Kornimate/medical-research-clean huggingface dataset:
human papilloma virus infection in hiv-positive indian men who have sex with men

Conditions: Nonneoplastic Condition; Precancerous Condition

Summary: rationale: gathering information about human papilloma virus (hpv) infection in hiv-positive men who have sex with men may help doctors learn more about the disease. purpose: this clinical trial is studying hpv infection in hiv-positive indian men who have sex with men.

objectives: * describe the prevalence of penile, anal, and oral human papilloma virus (hpv) infection in hiv-seropositive indian men who have sex with men. * determine the spectrum of hpv types at these anatomic sites in these patients. * determine the distribution of strain variants of hpv 16, 18, and 31 at these anatomic sites in these patients. * describe risk factors for penile, anal, and oral hpv infection in these patients. outline: this is a multicenter study. patients complete interviewer-administered questionnaires on demographics, native place, socioeconomic status, medical history, numbers of sexual partners and sexual practices, circumcision status, and risk factors for oral malignancies and human papilloma virus (hpv), including oral sex, smoking or chewing tobacco, drug use, oral hygiene, and tooth loss. patients undergo cell sample collection from the penis, scrotum, anus, and mouth, and saliva sample collection for hpv dna testing by pcr. patients also undergo blood sample collection to measure cd4+ count and hiv viral load by facs and pcr.

Eligibility criteria:
disease characteristics: * hiv-1 infection, as documented by elisa and confirmed by a second testing method (e.g., western blot, hiv-1 culture, hiv-1 antigen, plasma hiv-1 rna, or a second antibody test by a method other than elisa) - if prior documentation and confirmation of hiv-1 infection is not available, two licensed rapid hiv tests are allowed * must have had receptive or insertive anal intercourse with another man within the past 6 months patient characteristics: * speaks hindi (in mumbai) or tamil (in vellore) * no active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements * no history of a sex-change operation that would preclude collection of penile or scrotal specimens prior concurrent therapy: * not specified

Keywords: human papilloma virus infection hiv infection hiv infections
preeclampsia: a marker for future cardiovascular risk in women

Conditions: Preeclampsia; Pregnancy Induced Hypertension

Summary: this study will compare blood vessel and hormone differences between women who have a history of a pregnancy complicated by preeclampsia or high blood pressure, and women who have a history of uncomplicated pregnancy in the last 10 years. the investigators hypothesize that postpartum women with history of preeclampsia will have altered blood vessel function and abnormal hormone levels compared with postpartum women with history of uncomplicated pregnancy. this study will take place over the course of 2 weeks. each subject will be assessed on a fixed low-salt diet and a fixed high-salt diet. subjects will have 2 non-invasive blood vessel imaging tests and fasting blood draws.


Eligibility criteria:
inclusion criteria: 1. healthy female premenopausal volunteers, with regular menstrual cycles (at least 8 cycles per year) 2. age 21 to 50 years 3. systolic blood pressure \ 90 mmhg and diastolic blood pressure \ 60 mmhg at the screening visit 4. body mass index \< 35 kg/m2 5. history of normotensive pregnancy or history of preeclamptic or hypertensive pregnancy within the last 10 years 6. no clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis, and electrocardiogram) exclusion criteria: 1. current pregnancy 2. lactation 3. elevated blood pressure (systolic blood pressure \> 140 mmhg or diastolic blood pressure \> 90 mmhg) 4. current diagnosis of hypertension 5. current diagnosis of diabetes mellitus 6. personal history of coronary disease, stroke and kidney disease 7. use of prescription medications (with the exception of stable thyroid hormone replacement dose) within 2 weeks of study 8. use of oral contraceptives or other hormone therapy within 3 months of study; 9. renal impairment (estimated gfr\<60) 10. active liver disease (ast, alt, alkaline phosphatase \> 1.5 times normal); 11. current smoking, defined as smoking within the 6 months before the screening visit 12. current or past recreational drug use

Keywords: preeclampsia pregnancy induced hypertension
obesity treatment enhanced with working memory training

Conditions: ADHD; Weight Loss

Summary: this study will examine the effects of providing subjects who have attention deficits, with or without a formal diagnosis of attention deficit hyperactivity disorder (adhd), with working memory computerized training and explore whether this training is a feasible way to help them better engage in a weight loss treatment program, thereby enhancing weight loss results. half of the participants will receive five weeks of online adaptive wm training concurrently while attending an in-person 24-week behavioral weight management program and half will receive five weeks of a non-adaptive form of cognitive training concurrently while attending a 24-week behavioral weight management program in person.

populations with adhd or attention issues tend to have more weight loss attempts, struggle more with losing weight, and drop out of treatment more frequently than those without attention difficulties. adaptive working memory training has been used to strengthen working memory and to mediate the symptoms associated with adhd. the adaptive training becomes progressively more challenging as participants master each level of the training, while non-adaptive training remains at the same level throughout. both groups will attend 24 weekly, in-person weight management classes on the university of vermont campus. both groups will do cognitive training on their own home computers five days a week for 30-40 minutes for five weeks concurrently while engaged in the weight loss program.

Eligibility criteria:
inclusion criteria: * must score 4 or higher on the asrs v. 1.1 * must live within 45 minutes driving distance from uvm campus * must be able to exercise * must have a computer with internet access and ability to utilize flash * must be 18 or older exclusion criteria: * health issues that preclude exercise * use of medications that interfere with the ability to lose weight * vacation longer than two weeks * current participation in another weight loss program * reside more than 45 minutes from uvm campus in burlington * no internet access, no home computer, or computer cannot use flash

Keywords: working memory training, weight loss,
evaluation of respiratory function and functional capacity in pediatric patients with chronic kidney disease (ckd)

Conditions: Chronic Kidney Diseases; Chronic Renal Disease; Chronic Renal Failure

Summary: chronic kidney disease (ckd) is defined as a permanent abnormality in kidney structure or function that persists for more than 3 months (for example, glomerular filtration rate \[gfr\] \<60 ml/min/1.73 m2 or albuminuria ≥30 mg/24 hours) and, it effects the 8% to 16% of the population worldwide.in pediatric patients with ckd, exercise capacity begins to decline in stage 3 of the disease and progressively decreases in stage 5, in dialysis and transplant patients (4, 5). reduction in respiratory muscle strength and six minute walk test (6mwt) is observed in patients with ckd treated with hemodialysis (hd).the aim in present study is to evaluate the relationship between functional capacity and respiratory functions in stage 1-5 pediatric chronic kidney disease patients.

the aim of this study is to evaluate functional capacity with six minutes walk test (6mwt), respiratory functions with spirometer and the correlation between functional capacity and respiratory functions in pediatric ckd patients.

Eligibility criteria:
inclusion criteria: * being between the ages of 5-18, having stage i-v chronic kidney disease, * having chronic kidney disease for at least 6 months, * not having visual and hearing impairment exclusion criteria: presence of mental retardation, * insufficient turkish communication, inability to communicate, * having metabolic-neurological problems, * presence of cardiomyopathy, angina pectoris, * presence of orthopedic problem that will prevent standing and walking * cerebrovascular disease * patients will not be included in the study in the presence of metastatic carcinoma.

Keywords: pediatric chronic kidney disease pulmonary function functional capacity
comparing hydrocortisone and prednisolone for community acquired pneumonia (cap)

Conditions: Community Acquired Pneumonia (CAP)

Summary: the goal of this cluster randomized controlled trial is to determine the optimal treatment for community aquired pneumonia (cap). the study compares the effects and side effects of hydrocortisone and prednisolone in patients above 18 years old diagnosed with severe cap. the main question is whether there is a difference in all cause mortality within thirty days. participants will be randomized to receive treatment with either hydrocortisone or prednisolone.


Eligibility criteria:
inclusion criteria: * age \> 18 years * diagnosis of severe cap for who the physician in charge decides for corticosteroid therapy for severe cap. exclusion criteria: * admitted \>24 h * pregnant or breastfeeding women * active tuberculosis or fungal infection * pneumonia caused by influenza * intolerance to either study drug
identification of predictive gene expression profile of sunitinib response in metastatic clear cell renal carcinomas

Conditions: Kidney Cancer; Biomarkers; Gene Expression

Summary: renal cell carcinoma accounts for 2-3% of all cancers in western countries. brazilian kidney cancer data show an incidence of 6,270 new cases for 2018. new target-molecular therapies have emerged in recent years for the treatment of metastatic kidney cancer. due to the heterogeneity of these patients and the lack of specific markers, therapeutic is currently based on clinical and laboratory analysis. the research for predictive biomarkers may better characterize the kidney cancer therapeutic management. the objectives are to identify a predictive gene expression profile in patients with advanced clear cell renal carcinoma treated with first-line sunitinib and correlate it with rate response, seeking to identify a predictive gene expression profile. as secondary objectives, the investigators will compare the gene expression profile found, with global survival and clinical-pathological characteristics. materials and methods: to determine through systematic data collection the epidemiological profile, clinical-pathological characteristics, response rate, disease free survival and overall survival of 60 patients with metastatic clear cell renal carcinoma who used sunitinib in the first line between 2009 and 2018 at the barretos cancer hospital. for evaluation of gene expression profile, the investigators will use a panel of a panel with 770 genes related to disease progression using nanostring technology. keywords: renal cell carcinoma; sunitinib; biomarkers; gene expression; nanostring.


Eligibility criteria:
inclusion criteria: * adult patients * at least 18 years * metastatic clear cell renal carcinoma * primary tumors sample of nephrectomy or core biopsy exclusion criteria: * insufficient sample for molecular analysis * patients with no record of treatment response data * patients with a history of previous systemic treatment for metastatic clear cell renal carcinoma * patients with second primary synchronic or metachronic tumor undergoing treatment * patients having received less than one cycle of sunitinib in the first line * patients have received previous adjuvant and/or neoadjuvant treatment with an interval \< 1 year between the end of treatment and the diagnosis of metastasis.

Keywords: kidney cancer biomarkers gene expression predictive rate response nanostring
observation of gas exchange in the middle ear

Conditions: Normal Middle Ears.; Otitis Media Ears.

Summary: observation of fluid behavior over a perforated eardrum. a comparison of the behavior of the gas in normal vs. different kinds of otitis media ears.

fluid present in middle ears is observed during the regular treatment of patients. the observation in made during the treatment and not as an additional activity. the fluid is either a steroids solution or sterile normal saline or ear's mucus discharge, all in perforated eardrums, either as a part of their intra-tympanic treatment for sudden hearing loss, or traumatic perforation \[considered as the normal ears\] compared to otitis media ears. the observation is made on bubble formation over the perforation. the time length of the inspection is about 1 minute, under the microscope, during the treatment.

Eligibility criteria:
inclusion criteria: * patients having perforated eardrum. exclusion criteria: * non cooperative patients.

Keywords: gas middle ear
relative bioavailability study of hr19042 in healthy subjects

Conditions: Primary IgA Nephropathy; Autoimmune Hepatitis

Summary: this is a single-center, randomized, open-label, three-period, dual latin square crossover study. primary objective： 1. to evaluate the oral relative bioavailability of hr19042 capsules compared with budesonide delayed-release capsules (tarpeyo®) and budesonide enteric-coated capsules (budenofalk®). secondary objective 2. to assess safety following administration.


Eligibility criteria:
inclusion criteria: 1. male or female subjects, ages 18 to 45, inclusive, at the time of informed consent. 2. female subjects weigh ≥ 45 kg, male subjects weigh ≥ 50 kg, and bmi between 19.0 and 28.0 kg/m2, inclusive, at screening. 3. understands the study procedures in the informed consent form icf and be willing and able to comply with the protocol. exclusion criteria: 1. subject with any history of severe allergic or anaphylactic reactions to any allergen including drugs, or allergic disease diagnosed and treated by a physician. 2. clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders 3. subject has positive results at screening for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), hepatitis c virus (hcv), or treponema pallidum antibody. 4. history of any gastrointestinal surgery or cholecystectomy that could impact the pk of study drugs. 5. participated in other clinical trials within 3 months before screening or plan to participate in other clinical trials during this study. 6. blood loss or blood donation of more than 300 ml within 3 months before screening, or intended to donate blood during the trial. 7. those who have been vaccinated with vaccines within 3 month before screening or who have an intention to vaccinate during the trial. 8. difficulty in venous blood sampling or fear of needles/blood. 9. difficulty in swallowing capsules, or inability to comply with the provided diet and study-related instructions.
deep brain stimulation in treatment resistant schizophrenia

Conditions: Refractory Schizophrenia

Summary: this study aims at assessing efficacy and safety of deep brain stimulation (dbs) for treatment of patients with treatment resistant schizophrenia, by means of a random, controlled and crossed study.

the first phase of the study will consist of implanting electrodes. recruited patients will be random to 2 targets: (1) medial prefrontal cortex (mpfc); (2) nucleus accumbens (nacc). continuous stimulation will be applied until the patients stabilise clinically. this period is anticipated between 6 and 9 months. after this stage, the next phase will consist of the crossover study. those patients who respond to dbs will be randomly distributed in two groups, for a period of 3 months: on stimulation group and off stimulation group. patients will then be crossed over to the other group for a further 3 months. weekly visits during first month after, and fortnightly visits will be made during the entire study to evaluate treatment efficacy and patient tolerance. patients who complete the study and respond to treatment with dbs will be provided continuing with treatment, and keeping control visits to assess the long-term effectiveness.

Eligibility criteria:
inclusion criteria: 1. male or female aged between 18 and 55 years. 2. dsm iv-tr diagnosis of schizophrenia for at least 3 years prior to the screening visit. 3. determined to be treatment-resistant as demonstrated by: 1. persistence of positive symptoms which have not responded to appropriate treatments for at least 2 years. 2. inadequate response from adequate trials of two different classes of antipsychotic drugs (not including clozapine), at least 8 weeks. 3. inadequate response from adequate trial of clozapine, at least 3 months, or unable to tolerate clozapine because of intolerable side effects. 4. ect is contraindicated or have failed to produce a maintained response. 4. persistence of positive symptoms defined as i) requiring a score of 4 (mild) or more on at least 2 of the next panss items: delusions, hallucinatory behavior, suspiciousness and unusual thought content; or as ii) requiring a score of 6 (severe) or more on at least 1 of the above panss items. 5. current cgi score 6 or more 6. stable antipsychotic treatment for last 2 months. 7. women of childbearing age using medically approved contraceptive methods. 8. adequate familiar or social support during all study procedures. exclusion criteria: 1. mri (magnetic resonance imaging) contraindication to stimulation or contraindications for mri 2. history of epilepsy or clozapine-induced seizures, where use of anticonvulsants was needed 3. current suicidal ideation, plan or intent for self-harm during last 2 months. 4. evidence of global cognitive impairment. 5. current acute, serious or unstable illnesses. 6. history of substance abuse (other than tobacco or caffeine). 7. comorbid axis i or ii dsm iv-tr disorders. 8. female patients who are pregnant or breastfeeding.

Keywords: treatment-resistant schizophrenia deep brain stimulation
a study in healthy volunteers

Conditions: Hepatitis B; Infectious Disease; Liver Diseases

Summary: this is three part study that will, in part one assess the safety, tolerability, and pk of a single dose of crv431 in healthy volunteers. the second part of the study will be a single dose drug-drug interaction study in healthy volunteers with crv431 co-treated with tdf. the third part of the study will assess the safety, tolerability, pk, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of crv431 with tdf in stable hbv patients.


Eligibility criteria:
inclusion criteria: * capable of giving written informed consent * willing and able to complete all study requirements * healthy male or female between 18 and 55 years of age (inclusive); * body mass index 16 to 32 kg/m2 (inclusive); exclusion criteria: * positive test for hcvab or hivab. for healthy subjects only: positive test for hbsag * current or history of abuse of alcohol or illicit drugs * received an investigational drug, vaccine or medical device within 90 days prior to first dose of study drug. additional exclusion criteria for hbv pilot subjects only: * evidence of significant liver fibrosis or cirrhosis * history of nafld or nash * positive test for hdv

Keywords: crv431 hepatitis b virus hepatitis virus
a short metaphyseal fitting total hip arthroplasty in young and elderly patients

Conditions: Osteonecrosis; Osteoarthritis

Summary: the investigators determined whether 1. new short, metaphyseal-fitting cementless anatomical femoral stem provides major functional improvements 2. radiographically secure implant fixation is achieved with this new stem 3. the bone content is preserved at the baseline level or above at the final follow-up 4. these procedures are associated with early failure and complications.

to attempt reduction of stress shielding and thigh pain as well as to improve survivorship, a new short, metaphyseal-fitting cementless anatomical femoral stem was developed. the question arises as to whether it is possible to obtain rigid fixation of the stem without diaphyseal fixation in the young as well as in the elderly patients. the purpose of this study was to determine the clinical and radiographic results of the new short, metaphyseal-fitting cementless anatomical femoral stem in the young as well as in the elderly patients.

Eligibility criteria:
inclusion criteria: * osteoarthritis of hip joint requiring total hip arthroplasty exclusion criteria: * neurologic disorders affecting motor function of lower extremity foot and ankle disorders limiting ambulation of the patient * patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism * multi-systemic inflammatory arthritis which debilitates patients other than hip joint.

Keywords: short, metaphyseal-fitting femoral stem cementless anatomical femoral stem young patient elderly patient
nis for patients using symbicort turbuhaler for maintenance and reliever therapy in a single inhaler

Conditions: Asthma

Summary: the aim of this non-interventional study is to ensure that patients in routine clinical practice follow given treatment instructions and to evaluate the number of reliever inhalations as well as the number of patient/days with more than 8/12 total inhalations at any day. if the number of reliever inhalations and thus the received inhaled glucocorticosteroid dose is not excessive, the safety conclusions from the clinical studies can be extrapolated to real life for better acceptance of smart (symbicort maintenance and reliever therapy).


Eligibility criteria:
inclusion criteria: * persistent asthma * prior symbicort turbuhaler maintenance and reliever therapy in a single inhaler

Keywords: asthma smart inhaled glucocorticosteroid reliever maintenance single inhaler