Kornimate/medical-research-clean huggingface dataset:
a study of pertuzumab in combination with trastuzumab (herceptin) and a taxane in first-line treatment in participants with human epidermal growth factor 2 (her2)-positive advanced breast cancer

Conditions: Breast Neoplasms

Summary: this multicenter, open-label, single-arm, phase iiib study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent her2-positive breast cancer. participants will receive pertuzumab intravenously (iv) and trastuzumab (herceptin) iv plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection * her2-positive breast cancer * eastern cooperative oncology group (ecog) performance status 0, 1 or 2 * lvef of at least 50 percent (%) exclusion criteria: * previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease * disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (\</=) 6 months * previous approved or investigative anti-her2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting * disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting * history of persistent grade 2 or higher (national cancer institute common toxicity criteria \[nci-ctc\], version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy * central nervous system (cns) metastases * current peripheral neuropathy of grade 3 or greater (nci-ctc, version 4.0) * history of other malignancy within the last 5 years prior to first study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma * inadequate bone marrow, liver or renal function * uncontrolled hypertension * hepatitis b, hepatitis c or human immunodeficiency virus (hiv) infection
a follow-up study on safety and tolerability of intracerebroventricular administration of snn0031 to patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to document the long-term safety and tolerability after intracerebroventricular (icv) administration of snn0031 (pdgf-bb) in patients who participated in study snn0031-001


Eligibility criteria:
inclusion criteria: * previous participation in study snn0031-001 with completion of 12 study weeks without development of clinically significant safety concerns, defined as being any drug-related or device related serious adverse event that resulted in premature termination of treatment or a medical device incident that could not be resolved during the conduct of study snn0031-001 * the patient has a diagnosis of idiopathic pd * the patient has been given written and verbal information about the follow-up study, has had the opportunity to ask questions about the study, and understands the time and procedural commitments * the patient has provided written informed consent to participate in the follow-up study exclusion criteria: * the patient has been included or participates in another clinical study after participation in study snn0031-001 * the patient has, since participation in study snn0031-001, had functional neurosurgical treatment for pd (e.g., deep brain stimulation). * patients will only be excluded from participation in the event of a laboratory test abnormality that is indicative of a medical condition requiring treatment which, in the opinion of the investigator, is not compatible with participation in the present study
a trial to test the efficacy of a tailored intensive smoking cessation intervention in persons with hiv (pwhs)

Conditions: Smoking; HIV Infections; AIDS

Summary: the purpose of this study is to determine whether an intensive, eight session behavioral intervention is superior to standard care in achieving abstinence from cigarettes in smokers living with hiv/aids.


Eligibility criteria:
inclusion criteria: * hiv-infection * current cigarette smoker * high motivation to quit exclusion criteria: * pregnancy * breastfeeding

Keywords: hiv aids smoking tobacco cessation tobacco use in persons living with hiv/aids
systematic use of telepsychiatry for outpatients

Conditions: Borderline Personality Disorder; Depressive Disorder; Ptsd; Anxiety Disorders

Summary: implementation and evaluation of video consultation in psychiatric outpatient treatment. the study will focus on patients' experiences regarding the use of vc. the study will also examine important aspects of the telepsychiatric consultation such as therapeutic alliance, consultation content, psychopathology and satisfaction levels compared to face-to-face consultations.


Eligibility criteria:
inclusion criteria: * age \> 18 years * danish-speaking. exclusion criteria: * exclusion criteria included a diagnosis of schizophrenia or bipolar disorder, or suffering from substance abuse. * additionally, participants in the vc group were excluded if they did not have a smartphone, tablet, laptop, or personal computer with a webcam.
genetics of periodontal diseases in european caucasians

Conditions: Periodontitis

Summary: (a retrospective case control study to validate the association between interleukin-1 gene variations and adult chronic periodontal disease in european caucasians)


Eligibility criteria:
inclusion criteria: * ethnicity: dutch or german caucasian exclusion criteria: * none (however, diabetics were excluded during original patient recruitment at several clinical sites).
thrombus aspiration during percutaneous coronary intervention in acute non-st-elevation myocardial infarction study

Conditions: Non-ST-Elevation Myocardial Infarction

Summary: in this trial, the investigators will evaluate the effect of thrombus aspiration followed by stent implantation in improving myocardial blush grade in patients with acute non-st-elevation myocardial infarction compared to conventional percutaneous coronary intervention (pci).

the thrombus aspiration during percutaneous coronary intervention in acute myocardial infarction study (tapas) has shown that thrombus aspiration improves myocardial perfusion and clinical outcome compared to conventional primary percutaneous coronary intervention (pci) in patients with st-segment elevation myocardial infarction. impaired myocardial perfusion due to spontaneous or angioplasty-induced embolization of atherothrombotic material also occurs in patients with non-st-elevation myocardial infarction (nstemi). the aim of this study is to determine whether thrombus aspiration before stent implantation will result in improved myocardial perfusion in patients with nstemi compared to conventional pci. the study is a single-centre, prospective, randomised trial with blinded evaluation of endpoints. the planned inclusion is 540 patients with acute nstemi who are candidates for urgent pci. if thrombus aspiration leads to significant improvement of myocardial perfusion in patients with acute nstemi it may become part of the standard interventional approach.

Eligibility criteria:
inclusion criteria: * diagnosis of acute nstemi defined by * chest pain suggestive for myocardial ischemia for at least 30 minutes, * time from onset of symptoms of less than 72 hours * ecg with st-segment shifts (depression of \>0.1 mv in at least two contiguous leads or transient st-segment elevation \>0.1 mv in at least two contiguous leads for less than 30 minutes) and/or t-wave changes (inversion of \>0.15 mv in at least two contiguous leads) * positive cardiac troponin t \>0,01 μg/l. * clinical indication for urgent pci of the ischemia-related target lesion as identified at coronary angiography exclusion criteria: * persistent st-elevation of more than 0.1 mv in 2 or more leads * presence of cardiogenic shock * inability to obtain informed consent * known existence of a life-threatening disease with a life expectancy of less than 6 months

Keywords: myocardial infarction percutaneous coronary intervention thrombus aspiration
adult dacryocystocele among patients with epiphora

Conditions: Lacrimal Passage Obstruction

Summary: patients with lacrimal dacryocystocele were chosen for the study. dacryocystorhinostomy were done for them after their evaluation.

evaluation for lacrimal passage in the included patients using syringing, probing and dye disappearance test. dacryocystorhinostomy were done for all patients and followed up for at least 6 months.

Eligibility criteria:
inclusion criteria: * lacrimal sac mucocele * acquired type exclusion criteria: * no previous lacrimal sac surgery * suspected lacrimal sac malignancy
safety/efficacy of valsartan/hydrochlorothiazide combination compared to hydrochlorothiazide in obese hypertensive adults

Conditions: Hypertension

Summary: the purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (hctz) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure \[mssbp\] \>150 mmhg) patients.


Eligibility criteria:
inclusion criteria: * 40 years of age or older * moderate or severe high blood pressure defined as systolic blood pressure (the top number) greater than or equal to 150 mmhg and diastolic blood pressure (the bottom number) less then 110 mmhg * central (abdominal) obesity exclusion criteria: * systolic blood pressure (the top number) greater than or equal to 180 mmhg and diastolic blood pressure (the bottom number) greater than or equal to 110 mmhg * currently taking more then 3 medications to treat high blood pressure * inability to stop all current blood pressure medications if any up to 4 weeks * history of type 1 or type 2 diabetes * history of stroke, mini-stroke (transient ischemic attack) or heart attack within the last 6 months * history of or current diagnosis of congestive heart failure * history of cancer within the past 5 years with the exception of localized basal cell carcinoma or squamous cell carcinoma * women who are pregnant or nursing * alcohol or drug abuse within the last 2 years other protocol-defined inclusion/exclusion criteria may apply

Keywords: obesity, hypertension, valsartan/hydrochlorothiazide
the stim-adhf study

Conditions: Acute Decompensated Heart Failure

Summary: the stim-adhf study is a multi-center, observational study to assess the performance and safety of the cpns system in patients with adhf.

the cpns system is a neuromodulation system used to treat adhf, a sudden or slow deterioration of chronic heart failure. the cpns system is intended to provide acute (≤ 5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery (pa) in hospitalized adhf patients. the system consists of an acute temporary neuromodulation stimulation catheter placed in the right pulmonary artery via venous access and a custom stimulator, denoiser, and associated cables. the cn2 catheter is delivered to the right pa and provides an inotropic and/or lusitropic therapeutic effect by electrical stimulation to the terminal sympathetic nerve branches within the cardio-pulmonary plexus. the study will be conducted at up to 20 study sites worldwide. up to 50 subjects who meet the eligibility criteria, will be enrolled, treated in-hospital with the cardionomic cpns system, monitored closely throughout the hospitalization and followed through 30 days post hospital discharge to evaluate the effect of the cpns treatment.

Eligibility criteria:
inclusion criteria: * admitted to the hospital or planned to be admitted with a principal diagnosis of acute decompensated heart failure * bmi adjusted bnp ≥ 500 pg/ml or nt-probnp ≥ 2000 pg/ml * lvef ≤ 50% * at least one sign/symptom of fluid overload * at least one of the following: * inadequate diuretic response * at least one sign or symptom of low perfusion exclusion criteria: * received an inotrope during current hospitalization * requires mechanical support * cardiogenic shock or impending cardiogenic shock * multi-organ failure * systolic blood pressure \ 140mmhg * symptomatic hypotension * egfr \< 25 ml/min/1.732 * severe hepatic disease

Keywords: neurostimulation contractility right pulmonary artery
efficacy and safety of sitravatinib plus tislelizumab or placebo plus tislelizumab versus placebo as adjuvant treatment in participants with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to compare the efficacy and safety of sitravatinib plus tislelizumab or placebo plus tislelizumab versus placebo. the study will also compare the recurrence-free survival (rfs) in participants with hepatocellular carcinoma (hcc) who are at high risk of recurrence after surgical resection.


Eligibility criteria:
key inclusion criteria: 1. participant with a first diagnosis of hcc must have undergone a curative-intent resection within 4 to 12 weeks before randomization and have a documented histological confirmation of hcc diagnosis and negative surgical margins (r0 resection) of the resected tumor 2. participant must have tumor-free status as assessed by the investigator and have fully recovered from surgical resection before randomization 3. participant must have no extrahepatic hcc 4. ecog performance status ≤ 1 5. participant who has undergone surgical resection and is defined as having a high risk of hcc recurrence key exclusion criteria: 1. known fibrolamellar hcc, sarcomatoid hcc, or mixed cholangiocarcinoma and hcc histology 2. evidence of residual, recurrent, or metastatic disease of hcc before randomization 3. major macrovascular (gross vascular) invasion of the portal vein (vp3 or vp4) or any grade of macrovascular invasion in the hepatic vein or inferior vena cava 4. untreated chronic hepatitis b (hbv) or chronic hbv carriers with hbv dna ≥ 2000 iu/ml at screening 5. untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding note: other protocol defined inclusion/exclusion criteria may apply

Keywords: hepatocellular carcinoma sitravatinib tislelizumab
role of mri in assessment of the urinary bladder wall post transurethral tumor resection

Conditions: Urinary Bladder Cancer

Summary: to study the feasibility of using magnetic resonance imaging (mri) in evaluation ub wall thickening after transurethral resection (tur) of bladder cancer.

urinary bladder carcinoma is the second most common tumour of the urinary tract and 70% of such carcinomas are non-muscle-invasive (superficial) at presentation. transurethral resection (tur) is the standard treatment; however, recurrence of the tumour is not uncommon so such patients require long-term close supervision. staging is based on tnm system. ta tumors are treated with transurethral resection of bladder tumor (tur-bt). t1 and carcinoma in situ (tis) tumors have risk of progression and intravesical immunotherapy with bacillus-calmette-guerin (bcg) instillations is used to obtain local control and organ preservation. invasive bladder cancer (mibc) is an aggressive disease and standard treatment is radical cystectomy (rc), accompanied by pelvic lymph node dissection (plnd). in addition to radical surgery, neoadjuvant chemotherapy (nac) has been demonstrated to increase overall survival in mibc and is recommended by consensus guidelines. compared to contrast enhanced ct, mri has better soft tissue contrast which may improve local tumor evaluation. surveillance strategies for urinary bladder carcinoma recurrence have historically relied on cystoscopy, but this procedure has drawbacks, including its high cost, invasiveness and the fact that it may lead to iatrogenic bladder injury and urinary sepsis. in addition, it cannot diagnose upper tract tumours. the presence of a radiological method that could differentiate between benign and malignant lesions of the bladder would avoid the need for invasive cystoscopy, provided that upper tract tumours were excluded. diffusion-weighted (dw) mri is a non-invasive technique measuring the microscopic mobility of water molecules in the tissues without contrast administration. it provides information on perfusion and diffusion simultaneously in any organ, so it can be used to differentiate normal and abnormal structures of tissues, and it might help in the characterization of various abnormalities. during follow-up of patients after trans-urethral resection (tur), it is difficult to distinguish residual cancer from fibrotic and inflammatory changes secondary to tur and intravesical chemotherapy, both of which manifest as bladder wall thickening on t2-weighted mri.

Eligibility criteria:
inclusion criteria: -patients who had a history of tur of superficial bladder tumors and fit for the mri examination. exclusion criteria: * patients with pacemaker, claustrophobia or metallic prosthesis which are not mri compatible. * patients with contraindications for cystoscopy (unfit for anesthesia or urethral stricture). * patients refusing consent for the study.
the effects of corneal collagen cross-linking

Conditions: Corneal Ectasia Disorders Including Keratoconus

Summary: the corneal collagen cross-linking treatment has been used with increasing success to treat corneal dystrophies such as "keratoconus." recent advances have allowed different techniques for performing this cross-linking treatment. this study investigates the effects of corneal cross-linking using different surgical techniques.


Eligibility criteria:
inclusion criteria: * age 10-70, willing to participate, diagnosis of corneal ectasia disorder exclusion criteria: * unwilling or unable to participate in trial

Keywords: keratoconus, corneal collagen crosslinking, riboflavin, corneal ectasia
a study to assess the safety of brexanolone in the treatment of adolescent female participants with postpartum depression (ppd)

Conditions: Post Partum Depression

Summary: this is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of brexanolone in the treatment of adolescent female participants with postpartum depression (ppd).


Eligibility criteria:
key inclusion criteria: 1. participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by structured clinical interview for diagnostic and statistical manual of mental disorders (dsm-5) axis i disorders (scid-5). 2. participant is ≤6 months postpartum at screening. key exclusion criteria: 1. active psychosis 2. attempted suicide during current episode of ppd 3. medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder. note: other protocol-defined inclusion/exclusion criteria may apply.
acupuncture for the treatment of posttraumatic stress among military personnel

Conditions: Posttraumatic Stress Disorder (PTSD)

Summary: the purpose of this study is to determine the effectiveness of acupuncture as a treatment for posttraumatic stress disorder (ptsd) among military personnel.

untreated posttraumatic stress disorder (ptsd) leads to decreased force readiness and increased health care utilization. yet, service members with the disorder may be resistant to traditional treatments or find them undesirable because of side-effects, stigma, and long-term commitment. acupuncture, which has few known side effects, holds promise as an effective treatment option for ptsd. acupuncture has been shown to improve well-being and has been successfully used to treat stress, anxiety and pain conditions. in order to test the efficacy of acupuncture for treating the symptoms of ptsd-measured by the ptsd checklist (pcl)-a 12-week, randomized, waitlist-controlled trial will be conducted using a sample of 75 active duty military personnel. participants will receive an eight-session acupuncture treatment, and will be evaluated throughout the study by way of clinical assessments and an independent assessing acupuncturist.

Eligibility criteria:
inclusion criteria: * active duty military personnel * criteria met for ptsd based on clinician-administered ptsd scale (caps) interview * a stable medication dosing regimen or therapeutic treatment schedule for at least eight (8) weeks prior to beginning the study. exclusion criteria: * acupuncture treatment within the previous 6 months * pain greater than or equal to level 8 on the numeric rating scale for pain * significant head injury with loss of consciousness greater than 1 hour * uncontrolled diabetes mellitus: fasting blood glucose \>180 mg/dl * unstable or uncontrolled endocrine disorders, thyroid disease, renal failure, anemia, hemorrhagic diathesis, renovascular disease, cushing's disease, or hyperaldosteronism * unwillingness on the part of participants to complete all study visits and/or the daily life chart * pregnancy * scheduled surgery during the treatment phase of the study * medical instability sufficient to warrant inpatient treatment in the medical or intensive care units * psychiatric symptoms sufficient to warrant inpatient treatment by the clinical care team * psychosis within the past two years * a traumatic experience, as defined by the dsm-iv criterion a for asd/ptsd, within the past 30 days

Keywords: ptsd posttraumatic stress acupuncture randomized controlled trial complementary medicine alternative medicine chinese medicine military healthcare
leg elevation to prevent hypotension during labor

Conditions: Hypotension; Labor Complication

Summary: when hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. the purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of leg elevation in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. this study will use a randomized, non-blinded, controlled design with two arms: arm 1: patient will be put in a left tilt position with her hip on a wedge and both legs elevated on a peanut ball. she'll remain in this position for approximately 40 minutes. arm 2: patient will be put in a left tilt position with her hip on a wedge and no leg elevation. she'll remain in this position for approximately 40 minutes.

when hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. the purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of leg elevation in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. this study will use a randomized, non-blinded, controlled design with two arms: arm 1: patient will be put in a left tilt position with her hip on a wedge and both legs elevated on a peanut ball. she'll remain in this position for approximately 40 minutes. arm 2: patient will be put in a left tilt position with her hip on a wedge and no leg elevation. she'll remain in this position for approximately 40 minutes. outcome variables include occurrence of maternal hypotension or late or prolonged decelerations within the first hour after epidural placement.

Eligibility criteria:
inclusion criteria: * laboring at good samaritan hospital labor \& delivery unit * 37+ weeks gestation * planned vaginal delivery * planned epidural analgesia exclusion criteria: * under 18 years old * does not speak english * unable to consent to involvement in the research study * attended less than 3 prenatal care office visits * diagnosed with fetal demise * diagnosed with fetal anomalies * contraindications to both legs being elevated (ex: fractured bones, lower limb amputation, etc.) * contraindications to receiving 1l of iv fluids * requiring iv hypertensive medications * requiring iv magnesium