Kornimate/medical-research-clean huggingface dataset:
ptg-300 in patients with polycythemia vera and elevated hematocrit

Conditions: Polycythemia Vera

Summary: this is an open label, single arm trial of ptg-300 in subjects with pv who are newly diagnosed or for whom current therapy is not sufficient to control their hematocrit and have hematocrit \>48% prior to dosing. the ptg-300 dose and schedule may be adjusted every 2 to 4 weeks to maintain hematocrit \<45% with a target of \<43%. subjects may receive ptg-300 treatment for up to 52 weeks.


Eligibility criteria:
inclusion criteria: 1. known diagnosis of polycythemia vera. 2. hematocrit \>48% before dosing. 3. evidence of hematocrit \>48% three or more times in the 28 weeks before dosing or five or more times in 52 weeks before dosing (except for newly diagnosed patients). 4. clinically reasonable alternative causes for erythrocytosis have been evaluated and excluded. 5. eastern cooperative oncology group (ecog) performance status 0, 1 or 2. exclusion criteria: 1. clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 3 months of screening. 2. active or chronic bleeding within 4 weeks of screening. 3. meets the criteria for post-pv myelofibrosis as defined by the international working group-myeloproliferative neoplasms research and treatment (iwg-mrt). 4. infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 3 months of dosing; any infection requiring systemic antimicrobial therapy within 4 weeks of dosing. prophylactic antibiotics are allowed. 5. any serious or unstable medical or psychiatric condition that would prevent, (as judged by the investigator) the subject from properly providing informed consent or any condition which would jeopardize compliance with the study. 6. known primary or secondary immunodeficiency. 7. known positive for active hepatitis b, hepatitis c or human immunodeficiency virus (hiv) infection. 8. any surgical procedure requiring general anesthesia within 1 month prior to screening or planned elective surgery during the study. 9. history of invasive malignancies within the last 2 years, except non-melanoma skin cancer and localized curatively treated prostate cancer or cervical cancer. 10. current or recent history of alcohol dependence or illicit drug use within 1 year prior to screening.

Keywords: pv
activity of ave1625 in mild to moderate alzheimer's patients.

Conditions: Alzheimer Disease

Summary: primary: this study is being conducted to evaluate if ave1625 is safe and tolerated in patients with alzheimer's disease that is not too severe. there is also evaluation of whether patients who take the study medication improve compared to patients who take a placebo (sugar pill). secondary:the study will also evaluate the blood levels of the study medication, ave1625 in patients who join the study.


Eligibility criteria:
inclusion criteria: * the diagnosis of alzheimer's disease * recent brain image(computerized axial tomographic scan -cat scan or magnetic resonance imaging - mri) * mild to moderate range of disease; not too severe exclusion criteria: * severe or unstable medical diseases * neurological disorder other than alzheimer's disease * depression that is not well controlled * treatment with memantine * inpatient in a total care facility (e.g.: nursing home) * lack of reliable caregiver

Keywords: alzheimer's disease symptomatic cognition
characterization of 18f-fluciclovine pet amino acid radiotracer in resected brain metastasis

Conditions: Brain Metastases; Brain Cancer

Summary: this study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (srs) after their brain surgery. it will be optional for patients to have a pre-surgery 18f-fluciclovine pet/ct scan. the goal of the study is to determine whether a specific imaging agent, known as 18f-fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what mri alone can identify as well as improve the physicians' ability to detect recurring disease. this agent (18f-fluciclovine) is investigational for the imaging of brain metastases.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. performance status, eastern cooperative oncology group (ecog) 0-3 3. radiographic diagnosis of brain metastasis 4. patient planned for surgical intervention for at least 1 metastasis 5. patient planned for postoperative srs male or female patients of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18f-fluciclovine pet/ct. highly effective and acceptable forms of contraception are: * male condom plus spermicide * cap plus spermicide * diaphragm plus spermicide * copper t * progesterone t * levonorgestrel-releasing intrauterine system (e.g., mirena®) * implants * hormone shot or injection * combined pill * mini-pill * patch postmenopausal people on the study (that will not need contraception) is defined as at least one of the following: * amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments * luteinizing hormone (lh) and follicle stimulating hormone (fsh) levels in the postmenopausal range for women under 50 * radiation-induced oophorectomy with last menses \> 1 year ago * chemotherapy-induced menopause with \>1 year interval since last menses * surgical sterilization (bilateral oophorectomy or hysterectomy). exclusion criteria: 1. prior anaphylactic reaction to 18f-fluciclovine 2. evidence of leptomeningeal disease 3. prior whole-brain radiation therapy 4. contraindication to mri (e.g., due to safety reasons, such as presence of a pacemaker) 5. pregnant at the expected time of 18f-fluciclovine administration 6. expecting to be breastfeeding at the time of 18f-fluciclovine and unwilling to stop breast-feeding for 24 hours. temporary cessation of breastfeeding 24 hours after the time of imaging is allowed.

Keywords: brain metastases brain cancer stereotactic radiosurgery
azithromycin reduction to reach elimination of trachoma

Conditions: Trachoma

Summary: the investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of maradi, niger. the investigators will randomize communities with up to 20% trachomatous inflammation - follicular (tf) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution.


Eligibility criteria:
inclusion criteria: * provision of appropriate informed consent * stated willingness to comply with all study procedures * live in one of the 80 communities with up to 20% prevalence of tf selected for the trial exclusion criteria: * does not consent to participation * unwilling to comply with all study procedures * does not live in one of the 80 communities with up to 20% prevalence of tf selected for the trial
multicenter validation on predicting mortality for patients with bleeding peptic ulcers

Conditions: Bleeding Peptic Ulcer

Summary: this study aimed to validate cu prediction model on mortality for patients with high risk bleeding peptic ulcers after therapeutic endoscopy.

despite advances in management of patients with bleeding peptic ulcers, mortality is still 10%. we previously reported a prediction score for ulcer bleeding related mortality developed from a local cohort. the risk factors for mortality included patients older than 70, presence of co-morbidity, more than one listed co-morbidity, hematemesis, sbp \< 100 mmhg, in-hospital bleeding, rebleeding, and need for surgery. study objective this study aimed to validate the prediction of mortality among patients with bleeding peptic ulcers from different asian countries. method consecutive patients with bleeding peptic ulcers who presented to the study centers in hong kong, japan and taiwan were recruited after successful primary endoscopic hemostasis. the baseline demographics, ulcer characteristics, the predictive factors, 30 days mortality, rebleeding, hospital stay and need of surgery were recorded. the accuracy of prediction for adverse events including mortality and rebleeding with the prediction risk scoring system would be analysed.

Eligibility criteria:
inclusion criteria: 1. patients presented with bleeding peptic ulcers 2. age \> 18 year old 3. informed consent for the study and ogd exclusion criteria: 1. unable or refuse to give consent 2. onset more than 7 days 3. pregnancy

Keywords: bleeding peptic ulcer prediction model mortality prediction of in-hospital mortality for bleeding peptic ulcer
laparoscopic adjustable gastric banding as a treatment for morbid obesity in adolescents

Conditions: Morbid Obesity

Summary: the purpose of this study is to determine whether the lap-band system is safe and effective in morbidly obese adolescents.

the aim of this research is to evaluate the safety and efficacy of the use of the lap-band system in the morbidly obese adolescent population in the united states. we also propose to take advantage of the opportunity for liver biopsy and the data collected for the fda study in adolescents to answer several questions: 1) what is the true incidence of non-alcoholic fatty liver disease (nafld) and its variants in morbidly obese adolescents; 2) what is the course of the nafld disease in adolescents who have undergone weight loss, including the progression from steatosis to nash/ fibrosis or the progression of nash to cirrhosis? 3) what are the factors implicated in this progression and 4) is there a link between the excess visceral fat, ms and nafld as assessed by parallel changes in metabolic syndrome (ms) and nafld following weight loss intervention. the lapband may provide obese adolescents with a significantly less morbid and reversible surgical option for weight loss.

Eligibility criteria:
inclusion criteria: * ages 14 through 17 * bmi greater than 40 * bmi 35 to 40 and also having an obesity related comorbidity * have a history of working in a multidisciplinary weight loss program utilizing nutritional training, behavior modification, and activity training exclusion criteria: * subject history of congenital or acquired anomalies fo the gastrointestinal tract * severe cardiopulmonary or other serious organic disease * severe coagulopathy * hepatic insufficiency or cirrhosis * history of bariatric gastric or esophageal surgery * history of intestinal obstruction or adhesive peritonitis * history of esophageal motility disorders * type i diabetes

Keywords: morbid obesity adolescents gastric restrictive procedure adjustable gastric band treatment
bridging hemophilia b experiences, results and opportunities into solutions (b-hero-s)

Conditions: Haemostasis; Congenital Bleeding Disorder; Haemophilia B

Summary: this study is conducted in the united states of america (usa). tha aim of this study is bridging hemophilia b experiences, results and opportunities into solutions (b-hero-s).


Eligibility criteria:
inclusion criteria: * adults aged below or equal to 18 years with hemophilia b (any severity, with or without inhibitors) * caregivers of children currently aged below 18 years with hemophilia b (any severity, with or without inhibitors) * subjects must have access to the internet, either at home or at a location convenient to them * provision of informed consent before the start of any survey-related activities exclusion criteria: * inability to understand and comply with written instructions in english * previous completion of the b-hero-s study with receipt of compensation * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
effects of yoga exercise on participates with tinnitus

Conditions: Tinnitus

Summary: this study aimed to investigate the effectiveness of yoga on the tinnitus handicap and sleep quality in humans. we selected adult participates with chronic tinnitus (\>6 months). all participates performed yoga exercise once per week at outpatient department under the guidance of a professional teacher, and performed once daily by themselves at home for 12 weeks. questionnaires of tinnitus handicap inventory and pittsburgh sleep quality index were measured before the start of this study, at the end of this study, and 1 month after the end of this study.

tinnitus is the auditory phantom sensation in the absence of external sound stimulation. tinnitus that persisted more than six months without improvement can be called chronic tinnitus. one report proposed the neurophysiological model of tinnitus. in addition, tinnitus patients suffered from insomnia, irritability, anxiety and/or depression. current management of tinnitus is a drug-based treatment and/or nutritional supplementation. music therapy, hearing aid therapy, and tinnitus retraining therapy (trt), were also applied for patients with tinnitus. even though, success rates of various tinnitus treatments were still unsatisfactory till now. this study aimed to investigate the effectiveness of yoga on the tinnitus handicap and sleep quality in humans. we selected adult participates with chronic tinnitus (\>6 months). all participates performed yoga exercise once per week at outpatient department under the guidance of a professional teacher, and performed once daily by themselves at home for 12 weeks. questionnaires of tinnitus handicap inventory and pittsburgh sleep quality index were measured before the start of this study, at the end of this study, and 1 month after the end of this study.

Eligibility criteria:
inclusion criteria: 1. participates with tinnitus persisted more than 6 months from ear, nose, and throat out-patient department. 2. no drug treatment for their tinnitus in recent 3 months. 3. no respiratory diseases (eg, asthma). 4. normal cognitive function. 5. normal language comprehension. exclusion criteria: 1. pregnant females or menopausal females with hormone replacement therapy. 2. hypertension 3. glaucoma. 4. those who cannot express their opinions or follow orders. 5. cancer patients. 6. objective tinnitus.

Keywords: yoga tinnitus sleep
study to evaluate the feasibility of community-based test and treat strategies among men who have sex with men and transgender women to increase the uptake of hiv testing and treatment services in thailand

Conditions: HIV Test and Treat

Summary: hiv counseling and testing, risk reduction counseling, provision of condoms and lubricants same-day result hiv testing along with pre-test and post-test counseling, including risk reduction counseling, will be provided according to the standard practice at each study site at enrollment and every 6 months in hiv-negative participants. hiv-negative participants can also access non-occupational post-exposure prophylaxis service and symptomatic std service if these are available at study sites. hiv-positive participants will also receive risk reduction counseling every 3 months. condoms and lubricants will be provided free of charge.

this study is a prospective observational cohort study that will enroll up to 6,000 thai msm and tg from drop-in centers in bangkok, chiang mai, chonburi and songkhla. each participant will have hiv testing at baseline and will be followed up for 18 months. hiv-negative participants will be asked to have hiv re-testing every 6 months. hiv-positive participants will have poc cd4 testing and art initiation regardless of cd4 count will be offered. those who accept art will be followed up at week 2, week 4, month 2, month 3 and every 3 months thereafter. those who deny art will be followed up every 3 months. uptake of hiv re-testing will be determined. access to poc cd4 testing and acceptability of art initiated at hiv diagnosis regardless of cd4 count along with art adherence will also be determined.

Eligibility criteria:
inclusion criteria: 1. thai national 2. age \>18 years 3. men or transgender women who report unprotected anal intercourse with a man at least one time in the past 6 months 4. not known to be hiv-positive, i.e., never tested for hiv or previous hiv test(s) negative 5. willing to participate in the study 6. provide written informed consent exclusion criteria: 1. known hiv-positive serostatus

Keywords: 6,000 thai msm and tg from study sites in bangkok, chiang mai, chonburi and songkhla
the use of molecular breast imaging in the evaluation of tumor response to neoadjuvant therapy in women with breast cancer

Conditions: Neoadjuvant Therapy; Chemotherapy; Hormone Replacement Therapy; Breast Cancer

Summary: in patients with breast cancer who undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy molecular breast imaging (mbi) is an accurate test for assessing response rate to neoadjuvant therapy.

the investigators propose to evaluate molecular breast imaging in patients undergoing neoadjuvant therapy for breast cancer with the aims to document that 1) the change in uptake of 99mtc-sestamibi prior to initiation of neoadjuvant therapy, after 3-5 weeks of neoadjuvant therapy and at completion of neoadjuvant therapy prior to breast cancer surgery will be a reflection of the tumor response to neoadjuvant therapy. 2) tumor response at 3-5 weeks of neoadjuvant therapy is predictive of tumor response at completions of neoadjuvant therapy. 3) post-neoadjuvant tumor size as determined by mbi corresponds to size found at surgery.

Eligibility criteria:
inclusion criteria: * women with breast cancer scheduled to undergo neoadjuvant chemotherapy therapy or neoadjuvant hormone therapy and who have undergone any breast imaging procedure, and in whom a repeat imaging procedure is planned prior to definite surgery. mri of the breast for accurate tumor size evaluation is recommended but not necessarily required for study inclusion. * are able to return for a 3-5 week follow-up mbi study and for the final mbi study at completion of the neoadjuvant therapy. * patient age \> 18 exclusion criteria: * unable to understand or sign a consent form * pregnant or lactating * physically unable to sit upright and still for 40 minutes

Keywords: neoadjuvant therapy chemotherapy hormone therapy breast cancer mbi molecular breast imaging
a study on the management of combination anti-hiv drug therapy in hiv-positive children with prior treatment

Conditions: HIV Infections

Summary: the purpose of this study is to determine the value of changing anti-hiv medications in children with progressive hiv disease who have received previous treatment. plasma viral load (the level of hiv in the blood) is probably most effectively reduced by giving patients anti-hiv drugs which affect the virus at various stages of development. changing the medications may enhance the results of treatment.

the master rad protocol is based on the concept that optimal suppression of viral load in vivo will be achieved in patients with rapidly progressing or advanced hiv disease (rad) using antiretroviral combinations inhibiting viral replication at distinct sites of action. antiretroviral combinations are chosen with the hypothesis that simultaneous change to as many new agents as possible is necessary to maximally reduce plasma viral load. in this open-label, multicenter study patients are randomized into 1 of 4 groups based on prior antiretroviral experience. each regimen consists of 4 drugs that include a combination of nucleoside reverse transcriptase inhibitors (stavudine, lamivudine, zidovudine, didanosine, zalcitabine) plus nevirapine (nvp), nelfinavir (nfv), or ritonavir (rtv). patients must be naive to at least 2 of the 4 drugs in the regimen and at least 1 of the novel drugs must be nvp, nfv, or rtv. prior to randomization to a nfv- or rtv-containing regimen, patients are stratified by hiv rna (greater than or equal to 50,000 or less than 50,000) and must able to receive 2 or more novel drugs.

Eligibility criteria:
inclusion criteria your child may be eligible for this study if he or she: * is hiv-positive. * is between the ages of 6 months and 21 years (consent of parent or guardian required if under 18). * has an hiv blood level above 50,000 copies/ml on 2 consecutive occasions, while taking anti-hiv therapy. * has advanced hiv disease or disease progression while receiving 8 weeks or more of continuous unchanged anti-hiv therapy. * is able to receive at least one of the following: rtv, nvp, or nfv. exclusion criteria your child will not be eligible for this study if he or she: * is receiving treatment for a serious bacterial, viral, or opportunistic (hiv-associated) infection within 14 days prior to study entry. * has a history of pancreatitis or peripheral neuropathy. * has cancer requiring chemotherapy. * is allergic to the study medications. * is taking certain medications. * is pregnant.

Keywords: zalcitabine didanosine drug therapy, combination zidovudine nevirapine stavudine ritonavir lamivudine rna, viral anti-hiv agents nelfinavir
wired magnetically assisted capsule endoscopy and esophageal varices

Conditions: Esophageal Varices

Summary: the goal of this clinical trial is to compare the safeness and effectiveness of traditional esophagogastroduodenoscope (egd) and wired magnetically assisted capsule endoscopy (mace) in the diagnosis of esophageal varices in biliary atresia (ba) patients. the main questions it aims to answer are: * subjects who do wired magnetically assisted capsule endoscopy do not need to open the mouths during the process, this study also want to know whether wired magnetically assisted capsule endoscopy can reduce the generation of droplets. * diagnostic accuracy between traditional esophagogastroduodenoscope and wired magnetically assisted capsule endoscopy in biliary atresia patients with esophageal varices. participants will do either traditional esophagogastroduodenoscope or wired magnetically assisted capsule endoscopy.


Eligibility criteria:
inclusion criteria: * biliary atresia patients \> 6 years old * vital signs are stable * without acute gastrointestinal bleeding exclusion criteria: * patients with metal implants, metal stent, artificial joints, bone plates, and bone screw * patients with electronic devices, such as pacemakers, cochlear implants, or other implanted electronic medical devices * throat or esophageal obstruction leading to dysphagia patients * consciousness disturbance patients unable to swallow * patients with acute upper gastrointestinal bleeding * patients with platelet lower than 40k or pt inr \> 1.5

Keywords: upper endoscopy biliary atresia