Kornimate/medical-research-clean huggingface dataset:
optetrak posterior stabilized versus optetrak hi-flex

Conditions: Arthropathy of Knee; Arthritis and/or Post-traumatic Degenerative Problems

Summary: the purpose of this study is to evaluate the differences in clinical outcomes between the optetrak® posterior stabilized ("optetrak® ps", exactech, gainesville, fl) and the optetrak® hi-flex™ ("optetrak® hf", exactech, gainesville, fl) knee designs.

the purpose of this study is to evaluate the differences in clinical outcomes between the optetrak® posterior stabilized ("optetrak® ps", exactech, gainesville, fl) and the optetrak® hi-flex™ ("optetrak® hf", exactech, gainesville, fl) knee designs. the null hypothesis is that there is no difference in postoperative knee flexion between the optetrak® ps and optetrak® hf groups.

Eligibility criteria:
inclusion criteria: 1. patient is indicated for total knee replacement with a posterior stabilized device. 2. patient is between the ages of 50 and 80 years old 3. patient has a body mass index (bmi) \< 35.0 using the following method (or comparable method) • bmi = weight (lbs.) ÷ height (in.)2 x 703 4. patient is skeletally mature. 5. patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of studyrequired questionnaires. 6. patient is willing and able to review and sign a study informed consent. exclusion criteria: 1. patient has a body mass index (bmi) \> 35.0 using the following method (or comparable method) • bmi = weight (lbs.) ÷ height (in.)2 x 703 2. patient is skeletally mature 3. patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of study required questionnaires. 4. patient is willing and able to review and sign a study informed consent.
gum arabic as anti-oxidant, anti-inflammatory and fetal hemoglobin inducing agent in sickle cell anemia patients

Conditions: Sickle Cell Anemia in Children

Summary: to study the efficacy of gum arabic as an anti-oxidant, anti-inflammatory and fetal hemoglobin-inducing agent among sickle cell disease children. half of participants will receive gum arabic and the other half will receive placebo

polymerized hemoglobin is injurious to the red cell membrane, resulting in oxidative damage in sickle cell disease . fetal hemoglobin is protective against sickling and its decrease is associated with vaso-occlusive crisis . gum arabic is soluble fibers with prebiotic properties. it increased the level of serum butyrate which is short chain fatty acid. the latter proved to serve as fetal hemoglobin inducing agent both in vivo and in vitro study. and also has strong anti-inflammatory properties. so our aim to test whether oral digestion of gum arabic will induce fetal hemoglobin among sickle cell pediatric patients

Eligibility criteria:
inclusion criteria: * homozygous for sickle cell disease (ss) as documented by haemoglobin electrophoresis. subjects whom medications and dosages had been stable for 2 weeks before study entry. subjects who have not received blood transfusion or had acute episode related to sickle cell disease in the last two weeks before the start of intervention. exclusion criteria: * patients with history of gum arabic allergy. patients who have ischemic heart disease, liver dysfunction or hepatitis. pregnant female patients who plan to conceive in the next 4 months and fertile female patients who are not using an effective contraception method. patients who are currently using gum arabic. patients who are on steroids or chemotherapy.

Keywords: sickle cell anemia gum arabic fetal hemoglobin
integrated prep interventions for people who inject drugs in rural kentucky

Conditions: HIV Prevention

Summary: the overarching goal of this study is to adapt and feasibility test an evidence-based strengths-based case management (sbcm) intervention for pre-exposure prophylaxis (prep) initiation, and examine preliminary efficacy of the intervention comparators (sbcm-prep) and (centers for disease control (cdc)-prep). within this context, the specific aims are to: 1) assess client, provider, organization, and structural-level facilitators and barriers to integration of a prep focused sbcm (sbcm-prep) intervention into routine syringe service program (ssp) practice; 2) adapt an evidence-based sbcm protocol to provide prep intervention services for people who inject drugs (pwid) in ssp sites; and, 3) examine feasibility, acceptability and preliminary efficacy of the adapted sbcm-prep. 80 participants will be randomized into: cdc-prep (an in-use prep intervention based on cdc guidelines) or sbcm-prep.


Eligibility criteria:
inclusion criteria: * age 18 years or older; * hiv-negative status; * past month drug injection; * client of ssp in targeted sites exclusion criteria: • hiv-positive status
predictors of severe covid-19 outcomes

Conditions: Acute Respiratory Distress Syndrome; COVID-19

Summary: this is a longitudinal, multi-center, observational study collecting diverse biological measurements and clinical and epidemiological data for the purpose of enabling a greater understanding of the onset of severe outcomes, primarily acute respiratory distress syndrome (ards) and/or mortality, in patients presenting to the hospital with suspicion or diagnosis of covid-19. we seek to understand whether there are early signatures that predict progression to ards, mortality, and/or other comorbid conditions. the duration of the study participation is approximately 3 months.


Eligibility criteria:
inclusion criteria: * participant or legally authorized representative willing and able to provide informed consent * receiving care at a participating site * age 18 years old or older * u.s. resident * confirmed positive for covid-19 * willing and able to comply with all study procedures exclusion criteria: * self reported pregnancy
effects of lithium on suicide prevention in adolescents and young adults with bipolar disorder in china

Conditions: Bipolar Disorder; Suicidal Ideation; Suicide, Attempted; Nonsuicidal Self Injury

Summary: this study aims to use a retrospective cohort approach to explore the impact of lithium carbonate on suicide and self-harm related events among adolescents and young adults with bipolar disorder in china.the primary objective of this study is to investigate the effects of lithium carbonate on suicidal ideation in adolescents and young adults with bipolar disorder in china. secondary objectives include exploring its effects on preventing suicide attempts, non-suicidal self-injury, and aggressive behaviors in this population.


Eligibility criteria:
inclusion criteria: - 1 for lithium group 1. aged 12-45 years (adolescents 12-17, young adults 18-45). 2. diagnosed with bipolar disorder using the the mini-international neuropsychiatric interview (m.i.n.i.) (m.i.n.i.; version 5.0) based on diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria. 3. adolescents diagnosed using the m.i.n.i. kid version. 4. lithium medication adherence of at least 80% in the first six months over the past year. 5. not in an acute phase of illness. 6. patient or guardian able to participate in assessment interviews. 7. informed consent signed by participants and guardians (for adolescents). 2 for non-lithium group 1. aged 12-45 years (adolescents 12-17, young adults 18-45). 2. diagnosed with bipolar disorder using the mini-international neuropsychiatric interview (m.i.n.i.; version 5.0) based on dsm-iv criteria. 3. adolescents diagnosed using the m.i.n.i. kid version. 4. no lithium use over the past year. 5. not in an acute phase of illness. 6. patient or guardian able to participate in assessment interviews. 7. informed consent signed by participants and guardians (for adolescents). exclusion criteria: 1. severe physical illness or active substance abuse. 2. severe cognitive impairments, including developmental delays or dementia.

Keywords: lithium bipolar disorder suicide nonsuicidal self injury
lord´s procedure versus sclerotherapy for testicular hydrocele; a randomized controlled study

Conditions: Testicular Hydrocele

Summary: this study will compare a minimal invasive operation in local anesthesia with sclerotherapy for symptomatic testicular hydrocele within 6 months after randomization. thirty days complication rates will be assessed. the hypothesis is that surgery will lead to faster cure while sclerotherapy would be cheaper and have less complications.

testicular hydrocele is a common disorder even though it´s exact prevalence is unknown. in areas with filariasis it´s endemic. hydrocele is a benign condition where fluid accumulates in between two layers of tunica vaginalis (embryologically, the peritoneum), surrounding the testicle. the cause is unknown but inflammatory conditions is believed to induce these changes. the pathogenesis of hydrocele is believed to be a nonbalanced secretion and resorption of fluid. diagnosis of hydrocele is easy since the patient presents with an enlarged scrotum and clinical investigation including palpation and transillumination of the scrotum confirms the diagnosis. a scrotal ultrasound might be indicated to rule out a malignancy or if the diagnosis is unclear. treatment for hydrocele is only indicated when the patient has symptoms since all treatment modalities carries risk of complications, such as hematoma, infection, pain and even infertility concerns has been raised. operative management is considered the golden standard of treatment when considering recurrence but less invasive procedures such as sclerotherapy is frequently used, mainly due to cost and complications issues. lord´s procedure has in several series shown low frequency of complications and excellent recurrence rates. however, lord´s procedure and sclerotherapy has not been tested head to head and the optimal treatment for hydrocele is yet to be determined. this study aims to compare these techniques and evaluate the results within 1 year after randomization on cure, complication rates and various secondary descriptive outcomes. the investigators aim to adhere to consort.

Eligibility criteria:
inclusion criteria: * symptomatic testicular hydrocele, with more than 2 points on a validated inguinal botherscore (inguinal pain questionnaire, ipq) * more than 40ml of hydrocele fluid * age\>40 years * completed reproduction * oral and written consent to participate in the study * american association of anesthesiology (asa) grade≤ 3 exclusion criteria: * other ipsilateral scrotal disease (tumour, ongoing inflammatory disease of the scrotum,) * ongoing urinary infection * ipsilateral inguinal hernia * ascites * paternity wish * not possible to drain the hydrocele fully * opaque fluid drained on emptying the hydrocele * bilateral hydrocele where both sides has symptom score more than 2p on ipq.

Keywords: testicular hydrocele hydrocele sclerotherapy surgery complications
a 12-week study to compare the efficacy and safety of albuterol spiromax® versus a placebo in people 12 years and older with persistent asthma

Conditions: Asthma

Summary: the study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: albuterol spiromax® or placebo.


Eligibility criteria:
inclusion criteria: * written informed consent/assent * general good health * persistent asthma, with an fev1 50-80% predicted. * ability to perform spirometry in an acceptable manner as per protocol guidelines. * ability to perform pefr with a handheld peak flow meter. * demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline fev1. * taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the screening visit. * non-smokers. * capable of understanding the requirements, risks, and benefits of study participation. * other inclusion criteria apply. exclusion criteria: * participation in any investigational drug trial within the 30 days preceding the screening visit (sv). * a known hypersensitivity to albuterol or any of the excipients in the formulations. * history of severe milk protein allergy. * history of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the screening visit (sv). * currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents. * history of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation. * any asthma exacerbation requiring oral corticosteroids within 3 months of the screening visit (sv). a subject must not have had any hospitalization for asthma within 6 months prior to the screening visit (sv). * historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including. * other exclusion criteria apply.

Keywords: asthma dry powder inhaler short-acting beta2-agonist saba bronchoconstriction bronchodilation bronchodilator metered dose inhaler
urinary symptoms and the omission of the bladder flap at the time of primary cesarean delivery

Conditions: Pelvic Floor Disorders

Summary: the bladder flap at the time of cesarean delivery is the term used to describe the separation of the bladder from the lower uterine segment by sharply incising the vesico-uterine peritoneum or serosa and using blunt and/or sharp dissection to develop this potential space which facilitates placement of a retractor, known as the bladder blade. creating a bladder flap at the time of cesarean delivery is largely based on individual practice patterns and practitioners are divided in their use of this step. while creating a bladder flap has a theoretical advantage of protecting the bladder from injury, it is unknown whether this step has an effect on postoperative bladder function. the purpose of this study was to evaluate whether the omission or creation of a bladder flap results in a change in urinary symptoms as measured by the udi-6 component of the pfdi-20.

this is a parallel assignment design study. the pfdi-20 symptom questionnaire was completed upon enrollment. after the patient was prepped and draped, the operating room nurse opened a sealed opaque envelope marked with the study subject number containing a card marked with the assignment to bladder flap or no bladder flap, which was shown to the surgeons prior to the skin incision. the patient did not see the allocation nor was it verbalized in the operating room. the pfdi-20 was repeated 6-8 weeks after delivery at the patient's postpartum exam clinic visit. equal number of bladder flap and no bladder flap assignment cards were randomly shuffled and placed in envelopes marked with the study subject id number prior to the start of the study. the study hypothesis was that the omission of the bladder flap at the time of primary cesarean delivery would be associated with lower urinary symptoms scores in the postpartum as measured by the udi-6 component of the pfdi-20.

Eligibility criteria:
inclusion criteria: * pregnant at 37 weeks gestation or greater * scheduled for a non-urgent primary cesarean delivery exclusion criteria: * pre-term (defined as less than 37 weeks 0 days gestation) prior pelvic surgery involving the bladder * a diagnosis of any of the following conditions: endometriosis, uterine leiomyomata, chronic pelvic pain, urinary incontinence prior to pregnancy, nephrolithiasis during the current pregnancy, * any circumstance that precluded adequate informed consent at the time of recruitment (such as a need to for urgent or emergent delivery) * if the indication for cesarean was a failed trial of operative vaginal delivery (forceps or vacuum extraction)

Keywords: cesarean delivery obstetrical delivery pfdi-20 udi-6 bladder flap
a phase 1 study of ctim-76 in patients with recurring ovarian cancer and other advanced solid tumors

Conditions: Platinum-resistant Ovarian Cancer; Testicular Cancer; Endometrial Cancer

Summary: this is a phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and efficacy of ctim-76 (study drug), a humanized t cell engaging bispecific antibody targeting cldn6, in subjects with platinum-refractory/resistant ovarian cancer (prroc) and other advanced cldn6-positive solid tumors (i.e., testicular and endometrial).

the phase 1a dose escalation portion of the trial will enroll subjects with platinum-resistant/refractory ovarian cancer (prroc), testicular, or endometrial cancer into one of approximately 9 dose escalation cohorts to assess safety, tolerability and to determine the recommended dose for expansion (rde). ctim-76 is to be administered once weekly (q1w) for each cycle. a cycle is defined as 28 days. subjects will be dosed until documentation of disease progression, unacceptable toxicity, or subject/physician decision. the phase 1b dose expansion phase will evaluate ctim-76 in one indication (prroc, endometrial or testicular) at up to 2 doses (n=15 response evaluable subjects at each dose level). this is to enable dose- and exposure-response analyses. dosing will follow the same schedule as phase 1a. a priming dose will be administered on day 1, and the full cohort dose will be administered weekly thereafter. expansion doses for phase 1b will be determined by sponsor in conjunction with safety review committee (src) based upon all available safety, pharmacokinetic (pk), pharmacodynamic (pd), biomarker and preliminary efficacy data from phase 1a. the selection of the recommended phase 2 dose (rp2d) will be based on the totality of data from phase 1b.

Eligibility criteria:
inclusion criteria: * subjects with cldn6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer. * subject with measurable disease per recist 1.1 * ecog 0, 1, or 2 * subjects with adequate organ function. exclusion criteria: * evidence of central nervous system metastases, leptomeningeal disease or spinal cord compression. * uncontrolled significant active infection or any medical or other condition that in opinion of the investigator would preclude the subject's participation in the study. * prior treatment with cldn-6 targeted therapy. * concurrent participation in another investigational clinical trial.
the evaluation of anti-interference ability and clinical specificity of hiv ag +ab assay kit (sysmex)

Conditions: HIV Seropositivity; Cancer; Blood Disease

Summary: to evaluate the anti-interference and specificity of hiv ag +ab assay kit (sysmex) for the detection of hiv antigens and antibodies.

first,hiv ag +ab assay kit (sysmex)assay kit (sysmex) was used to detect hiv antigens and antibodies in the serum of patients with tumor and blood diseases, and then confirmed by using the gold standard for hiv diagnosis,human immunodeficiency virus (hiv type 1+2) antibody assay kit (immunoimprinting). the specificity of hiv ag +ab assay kit (sysmex) for hiv assay in patients with tumor and hematological diseases was calculated.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of tumor disease or blood disease * blood samples must meet the test requirements exclusion criteria: * n/a
transpulmonary pressure under stressing conditions

Conditions: Ventilator-Induced Lung Injury

Summary: study aims to prospectively evaluate if the pressures normally applied during mechanical ventilation in laparoscopic surgery induce stress on the pulmonary wall. to do this is used measure the variation of esophageal pressure, as indirect index of the pleural pressure and therefore of the transpulmonary pressure, in response to changes in airway pressures in a group of patients undergoing robotic assisted radical prostatectomy or videolaparoscopy.


Eligibility criteria:
inclusion criteria: * asa (american society of anesthesiologists) score ≤ iii * patients underwent laparoscopic prostatectomy exclusion criteria: * bmi (body mass index) ≥ 30 * impossibility to insert nasogastric tube * anatomic rib cage alterations
3d011-08 monotherapy in subjects with advanced solid tumors

Conditions: Solid Tumor, Adult

Summary: the purpose of this study is evaluate the the safety, tolerability, pharmacokinetics profiles, and preliminary efficacy of 3d011-08 in subjects with advanced solid tumors.

detailed description: this study was initiated on february 24, 2022, at fudan cancer hospital. however, noparticipants were screened or enrolled after the initiation. due to strategic development adjustments, thecompany terminated the study on september 11. 2023.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors(part 1 dose escalation); histologically confirmed locally advanced or metastatic hepatocellular carcinoma (cohort 1),advanced renal cell carcinoma (cohort 2), and metastatic castration-resistant prostate cancer (cohort 3) for which not amenable to local therapy.(part 2 dose expansion). 2. cohort 1 and 2: at least one measurable lesion (according to recist 1.1 criteria);cohort 3: at least one measurable or unmeasurable lesion (according to recist 1.1 criteria). 3. subjects must have failed or have been intolerant to established standard therapies, or standard therapies did not exist or were no longer effective for a given tumor type, or in the opinion of the investigator have been considered ineligible for a particular form of standard therapy on medical grounds(part 1 dose escalation). cohort 1 (advanced hepatocellular carcinoma)and cohort 2 (advanced renal cell carcinoma): subjects had disease progression after received previous first-line of systemic treatment, or subjects are intolerant of or have refused to receive first-line of systemic treatment. cohort 3 (metastatic castration-resistant prostate cancer) : patients who had failed or had refused prior abiraterone and/or docetaxel chemotherapy.(part 2 dose expansion) 4. ecog performance status ≤ 2(part 1 dose escalation).≤ 1.(part 2 dose expansion) 5. life expectancy ≥ 12 weeks. 6. adequate organ and bone marrow function. exclusion criteria: 1. investigational products or devices in other clinical trials or received antibody drug therapy within 4 weeks before the first dose,or chemotherapy, targeted therapies,or radiotherapy within 2 weeks before the first dose. 2. participants need to continue using medications known to have a significant risk of causing qtc prolongation or a cyp3a4 strong inhibitor or strong inducer. 3. participants who have previous toxicity of anti-tumor therapy that has not been returned to level 0 or 1. 4. participants with diseases at risk of bleeding within 3 months prior to enrollment 5. participants with concomitant medical conditions requiring anticoagulant therapy at a therapeutic dose 6. history or current condition of uncontrolled cardiovascular disease. 7. participants with gastrointestinal disease associated with a risk of perforation or fistula formation
teriflunomide concentration in serum and cerebrospinal fluid from patients with multiple sclerosis

Conditions: Multiple Sclerosis, Pharmacokinetics

Summary: serum and cerebrospinal fluid will be obtained from 20 patients with relapsing-remitting multiple sclerosis treated with teriflunomide tablets 14 mg daily

teriflunomide concentration in cerebrospinal fluid and serum will be determined in 12 patients with multiple sclerosis. they have been treated for at least 6 months and the sampling from blood and by spinal tap is done before dose at 8 am in 10 patients and at 12 am in 10 patients. the dependence from age, sex, and blood-brain barrier (bbb) integrity will be evaluated.the ratio between serum and cerebrospinal fluid will determine the passage over the bbb.

Eligibility criteria:
inclusion criteria: * patients with multiple sclerosis treated with teriflunomide 14 mg for at least 6 months exclusion criteria: * other immunosuppressive or immunomodulating drugs, other cns diseases