Kornimate/medical-research-clean huggingface dataset:
use of the shang ring circumcision device in boys below 18 years old in kenya

Conditions: Human Immunodeficiency Virus

Summary: a proof of concept study to evaluate the feasibility of using the shang ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. the study will evaluate the safety, efficacy and course of wound healing when using the shang ring technique across the four childhood age groups.

a proof of concept study to evaluate the feasibility of using the shang ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. the study will evaluate efficacy, procedure time, difficulties during surgery and post-operative events shall be assessed. to evaluate safety, the investigators will clinically observe for adverse events during the course of healing. the investigators will also evaluate to length of time taken for complete healing to be achieved.

Eligibility criteria:
inclusion criteria: * must be accompanied by the parent or legally acceptable representative (lar), who freely consents for participation of the child into the study; * assent from participant 7 years of age and above who understand study procedure; * aged between 1 month and 17 years(inclusive); * body weight of more than 2.5 kgs and penile shaft more than 1 cm in length. * must be in good general health; * must be free of genital ulcerations or other visible signs of sti (on examination); * parent or lar and if possible the client must be able to understand study procedures and requirements of study participation; * parent or lar must agree to return the client to the study site for the full schedule of follow-up visits after his circumcision; * parent or lar must have a cell phone or access to a cell phone; and, * parent or lar must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study. exclusion criteria: * has a known allergy or sensitivity to lidocaine or other local anesthesia; * takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid; * has known bleeding/clotting disorder (e.g. hemophilia); * has any congenital genitourinary abnormality; * has an active genital infection, anatomic abnormality or other condition (e.g. severe obesity, diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study; or * is currently participating in another biomedical research study.

Keywords: hiv prevention male circumcision children childhood shang ring
market research - acceptability study for a new pku protein substitute

Conditions: PKU; Phenylketonurias; Inborn Errors of Metabolism; Metabolic Disease

Summary: the aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with pku.


Eligibility criteria:
inclusion criteria: * diagnosis of pku or pku variant requiring a protein substitute. * subjects who were already taking a phenylalanine-free/low phenylalanine protein substitute and were willing to try the study product for 7 days. * patients aged 3 years of age to adulthood. * written informed consent obtained from participant or parental caregiver (as appropriate). exclusion criteria: * presence of serious concurrent illness * investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements * participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. * any patients having taken antibiotics over the previous 2 weeks leading up to the study. * patients less than 3 years of age.
commit depression trial nepal

Conditions: Depression

Summary: community health workers (chws) have successfully used motivational interviewing (mi) to improve treatment adherence (i.e. taking medications and attending clinic appointments) for patients with depression in the us and globally. mobile health (mhealth) tools can address challenges in implementing mi by providing real-time support in the community and facilitating ongoing coaching and supervision for chws, as these two challenges currently impede chws' ability to use mi. the investigators will develop then test a new mhealth app, which can potentially be used in the us and abroad, to help chws receive decision-support for mi and capture consented audio recordings of patient interactions for review and feedback by facility-based nurses with mi expertise.


Eligibility criteria:
inclusion criteria: 1. inclusion criteria for patient population: a. adult patients aged 18 or older; and b. must have with active diagnosis of moderate to severe depression (last phq-9 ≥10) in the electronic health record system at the research performance site in nepal; and c. have poor adherence (did not refill medications 1 week past the expected date and/or missed a scheduled clinic visit by at least 2 weeks; and d. must reside in dolakha, nepal 2. inclusion criteria for community health worker or a community health worker supervisor: a. community health workers and their supervisors currently employed by and working at the research performance site, serving communities in dolakha; and b. have received training in motivational interviewing and use of the commit mobile application. exclusion criteria: 1. exclusion criteria for patient population: patients with bipolar disorder (their treatment will be different from standard antidepressants) and those with substance use or psychotic disorders (their motivational factors will be substantially different from those of other depressed patients). 2. exclusion criteria for a community health worker or a community health worker supervisor: includes decision not to participate in the study.

Keywords: low- and middle-income countries mhealth human-centered design and engineering digital tools nepal motivational interviewing non-physician healthcare workers community health workers depression
induction therapy study in live donor kidney transplant recipients with a positive crossmatch

Conditions: Kidney Failure, Chronic

Summary: the purpose of this study is to determine whether the anti-t cell antibody, thymoglobulin is a more effective induction medication than the anti-il-2r inhibitor daclizumab, in kidney transplant recipients who have a positive crossmatch with their live donor.

kidney transplantation is widely recognized as the optimal therapy for the management of end-stage renal disease. presently, the deceased donor kidney waiting list has expanded disproportionately with the number of transplant procedures that are performed in the united states. to further compound this problem, as many as 1/3 of the patients on this list are highly sensitized against a broad range of potential donors. in order to address this problem, we developed an antibody depletion protocol that permits transplantation in patients who have a positive crossmatch with their live donor. the protocol consists of standard immunosuppressant therapy, plasmapheresis, and intravenous immunoglobulin infusion. we have successfully performed transplantation in over 100 such patients with low complication rates. because these patients have been exposed to their donor's human leukocyte antigen (hla) they are at high risk for both acute cellular and acute antibody-mediated rejection. this intent of this prospective, randomized, open-label trial is to determine whether induction therapy (i.e. therapy given at the time of transplantation for prophylaxis) with thymoglobulin is associated with a lower 6-month incidence of acute cellular and antibody-mediated rejection than with our standard therapy, daclizumab.

Eligibility criteria:
inclusion criteria: * adult (18 years or older) * end-stage renal disease * identified to have positive lymphocytotoxic crossmatch or flow cytometric crossmatch with live donor exclusion criteria: * deceased donor recipients * pregnancy * active infection * history of cancer within the past two years (with the exception of non-melanomatous skin cancer) * history of heparin induced thrombocytopenia * medical contraindications to transplant procedure

Keywords: kidney transplantation positive crossmatch antibody mediated rejection rejection induction therapy trial
insulin effects on metabolism and cardiovascular function in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: compared to human insulins analogue insulins offer the option of optimizing metabolism also in type 2 diabetes. especially, fast acting insulin analogues lower postprandial glucose levels more effectively than human regular insulin. however, it is not known whether therapy with analogue insulins can also improve the subclinically impaired myocardial function in type 2 diabetes. this prospective, randomized, open long term study compared the effects of a basal-bolus insulin therapy with analogue insulins versus human insulins on metabolic control and systolic and diastolic myocardial function, testing the hypothesis that optimized postprandial glucose control improves cardiac function and cardiovascular risk.

this is a single centre, long term (24-48 months), therapy controlled and randomised study with blinded analysis of the ultrasound data in 120 patients with type 2 diabetes mellitus and with previous insulin therapy. after recruitment and informed consent, patients are randomized to two treatment arms according to a randomisation protocol which takes into account age and absence or presence of cardiovascular events in each patient's history. in one treatment arm, the intensive insulin therapy is based on human insulin (insulin nph and regular human insulin) while in the other arm, the intensive insulin therapy is based on analogue insulin (insulin detemir and insulin aspart). both treatment arms will be titrated to identical glycemic goals (fasting blood glucose \<110 mg/dl and post prandial blood glucose \<150 mg/dl). all patients will be updated in their skills of self medication by the departmental diabetic teaching programme und will receive life style instructions during each visit. furthermore, they are encouraged to keep records of any episode of hypoglycemia throughout the study. outpatient visits for metabolic control are every 3 months and ultrasound and blood tests every 6 months.

Eligibility criteria:
inclusion criteria: * type 2 diabetes, insulin therapy exclusion criteria: * type 1 diabetes, bmi \>40, pregnancy,

Keywords: postprandial glucose, diastolic function, analogue insulins
the role of posterior fossa irradiation (pfi) plus stereotactic radiosurgery (srs) for cerebellar metastases

Conditions: Neoplasm Metastasis

Summary: the aggregate of data pertaining to brain metastases suggests that optimal results are achievable with a 2-pronged approach that addresses both the specific focus (with surgery or radiosurgery) and the surrounding brain parenchymal tissue that may harbor micrometastases. patterns of failure following treatment of metastases that arise in the posterior fossa have not been reliably defined. although most would agree that radiosurgery alone is not sufficient treatment for focal metastases in the cerebellum, it may be possible to deliver less than wbi as an "expanded port" beyond the srs volume. the current study acknowledges that at least two therapeutic modalities are requisite for patients with cerebellar metastases but hypothesizes that it is unnecessary to extend the treatment of ostensibly uninvolved brain tissue beyond the limits of the posterior fossa. in so doing, it is hoped that the putative advantage derived from foregoing whole brain irradiation (e.g., reduction in neurocognitive impairment) will not be at the expense of excessive surpratentorial failure.

schema: * posterior fossa irradiation as defined by diagnostic mri and ct simulation. * 37.5 gy in 2.5 gy fractions administered via conformal beams. * radiosurgical boost (with dose titrated to parameters of rtog 9005). * contrast enhanced mri will be obtained at baseline and then at 3, 6, and 12 months following completion of posterior fossa irradiation. * the mini mental status examination will be used to evaluate global cognitive function at baseline and then at 3, 6, and 12 months following completion of posterior fossa irradiation.

Eligibility criteria:
inclusion criteria: * histologically confirmed malignant disease * all primary tumors exclusive of: * small cell lung cancer * renal cell cancer (hypernephroma) * melanoma * sarcoma * 1-3 intraparenchymal metastases * age ≥18 years * rpa(14) 1 or 2 * patients who have undergone resection are eligible provided residual disease is evident on imaging * no clinical or radiographic evidence of progression of extracranial disease in month prior to enrollment on study. exclusion criteria: * major psychiatric illness * lesions in brainstem, midbrain, pons, medulla * patient who have undergone complete resection of all known infratentorial disease * patients with leptomeningeal metastases * patients with hepatic metastases * patients with metastases from the following primary tumors are ineligible: small cell lung cancer; rena cell carcinoma; melanoma; sarcoma * previous cranial irradiation

Keywords: irradiation stereotactic radiosurgery posterior fossa cerebellar metastases
development of a tailored smoking cessation program for individuals with hiv infection in washington, d.c.

Conditions: Tobacco Smoking

Summary: morbidity and mortality from smoking-related diseases among people living with hiv (plwh) in the u.s. surpasses that due to hiv itself. conventional smoking cessation treatments have not demonstrated strong efficacy among plwh. the investigators conducted a pilot randomized controlled trial (rct) to evaluate a tailored smoking cessation intervention based on the minority stress model, hypothesizing that behavioral counseling through this lens would enhance cessation. the investigators compared standard of care counseling (soc) to a tailored intervention (ti) including one face-to-face counseling session incorporating cognitive behavioral therapy to build resilience, and 30 days of 2-way text messaging.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * report being hiv-infected * be a resident of the washington, d.c. area * current, daily smokers of tobacco * have a confirmed smoking status of 6 parts per million (ppm) or more by using an exhaled carbon monoxide breath monitor * agree to participate * be willing to set a quit date within 7 days of baseline assessment. exclusion criteria: * are currently using smokeless tobacco or electronic cigarettes at least every day * are currently using nicotine replacement therapy or other smoking cessation treatment * report being hiv-uninfected * report having heart disease or high blood pressure not controlled by medication * are currently in an alcohol treatment program * are pregnant (exclusion items 4-6 are contraindications of nicotine replacement therapy, which will be provided) * do not have a primary care provider or hiv care provider to refer to in the event of an adverse reaction to nicotine replacement therapy.
goal directed ammonia lowering therapy in hyperammonemic aclf patients with no overt he to reduce major adverse liver related outcomes (goal trial)

Conditions: Acute on Chronic Liver Failure

Summary: sirs in aclf exacerbate adverse effects of ammonia - sarcopenia, infections, immune dysfunction, he and organ dysfunction persistent or incident hyperammonemia during first week of hospitalization in patients with aclf is associated with increased risk of organ failure and death. prospective studies on the efficacy of ammonia lowering therapies on major adverse liver related outcomes (malo) (any of aarc iii, bacterial infection, overt he grade or death) in hyperammonemic aclf patients with no overt he are limited. in this study we aim to to compare the safety and efficacy of ammonia lowering therapy (goal directed lactulose and rifaximin) compared to smt to prevent major liver related outcomes (malo) (any of aarc iii, bacterial infection, overt he grade or death) in hyperammonemic aclf patients with no overt he.

hypothesis: goal directed ammonia lowering therapy in hyperammonemic aclf patients with no overt he leads to reduced incidence of major adverse liver related outcomes (malo) (any of aarc iii, bacterial infection, overt he grade or death) at day 7, 28 and day 90. aim:- to compare the safety and efficacy of ammonia lowering therapy (goal directed lactulose and rifaximin) compared to smt to prevent major liver related outcomes (malo) (any of aarc iii, bacterial infection, overt he grade or death) in hyperammonemic aclf patients with no overt he. study design: * a prospective randomized controlled trial. * single centre. * open label. * block randomization will be done , it will be implemented by iwrs method. * the study will be conducted in department of hepatology, ilbs.

Eligibility criteria:
inclusion criteria: 1. age 18-70 years 2. aclf as per apasl criteria (aarc grade i/ii) 3. baseline ammonia levels of ≥135ug/dl or 79.5umol/l 4. given informed consent exclusion criteria: * 1. overt he 2. aarc grade iii 3. confirmed or suspected bacterial infection 4. extrahepatic organ failure 5. renal dysfunction lasting for more than 48 hours or need for vasoconstrictors 6. paralytic ileus 7. patients with hepatocellular carcinoma beyond milan criteria or any other neoplastic disorder 8. pregnant and lactating women 9. use of lactulose, rifaximin or lola in past 48h 10. uncontrolled dm, ht, cad 11. patients with allergy or other contraindications of the used drugs
clinical trial to investigate the effect of proton pump inhibitor on the pharmacokinetics and pharmacodynamics of metformin

Conditions: Healthy

Summary: this study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics and pharmacodynamics of metformin in healthy korean men.


Eligibility criteria:
inclusion criteria: * healthy male subject aged 20 to 45 at screening * a body weight in the range of 50 kg (inclusive) - 100 kg (inclusive) with ideal body weight range of +- 25% * subjects who decide to participate voluntarily and write a informed consent form exclusion criteria: * subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor * subject judged not eligible for study participation by investigator.

Keywords: metformin proton pump inhibitor drug interaction
application of shock wave technique in conservative treatment of rotator cuff tear

Conditions: Rotator Cuff Tear

Summary: this study is a prospective cohort study and is a single-center clinical trial. sample: this study will enroll about 22 patients from the department of sports medicine and rehabilitation outpatient department of beijing third hospital who are diagnosed with rotator cuff tear and choose conservative treatment.

a single-center randomized controlled clinical trial was conducted to compare the effect of eswt combined with conventional rehabilitation training on patients with rotator cuff tear. to explore the effect of eswt on the clinical efficacy of patients with rotator cuff tear, and to explore the application of shockwave technology in the conservative treatment of rotator cuff tear. it provides a new treatment idea for patients with rotator cuff tear who choose conservative treatment, promotes tendon healing for patients with partial rotator cuff tear, improves shoulder joint function, and provides a new treatment plan for patients to accelerate their return to life and exercise, and provides a theoretical basis for the clinical application of eswt.

Eligibility criteria:
inclusion criteria: * identify patients with rotator cuff tears and choose conservative treatment * able to complete cardiopulmonary exercise tests * able to cooperate with rehabilitation training and complete questionnaire survey exclusion criteria: * previous shoulder surgery history * irreparable rotator cuff damage * retear after arcr

Keywords: shock wave technique conservative treatment
multicentric study vats major introperative complications

Conditions: Lung Neoplasms

Summary: this study investigates the most common major complications that result in unplanned additional surgery in patients undergoing vats anatomical resections. several high-volume european centres participate. the purpose is to quantify these major complications, discuss the steps that can be taken to prevent these events, how they can be dealt with, be it by vats or conversion

vats lobectomy is becoming the standard of care for early stage lung cancer. several studies have shown feasibility and safety in dedicated centres. compared to thoracotomy the procedure results in at least equal oncologic results and survival, perhaps better. most series do not publish their early experience. they are retrospective and report on lobectomies and segmentectomies, excluding the live-saving pneumonectomies. they are potentially ignoring the intention-to-treat principle, excluding conversions. based on scarce existing literature and conference worst-case presentations a pattern of the most common intraoperative major complications can be drawn in europe, a large percentage of high-volume-centres have now successfully implemented a vats lobectomy program. in this era with low-volume-centres switching into vats anatomical resections, it is important to focus on potentially life-threatening complications. to be aware of potential hazards is the best way to avoid them.

Eligibility criteria:
inclusion criteria: * patients that did undergo resection for oncologic reasons exclusion criteria: * patients that did not undergo resection for oncologic reasons, such as pleural metastasis, irresectable disease.

Keywords: thoracic surgery, video-assisted
liquid biopsy using methylation sequencing for lung cancer

Conditions: Lung Cancer; Diagnoses Disease

Summary: this study aims to investigate the utility of circulating tumor dna (ctdna) methylation sequencing in the diagnosis of primary lung cancer.

plasma sample of patients with and without lung cancer will be collected and analyzed using methylation-sensitive enzyme sequencing method. diagnostic performance of ctdna methylation sequencing will be compared with that of tumor markers (cea, cyfra 21-1, and nse) combined.

Eligibility criteria:
inclusion criteria: * lung cancer group 1. pathologically proven lung cancer 2. clinically suspected lung cancer on chest ct scan * benign pulmonary disease group * chronic obstructive pulmonary disease, interstitial lung disease, pneumonia, bronchiectasis, non-tuberculous mycobacterial lung disease, pulmonary vascular disease exclusion criteria: * patients with previous history of lung cancer * patients who have been diagnosed with other malignancy within 5 years * unstable vital status * active pulmonary tuberculosis * infection with hepatitis b virus (hbv), hepatitis c virus (hcv), or human immunodeficiency virus (hiv)

Keywords: lung cancer methylation sequencing liquid biopsy
cross linking for treatment of corneal infection

Conditions: Infectious Keratitis

Summary: this study is comparing 45 minute and 30 minute treatment durations with the uvx corneal cross linking system to treat corneal infections.


Eligibility criteria:
inclusion criteria: * diagnosis of infectious keratitis exclusion criteria: * corneal ulcer that has perforated * corneal ulcer that has produced a descemetocele * women who are pregnant or breastfeeding * patients who are immunocompromised or unwilling or unable to comply with a medication regimen

Keywords: infectious keratitis cross linking corneal ulcer corneal infection collagen cross linking