:
inclusion criteria: 1. all subjects between the ages of 18 and 75 with cirrhosis of any etiology followed at the georgetown transplant institute, washington, dc, will be offered entry into this study. the diagnosis of cirrhosis will be based on clinical, imaging or histological studies. 2. no evidence of hcc on entry imaging study ( if liver nodules are present, these should be classified as lirads 1-3 only). 3. model for end stage liver disease (meld) score under 22 (a meld score over 22 would predict a 3 month mortality rate of approximately 20%). 4. not currently participating in another intervention study. 5. not pregnant or lactating, and willing to use effective contraception during study period. 6. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. 7. ability to provide written informed consent according to national/local regulations exclusion criteria: 1. any diagnosis of kidney stones 2. a diagnosis of granulomatous diseases (e.g., sarcoidosis), active chronic fungal or mycobacterial infections (e.g., tuberculosis, histoplasmosis, coccidioidomycosis, blastomycosis, berylliosis, or wegener's granulomatosis) in the past 6 months 3. a diagnosis of hyperparathyroidism or other serious disturbance of calcium metabolism in the past 5 years 4. a diagnosis of severe kidney disease, e.g., chronic renal failure, in the past 6 months 5. a diagnosis of unexplained hypercalcemia in the past 6 months 6. any diagnosis of osteoporosis with physician recommendation for treatment of low bone mass 7. a diagnosis of two or more low trauma fractures in the past 6 months 8. a diagnosis of a medical condition requiring treatment with vd (e.g., osteomalacia) in the past 6 months

Keywords: vitamin d
analysis of equilibrium and motor coordination of deaf children's pre and post intervention physiotherapeutic

Conditions: Motor Skills in Deaf Children; Deafness

Summary: this study aimed to assess and reassess the balance and motor skills of deaf children, passed six weeks of intervention and to verify whether a program of physical therapy intervention can match or improve motor skills. this study was quasi-experimental before and after, with 10 children from a school in caxias do sul / rs. motor skills were evaluated using pre and post test ktk coordination body, and the activities were held once a week for six weeks in sessions of forty minutes. it was used for statistical analysis the student t test dependent and independent (p ≤ 0.05).


Eligibility criteria:
inclusion criteria: * age 7 to 10 years of age. * hearing disorders proven by presenting specific examination of auditory evoked potential and examination of the brainstem (brainstem evoked response - bera). * consent of parents / guardians of children to participate in the study by signing term of informed consent (ic). exclusion criteria:

Keywords: physiotherapy. deafness. postural balance. motor skills.
preterm immune system development and response to immunization

Conditions: Immune System Disorder; Preterm; Vaccination Failure

Summary: in this study the response to vaccination and development of the immune system in very preterm infants upon the current vaccination schedule will be compared to healthy term infants.

preterm infants are at increased risk of developing infections early in life due to a less mature immune system compared to full-term infants. moreover, protection by the placental transfer of maternal antibodies in general and specifically against vaccine antigens has shown to be significantly lower in very preterm infants (gestational age (ga)\< 32 weeks) compared to term infants. in this study we aim to investigate the immune system development of very preterm infants. adequate immune response to vaccination is considered both clinically important as well as a functional test of the immune system. however, data on the antibody and ag-specific memory b cell response to vaccination in preterm infants are limited. primary objective is to study the antibody immune response to routine vaccinations in very preterm infants (ga\<32 weeks). secondary aim is to study the immune system more extensively using flow cytometry, elisa and single cell transcriptomics to measure development of ag-specific memory b cells raised in response to vaccination, and by using proteomics, epigenetics, and microbiome studies.

Eligibility criteria:
to be eligible to participate in this study, a preterm infant must meet all following criteria: * preterm infant born at gestational age less than 32 weeks (whose mothers did or did not receive a t dap vaccination during pregnancy) * parents/ guardians must have sufficient understanding of the dutch language to be eligible to participate in this study, a healthy full-term infant must meet all following criteria: * healthy full-term infant whose mother received a tdap vaccination during pregnancy * parents/ guardians must have sufficient understanding of the dutch language to be eligible to participate in this study, a mother must meet all following criteria: - mother of preterm or health full-term infant who are participating in the study exclusion criteria: * parents/guardians of the infant are not able or willing to provide informed consent * infant with congenital anomaly which are more likely to cause adverse effects after immunization (for example hemodynamically significant congenital heart defect) * infant with a (possible) hiv infection or immunodeficiency * maternal use of immunosuppressive drugs during pregnancy

Keywords: immune system development preterm infant vaccination
an observational study of avastin (bevacizumab) in patients with colorectal cancer

Conditions: Colorectal Cancer

Summary: this observational study will assess the progression-free survival, overall response and safety of avastin (bevacizumab) in combination with chemotherapy in a real life setting in patients with metastatic colorectal cancer. data will be collected from patients for approximately 2 years.


Eligibility criteria:
inclusion criteria: * adult patients, age \>/=18 years * proven metastatic colorectal carcinoma * patients have measurable disease * patients are eligible to receive first-line avastin * patients have signed data release form exclusion criteria: * contra-indication to receive avastin according to the local labeling * participation in a clinical study within 30 days prior to enrolment * patients have any other primary cancer * concomitant treatment with other biologics * history of other malignant disease in the past 5 years except basal cell carcinoma
positive pregnancy program

Conditions: HIV Positive Pregnant Women

Summary: the positive pregnancy program is an innovative, unique, interprofessional model of care for hiv-positive pregnant women. this program has been in place at st. michael's hospital for five years. this study is important because it will allow for a critical evaluation of the program, and to identify strengths and weaknesses. this will in turn provide the opportunity to improve delivery of care for hiv positive women.

the aim of the p3 program is to provide supportive and comprehensive care from a variety of perspectives, including medical, social, and psychological. the premises on which the program are built include: a commitment to the respect, confidentiality, dignity and medical care of clients; health promotion; normalizing the care of hiv-positive pregnant women; knowledge translation; and the intentions to build a model of care that is transferable to other clinicians and to other conditions. during antenatal visits, pregnant women are seen by a multidisciplinary team of professionals including an obstetrician, midwife, prenatal nurse and social worker. different rooms are used for routine antenatal care maneuvers and for consultation and counseling. the midwife attends the births of the women in the program, and does home post partum care visits. care is provided that is patient- and family-centered. partners are invited to attend as many visits as the couple wishes. because of this team approach, significantly more time is spent with each woman than would occur at a routine prenatal visit. the patient population at the st. michael's clinic is largely made up of immigrant women. many of these women are refugees, and have fled conflict zones or wars to come to canada. more than 50% have lived in canada for less than five years. many of these women are marginalized, and may not access care elsewhere. they have many issues beyond hiv, and some of the social determinants of health that we observe during their time in the program include issues surrounding housing, finance, immigration, legal issues, social support, co-morbid conditions and substance use. since the launch of the program, there has been a rapid increase in the number of women attending each year. the program has also attracted significant attention, both from within the medical and health care communities and beyond. this study seeks to determine if women cared for in the positive pregnancy program will have a high degree of satisfaction with this model of care.

Eligibility criteria:
inclusion criteria: * hiv positive pregnant women who took part in p3 program exclusion criteria: * hiv negative * did not take part in p3 program
the immediate effect of shockwave therapy on the quadratus lumborum (ql) muscle trigger points vs regular back exercises in chronic nonspecific low back pain

Conditions: Low Back Pain, Mechanical

Summary: the study aims to compare the effect of regular back exercises with shockwave therapy by treating male patients with non-specific low back pain between the age of (20-40). who will be devided into 3 groups, and will be treated by shockwave therapy , exercises or both combined. after signing a consent form, patients will be assigned to the groups blindly, so the patients will not know if they are in the experimental or control group. hypothesis: the hypothesis of this study states that: o research hypothesis: there will be a significant difference between the radial eswt and back exercises in reducing lbp


Eligibility criteria:
inclusion criteria: * only male patients will be included. * age 20-40 years old. * non-specific lbp for at least 3 months. * at least one local tenderness or active trigger point in the anatomical region of the ql muscle. * pain intensity on numerical pain scale should be more than 4 exclusion criteria: * lbp due to a pathology or trauma. * below 20 years of age. * previous lumbar surgeries. * malignancy. * patients under medications or painkillers.
tapb vs. caudal for lower abdominal surgery in children: a double-blinded randomized controlled trial

Conditions: Anesthesia, Recovery Period

Summary: transversus abdominis plane block (tapb) has emerged as a safe and effective regional anesthesia technique for providing postoperative lower abdominal analgesia. complications associated with tapb are very rare and pose a lower overall risk to the patient receiving a tapb versus a caudal block, which is considered the gold standard for pediatric lower abdominal regional anesthesia. our study hypothesis was that tapb would be equivalent to caudal block initially in providing postoperative pain control but would show improved pain relief beyond the anticipated caudal duration.

the study design was a double-blinded randomized controlled trial. a minimum of 44 children between the ages of 1 and 9 undergoing bilateral ureteral reimplantation surgery through a low transverse incision will be enrolled. narcotic requirement, pain scores (flacc/faces), episodes of nausea/vomiting, and anti-spasmodic requirement will be recorded in the pacu and at 6 hour intervals through 24 hours from the time of the block placement.

Eligibility criteria:
inclusion criteria: * patients aged 1 to 9 years old scheduled for intravesicular ureteral reimplantation surgery exclusion criteria: 1. coagulation status or anatomic variations precluded safe placement of either tapb or caudal epidural, 2. there was a preexisting chronic pain disorder, 3. there was a history of constipation that persisted despite appropriate treatment and that may have impacted postoperative pain assessments, 4. additional procedures were planned via a separate incision at the time of the ureteral reimplantation, 5) there was a contraindication to receiving the medications described in the protocol.

Keywords: transversus abdominis plane block caudal epidural pediatric pain control pain control for lower abdominal surgery
viral specific t-cells for treatment of covid-19

Conditions: Viral Infection

Summary: the purpose of this research study is to learn more about the use of viral specific t-lymphocytes (vsts) when given in the presence of covid-19 signs and symptoms, caused by the virus sars-cov-2. vsts are cells specially designed to fight viral infections. these cells are created from a blood sample collected from a donor who has recovered from covid-19 infection. vsts are investigational meaning that they are not approved by the food and drug administration (fda). covid-19 is a new virus and treatment options are evolving rapidly. vsts have been successfully used to treat many different viral infections and may be beneficial in treating covid-19 in the absence of other treatments.


Eligibility criteria:
inclusion criteria: 1. patients who have evidence of infection with sars-cov-2 2. patients with symptomatic covid-19 disease, as defined by at least one of the following 1. imaging (cxr, ct scan, etc.) with pulmonary infiltrates consistent with covid-19 infection 2. requirement for supplemental oxygenation 3. need for additional respiratory support, including, but not limited to high flow 02, cpap, bipap, mechanical ventilation 3. age \>1 day 4. clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent 5. have failed at least one fda-approved treatment for covid-19 disease 6. must be able to receive vst infusion in ohio (informed consent obtained by cchmc pi or sub-investigator either in person or by phone) exclusion criteria: 1. uncontrolled bacterial or fungal infection 2. uncontrolled relapse of malignancy 3. unlikely to survive within 48 hours of vst infusion
clinical performance evaluation of the cholestech ldx cardiac hscrp test (clear)

Conditions: Cardiovascular Disease

Summary: this is a multi-center study designed to assess the accuracy and precision of the cholestech ldx cardiac hscrp test for the quantitative determination of c-reactive protein (crp) in whole blood, serum and plasma from individuals being assessed for risk of cardiovascular disease. the cholestech ldx cardiac hscrp test consists of the crp cassette and ldx analyzer and measures crp with high sensitivity on fingerstick or venous whole blood at the point-of-care (poc). the results of this study are intended to be used for regulatory 510k filings for use as an in vitro diagnostic test.


Eligibility criteria:
inclusion criteria: 1. adults (18 years of age or older) presenting to their physician's office or outpatient clinic for routine or pre-scheduled visits and a candidate for cardiovascular risk assessment. 2. willing and able to provide written informed consent and comply with study procedures. exclusion criteria: 1. known hematocrit \ 52%; 2. history of medical conditions - other than risk of cardiovascular disease - that may elevate crp as listed in appendix b (e.g., tissue damage, infection, inflammation, malignant neoplasia) 3. vulnerable populations deemed inappropriate for study by the site's principal investigator.