Kornimate/medical-research-clean huggingface dataset:
effect of routine deworming on weight of children

Conditions: Soil Transmitted Helminths

Summary: soil transmitted helminths (sth) are among the most common infections in the world today. the world health organization (who) recommends mass administration of deworming medicine as a single routine annual dose to all school age children (sac)(age 5-16 years) in countries where prevalence of soil transmitted helminthic infections (sthi) is \> 20% as a safe public health intervention that promotes healthy growth (category 2 recommendation). pakistan is classified as a low burden community with a reported prevalence of sthi \<50%, however,routine deworming is not a policy in pakistan. currently, pakistan is also facing a huge burden of malnutrition in all age groups especially in population belonging to low socioeconomic group. incidentally, worm infestation by sth also occurs in this group due to associated lack of hygiene and poor living conditions. the coexistence of even moderate sth infections can cause or aggravate malnutrition. the urban slums of karachi provide environmental, social and behavioral conditions that favor both sth infections and a risk of under nutrition. it is unknown if administering routine dose of deworming medicine to sac as per who recommendation will contribute to improvement in indicators of nutrition status in pakistani children living in urban slum conditions by eliminating worm infection.therefore, this study is being conducted to determine the effect of deworming on weight of school age children aged between 5 to 16 years.

a randomized control trial will be conducted in an urban slum of karachi. eligible 5 to 16 year old school age children will be enrolled after parental consent. the calculated total sample size is n= 258. subjects will be visited at home by researcher and background information, risk factor presence and baseline measurements of weight, mid upper arm circumference (muac) and tricep skinfold thickness (tsf) will be measured. the intervention arm will be administered a single dose of chewable albendazole 400 mg and the placebo arm will receive 400 mg chewable calcium tablets. the weight, muac and tsf will be measured again after 8 weeks to determine the change if any. the selection of locality and allocation of intervention will be done using simple random sampling and computer generated random numbers.

Eligibility criteria:
inclusion criteria: * aged 5 - 16 years, healthy, able to chew/swallow tablets exclusion criteria: * acutely ill * previous deworming dose \< 6 months ago * intellectually challenged or physical condition interfering with measurement of primary outcome variables

Keywords: deworming sth
a study to evaluate the safety and efficacy of paricalcitol capsules in reducing serum intact parathyroid hormone levels in end stage renal disease subjects on peritoneal dialysis

Conditions: End Stage Renal Disease

Summary: to determine the safety and efficacy of paricalcitol capsules as compared to placebo for treatment of secondary hyperparathyroidism by decreasing serum intact parathyroid hormone levels in end stage renal disease subjects on peritoneal dialysis.


Eligibility criteria:
inclusion criteria: * subject is greater than or equal to 18 years. * subject is diagnosed with esrd and must be on continuous pd 7 days per week for at least 2 months prior to screening phase. * if female, subject is either not of childbearing potential or is of childbearing potential and practicing one of the recommended methods of birth control. * if female, subject must have a negative serum pregnancy test prior to treatment. * if female, subject is not breastfeeding. * subject is undergoing full pd regimen and is expected to remain on this pd regimen for the duration of the study. * for those subjects who have been taking a phosphate binder prior to therapy, the subject has been on a stable type of phosphate binder at least 4 weeks prior to the pre-treatment phase. * for entry into the pretreatment phase the subject must have: calcium level less than or equal to 10.5 mg/dl and ca x p level less than or equal to 65. * for entry into the treatment phase the subject must have: ipth greater than or equal to 300 pg/ml, calcium level of 8.0 to 10.5 mg/dl, inclusive, and ca x p less than or equal to 65. * subject has voluntarily signed and dated an irb approved informed consent. exclusion criteria: * subject has history of an allergic reaction or significant sensitivity to drugs similar to the study drug * subject has had active peritonitis within 1 month prior to screening phase. * subject has had more than one episode of peritonitis within 4 months prior to screening phase. * subject has received a partial parathyroidectomy within 1 year prior to screening phase. * subject has had acute renal failure within 3 months of screening phase. * subject has chronic gastrointestinal disease. * subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the screening phase or will require these medications greater than 3 weeks in the study. * subject has a current malignancy or clinically significant liver disease. * subject has a history of drug or alcohol abuse within 6 months prior to screening phase. * subject has evidence of poor compliance with diet, medication, or pd. * subject has participated in any investigational drug or device study within 4 weeks prior to the treatment phase. * subject is taking maintenance calcitonin, glucocorticoids, or other drugs that may affect calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy. * for any reason, subject is considered by the investigator to be an unsuitable candidate to receive paricalcitol capsules. * subject is known to be hiv positive.
primary imiquimod treatment versus surgery for vulvar intraepithelial neoplasia

Conditions: Vulvar Intraepithelial Neoplasia

Summary: to evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (vin).


Eligibility criteria:
inclusion criteria: * histologically confirmed vin (only usual type, formerly vin 2-3) * visible, measurable lesion(s) * contraception (for premenopausal women) exclusion criteria: * evidence of invasion * history of cancer or severe inflammatory dermatosis of the vulva * pregnancy, lactation * immunodeficiency * any treatment for vin within the previous three months * known hypersensitivity to imiquimod

Keywords: vin imiquimod surgery hpv patient satisfaction
genetics of polycystic ovary syndrome

Conditions: PCOS

Summary: the purpose of this study is to look at genes (dna) and how they affect health and disease. genes are the instruction manual for the body. the genes you get from your parents decide what you look like and how your body behaves. they can also tell us a person's risk for certain diseases and how they will respond to treatment. we will collect a saliva sample for genetic research.

polycystic ovary syndrome (pcos) is a common endocrine disorder of women, characterized by elevated levels of male hormones, absent menstruation, infrequent or very light menstruation, and reduced ability to reproduce. genetic factors likely contribute to the etiology of pcos, but no genes have been identified with certainty. the findings from these studies will enhance our understanding of the genetics of pcos, a major contributor to female infertility. better knowledge of "pcos genes" will also help in predicting responses to treatments for infertility, insulin resistance, and other aspects of the disease. women with pcos may be eligible to participate in this study if they are between the ages of 18 and 50 and have two living biological parents who are also willing to participate. study participation involves telephone screening and consent and home collection by subjects (probands) and their parents of sputum (saliva) in a provided container. specimen containers and signed consent forms will be returned to the study site by mail. the major goal of this research project, the identification of genes contributing to pcos, will provide basic understanding of the genotype-phenotype relationships that contribute to features of pcos. knowledge of "pcos genes" would assist physicians in predicting and assessing responses to interventions that promote fertility, improve insulin sensitivity, and treat other aspects of the disease.

Eligibility criteria:
inclusion criteria: * diagnosis of pcos * both biological parents alive * yes to both answers and parents willing to participate exclusion criteria: * healthy women
docetaxel and gemcitabine in hormonal refractory metastatic prostate cancer

Conditions: Prostate Cancer

Summary: the aim of the study is to determine the optimal dose of the combination of docetaxel and gemcitabine in patients with hormone refractory prostate cancer, and evaluate this dose with respect to efficacy and toxicity in a phase ii trial.


Eligibility criteria:
inclusion criteria: * histologically verified adenocarcinoma of the prostate. * hormone refractory prostate cancer (hrpc) defined as progression during previous anti-hormone treatment. patients must have been off previous anti-androgen therapy for more than 4 weeks. * stage iv disease (verified by imaging or clinical examination). * psa \> 10 microgram/l. * psa progression defined as a \> 25% increase between two independent measurements performed with a 1-month interval or more after discontinuation of anti-androgen treatment. * castrate level of testosterone (\< 50 ng). * no previous oestrogen or steroid as metastatic prostate cancer treatment. * satisfactory hepatic function in the form of total bilirubin ≤ unl (upper normal limit), asat/alat ≤ 2.5 x unl, alkaline phosphatase ≤ 5 x unl. * satisfactory renal function, defined as serum creatinine ≤ 1.5 x unl. * satisfactory haematologic function defined as anc \>1.5 x 10\^9/l, leucocytes \>3.0 x 10\^9/l, thrombocytes ≥ 100 x 10\^9/l, haemoglobin \> 7 mmol/l * ecog performance status ≤ 2. * life expectancy \> 3 months. * patient must be able to adhere to protocol requirements. * written informed consent. * \> 18 years of age. exclusion criteria: * previous prostate cancer treatment with oestrogens or steroid hormones. * previous chemotherapy. * previous treatment with systemic radioactive isotopes. * bisphosphonate treatment (concomitant). * radiation therapy covering more than 25% of the bone marrow producing area. * other serious coincidental and/or concomitant medical condition. * symptomatic cerebral metastases. * other previous or current malignant disease, excluding \*adequately treated and cured planocellular skin carcinoma; or \*other cancer assessed to carry minimal risk of recurrence. * ecog performance status \> 2.

Keywords: hormonal refractory, chemotherapy, docetaxel, gemcitabine
a study to investigate a research drug as an aid for smoking cessation in chronic cigarette smokers (0364-007)

Conditions: Smoking

Summary: the purpose of this study is to evaluate the safety and tolerability of an investigational drug that may help individuals to stop smoking.


Eligibility criteria:
inclusion criteria: * smoking greater than/equal to 10 cigarettes/day for at least 1 year * laboratory tests that meet the criteria of the study * in overall good health as determined by the investigator exclusion criteria: * psychiatric diagnoses * certain cancers * patients who use nicotine replacement therapy * patients on a diet regimen
validation of metrological properties of lymphoqol

Conditions: Primary Lymhedema

Summary: the constitutional lymphœdema is a rare disease with an annual incidence before the age of 20 years considered at 1,15/100 000. this chronic, incurable disease without hiring directly the prognosis for survival, alter the body image imposing a "visible" deformity and of which the treatment which aims at reducing and at stabilizing the physical deformation is binding and expensive. the lymphœdema is a crippling disease of the child. as such, it rings on the everyday life of the child and on the family environment. this question is all the more important, that all the studies show that the success of the treatment bases on the compliance in the concentration and in the care of hygiene. the parameters of the success of these treatments at the child are not known.

in the literature we find no specific information on the psychic and social repercussions of the lymphœdema for the child who is affected. if the psychic and social repercussions of the secondary lymphœdema in the breast cancer are well known, very few things are it on those of the primary lymphœdema. some studies estimate globally the quality of life of the patients with a lymphœdema whatever is the origin and the etiologie. these studies of money groups suggest that the psychic difficulties and of therapeutic care are not identical. a single study approaches the specific question of the lymphœdema of the child by focusing on the real-life experience of expanding child of a primary lymphœdema.the construction and the validation of a tool measuring the quality of life of the children and the young adults affected by lymphœdema congenital appears as a starting point. a tool which would first of all allow to make the current situation for the regional level, and then can envisage national actions common. according to recent studies, the evolution of the lymphoedema is different according to the forms of initial clinical expression of the lymphoedema, we wish we can thus know during this study the impact of these various clinical forms on the quality of life of the patients. a genetic collection will be realized for that purpose (genetic research).

Eligibility criteria:
inclusion criteria: * primary lymphedema, stage 2 or 3 isl exclusion criteria: * primary lymphedema stage 1, secondary lymphedema, minimum 6 years, maximum 25

Keywords: primary lymphedema quality of life, genetic research
90second ibd for the improvement of self efficacy and quality of life in inflammatory bowel disease patients

Conditions: IBD; Crohn Disease; Ulcerative Colitis

Summary: patients with inflammatory bowel disease (ibd) have poorer quality of life than healthy people. despite the high prevalence of psychological issues and its profound influence on quality of life, most ibd patients have limited access to mental health support. as well, many may decline support if it is offered because mental health is often not thought of as part of ibd care. patients may be able to access cognitive behavioural therapy (cbt) through a psychologist, however this intervention is costly and requires considerable commitment on the part of person with ibd. there is a need for new methods of reaching ibd patients to provide information on their psychological needs, and normalize the psychological effects of ibd. these new methods should integrate medical issues with psychosocial issues while being effective, scalable, and low cost to the health care system. 90secondibd is a novel way of delivering health information about ibd using persuasive design technology embedded in a planned behavior model. this project will investigate the effect of the intervention "90secondibd", a weekly online health letter, on ibd patients' quality of life and self efficacy. regression modelling will be performed to explore the ability of clinical and demographic factors to predict quality of life and self efficacy scores following receipt of 90secondibd educational health letters weekly for 6 months and 12 months.


Eligibility criteria:
inclusion criteria: * adult, resident of canada, diagnosis of ibd, access to a computer or cell phone exclusion criteria: * n/a
investigation of mortality, morbidity and risk factors after pediatric liver transplantation

Conditions: Liver Transplantation; Liver Diseases; Biliary Atresia; Morbidity;Infant; Mortality

Summary: the department of organ transplantation in memorial hospitals has started pediatric liver transplantation program in 2016. as of the end of 2020, we have performed 169 pediatric liver transplantation. the aim of this study is to investigate the overall mortality, morbidity and risk factors for adverse outcomes in pediatric liver transplantation. the patients' records will be retrospectively scanned and the data will be gathered.


Eligibility criteria:
inclusion criteria: * pediatric patients with liver transplantation (\<18 years) exclusion criteria: * patients with incomplete medical records will be excluded
phase iii randomized study of oral acyclovir in infants with herpes simplex virus infection limited to skin, eyes, and mouth

Conditions: Herpes Simplex

Summary: objectives: i. determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection limited to skin, eyes, and mouth. ii. determine the neurologic outcome in these patients when treated with this regimen. iii. evaluate the significance of a positive cerebrospinal fluid (csf) polymerase chain reaction (pcr) result when all other csf parameters remain normal in these patients. iv. correlate the time to first positive csf pcr result in the first 12 months of life with clinical neurological assessment in these patients when treated with this regimen. v. determine whether the continuous administration of this drug suppresses recurrent skin lesions in these patients. vi. determine the safety of this regimen in these patients.

protocol outline: this is a randomized, double blind, placebo controlled, multicenter study. all patients undergo a lumbar puncture and then receive acyclovir iv every 8 hours on days 1-14. on day 12, patients may undergo a lumbar puncture (at discretion of investigator). whole blood is obtained for herpes simplex virus pcr analysis. upon completion of intravenous therapy, patients with a negative csf pcr are randomized to one of two treatment arms. arm i: patients receive oral acyclovir three times daily for 6 months. arm ii: patients receive placebo three times daily for 6 months. in case of cutaneous recurrence during the first 12 months of the study, patients receive open label oral acyclovir (if csf pcr is negative) or acyclovir iv (if csf pcr is positive) for 5 days. patients may or may not continue on study drug following this treatment. patients are followed at 6, 12, 24, 36, 48, and 60 months of age.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- infants diagnosed with herpes simplex virus infection limited to skin, eyes, and mouth; hsv-1 or hsv-2 isolated from cutaneous lesions, conjunctivae, or oropharynx (presence of skin lesions not required); normal csf indices: wbc less than 22/mm3 and protein less than 115 mg/dl for term infants or wbc less than 25/mm3 and protein less than 220 mg/dl for preterm infants; no evidence of cns involvement by ct with contrast, mri with gadolinium, or head ultrasound; no visceral dissemination (normal liver function tests, normal chest x-ray, etc.); negative csf pcr result birth weight at least 800 grams --prior/concurrent therapy-- no concurrent nursing from a mother who is receiving acyclovir, valacyclovir, or famciclovir for longer than 120 hours or 5 days; no prior prophylactic acyclovir for risk of herpes simplex virus infection --patient characteristics-- renal: creatinine no greater than 1.5 mg/dl cardiovascular: no prior grade 3 or 4 intraventricular hemorrhage other: no infants known to be born to hiv-positive women

Keywords: herpes simplex virus infection herpesvirus infection immunologic disorders and infectious disorders rare disease viral infection
real-world effect of switching from intermittently-scanned to real-time continuous glucose monitoring (switch cgm retro)

Conditions: Diabetes Mellitus

Summary: the objective of this retrospective, observational study, is to better understand the real-world glycemic effectiveness of switching to real time continuous glucose monitoring (rtcgm) from intermittently scanned continuous glucose monitoring (iscgm) among adults with type 1 diabetes or type 2 diabetes in canada.


Eligibility criteria:
inclusion criteria: * 18 years or older as of the index date * clinical diagnosis of t1d or t2d ≥ one year * using either mdi or csii therapy * initiated a freestyle libre® iscgm device between january 1, 2018 and july 31, 2023 (iscgm cohort) * switched from a freestyle libre® 1 or libre 2® iscgm device to a dexcom® g5 or g6 cgm device between april 1, 2018 and july 31, 2023 (rtcgm cohort) * baseline hba1c ≥7.0% for primary objective with rtcgm cohort * baseline hba1c ≥8.0% for key secondary objective comparing rtcgm cohort to iscgm cohort * known rtcgm/iscgm start date (month and year) * exclusive use of iscgm for ≥ 3 months * ≥ one hba1c value up to 6 months (± 6 weeks) prior to index date (hba1c value must be after iscgm initiation and no more than 6 weeks after the index date) * ≥ one hba1c value 6-12 months (± 6 weeks) following the index date * informed consent for their medical record data to be used for research purposes exclusion criteria: * have a prior history of rtcgm within 12 months of the index date * are pregnant at the time of iscgm initiation or time of switch to rtcgm * used the iscgm or rtcgm for \< 3 months
study to evaluate the efficacy and safety of k-808 (pemafibrate) in participants with primary biliary cholangitis (pbc) with inadequate response to ursodeoxycholic acid (udca) and/or obeticholic acid (oca) treatment.

Conditions: Primary Biliary Cholangitis

Summary: study to investigate the efficacy and safety of two doses of k-808 (pemafribate) in subjects with pbc.


Eligibility criteria:
inclusion criteria: * male or female participant who has a pbc diagnosis as demonstrated by the presence of ≥2 of the following three diagnostic criteria: * history of alp above uln for at least 6 months * history of positive antimitochondrial antibody (ama) titer or positive pbc-specific antinuclear antibody (ana) titer * historical liver biopsy consistent with pbc * participant has the following qualifying biochemistry value at screening: * alp ≥1.5 × uln * participant is ≥18 years of age at consent. * participant meets all other eligibility criteria outlined in the clinical study protocol. exclusion criteria: * participant meets any one of the following criteria at screening: * alp\>10 × uln * alt or ast \>5 × uln * hepatitis c treatment within 5 years of screening, or active hepatitis c as defined by positive hepatitis c antibody with the presence of hepatitis c virus ribonucleic acid; subjects with active hepatitis b (hbv) infection (hepatitis b surface antigen \[hbsag\] positive) will be excluded. a subject with resolved hepatitis a at least 3 months prior to the screening visit can be screened. * primary sclerosing cholangitis and secondary sclerosing cholangitis (eg, due to cholangiolithiasis, ischemia, telangiectasia, vasculitis, infectious diseases) * alcoholic liver disease * history of definite autoimmune hepatitis or pbc/autoimmune hepatitis overlap, defined as both of the following: 1) igg \>2 × uln and/or positive anti-smooth muscle antibodies, 2) liver histology revealing moderate or severe periportal or periseptal inflammation * nonalcoholic steatohepatitis (nash) * gilbert's syndrome * alpha-1-antitrypsin deficiency, cystic fibrosis, wilson's disease, hemochromatosis based on historically established diagnosis * drug-induced liver injury (dili) as defined by typical exposure and history * known condition that involves bile duct obstruction or cholestasis other than pbc, eg, vascular diseases (eg, budd-chiari syndrome, sinusoidal obstruction syndrome, congestive hepatopathy), congenital conditions (ductal plate malformations, caroli syndrome, congenital liver fibrosis), idiopathic ductopenia * hepatocellular carcinoma * participant meets any other exclusion criteria outlined in the clinical study protocol.