Kornimate/medical-research-clean huggingface dataset:
camrelizumab plus apatinib and temozolomide as first line therapy in advanced acral melanoma

Conditions: Melanoma

Summary: it is a single-center,exploratory clinical trial aimed to evaluate the objective response rate (orr) of camrelizumab combined with apatinib and temozolomide as first line therapy in advanced acral melanoma.


Eligibility criteria:
inclusion criteria: 1. age:18-75 years, male or female. 2. histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage iii/iv). 3. has not received any systematic anti-tumor drug treatment. 4. measurable disease based on response evaluation criteria in solid tumors (recist) 1.1. 5. ecog 0-1. 6. adequate organ function. 7. life expectancy of greater than 12 weeks. 8. patient has given written informed consent. exclusion criteria: 1. patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy. 2. known history of hypersensitivity to macromolecular protein preparation or any components of the shr- 1210 formulation. 3. subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ); 4. subjects with any active autoimmune disease or history of autoimmune disease 5. uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> nyha ii congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; 6. active infection or an unexplained fever \> 38.5°c during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator); 7. received a live vaccine within 4 weeks of the first dose of study medication. 8. pregnancy or breast feeding. 9. decision of unsuitableness by principal investigator or physician-in charge.
prevention of skin damage in the patient in prone position: development of education interventions based on a training needs assessment study.

Conditions: Pressure Ulcer; Skin Lesion; Acute Respiratory Distress Syndrome

Summary: this is study 1 of 3 - of the overall project: the pronetection quality improvement project. the three aims of this study, study 1 are: 1. to establish the training needs critical care clinicians have regarding prone positioning, 2. to investigate the conditions for effective implementation as in an intensive care setting, 3. to develop an education and training package (the pronetection package) for an interdisciplinary team of clinicians on skin damage prevention of patients in the prone position

conduct a needs assessment by using semi-structured interviews with an interdisciplinary team of clinicians (ghent university hospital (uz gent), brussels university hospital (uz brussel) and several institutions in sweden, mainly örebro university hospital). concurrently, investigate the conditions for effective implementation in a critical care facility using the same interviews and participants (interviewees). develop the education and training package (the pronetection package). the pronetection package will be based on 1. the results of our recently published gap-analysis study, 2. the needs assessment results from the interviews, keeping the optimal conditions (facilitators) in mind for successful implementation, and 3. the critical review and evaluation by eleven key opinion leaders from the established international expert panel

Eligibility criteria:
inclusion criteria: * • clinicians (nurses, allied health professionals and doctors) working in intensive care units (icu) are eligible to participate. this can include critical care nurses, respiratory therapists, physiotherapists etc. and/or * nurses studying towards their speciality as critical care nurses. and/or * wound care specialists or those responsible for advising on skin damage prevention or managing skin damage/ wounds of the patient in the prone position. and/or • educators / clinical training facilitators within the hospital or teaching at the university. and/or * quality assurance managers or hospital managers. and * signed informed consent and voluntary participation. exclusion criteria: * other than the inclusion criteria

Keywords: prone position pressure ulcer moisture-associated skin damage medical device-related skin injury skin tear prone ventilation
pre-implementation study of improving thoracic surgical care using electronic patient-reported outcomes (epros)

Conditions: Thoracic Surgery

Summary: the purpose of the lccc 2202 is to evaluate the barriers and facilitators to implementing perioperative "epro monitoring". this study will inform a future hybrid effectiveness study (lccc 2141:improving thoracic surgical care using electronic patient-reported outcomes (epros). eligible thoracic surgery patients will be enrolled to epro monitoring using web-based or telephone surveys. patients will be asked to self-report symptoms for remote monitoring by their care team. patients will be approached for a semi-structured interview to understand the barriers and facilitators to epro use.

this is a single-site, non-randomized study in patients receiving major thoracic surgery, which commonly involves chest wall incisions and overnight admission eligible patients will be approached at any time point between their preoperative clinic visit and up to 30 days after discharge from the hospital. approximately 60 patients will be enrolled in the study. patients will complete symptom surveys via email or telephone. concerning symptoms will generate alerts for the clinical care team who will follow their usual protocols for the management of symptoms. patients will be purposively selected and invited to participate in a semi-structured interview to understand their experience using epro. interviews will continue until 30 complete interviews are obtained and/or thematic saturation is reached.

Eligibility criteria:
inclusion criteria: * 18 years or older * english speaking * able and willing to complete a web-based or telephonic symptom survey * planned to undergo surgery within 90 days or have undergone and been discharged from major thoracic surgery within the last 30 days. exclusion criteria: * not completing planned surgery within 3 months of obtaining informed consent (for subjects recruited preoperatively) * inability to read and speak english * planned for foregut surgery (e.g. paraesophageal hernia repair, esophageal resection or repair) * having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy) * dementia, altered mental status, or any psychiatric condition as determined by thoracic surgery provider team that would prohibit the understanding or rendering of informed consent. * current incarceration * pregnancy

Keywords: electronic patient-reported outcome
dtms in obsessive compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: high-frequency deep transcranial magnetic stimulation (dtms) over the medial prefrontal cortex (mpfc) and the anterior cingulate cortex (acc) with an h-coil has been approved by the food and drug administration for use in treatment-resistant obsessive-compulsive disorder (ocd). however, there is not yet strong scientific evidence concerning the efficacy and safety of performing a similar procedure with a double-cone coil or in an accelerated manner. the aim of this study was evaluating the efficacy of dtms over the medial prefrontal cortex (mpfc) and the anterior cingulate cortex (acc) in an accelerated manner with double-cone coil.

the current study aimed to investigate the efficacy and safety of multiple deep stimulations per day with a double-cone coil to the mpfc and acc in treatment-resistant patients with ocd. this study evaluated (i) the effectiveness of high-frequency stimulation of the mpfc and acc with a double cone coil, and (ii) the effectiveness of the application of this protocol in three weeks, not six weeks as approved by the fda. the participants were randomized into two parallel groups in a double-blind manner. high frequency (20 hz) dtms was applied to the mpfc and acc in one group and sham dtms to the same regions in the other group, twice a day, for a total of 30 sessions. this application was for three weeks in total, excluding weekends.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of obsessive-compulsive disorder * not having an adequate response to treatment despite using at least two selective serotonin reuptake inhibitors at a sufficient dose and duration for 12 weeks before the planned add-on treatment * aged 18-65 years * able to read and write exclusion criteria: * not providing consent to participate in the study * diagnosis of a psychiatric disorder, such as psychotic disorder, bipolar disorder, major depressive disorder \[hamilton depression rating scale (hdrs) score above 17\], mental retardation, alcohol-substance use disorder, and organic mental disorder (dementia, delirium, and head trauma, etc.) * diagnosis of an important medical or neurological disease (e.g., epilepsy); * mental retardation * illiteracy * having received electroconvulsive therapy (ect) or tms within the last six months; * having any prosthesis, such as an implant and pacemaker.

Keywords: obsessive compulsive disorder transcranial magnetic stimulation
nicotinic modulation of schizophrenia-like information processing deficits in healthy subjects

Conditions: Healthy Subjects

Summary: this study examines the interactive effects of ketamine and nicotine.


Eligibility criteria:
inclusion criteria: * 18-50 years old * smokers

Keywords: ketamine nicotine schizophrenia cognitive deficits p300 oddball paradigm mismatch negativity p50 gating
evaluation of phenotypic and genetic properties in male subjects affected by hypohidrotic ectodermal dysplasia

Conditions: Ectodermal Dysplasia

Summary: to characterize skin properties in male subjects with hed

this study is designed to obtain information from male subjects with hed and unaffected male control subjects. the study will consist of the standardized collection of data from hed medical history questionnaires and non-invasive tests. a subset of subjects will undergo genetic testing. all data will be collected from families attending the 2010 nfed family conference, july 22-24, 2010, in colorado springs, co. since hed is a rare disease, it is difficult to obtain reliable data on a sufficient number of subjects in any one region. the nfed family conference is a location where families affected with hed come together, and therefore, presents an ideal location to obtain data needed to design future studies. as the procedures are non-invasive and are designed to take a relatively short period of time, subjects can participate in this study while attending the nfed family conference.

Eligibility criteria:
inclusion criteria: 1. registered and attending the 2010 nfed family conference; 2. one year of age or greater; 3. conform to one of the following requirements for providing informed consent: * if more than 18 years of age, subjects must provide signed informed consent; * if less than 18 years of age and it is determined that the subject is capable of providing assent, both the assent of the subject and consent of the parent(s) or guardian of that subject must be granted. under this condition, both parents of the subject should give their permission, unless 1 parent is deceased, unknown, incompetent, or not available; * if the subject is incapable of providing assent, the consent of the parent(s) or guardian of the subject must be granted. under this condition, both parents should give their consent, unless 1 parent is deceased, unknown, incompetent, or not available. 4. subjects must meet one of the following criteria: * male subjects of original gender with the clinical characteristics of hed, including at least a history of decreased sweating and either abnormal teeth (fewer permanent teeth, teeth are smaller than average and often have conical crowns), and/or sparseness of scalp and body hair; * healthy male controls, i.e. either unaffected male family members or unaffected male volunteers. exclusion criteria: 1. known hypersensitivity to pilocarpine or pilocarpine-like muscarinic agonists. 2. presence of pacemakers. 3. subjects who are not able or are not willing to comply with the procedures of this protocol. 4. subjects with any major medical problem that will prevent them from participating in this study.

Keywords: hed xlhed hypohidrotic ectodermal dysplasia
a phase 2 study of trabectedin (yondelis) in adult male participants with advanced prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate safety and efficacy of trabectedin (et-743) in adult male participants with advanced metastatic (spread of cancer cells from one part of the body to another) prostate cancer.

this is an open-label (all people know the identity of the intervention), non-randomized, multi-center and phase 2 study in adult male participants with advanced metastatic prostate cancer. the study consists of 3 parts: screening (consists of 14 days before study commences on day -1); treatment (consists of 4-week dosing cycles wherein trabectedin will be administered as intravenously at a dose of either 0.58 milligram per square meter \[mg/m\^2\] weekly 3-hour infusion, or 1.5 mg/m\^2 or 1.2 mg/m\^2 every three weeks 24-hour infusion); and follow-up (until survival after the first dose of trabectedin). participants will discontinue study treatment at disease progression or unacceptable toxicity unless, in the investigator's opinion, it is deemed that the participants will continue to derive benefit from trabectedin. efficacy will be evaluated primarily through decline in prostate-specific antigen (substance in blood that is measured to check for prostate cancer) after 72 hours of therapy on day 1. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate * radiographically documented metastatic disease * surgical or chemical castration * prostate-specific antigen greater than or equal to (\>=) 5 nanogram per milliliter (ng/ml) * eastern cooperative oncology group performance status of 0, 1, or 2 * androgen independent disease exclusion criteria: * treatment with chemotherapy or radiation therapy that was terminated at least 4 weeks before study entry * treatment with extensive external beam radiation therapy or radionuclide therapy within 6 weeks of study entry (palliative radiation involving less than 20 percent of bone marrow reserves must have been completed at least 4 weeks before study entry) * participant not employing adequate contraception * other serious illness or medical conditions as : uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within six months preceding registration; active infectious process; chronic active liver disease, including chronic hepatitis b, chronic hepatitis c, or cirrhosis

Keywords: prostate cancer advanced prostate cancer metastatic prostate cancer trabectedin yondelis et-743
prophylactic cranial irradiation in erlotinib/gefitinib-responders with non-small cell lung cancer (nsclc) (rt1001)

Conditions: Non-small Cell Lung Cancer

Summary: rationale: radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. it is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer. purpose: this randomized phase iii trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer

objectives: primary determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride. secondary determine the progression-free survival in patients treated with this regimen. determine the overall survival in patients treated with this regimen. determine the safety and tolerability of this regimen in these patients. determine the psycho-neurological effects of this regimen in these patients. determine the quality of life of patients treated with this regimen. outline: this is a multicenter study. patients with good response( cr/pr) to egfr-tki(erlotinib or gefitinib) are randomized to receive egfr-tki plus pci or egfr-tki alone,stratified according to prior chemotherapy regimens (first line vs second line), and disease response status. group 1: patients undergo prophylactic brain radiotherapy. group 2: patients undergo observation. patients complete quality of life questionnaires periodically. after completion of study therapy, patients are followed up periodically.

Eligibility criteria:
inclusion criteria: 1. patients were required to have histologically or cytologically documented 2. nsclc and no brain metastasis documented by magnetic resonance imaging (mri)within 21 days after confirmed response (rr+sd) to chemotherapy 3. no previous history of radiotherapy and surgery of brain 4. good response( cr/pr) to erlotinib or gefitinib. 5. agree to radiotherapy 6. age \> 18 and \<75 years,ecog performance status 1 or less 7. good renal and hepatic and haematological (absolute neutrophils count 15 x1o9/l and platelet count 90 x 109/l,hb\>=80g /dl) functions 8. have provided informed consent exclusion criteria: 1. seizure cannot be controled by the drugs 2. combined with other disease of the brain such as tumour or infarction 3. hypersensitivity to mr enhancer -

Keywords: nonsmall cell lung cancer brain metastasis prophylactic cranial irradiation
impact of a corneal pre-cut on wound architecture and astigmatism in cataract surgery - a pilot study

Conditions: Cataract

Summary: we would like to evaluate the use of a 600μm pre-cut regarding wound architecture and surgically induced astigmatism as compared to a stab-incision (a corneal incision without a pre-cut). a dedicated wound architecture score will be used to evaluate wound configuration. postoperatively, oct scans will be obtained, corneal curvature will be measured and subjective and objective refraction will be performed in order to measure the surgically-induced astigmatism.

corneal wound architecture in cataract surgery has recently been assessed1-4 using optical coherence tomography. however, none of these studies observed the effect of the wound architecture on postoperative astigmatism. in a previous study performed at our center, cataract surgery using a 1.8 mm micro incision (mics) was compared to a 2.5 mm standard incision (sics) regarding wound architecture and surgically induced astigmatism. wound size and wound architecture were assessed using a time-domain oct intraand postoperatively. after implantation of the iol the incisions were shown to be larger than planned. this effect was shown to be more pronounced in the small incision group. both epithelial and endothelial wound gaping at the end of surgery occurred more often in the mics group. furthermore, this study showed no effect of a 300 μm pre-cut on postoperative wound architecture and surgically induced astigmatism. based on these findings we would like to perform another study using a high-resolution spectral-domain oct, which allows for a three-dimensional depiction of wound architecture and a better understanding of the dynamic changes in wound structure during surgery. furthermore a new high resolution oct device will be available outside the operating theatre for postoperative measurements. both devices are ce certified, will be used according to their indication and allow noncontact and therefore pain free measurements. as no significant impact of a 300μm pre-cut on wound architecture and astigmatism was shown in the predecessor study, we would like to evaluate the use of a 600μm pre-cut regarding wound architecture and surgically induced astigmatism as compared to a stab-incision (a corneal incision without a pre-cut). a dedicated wound architecture score will be used to evaluate wound configuration. postoperatively, oct scans will be obtained, corneal curvature will be measured and subjective and objective refraction will be performed in order to measure the surgically-induced astigmatism.

Eligibility criteria:
inclusion criteria: * age-related cataract * age 21 and older * written informed consent prior to recruitment exclusion criteria: * pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age) * any ophthalmic abnormality that could compromise the measurements

Keywords: cataract incision precut corneal oct intraoperative oct imaging astigmatism clear corneal incision
researching covid-19 outcomes in diabetes (recode)

Conditions: Covid19; Diabetes

Summary: the purpose of this study is to observe any changes that may occur to certain organs following a confirmed diagnosis of covid-19 in people with and without diabetes.


Eligibility criteria:
inclusion criteria: for type 2 diabetes (t2d) 1. male or female 18 years of age and older willing and able to give informed consent to participate in the study 2. confirmed diagnosis of sars-cov-2 rna via a polymerase chain reaction (pcr) assay (having been discharged at least 2 months from hospital but not greater than 6 months). 3. diagnosis of t2d according to american diabetes association (ada) criteria. 4. must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments. for participant without type 2 diabetes (t2d) 1. male or female 18 years of age and older willing and able to give informed consent to participate in the study 2. confirmed diagnosis of sars-cov-2 rna via a polymerase chain reaction (pcr) assay (having been discharged at least 2 months from hospital but not greater than 6 months). 3. must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments. exclusion criteria: 1. symptoms of active respiratory viral infection: 1. high temperature (over 37.8°c/100.4°f) 2. cough (consistent for over an hour; 3 or more episodes in 24 hours) 2. any history of type i diabetes 3. the participant may not enter the study with any known contraindication to magnetic resonance imaging including 1. pregnancy, lactation or 6 months postpartum from the scheduled date of collection 2. metal implants (pacemaker, aneurysm clips) based on investigator's judgment at screening 3. unable to participate in mri assessments due to physical limitations of equipment tolerances (e.g. mri bore size) based on investigator's judgment at screening 4. unable to tolerate mri imaging or claustrophobia 4. any condition, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.