Kornimate/medical-research-clean huggingface dataset:
phase ii study evaluating safety/efficacy of otx-dp for treatment of ocular inflammation and pain after cataract surgery

Conditions: Ocular Inflammation and Pain

Summary: to evaluate the safety and efficacy of otx-dp as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.


Eligibility criteria:
inclusion criteria: * has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule * is greater than or equal to 21 years of age * has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens exclusion criteria: * any intraocular inflammation in the study eye present during the screening slit lamp examination * score greater than "0" on the ocular pain assessment at screening * compromised immune system or an autoimmune disease that in the opinion of the investigator could affect the quality of the ocular surface
prospective cohort for adult hemophagocytosis

Conditions: Hemophagocytic Lymphohistiocytoses

Summary: this prospective study enrolls subjects who have clinical and laboratory manifestations related with hemophagocytic lymphohistiocytosis. the purpose of the study is to evaluate clinical and biological features of adult hemophagocytic lymphohistiocytosis. the enrolled subjects into this study will be evaluated according to the hlh (hemophagocytic lymphohistiocytosis)criteria and treated with systemic immunosuppressive therapy or chemotherapy. all subjects will be regularly monitored by physicians participating in this study.

study process is as follows. 1. informed consent for subjects fulfilling the inclusion criteria. 2. laboratory evaluation will be done for subjects according to the following diagnostic criteria. * diagnosis will be established if one of either 1 or 2 below is fulfilled 1. a molecular diagnosis consistent with hlh 2. diagnostic criteria for hlh fulfilled (5 out of 8 criteria below) * fever ≥ 38.5'c for ≥ 7 days * splenomegaly ≥ 3 finger breadth below left subcostal margin * cytopenias affecting ≥2 of 3 lineages in peripheral blood (hemoglobin \< 9 g/l, platelets \< 100 × 109/l, absolute neutrophil count \< 1.0 × 109/l) * hypertriglyceridemia and/or hypofibrinogenemia: fasting triglycerides ≥ 265 mg/dl, fibrinogen ≤ 1.5 g/l * hemophagocytosis in bone marrow or spleen or lymph node * low or absent nk-cell activity (according to local laboratory reference) * ferritin ≥ 500 mcg/l * soluble cd25 (sil-2 receptor) ≥ 2,400 u/ml

Eligibility criteria:
inclusion criteria: * subjects should fulfill the following criteria 1. subjects should have at least one of the following problems 1. presence of hemophagocytosis in tissue or bone marrow 2. presence of at least 3 conditions among 8 conditions of hlh diagnostic criteria 2. age \> 18 years 3. written informed consents exclusion criteria: * subjects cannot satisfy the inclusion criteria

Keywords: hemophagocytic lymphohistiocytosis
assessment of tramadol as a treatment for opioid addiction

Conditions: Opioid-Related Disorders

Summary: opioids are one of the most commonly abused drugs among individuals who seek treatment for drug abuse. thus, it is necessary to develop new treatments for opioid addiction. the purpose of this trial is determine whether tramadol is effective in treating opioid dependent individuals.

this human laboratory study will test the effects of tramadol as a step in its development as a new treatment for opioid dependence. tramadol is a moderate mu agonist opioid that may produce low levels of opioid physical dependence. tramadol's capacity for producing physical dependence has not been systematically studied in humans. it is important to quantify tramadol, as it provides a measure of its opioid agonist effects. this would also be informative in regards to the abuse liability of tramadol when used as an analgesic (as currently marketed), or when used in the treatment of opioid addiction (as proposed in this study). the purpose of this trial is to evaluate the level of physical dependence as well as blockade efficacy produced by chronic maintenance on oral tramadol in opioid dependent individuals. participants will be randomly assigned to receive different doses of tramadol or placebo for up to six weeks. experimental sessions will take place up to three times per week during the treatment period. during challenge sessions, participants will receive an injection; four different kinds of effects may occur in a session following this injection. first, no effect may occur (a placebo). second, an opioid agonist effect may occur (opioid agonists include heroin, morphine, hydromorphone, tramadol, and methadone), which may cause the participant to feel "high." third, an opioid antagonist effect may occur (e.g., naloxone, naltrexone), which may cause the participant to feel a sense of opioid withdrawal.

Eligibility criteria:
inclusion criteria: * currently opioid dependent exclusion criteria: * significant medical illness (e.g., diabetes mellitus) * history of seizure * current sedative or alcohol dependence * pregnant or breastfeeding
effect of dietary protein restriction on prognosis in patients with diabetic nephropathy

Conditions: Type 1 Diabetes Mellitus With Diabetic Nephropathy

Summary: the purpose of the investigators study was to determine the effect of dietary protein restriction on survival and progression to end stage renal disease (esrd) in diabetic nephropathy.

the study was a prospective, randomized, unmasked, controlled trial carried out at the steno diabetes center. with concealed randomization the patients were (in blocks of two according to the level of gfr) assigned to receive either a usual-protein diet or a low-protein diet. after randomization an iso-caloric low-protein diet of 0.6 g/kg/day was prescribed to patients in the low-protein diet group. the usual-pro tein diet consisted of the patients' pre-study diet. the planned duration of follow-up was four years, scheduled visits every three-months. all patients gave complete history of medication, underwent examination of weight, urinary albumin-, sodium- and urea excretion, serum albumin, serum urea, hemoglobin, hemoglobin a1c, blood pressure, serum total-cholesterol, high-density lipoprotein (hdl) cholesterol. gfr, serum triglycerides,calcium and phosphorous, anthropometric measurements, nutritional status and smoking habits were evaluated every six months. dietary protein intake was estimated on the basis of three consecutive 24-hour urine samples completed before each visit, using urinary excretion of urea nitrogen. gfr was measured by plasma clearance of 51cr-edta over a 4 hour period and standardized for 1.73m2 body surface area using the same surface for each patient during the study.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 1 * duration at least 10 years * onset before age of 35, * presence of diabetic retinopathy * albuminuria\>=300mg/24 h in at least 2/3 sterile urine samples * no clinical or laboratory evidence of other kidney or urinary tract disease * gfr above 20ml/min/1.73m2 * pre-study decline in gfr\>= 2 ml/min/year exclusion criteria: * pregnancy * history of congestive heart failure or myocardial infarction or coronary bypass surgery within the last three months

Keywords: survival protein restriction diabetic nephropathy type 1 diabetes gfr esrd progressive renal disease
the value of amniopatch in preterm premature rupture of membranes

Conditions: Preterm Premature Rupture of Membrane

Summary: a randomized controlled trial that involved 100 women diagnosed with pprom between 24 and 34 weeks of gestational age. participants were randomized equally into 2 groups. group i in which amniopatch was done (an amnioinfusion of platelet concentrate followed by fresh frozen plasma in addition to the routine management used in the control group. group ii were treated with routine management including antibiotics and corticosteroids

all patients were started on a regimen of hospital bed rest and received antibiotic prophylaxis consisting of ampicillin 2g iv every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days . antenatal corticosteroids were given in the form of dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses. fifty to two hundred ml of normal saline was infused to create an adequate pocket in which the infusion needle can be stabilized. after injection of normal saline, alternate infusions of 20 ml of platelets, normal saline (which does not contain calcium, needed for the clotting process), and 20 ml of (ffp). the infused substances were warmed to a temperature of 37°c. avoiding contact between the blood products prevents clotting in the lines. during infusion, the fetal heart rate as well as the accumulation of amniotic fluid was monitored by ultrasound. usually a total of around 60-80 ml of platelets, 100-150 ml of ffp and 100-150 ml of amnioinfusion fluid was used throughout the procedure

Eligibility criteria:
inclusion criteria: * healthy pregnant women * gestational age of 24 to 34 weeks (calculated by the sure dates of the last menstrual period and confirmed by early 1st trimesteric ultrasound). all women carried a normal healthy singleton fetus exclusion criteria: * established preterm labor at admission * those with symptoms or signs suggestive of clinical chorioamnionitis. * women with uncontrolled medical disorder e.g. severe hypertension, uncontrolled diabetes, chronic renal impairment * women with vaginal bleeding regardless its cause. * pregnancies associated with major congenital fetal malformations * placental insufficiency or anomalies * anterior position of the placenta * iatrogenic pprom
safety and efficacy study of vitrase for clearance of severe vitreous hemorrhage

Conditions: Vitreous Hemorrhage; Diabetic Retinopathy

Summary: the purpose of this study is to determine if intravitreal injection of vitrase (ovine hyaluronidase) clears vitreous hemorrhage


Eligibility criteria:
inclusion criteria: * severe vitreous hemorrhage that obscures visualization of the fundus on indirect ophthalmoscopy, that has been present \>/= 1 month by history or exam * bcva is worse than 20/200 at time of screening exclusion criteria: * corneal or lenticular abnormalities that preclude fundus observation * ongoing ocular infection, inflammation or history of herpetic corneal lesion * current or prior retinal detachment or retinal tears or breaks or intraocular tumor * more than 1 severe vitreous hemorrhage within 6 months * previous vitrectomy for any reason * hemorrhage is exclusively pre-retinal, or old \& organized * prior vitrase for intravitreal injection in either eye * no light perception in either eye at any time * known contraindications to study medication * sickle cell disease
pyrotinib combined with dalpiciclib combined with letrozole in er-positive and her2-positive advanced breast cancer

Conditions: Breast Cancer

Summary: this is a a multicenter phase ii clinical study investigating efficacy of pyrotinib combined with dalpiciclib combined with letrozole in er-positive and her2-positive advanced breast cancer patients. the sample size is 63.

this is a a multicenter phase ii clinical study investigating efficacy of pyrotinib combined with dalpiciclib combined with letrozole in er-positive and her2-positive advanced breast cancer patients. patients receive pyrotinib 320mg/d, dalpiciclib 125mg/d, d1-21, q28d. one cycle is 28d.

Eligibility criteria:
inclusion criteria: 1. the subjects voluntarily joined the study, signed the informed consent, and had good compliance 2. postmenopausal or premenopausal/perimenopausal women aged ≥18 years and ≤75 years 3. patients with recurrent/metastatic breast cancer confirmed by histopathology with positive er expression and positive her2 expression 4. have at least one extracranial measurable lesion that meets recist 1.1 criteria 5. at most one previous trastuzumab containing systemic therapy for recurrent metastatic breast cancer exclusion criteria: 1. subjects had untreated central nervous system metastasis 2. bilateral breast cancer, inflammatory breast cancer, or latent breast cancer 3. previous treatment with any cdk4/6 inhibitors 4. inability to swallow, intestinal obstruction, or other factors affecting drug use and absorption 5. subject has had other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within 5 years or at the same time
randomized trial of in-home cervical cancer screening in underscreened women

Conditions: Cervical Cancer

Summary: the purpose of this trial is to determine whether mailing in-home human papillomavirus (hpv) screening kits is effective in increasing uptake of cervical cancer screening and early detection and treatment of cervical neoplasia in underscreened women.

over half of all cervical cancers in the u.s. are diagnosed in unscreened or underscreened women. new national guidelines identify increasing screening uptake as the number one priority for reducing cervical cancer-related morbidity and mortality. innovative screening strategies that eliminate the need for clinic-based screening could be highly effective in improving screening compliance while maintaining high-quality care. we propose a large, pragmatic randomized controlled trial within group health (a large integrated health care delivery system in washington state) to compare effectiveness of two programmatic approaches to increasing cervical cancer screening among overdue women. the first approach (control arm) is usual care at group health, which consists of patient- and provider-level services to promote adherence to pap screening, and the second approach (intervention arm) includes usual care plus a mailed in-home high-risk human papillomavirus (hrhpv) screening kit. we will randomize eligible women to the in-home hrhpv screening arm or the usual care arm. compared to usual care, we hypothesize that in-home hrhpv screening will enhance early detection and treatment of cervical neoplasia and improve compliance with screening. the trial will provide definitive evidence-based data on the impact of an in-home hrhpv screening program in a real-world clinical setting.

Eligibility criteria:
inclusion criteria: * female * 30 to 64 years of age * have a primary care provider at group health * received annual "birthday letter" with pap screening reminder 5 months earlier * no pap test in the past 3.4 years * continuously enrolled at group health for at least 3.4 years * no hysterectomy exclusion criteria: * currently pregnant * language interpreter needed * on "do not contact list" for research studies

Keywords: cervical cancer screening human papillomavirus cervical intraepithelial neoplasia
a study of neoadjuvant shr6390 in combination with anastrozole, pyrotinib, and trastuzumab in patients with er+/her2+ breast cancer.

Conditions: Breast Cancer; HER2-positive Breast Cancer; ER-positive Breast Cancer

Summary: to evaluate the efficacy and safety of the shr6390 in combination with anastrozole, pyrotinib, and trastuzumab in patients with er-positive, her2-positive breast cancer in the neoadjuvant setting.


Eligibility criteria:
inclusion criteria: 1. written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures. 2. age at diagnosis ≥18 years and ≤75 years, female. 3. histologically confirmed diagnosis of unilateral er+/her2+ breast cancer. er-positivity is defined as \>1% stained cells；her2-positivity is defined as ihc 3+ or if ihc scored 2+, in-situ hybridisation (ish) suggests amplified her2 gene. 4. tumor diameter \>2 centimeters with the clinical stage being classified as from iia to iiic. 5. ecog ≤ 1, lvef ≥ 55%. 6. laboratory requirements: for hematology, absolute neutrophil count (anc) ≥1.5 × 109 / l and platelets ≥100 × 109 / l and hemoglobin ≥90 g/l; for hepatic function, total bilirubin ≤1.5 × unl, ast and alt ≤2.5 × unl; for renal function, scr ≤1.5 × unl. exclusion criteria: 1. evidence of bilateral invasive breast cancer or metastatic disease (m1). 2. pevious treatment with chemotherapy, hormonal therapy, an investigational drug for any type of malignancy, or radiation therapy. 3. any of the following exist in the last 6 months: known or suspected congestive heart failure (≥ nyha ii), persistent arrhythmias (≥ grade 2), atrial fibrillation of any grade, coronary / peripheral bypass, symptomatic congestive heart failure, cerebrovascular accidents (including transient cerebral hemorrhage attacks or symptomatic pulmonary embolism). 4. known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol. 5. active infection or severe symptomatic visceral disease in the last 4 weeks. 6. patients with hiv infection or known aids, or patients with infection of active hepatitis b (hbv dna ≥1000iu / ml) or hepatitis c (hepatitis c antibody is positive and hcv rna is above the lower limit of detection of the analytical method). 7. prior malignancy with a disease-free survival of \< 5 years, except curatively treated basalioma of the skin, ptis of the cervix uteri. 8. pregnant or lactating patients. patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment. 9. participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry. 10. not eligible for the trial assessed by the investigators of our study.
a study to assess the use of methylone in the treatment of ptsd

Conditions: Post Traumatic Stress Disorder

Summary: this study is evaluating the safety, tolerability, and efficacy of methylone in adults with ptsd. the study will be conducted in two parts. * part a is open-label and will enroll up to 15 participants with ptsd * part b is randomized (1:1), double-blind, placebo-controlled and will enroll up to 64 participants with ptsd eligible participants will enter a 4-week treatment period where they will receive methylone once weekly for 4 weeks (4 treatment sessions). following the treatment period, participants will enter a 6-week follow-up period which includes 3 reflection visits (week 4, 5, and 6) and a final study visit at week 10.


Eligibility criteria:
inclusion criteria: * meets the dsm-5 criteria for current moderate to severe ptsd diagnosis, with a symptom duration of at least 6 months * caps-5 score of ≥35 at screening. * failed at least one treatment for ptsd (either psychotherapy or pharmacological treatment). * proficient in reading and writing in local language sufficient to complete questionnaires. * free from any other clinically significant illness or disease exclusion criteria: * primary diagnosis of any other dsm-5 disorder * body mass index (bmi) \<18 kg/m2 or ≥40 kg/m2. * smokes an average of \>10 cigarettes and/or e-cigarettes per day * uncontrolled hypertension at screening * use of a psychedelic (e.g., lsd, psilocybin, dmt, mescaline), or entactogens such as mdma, within 12 months of screening. * use of an ssri or other antidepressant within 8 weeks of screening. * current or previous history of clinically significant cardiovascular/cerebrovascular conditions.

Keywords: methylone ptsd impact-1 transcend therapeutics
the relation between the prognosis of subthalamic nucleus deep brain stimulation surgery by microlesion effect and electrode position

Conditions: Parkinson&#39;s Disease (PD); Deep Brain Stimulation

Summary: background: parkinson's disease (pd) is a common movement disorder whose main symptoms include resting tremor, rigidity and bradykinesia. deep brain stimulation (dbs) has become one of the most effective treatments for pd by implanting electrodes in specific deep brain nuclei to alleviate motor symptoms in pd patients. during the implantation of electrodes in the dbs procedure, small lesions produced are known as the microlesion effect, which disappears within a short period. the mle efficacy is positively correlated with the overall efficacy of dbs, but whether the mle efficacy is affected by the symptoms has not yet been investigated, and a large-sample study is needed to further validate this. this study aims to examine the relationship between electrode implantation location and the prediction of mle efficacy produced by stn-dbs surgery in pd patients, assess the correlation between electrode implantation location and dbs efficacy in pd patients, and analyze the role of brain networks in the process. the study will also analyze the relationship between micro-destructive effects and long-term dbs efficacy, providing more effective efficacy prediction and a more accurate selection of electrode implantation locations for dbs treatment in pd patients. this study will guide the clinical practice of dbs treatment in pd patients and provide an important reference for future research in related fields. object: primary parkinson's disease patients between the ages of 18 and 75 years who meet stn-dbs surgery criteria aim: to observe the relationship between predicted efficacy and implantation location of stn-dbs for mle in pd surgery


Eligibility criteria:
inclusion criteria: 1. idiopathic parkinson disease 2. age from 18 to 80 years old 3. performed bilateral stn-dbs exclusion criteria: 1. does not meet stn-dbs surgical criteria 2. patients with severely offset electrode implantation position (imaging) 3. not fulfilling the criteria for an arbitrary cohort under exposure conditions; 4. patients who are unable to voluntarily sign an informed consent form; 5. patients who do not agree to cooperate with follow-up visits

Keywords: parkinson&amp;#39;s disease microlesion effect functional neuroimages deep brain stimulation