Kornimate/medical-research-clean huggingface dataset:
a study of herceptin (trastuzumab) in combination chemotherapy in patients with metastatic or locally advanced breast cancer

Conditions: Breast Cancer

Summary: this study will define an optimal chemotherapy dose regimen of myocet in combination with paclitaxel and intravenous herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally advanced breast cancer and her2 overexpression. the anticipated time on study treatment is 3-12 months.


Eligibility criteria:
inclusion criteria: * women 18-70 years of age; * metastatic or locally advanced breast cancer; * her2 overexpression; * \>= 1 measurable lesion. exclusion criteria: * prior treatment for advanced breast cancer; * prior treatment with herceptin; * bone or central nervous system metastasis as the only site of disease; * history of another malignancy (except basal cell skin cancer and cancer in situ of the uterine cervix, and contralateral breast cancer) within 5 years of study.
evaluation of centralised tb assay solutions

Conditions: Tuberculosis; Drug-resistant Tuberculosis

Summary: tuberculosis (tb) remains a life-threatening disease partly due to increasing incidence of multidrug and extensively drug-resistant tb. diagnostic based on culture and conventional drug susceptibility testing using media take several weeks leading to prolonged periods of ineffective therapy and ongoing transmission. development of rapid molecular diagnostic tests for the identification of mycobacterium tuberculosis (mtb) and drug resistance has become a high priority. the xpert® mtb/rif assay does not provide information on inh-resistance and the lpa is only recommended for use in smear-positive samples, complex to perform and requires manual interpretation. several novel assays have been recently developed/ce-marked offering high sample throughput and higher sensitivity for detection of mtb, rif- and inh-resistance in centralized laboratories. however, published data on their performance and operational characteristics is extremely limited. this is a prospective, multicentre, diagnostic accuracy trial in which the performance of centralised tb assay solutions will be assessed at the intended setting of use with culture, phenotypic dst and sequencing as reference standard. potential trial participants will be identified at participating tb clinics or hospitals (enrolment sites). sputum samples will be collected and transported to the associated tb reference laboratories (testing sites). in order for the results of this trial to be generalizable, adults with symptoms compatible with pulmonary tb undergoing evaluation will be screened for inclusion at geographically diverse participating centres in high burden tb countries. additionally, to supplement the drug-resistant cases to timely achieve accurate performance estimates, well-characterized frozen sputum samples from the find specimen bank will be used.


Eligibility criteria:
inclusion criteria: patients are eligible to be included as trial participants only if all of the following inclusion criteria apply: * aged ≥18 years * clinical suspicion of pulmonary tb including cough ≥2 weeks (or any duration if hiv positive ) and ≥1 other symptom typical of pulmonary tb listed below: * fever * malaise * recent weight loss * night sweats * contact with active case * haemoptysis * chest pain * loss of appetite exclusion criteria: participants are excluded from the trial if any of the following exclusion criteria apply: * unwilling or unable to provide informed consent * unwilling to provide four sputum specimens at enrolment i.e. 2x sputa on day 1 and 2x sputa on day 2 (up to 1 week from enrolment) * patients with only extra-pulmonary tb signs \& symptoms * receipt of any dose of tb treatment within 6 months prior to enrolment
acceptability of depo-subq in uniject

Conditions: Contraception

Summary: this is an observational study to assess the experience of current depot medroxyprogesterone acetate (dmpa) intramuscular (im) clients and providers when they try depo-subq in uniject and offer recommendations for the introduction of this method.

this is an observational study to assess the experience of current depot medroxyprogesterone acetate (dmpa) intramuscular (im) clients and providers when they try depo-subq in uniject and offer recommendations for the introduction of this method. a total of 560 participants will be enrolled in the study in the following groups: 360 participants (120 in uganda and 240 in senegal) who are current dmpa im clients who seek re-injection of dmpa from either community health workers (chws) or clinic-based providers; and are 18-40 years of age; received their most recent dmpa injection no more than 13 weeks prior to enrollment in the study \[16\]. up to 100 participants (50 in uganda and 50 in senegal) current dmpa im clients who meet the inclusion/exclusion criteria but do not want to receive the injection with depo-subq in uniject and are willing to complete a short questionnaire 80 chws (40 in uganda and 40 in senegal) and 20 clinic-based providers (from senegal only) who are trained to give depo-subq in uniject as part of this study

Eligibility criteria:
inclusion criteria: * age 18-40 * in general good health (the participant verbally reports she feels well) * using dmpa continuously for at least six months prior to enrollment in the study (i.e., had at least two previous injections) * received their most recent dmpa injection no more than 13 weeks prior to enrollment in the study at the study clinic or from a family planning provider involved in the study (senegal only) * received their most recent dmpa injection no more than 13 weeks prior to enrollment in the study from a family planning provider involved in the study (uganda only) * desires to be re-injected with dmpa * willing to sign an informed consent document * willing to provide contact information and be interviewed three months after enrollment.

Keywords: ae adverse event aids acquired immunodeficiency syndrome alt (sgpt) alanine aminotransferase art antiretroviral therapy ast (sgot) aspartate aminotransferase dcf data collection forms dmc data monitoring committee fda (u.s.) food and drug administration gcp good clinical practice guidelines hb sag hepatitis b surface antigen ich international conference of harmonisation ind investigational new drug application irb institutional review board iu international units mg milligram(s) mm3 cubic millimeter(s) pcr polymerase chain reaction sae serious adverse event µg microgram uln upper limit of the normal range wb western blot
mapping epileptic networks using multimodal imaging

Conditions: Epilepsy in Children

Summary: currently, mapping the epileptogenic zone is based on a comprehensive preoperative assessment involving clinical, imaging and electrophysiological examinations. to reduce the need for invasive stereoelectroencephalography (seeg) explorations, electrophysiological and imaging methods have been developed, such as resting-state functional mri (fmri) coupled with electroencephalogram and arterial spin-labeling perfusion mri (asl-mri). it has been published that these new methods enable precise delineation of the epileptogenic zone and better preparation for surgery. the aim is to determine whether, in children with focal lesional epilepsy, the combination of asl-mri-eeg and resting-state fmri-eeg enables precise identification of the epileptogenic zone to be defined by seeg, the current reference examination.


Eligibility criteria:
inclusion criteria: * be under 18 years of age on the day of inclusion. * present with one of the following forms of epilepsy: * refractory focal lesional epilepsy * rare non-lesional epilepsy * present abnormalities (spikes) on the intercritical eeg * have been selected by the "epilepsy" multidisciplinary staff. * in the case of refractory lesional epilepsy, be required to perform an eeg-video recording using intracranial electrodes (seeg) as part of the pre-surgical workup. * be affiliated to a health insurance scheme. exclusion criteria: * requiring general anesthesia for mri * require sedation specifically for research * have generalized epilepsy * be deprived of liberty or under guardianship.

Keywords: focal epilepsy lesional epilepsy nonlesional epilepsy
a multicenter study assessing the efficacy and safety of stn1010904 ophthalmic suspension 0.03% and 0.1% compared with vehicle in subjects with fuchs endothelial corneal dystrophy (fecd)

Conditions: Fuchs Endothelial Corneal Dystrophy

Summary: this is a phase iia study to assess efficacy and safety of stn1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to placebo in subjects diagnosed with fuchs endothelial corneal dystrophy (fecd). this study will consist of a screening period of up to 15 days and an 18-month double-masked treatment period, including 9 individual visits to the study site.


Eligibility criteria:
inclusion criteria: * male or female diagnosed with fecd. exclusion criteria: * females who are pregnant or lactating. * any ocular surgery for fecd (e.g., penetrating keratoplasty (pkp), descemet stripping endothelial keratoplasty (dsek), descemet membrane endothelial keratoplasty (dmek), descemet stripping automated endothelial keratoplasty (dsaek), descemet stripping only (dso) in the study eye.
adrenocorticotropic hormone (acth) for post-op inflammation in proliferative vitreoretinopathy (pvr)

Conditions: Proliferative Vitreoretinopathy

Summary: this is a pilot study to measure levels of albumin and inflammatory cytokines \[including transforming growth factor-beta (tgf-β) and interleukin-1 beta (il-1β)\] in the aqueous humor of post-operative proliferative vitreoretinopathy patients receiving subcutaneous injections of h.p. acthar®, an adrenocorticotropic hormone (acth) analog. the study will be conducted at the wilmer eye institute, johns hopkins hospital. a total of 15 patients will be enrolled and randomized 2:1 to h.p. acthar® or standard of care. treatment duration will be 8 weeks and study duration will be 12 weeks. there will be a total of 7 study visits (baseline, day of surgery, post-operative day 1, week 1, week 4, week 8, and week 12). subjects will self-administer subcutaneous injections of 80 units of h.p. acthar® starting on post-operative day 1 for twice a week until week 8. subjects in the control arm will be managed per the standard of care. aqueous samples will be obtained at the onset of surgery, 1 day, 1 week and 8 weeks after surgery. aqueous levels of albumin and inflammatory cytokines (including tgf-β and il-1β) will be measured at each time point.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * signed informed consent and authorization of use and disclosure of protected health information * patients undergoing surgery for retinal detachment due to pvr exclusion criteria: * patients with poorly controlled diabetes mellitus (defined as hba1c ≥ 8.0% on any anti-diabetic medications or insulin. if the patient is using any anti-diabetic medication/insulin, he becomes eligible if the medication is used continuously for \>30 days) * patients with poorly controlled hypertension (defined as systolic blood pressure \>180 mm hg and/or diastolic blood pressure \>100 mm hg at rest with up to 3 anti-hypertensive medications. if a patient's initial measurement exceeds these values, a second reading may be taken 30 or more mins later. if the patient is using any anti-hypertensives, he becomes eligible if the medication is used continuously for \>30 days) * patients with congestive heart failure * patients with scleroderma * patients with osteoporosis * patients with active systemic fungal infection * patients with active ocular herpes simplex * patients with prior or active bleeding peptic ulcer * pregnant patients or patients who wish to become pregnant during the course of the study (females of child-bearing age will be counselled to use contraception for the duration of the study)

Keywords: post-operative intraocular inflammation
micrornas from blood samples as biomarkers for gastric cancer detection

Conditions: Gastric Cancer; MicroRNAs

Summary: the goal of this observational study is to compare specific microrna levels from the plasma of gastric cancer patients and healthy volunteers to see if there is an upregulated expression in gastric cancer patients. the main question it aims to answer is: - can micrornas be effectively used as diagnostic biomarkers for gastric cancer? participants will be asked for their consent to obtain 5 cc of blood.


Eligibility criteria:
inclusion criteria for gastric cancer group: * recently diagnosed gastric cancer * never received any treatment for gastric cancer inclusion criteria for control group: * age 50 or above * underwent elective upper gastrointestinal endoscopy and negative for gastric cancer * no prior history of gastric dysplasia or cancer exclusion criteria: * patients who cannot give informed consent * pregnancy * lymphoma
a single dose trial in healthy caucasians and japanese subjects investigating the pharmacokinetics of somatropin

Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency; Healthy

Summary: this trial was conducted in the united states of america (usa). the aim of this clinical trial was to investigate the pharmacokinetics of somatropin in healthy japanese and caucasian subjects, and to identify somatostatin-related adverse events.


Eligibility criteria:
inclusion criteria: * signed informed consent before any trial related activities * japanese and caucasian males respectively * healthy subjects based upon medical history, physical examination, vital signs, ecg, serum biochemistry and haematology and urinalysis * body mass index (bmi) between 17 and 30 m2/kg, inclusive
the impact of thoracic paravertebral nerve block at different positions on pain relief in patients undergoing single-port thoracoscopic partial lung resection

Conditions: Lung Nodules; Lung Cancer

Summary: thoracic surgery is widely recognized as one of the most painful surgical procedures. compared to open thoracotomy, video-assisted thoracoscopic surgery (vats) offers similar therapeutic outcomes with less invasiveness, significantly reducing postoperative pain and promoting recovery. despite the use of video-assisted thoracoscopic surgery (vats), a significant proportion of patients still experience considerable discomfort. specifically, 78% of patients report moderate to severe pain, with 27% experiencing moderate pain, 34% severe pain, and 17% very severe pain. multiple studies have shown that the use of regional anesthesia, such as thoracic paravertebral nerve block (tpvb), in these surgeries can block the transmission of nociceptive signals via the intercostal nerves, producing good analgesic effects. this can reduce the consumption of postoperative opioids, decrease inflammatory responses, and improve patient survival rates after surgery. by comparing the differences in hemodynamic parameters, inflammatory stress indicators, and intraoperative and postoperative analgesic effects of thoracic paravertebral nerve block in different preoperative positions for patients undergoing thoracoscopic surgery, we aim to identify the optimal nerve block position, thereby promoting patient recovery.


Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 70 years old * bmi ≥ 18 and ≤ 28 * american society of anesthesiologists (asa) physical status classification i-ii ⑷ patients scheduled for elective thoracoscopic lung resection (including lobectomy, segmentectomy, and wedge resection) ⑸ patients who agree to participate in this study and sign the informed consent form exclusion criteria: * patients who refuse to undergo nerve block * patients with severe cardiac, pulmonary, hepatic, or renal insufficiency requiring postoperative admission to the icu for continued treatment (ef \< 40%, fev1/fvc \< 40%) * abnormal coagulation function ⑷ history of allergy to anesthetic drugs * history of chronic alcohol use, chronic pain, or long-term use of psychotropic medications ⑹ scars, infections, or tumors at the puncture site ⑺ history or family history of malignant hyperthermia ⑻ refusal to participate in this study or inability to cooperate with follow-up or poor compliance termination criteria: * failure to comply with the predetermined study protocol ⑵ occurrence of local anesthetic adverse reactions, puncture needle entering the pleural cavity, or other complications during puncture * changes in the patient's condition ⑷ the patient's unwillingness to continue participating in the study
study on the mode and mechanism of ultra-low frequency rtms for sleep disorders in patients with parkinson's disease

Conditions: Repetitive Transcranial Magnetic Stimulation; Parkinson Disease; Sleep Disorder

Summary: the study by giving a sleep disorder parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial magnetic stimulation for sleep disorder parkinson's disease treatment, to explore the mechanism of action, compare the difference between different modes.

parkinson's disease is the second most common chronic neurodegenerative disease.at present, researchers focus not only on the motor symptoms of parkinson's disease, but also on the non-motor symptoms of parkinson's disease (including mood disorders, sleep disorders, cognitive decline, and autonomic nervous kinetic disorder, etc.).the principle of transcranial magnetic stimulation is based on the electromagnetic principle proposed by faraday. when an electrifying coil is suspended over the scalp at a certain distance, the magnetic field generated by the coil current and the electric field generated by the magnetic field can reach the skull and directly or indirectly affect the synapses and neurons in the brain.the study by giving a sleep disorder parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial magnetic stimulation for sleep disorder parkinson's disease treatment, to explore the mechanism of action, compare the difference between different modes.

Eligibility criteria:
inclusion criteria: * in line with international movement disorders association (the movement disorder society, mds) in 2015 the diagnosis of parkinson's disease diagnosis standard and china standard (2016) * can cooperate to complete rating scale, the sleep monitoring, imaging and blood test * have a sleep disorder * aged 18 to 70 years old * agree to participate in this experiment, and have signed the informed consent exclusion criteria: * superposition of diagnosed with parkinson's syndrome * secondary diagnosed parkinson's syndrome * is equipped with heart pacemakers and other metal implants * cannot achieve scale assessment * has significant malignant diseases * has a history of seizures

Keywords: repetitive transcranial magnetic stimulation parkinson's disease sleep disorder
efficacy and safety study of azimilide on the incidence of cardiovascular hospitalizations/emergency department visits or cardiovascular death in patients with an implantable cardioverter defibrillator (icd) (shield-2)

Conditions: Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Implantable Cardioverter Defibrillator

Summary: this study will evaluate the efficacy and safety of azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with implantable cardioverter defibrillators (icds)


Eligibility criteria:
inclusion criteria: * have an icd implanted and a history of ventricular tachycardia, ventricular fibrillation, or an appropriate icd therapy. * have a left ventricular ejection fraction \<= 0.40 exclusion criteria: * have new york heart association (nyha) class iv congestive heart failure (chf) or have decompensated chf at the time of randomization; * have unstable angina pectoris or a myocardial infarction within 30 days of randomization; * have a history of torsade de pointes or heart transplantation * have chronic atrial fibrillation or atrial fibrillation/flutter, that is not adequately rate controlled in the judgment of the investigator, at screening; * are currently taking systemic class i or other class iii antiarrhythmic drugs * are currently taking systemic drugs that prolong the qt interval * if female, are currently pregnant or breast feeding, or plan to become pregnant during the course of the study
evaluation of a collaborative behavioral health program implementation in primary care

Conditions: Depression

Summary: this study will give researchers the opportunity to evaluate implementation of the collaborative behavioral health program (cbhp), based on the collaborative care model for depression, which aims to improve practice for physicians and staff; improve care for patients; and improve clinic operations through a model that allows for more efficient identification and referral for care for depression.

this study used a hybrid type 2 effectiveness-implementation design of a randomized roll-out trial of the collaborative care model for depression (cocm) in 11 primary care practices in a large healthcare system affiliated with an academic medical center. the collaborative behavioral health program (cbhp) is supported by leaders in the healthcare system and the primary care steering committee as a means of improving access to effective mental health services. implementation strategies including hiring and training the necessary staff for cocm, audit and feedback procedures, and health information technologies to assist with billing and the patient registry, will be provided for all practices. using a sequential mixed methods measurement approach, we will assess key stakeholders' perspectives of cbhp roll-out, focused on barriers and facilitators of implementation and sustainability. the stages of implementation tool will be used to measure the speed and quantity of implementation activities completed across the stages of implementation preparation, implementation, and sustainment over a 30-month period for each practice. effectiveness of cbhp for patient-level outcomes will be conducted on depressive symptoms, graduation rates for cbhp, and spillover effects on chronic health conditions. with its focus on implementation processes and strategies, this study will elucidate the critical drivers of cocm implementation that are understudied for a program with such a robust evidence base. this study will also be among the first to conduct economic analyses on a fee-for-service model with the new billing codes for cocm and can inform ways to improve implementation efficiency with our optimization approach to successive practices in the roll-out design. changes to the protocol and current status of the study are also discussed.

Eligibility criteria:
inclusion criteria: • phq-9 score \> 10 exclusion criteria: * current suicidality * bipolar disorder * substance abuse disorder * psychosis * other severe mental health condition

Keywords: primary care collaborative care model implementation