Kornimate/medical-research-clean huggingface dataset:
reducing posttraumatic stress disorder (ptsd) symptoms in first responders and frontline health care workers

Conditions: Post Traumatic Stress Disorder

Summary: this study addresses ptsd symptoms in first responders and healthcare workers. specifically, it tests whether a brief ptsd treatment (talk therapy) effectively treats ptsd when provided to first responders and healthcare workers by counselors in employee assistance programs (eaps). the central hypothesis is that the ptsd treatment, prolonged exposure for primary care (pe-pc), will reduce ptsd symptoms and improve functioning, compared to eap treatment as usual (tau).


Eligibility criteria:
inclusion criteria: * are employees at an orginization served by a participating eap * have a post-traumatic stress disorder checklist for diagnostic and statistical manual of mental disorders, fifth edition (pcl-5) score ≥33 * have had psychotropic medication stability for at least 4 weeks inclusion criteria for the qualitative portion of the study: - enrolled into the randomized clinical trial and were a treatment responder or were a treatment non-responder exclusion criteria: * severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment) * high risk of suicide (defined as meeting criteria for action step 3 on the participant suicide risk screening form: found in protocol) * need for detoxification * active psychosis or unmanaged bipolar disorder, as measured by items 12 and 13 of the cross cutting assessment * currently engagement in a trauma-focused behavioral treatment (such as prolonged exposure or cognitive processing therapy). * patients who do not speak english will be excluded for logistical reasons.

Keywords: employee assistance programs frontline healthcare workers prolonged exposure for primary care first responders
atrial fibrillation ablation device comparison study

Conditions: Atrial Fibrillation

Summary: atrial fibrillation is an irregular heart rhythm which requires long term anticoagulation to prevent risk of stroke and long term poor outcomes. at the same time one have heart surgery, a small additional procedure can be done to treat atrial fibrillation. surgeons have a choice of six different devices that he or she can use to treat your atrial fibrillation. it is not known at this point which device is best at treating you, as each device seems to have the same success rate at curing atrial fibrillation. one of the six devices will be selected randomly by card pulled out at the time of enrollment. it is therefore the purpose of this study to compare the devices to each other and to follow up after surgery to determine if any one device is best. this information will be valuable to surgeons and to patients as the treatment for atrial fibrillation develops in the future.

surgery has been used as a treatment for atrial fibrillation (af) for more than 20 years. although highly successful, it has not been widely adopted because operations designed to cure af require extensive cutting and suturing of the heart, inflicting a significant risk on the patient. newer technologies now permit the surgeon to create similar scars on the heart as cutting, but much more quickly and safely than before. over the last ten years at least six different devices have been developed, each of which can scar the heart: microwave, radiofrequency, ultrasound, laser and cold are some of them. although there are many papers in the literature studying these devices, each seems to cure about 80% of patients with very low risk of morbidity and/or mortality. this leaves the surgeon with almost no basis upon which to base his or her selection of a device: which is the best? which should be used? therefore, a comparison study is like this is desperately needed. at the time of the surgery, surgeon who perform the af treatment, he or she will select one of the six devices mentioned above at randomly assigned earlier, at the time of the enrollment. the device will be used to make scars on your heart exactly as described in the manufacturer's instructions and according to the surgeon's experience. the operation will then be completed per routine. in other words, the only part of the procedure that will be done differently from any other is that the actual device chosen to perform the ablation will vary from one study subject to another. patients will be followed up upto one year with ekgs, holter monitors, mri's, 6 minute walk tests, echocardiograms, blood tests like bnp and quality of life questionnaires.

Eligibility criteria:
inclusion criteria: * all patients undergoing concomitant cardiac surgery who also have af. exclusion criteria: * patients undergoing re-do or emergency procedures * females of child-bearing age who are pregnant * age less than 19 and more than 75 years old

Keywords: atrial fibrillation ablation device comparison ablation in right atria
treatment of insomnia in primary care study

Conditions: Insomnia Chronic

Summary: the goal of this clinical trial is to learn about insomnia treatment among primary care patients with chronic insomnia. the main question it aims to answer is: • does sleep school (a therapy for insomnia) work well to decrease harm of insomnia? participants will attend a group therapy intervention once a week for six weeks. researchers will compare sleep school to treatment as usual (short counselling by an educated nurse) to see if the sleep school works better than treatment as usual in decreasing the harm of insomnia.


Eligibility criteria:
inclusion criteria: * insomnia severity index (isi) score at least 8 * insomnia symptoms present at least for 3 months exclusion criteria: * diagnosed dementia based on medical records * acute suicidality * acute psychotic symptoms

Keywords: cognitive behavioral therapy for insomnia cbt-i primary care insomnia severity index quality of life depressive symptoms
efficacy and safety of chi-beac combining with auto-hsct to treat aggressive lymphoma subjects

Conditions: Lymphoma, Large B-Cell, Diffuse; Mantle Cell Lymphoma; Peripheral T Cell Lymphoma; Double-hit Lymphoma

Summary: this is a single arm, multi-center, open study to evaluating efficacy and safety of chi-beac combining with auto-hsct to treat aggressive lymphoma subjects


Eligibility criteria:
inclusion criteria: 1. aggressive lymphoma subjects: diffuse large b cell lymphoma confirmed by immunohistochemistry, aaipi≥2 or double-hit lymphoma, as first-line consolidation; diffuse large b cell lymphoma as second-line consolidation therapy; peripheral t-cell lymphoma except alk-positive type, as first-line or second-line consolidation therapy; mantle cell lymphoma, as first-line or second-line consolidation therapy. 2. adequate organ system function including: creatinine clearance rate ≥ 80ml/min and creatinine \< 160μmol/l alt/ast ≤ 2 upper limit of normal total bilirubin \< 2 upper limit of normal fev1、fvc and dlco ≥ 50% predictive value left ventricular ejection fraction ≥ 50% no symptomatic arrhythmia 3. age 18-60 years, male and female 4. ecog score 0-1 5. number of neutrophil ≥ 1.5×10\^9/l, number of platelet ≥ 70×10\^9/l, concentration of hemoglobin ≥ 90g/l, number of cd34+ cells ≥ 2.0×10\^6/kg 6. expected survival ≥ 12 weeks 7. volunteered to participate in this study and signed informed consent exclusion criteria: 1. have evidence of cns lymphoma 2. relapse after autologous hematopoietic stem cell transplantation 3. active hepatitis b or hepatitis c virus infection 4. severe active infection 5. hiv-infected persons 6. liver cirrhosis or hepatic fibrosis 7. qtc \> 500ms 8. have mental disorder or unable to sign informed consent 9. history of drug abuse and intemperance 10. women who are pregnant or lactating or have breeding intent 11. the investigators believe that any increase in the risk of the subject or interference with the results of the trial
a study to evaluate the efficacy and safety of the investigational drug pf-03446962 (a monoclonal antibody with antiangiogenic features) in combination with best supportive care versus placebo plus best supportive care in patients affected by recurrent liver cancer

Conditions: Carcinoma, Hepatocellular

Summary: the primary purpose of the study is to explore whether treatment with pf-03446962 and best supportive care is better than placebo plus best supportive care in prolonging survival of patients affected by recurrent liver cancer. in addition, the study will explore if adding pf-03446962 to best supportive care is safe, how pf-03446962 is metabolized, if there are patients' characteristics (biomarkers) that may predict response to pf-03446962, and if pf-03446962 has any effect on the patients' quality of life.

this study was terminated on june 24th, 2014 due to change in strategy of pf-03446962 clinical development. there were no safety or efficacy concerns regarding the study behind the decision to terminate the trial. the study was on temporary halt since march 10th and there are currently no patients on treatment or in the process of being randomized

Eligibility criteria:
inclusion criteria: * diagnosis of locally advanced or metastatic liver cancer obtained by histology/cytology or by imaging * documented progression on or after treatment with sorafenib, confirmed by the investigator upon review of appropriate imaging documentation * child pugh class a disease * ecog \[eastern cooperative oncology group\] performance status (ps) 0 or 1 * mandatory tumor biopsy at study entry (pre-randomization, unless already collected after sorafenib progression but within 3 months of enrollment and no systemic anticancer therapies received) exclusion criteria: * prior systemic treatment for advanced liver cancer other than sorafenib-including therapy * prior local therapy within 2 weeks of starting the study treatment * presence of main portal vein invasion by liver cancer

Keywords: hepatocellular carcinoma monoclonal antibody alk-1 best supportive care
serplulimab plus chemoradiotherapy for stage iii-iva cervical cancer

Conditions: Cervical Cancer

Summary: this study is a prospective, multicenter, randomized, open controlled clinical trial aimed at evaluating the effectiveness and safety of serplulimab plus chemoradiotherapy in figo 2018 stage iii or iva cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma patients who have not received prior treatment.

cervical cancer is the most prevalent malignant tumor of the female reproductive system in china, with an estimated 150,700 new cases and 55,700 new deaths annually. concurrent chemoradiotherapy (crt) remains the standard treatment for locally advanced cervical cancer (lacc). however, for high-risk lacc (hr-lacc) patients, the 2-year progression-free survival (pfs) rate is only 57%-62%, and the 5-year overall survival (os) rate is 52%-64%, which are the leading causes of patient mortality. the keynote-a18 study demonstrated that the combination of pembrolizumab and crt reduced the progression risk and death risk by 30% and 27%, respectively, for hr-lacc patients. following this, the fda approved pembrolizumab in combination with crt for the treatment of newly diagnosed stages iii-iva cervical cancer in january 2024. this prospective, multicenter, randomized, controlled clinical trial study aims to evaluate the effectiveness and safety of serplulimab induced and combined chemoradiotherapy in figo 2018 stage iii or iva cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma patients who have not received prior treatment.

Eligibility criteria:
main inclusion criteria: 1. age ≥ 18 years and ≤ 75 years at time of study entry. 2. has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix. 3. the international federation of gynecology and obstetrics (figo) 2018 stages iii-iva. 4. diagnosed with pd-l1-positive (combined positive score ≥1). 5. has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer. 6. who/ecog performance status of 0 or 1. 7. patient must have at least one measurable disease as defined by recist 1.1. main exclusion criteria: 1. has received prior therapy with an anti-programmed cell death receptor 1 (pd-1), anti-programmed cell death receptor ligand 1 (pd-l1), or anti-programmed cell death receptor ligand 2 (pd-l2) agent o.. 2. ongoing participation in another clinical study, or planned initiation of treatment in this study less than 28 days from the end of treatment in the previous clinical study. 3. known history of serious allergy to any active ingredie or any excipients list in monoclonal antibody. 4. the patient has other factors that, in the judgment of the investigator, may lead to forced early termination of the study.

Keywords: serplulimab concurrent chemoradiotherapy cervical cancer
long-term quality of life in patients with metastatic melanoma treated with checkpoint inhibitors

Conditions: Metastatic Melanoma

Summary: to identify and describe long-term quality of life (qol) issues in patients with metastatic melanoma treated with checkpoint inhibitors who achieved cancer control for a minimum of 12 months and remain on maintenance checkpoint inhibitor therapy.


Eligibility criteria:
inclusion criteria: * be able to speak and read english * be able to provide informed consent * have been diagnosed with metastatic melanoma at age 18 years or older * have been treated with either single agent or combination checkpoint inhibitor * be at least 12 months since first dose of above named agents * received no other systemic therapy after initiation of immunotherapy (interval radiation or surgery will be permitted based on review with primary treating medical oncologist) exclusion criteria: * patients with cognitive, visual, or motor impairment such that they cannot complete the survey as assessed by the research or clinical team * patients who developed a subsequent cancer after starting on checkpoint inhibitor(s), exclusive of non-melanoma superficial skin cancers * patients with clinical documentation of progressive disease on the most recent assessment in the electronic medical record * patients with symptomatic progression but continue on immunotherapy * note: for any patients where the disease status is not clear, we will confirm that the disease is either stable or responsive with their primary treating medical oncologist

Keywords: quality of life (qol) 17-518
ivs with buzzy in chronic pain patients

Conditions: Chronic Pain; Acute Pain

Summary: the investigators are conducting a study to compare the effectiveness of the buzzy® device with that of no pain relief method for iv placement in adults with chronic pain receiving lidocaine infusions.

iv placement is necessary for lidocaine infusions. unfortunately, some patients say that placing an iv is painful. the investigators are conducting this study to evaluate two techniques that could make the placement of the iv more comfortable. currently, some medical providers administer the iv without any pain-relieving techniques. some medical providers place a device called buzzy® on a patient's arm prior to the iv placement. the buzzy® device is the combination of an ice pack and a vibrator in the shape of a bumble bee. literature shows that the buzzy® device makes iv placement more comfortable for children, but there is minimal data in regard to whether it is helpful for adult patients. the investigators are conducting this study to compare the effectiveness of the buzzy® device with that of no pain relief method for iv placement in adults with chronic pain receiving lidocaine infusions. the use of the buzzy® device in adults is the investigational part of the study. this device has been fda approved for use.

Eligibility criteria:
inclusion criteria: * patients receiving lidocaine infusions at the pain clinic. exclusion criteria: -
characteristic analysis of retinopathy associated with high doses of interferon α-2b therapy

Conditions: Retinopathy

Summary: the high doses of interferon α-2b therapy in patients with melanomas of the skin may induced retinopathy, especially in the patients with hypertension or diabetes, so these patients should be followed up after treatment.

patients with melanomas of the skin whose tumors have been resected completely were collected. the detailed ocular examinations including intraocular pressure, slit lamp microscope, indirect ophthalmoscope and color fundus photography were done before the induction therapy, 2 weeks after the induction therapy, after the whole course of induction therapy and each month in the maintenance treatment period. fundus examinations were carried out by experienced ocular fundus doctors and the retinopathy characteristics were recorded.

Eligibility criteria:
inclusion criteria: 1. men and women, at least 18 years of age. 2. ecog performance status 0 or 1. 3. patients must have histologically confirmed stage ib to stage iii primary melanoma of cutaneous origin (ajcc 7th edition classification). 4. must complete all primary therapy (wide excision with or without lymphadenectomy). exclusion criteria: 1. mucous membrane or ocular melanoma. 2. any evidence of distant metastasis (ct-scan of brain, chest x ray or ct, abdominal ultrasound or ct and ultrasound of regional lymph nodes at screening). 3. patients with retinopathy on baseline fundoscopic examination at the start of interferon therapy. 4. history of any other malignancy within the last ten years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix). 5. patients with severe cardiac disease (e.g. nyha functional class iii or iv, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina), severe liver disease or severe renal disease. 6. patients who have a history of depression or other psychiatric diseases requiring hospitalisation. 7. history or presence of autoimmune disease (i.e. autoimmune hepatitis, thyroid auto-immune dysfunction, systemic lupus erythematodes), 8. unwilling or unable to comply with the requirements of the protocol for the duration of the study.

Keywords: characteristic analysis
three dimensional versus two dimensional laparoscopic salpingectomy in patients with hydrosalpinx undergoing ivf-et

Conditions: Hydrosalpinx

Summary: a three-dimensional laparoscopic vision system (3-d lvs) has gained acceptance and is being utilized in daily practice despite debates about its success.

a three-dimensional laparoscopic vision system (3-d lvs) has gained acceptance and is being utilized in daily practice despite debates about its success. in our study we will compare operative data and early postoperative outcomes of laparoscopic salpingectomy operations conducted using standard 2-d and 3-d laparoscopic vision systems

Eligibility criteria:
inclusion criteria: * patients with unilateral hydrosalpinx diagnosed with hysterosalpingography or laparoscopy exclusion criteria: * bilateral hydrosalpinx, * co-existent adnexal pathology, * body mass index (bmi) more than 40, * extensive pelvic adhesions, * coagulation defects or concurrent anticoagulant therapy, * compromised cardiopulmonary status, * and contraindications for general anesthesia.

Keywords: hydrosalpinx infertility in vitro fertilization laparoscopy
phase iia, randomized, double blinded, placebo controlled, dose finding study for tlc599 in oa patients

Conditions: Osteoarthritis of the Knee

Summary: this trial is a phase iia, randomized, double blinded, placebo controlled, dose finding study to investigate the safety and efficacy of tlc599 in subjects with osteoarthritis of the knee.

protocol no: tlc599a2003 name of finished product: tlc599 title of study: a phase iia, randomized, double blinded, placebo controlled, dose finding study for single dose administration of tlc599 in patients with osteoarthritis (oa) of knee. study duration: the trial will last around 27 weeks including a 21-day screening period and a 24-week follow-up period.

Eligibility criteria:
main inclusion criteria: 1. male or female patients, at least 50 years of age. 2. documented diagnosis of oa of the knee for at least 6 months 3. the study knee has oa with grade 2 to 3 severity based on the kellgren lawrence grades 4. patients with patient related visual analogue scale (vas) score of 5.0 to 9.0 at baseline. 5. willing and able to comply with study procedures and provide written informed consent. main exclusion criteria: 1. patients who received systemic corticosteroids within the last 30 days prior to dosing. 2. patients who use prohibited medications within 7 days prior to study drug administration or any pain control medication including acetaminophen within 48 hours prior to study drug administration. 3. patients who use prohibited medications other than acetaminophen and oral nsaids from screening visit to 7 days prior to study drug administration. 4. documented history and confirmed autoimmune disease 5. history of post-traumatic knee arthritis, or evidence of intra articular bleeding of the study knee 6. history of infective arthritis 7. unstable study knee joint 8. use of ia corticosteroid, hyaluronic acid, or other ia injection in the study knee within 3 months prior to the screening visit. 9. a history of treated malignancy which is disease free for ≤ 5 years prior to the screening visit 10. uncontrolled and unstable concurrent medical or psychiatric illness, that will jeopardize the safety of the patient 11. use of any chemotherapeutic or systemic immunosuppressant agents for inflammatory diseases within 6 months prior to the screening visit. 12. current use of anticoagulants, including warfarin, heparin, low molecular weight heparin, or dabigatran. 13. abnormalities of laboratory parameters as described below will qualify for exclusion: * hemoglobin \< 8 g/dl; * total white blood cell count \< 4000/ µl; * serum bilirubin/ alanine aminotransferase/ aspartate aminotransferase \> 2 times upper limit of normal (uln) for the laboratory reference ranges; * serum creatinine \> 2 times uln for the laboratory reference range; * serum uric acid \> uln for the laboratory reference range; * prothrombin time/international normalized ratio \> uln for the laboratory reference range. 14. contraindication to undergoing magnetic resonance imaging (mri)

Keywords: osteoarthritis of the knee tlc599 dexamethasone dsp
body awareness and functionality in lymphedema

Conditions: Lymphedema of Upper Limb

Summary: to determine whether body awareness and upper extremity functionality are affected in patients with or without lymphedema development after breast cancer surgery in comparison with individuals without a history of cancer.


Eligibility criteria:
inclusion criteria: first group: * being female, * being aged 18-65 years, * having undergone unilateral breast cancer surgery, * being diagnosed with secondary lymphedema in the upper extremity according to the international lymphedema association * not having any orthopedic disease that would prevent walking, and volunteering to participate in the study. second group:the inclusion criteria for the breast cancer surgery group * without lymphedema were being female, * being aged 18-65 years, * having undergone unilateral breast cancer surgery, and volunteering to participate in the study. lastly, the inclusion criteria for the control group were: * being female, * being aged 18-65 years, * having no history of cancer surgery, and volunteering to participate in the study. exclusion criteria: for all groups * not being willing to participate in the study; * the presence of metastases, neurological, or orthopedic disorders; * postural deformities, such as scoliosis and kyphosis; * mental and cognitive disorders; or communication/cooperation problems