Kornimate/medical-research-clean huggingface dataset:
electrochemotherapy for the treatment of vulvar cancer

Conditions: Vulvar Cancer

Summary: electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. with electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. the method is based on increased drug delivery to cells previously exposed to electroporation. the most commonly used cytotoxic agents are bleomycin and cisplatin. the aim of the proposed clinical trial is to determine the efficacy, feasibility and safety of electrochemotherapy in the treatment of vulvar cancer.


Eligibility criteria:
inclusion criteria: 1. local recurrence of vulvar cancer confirmed by histology 2. the longest diameter of tumor 50 millimeters or less 3. age more than 18 years 4. life expectancy of more than 3 months 5. performance status according to karnofsky ≥ 70 or \< or 2 according to the who scale 6. at least 2 weeks have passed since the last treatment 7. the patient must be able to understand the treatment process and possible side effects that may occur during the treatment 8. signed informed consent form 9. the patient must be presented at a multidisciplinary tumor board exclusion criteria: 1. life-threatening infection and/or heart failure and/or liver failure and/or markedly impaired pulmonary function and/or other life-threatening systemic diseases 2. regional or distant metastases 3. age less than 18 years 4. major disturbances in the coagulation system (which do not respond to standard therapy - replacement of vitamin k or fresh frozen plasma) 5. exposure to cumulative bleomycin doses greater than 400 mg 6. impaired renal function (creatinine \> 150 µmol/l) 7. epilepsy 8. pregnancy 9. patients who are unable to understand the treatment process or refuse to be involved in the treatment process
a phase 1 clinical trial to evaluate the safety and pharmacokinetic characteristics of dw1809-t2

Conditions: Osteoarthritis; Rheumatoid Arthritis; Back Pain; Acute Upper Respiratory Tract Infection

Summary: randomized, open-label, oral, single-dose, two-sequence, four-period, crossover study


Eligibility criteria:
inclusion criteria: * healthy volunteers who are ≥19 years old * body weight ≥50.0 kg and bmi between 18.0 and 30.0 kg/m2 and exclusion criteria: * clinically significant medical history * in the case of women, pregnant(urine-hcg positive) or lactating women
preoperative radiotherapy and local excision in rectal cancer

Conditions: Rectal Cancer

Summary: according to the current opinion, local excision in rectal cancer should be limited to selected t1n0 tumours. the investigators addressed the question whether preoperative radio(chemo)therapy can expand the use of this procedure for more advanced cancers. the rationale of preoperative radiotherapy is eradication of mesorectal subclinical disease. besides, there is a correlation between radiosensitivity of rectal cancers and low cancer aggressiveness. for this reason, conversion to abdominal surgery is needed in patients with radioresistant tumour. the investigators aim to compare the short-course radiotherapy schedule with the chemoradiation in order to determine an optimal scheme. the study hypothesis is that the chemoradiation assures 25% more patients who do not require conversion to an open surgery. in addition, the aim is to asses safety and efficiency of preoperative radiotherapy and local excision for radiosensitive rectal cancer.

local excision must involve all tissue invaded on pretreatment examination. for this reason, 4-5 tatoos of mucosa at the tumour border should be performed before the onset of treatment. next, the long-course radiochemotherapy or short-course radiotherapy is randomly allocated. after 6 weeks interval, the full thickness local excision should be carried out with 1 cm margin. patients with good pathological response (complete response or downstaging to ypt1 disease)are followed up. conversion to open surgery is offered to patients with poor pathological response (ypt2-3 or positive margin). close follow-up is carried out in order to detect an early local recurrence either in a bowel wall or in mesorectal lymph nodes. rescue surgery is offered in patients with local recurrence.

Eligibility criteria:
inclusion criteria: * biopsy proven good or moderately differentiated adenocarcinoma of rectum * extraperitoneal tumour (\< 3-4 cm; unfavourable ct1 or ct2-3; n0) * no evidence of distant metastases on chest x-ray and abdominal ct or sonography * signed by patient written informed consent exclusion criteria: * poorly differentiated pathology (g3) * patients unfit for chemotherapy * no agreement for randomisation

Keywords: rectal cancer preoperative radiotherapy and local excision
multidimensional geriatric pain assessment

Conditions: Pain

Summary: this descriptive study was conducted on 100 patients who applied to the gynecology outpatient clinic to determine the effectiveness of the geriatric pain measure (gpm) in elderly individuals. the data of the study were collected using the patient information form, the gpm, and the standardized mini mental state examination (smmse). the mean gpm score of the elderly individuals, who had an average age of 70 (65-90), was found to be 27.37 (0-88), the sub-dimension mean scores were 9.52 (0-49.9), 7.14 (0-14.2), 4.76 (0-9.5), 2.38 (0-11.9), and 4.76 (0-11.9) respectively. it was determined that 54% of the patients had mild pain (0-29), 38% of them had moderate pain (30-69), and 8% of them had severe pain (70 and above). the findings of the present study were similar to the results of numerous other studies in which both the same scale and different scales were used to assess pain in elderly individuals.


Eligibility criteria:
inclusion criteria: * 65 years and older patients, * scoring 23 or above in the standardized mini mental state examination, * have no obstacle to answering questions, * not addicted to alcohol or other substances, * no trauma in the last six months. exclusion criteria: * patients younger than 65, * scoring less than 23 points in the standardized mini mental state examination, * who have a situation that prevents them from answering questions, * are addicted to alcohol or other substances, * trauma in the last six months.

Keywords: geriatric pain measure pain assessment elderly adults
mind-body skills groups for the treatment of war-related trauma in adolescents in gaza

Conditions: Posttraumatic Stress Disorder

Summary: the objective of this study is to determine whether participation in a mind-body skills program by war-traumatized adolescents in gaza will result in improvement of posttraumatic stress symptoms, depression, and levels of aggression compared to a control group.


Eligibility criteria:
inclusion criteria: * having experienced a political violence or war-related criterion a stressor * meeting the american psychiatric association (dsm-iv-tr) criteria for ptsd according to screening scores on the child ptsd symptom scale exclusion criteria: * former psychosocial or medical treatment for mental health conditions * significant cognitive impairment
protocol based-furosemide stress test versus standard care to evaluate renal recovery during continuous renal replacement therapy

Conditions: Acute Kidney Injury

Summary: currently, continuous renal replacement therapy (crrt) is the main modality for renal support in critically ill patients with hemodynamic instability. most studies have investigated the timing of rrt initiation. however, prolonged crrt demonstrated the association of many unexpected events, such as catheter-related complications, catheter-related blood stream infection, hypotension, hypothermia, tachycardia, and atrial fibrillation. up to now, there is a lack of evidence regarding the timing of withholding crrt. the furosemide stress test (fst) is a tool that is easy to use and has more availability. the investigators aimed to apply fst to evaluate renal recovery compared with standard treatment in critically ill patients undergoing crrt.


Eligibility criteria:
inclusion criteria: * adult 20 year of age or older * acute kidney injury (aki) stage 3 according to kidney disease improving global outcomes (kdigo) classification with oliguria (urine \<400 ml/day) * initiate crrt in icu (medical icu, surgical icu, cardiac care unit) for at least 48 hours (time for initiation and modality of crrt can adjust by clinician) exclusion criteria: * use any inotropic drug (norepinephrine, epinephrine, dopamine, dobutamine) * blood urea nitrogen (bun) \>80 mg/dl * serum k \ 5 mmol/l * arterial potential of hydrogen (ph) \<7.3 * serum bicarbonate (hco3) \<15 mmol/l * urine volume \ 2,100 ml/day * urine creatinine clearance (crcl) at 6 hours \>20 ml/min * previous chronic kidney disease (ckd) stage 5 or estimated glomerular filtration rate (egfr) \<15 ml/min/1.73 m2 * previous rrt within 14 days * kidney transplantation * obstructive etiology for aki * toxin/drug that necessitates rrt * allergy to furosemide * moribund with expected death within 24 hours * pregnancy

Keywords: acute kidney injury continuous renal replacement therapy furosemide stress test critical care crrt
resveratrol, cardiovascular risk markers and cognitive performance in patients with schizophrenia

Conditions: Schizophrenia

Summary: resveratrol supplementation may improve cardiovascular risk factors and cognitive parameters in patients with schizophrenia taking antipsychotics?

randomized, double-blind, placebo-controlled trial comparing supplementation with resveratrol or placebo in patients diagnosed with schizophrenia.

Eligibility criteria:
inclusion criteria: men 18-65 years old, diagnosed with schizophrenia according to dsm-iv and icd-10, which are in clozapine medication for at least 6 months. exclusion criteria: patients will be excluded from the study: * have a diagnosis of diabetes * use other antipsychotic drugs, clozapine beyond * using medicines for diabetes or dyslipidaemia * accept not participate in any stage of the research.
feasibility of uninterrupted infant respiratory support treatment

Conditions: Respiratory Distress Syndrome, Newborn; Infant, Newborn; Respiratory Insufficiency Syndrome of Newborn

Summary: feasibility study of a simplified respiratory support system for newborn infants

the study is a "proof-of-concept" feasibility trial that evaluates usage of a simplified respiratory support system for newborn infants. the study aims to evaluate both the feasibility of providing uninterrupted support for the first hours of life as well as a modified respiratory support system. the system is a modified version of the commercially available rpap system. the revised design has a simplified gas supply and allows elimination of a complicated driver. the new system has low resistance to breathing equal to the rpap system. the study will recruit 40-60 infants in a single centre without a comparison arm. the trial is conducted as a first step towards a large randomised trial.

Eligibility criteria:
inclusion criteria: * vaginal delivery at gestational age between 28+0 and 34+6 * caesarean section at gestational age between 28+0 and 37+6 * infants in need of respiratory support in delivery-room exclusion criteria: * carciac malformations * airway malformations * known syndromes or neuromuscular disorders * transfer to other hospital within 4 hours likely

Keywords: continuous positive airway pressure resuscitation
genital wart and sexuality in adolescence

Conditions: Adolescent Development; Genital Wart; Sexual Dysfunction; Sexual Disorder, Physiological

Summary: the adolescence is a landmark in perceiving the sexuality and awareness about the sexual experiences. genitals warts were shown to be a potential risk to impair the sexual functions in women. adolescence is a vulnerable period in which the individuals may be prone to the negative effects of the disorders affecting sexual functions such as genital warts. the current study aimed to investigate the impact of genital warts on sexual functions in female adolescents.

this current study aimed to elucidate the impact of genital warts on female sexual function in adolescence. the current study also targeted to reveal whether there is any correlation between the genital warts and the female sexual dysfunction, as well as the sexuality related distress. the current study is conducted at youth center outpatient clinic of ankara city hospital which is a high-volume tertiary health care center in turkey. the study was prospectively designed and data were collected between the 1 august 2020 and 1 february 2021. totally 90 female adolescents between the age of 17-21 who had regular sexual intercourse with heterosexual partners were included. the study group composed of 45 adolescents who had genital warts and the control group included 45 healthy adolescents. female sexual function index (fsfi), arizona sexual experiences scale (asex) and female sexual dysfunction scale (fsds) scores were compared between the two groups to evaluate the sexual functions. difference between two independent means (two groups) power analysis demonstrated that this study achieved a power of 0.99, 0.98 , 0.99 with a 5% level of significance for comparison of 45 adolescents with genital warts and 45 healthy adolescents in terms of fsfi, asex, and fsds scores, respectively.

Eligibility criteria:
inclusion criteria: * the study group included adolescents who was diagnosed as positive for genital warts during the examination. * the control group was composed of healthy adolescents who admitted for contraceptive counselling. exclusion criteria: * chronical disease including rheumatological diseases, renal failure, diabetes mellitus, hypertension, dyslipidemia, obesity, thyroid dysfunction, cardiopulmonary diseases, malignancy, cerebrovascular diseases, psychiatric and mental disorders, cerebrovascular diseases, inflammatory bowel diseases. * drug administration which may interfere sexual function. * surgical intervention to genital organs. * history of pregnancy, delivery, and/or breastfeeding.

Keywords: genital wart female sexual dysfunction late adolescence sexuality related distress
evaluating benefits of hearing aid microphone directionality technologies

Conditions: Hearing Loss

Summary: this study will evaluate the impact of hearing aid microphone directionality technologies and settings on speech understanding in noise for experienced hearing aid users. it will also evaluate the participant's spatial awareness of sounds using these different hearing aid microphone directionality technologies.


Eligibility criteria:
inclusion criteria: * 18 years or older * experienced hearing aid users * moderate to moderate severe sensorineural symmetrical hearing loss defined as a difference of less than 10 db between ears * must be able to use app and smart phone exclusion criteria: * asymmetrical hearing losses * unable or unwilling to use app and smart phone
oral drug study in women with refractory metastatic breast cancer after first-line or second-line herceptin.

Conditions: Metastatic Breast Cancer; Neoplasms, Breast

Summary: the purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress her2/neu.


Eligibility criteria:
inclusion criteria: (the patient must meet the following criteria in order to be eligible for this study.) * signed informed consent * no more than two prior regimens for metastatic breast cancer. each regimen must have contained herceptin. * refractory stage iiib or iv breast cancer * her2/neu tumor overexpression * disease progression while receiving a prior chemotherapy regimen with herceptin alone or in combination with other chemotherapy. * tumor tissue available for testing. * 2 weeks since treatment with herceptin (alone or in combination). * able to swallow and retain oral medication * cardiac ejection fraction within the institutional range of normal as measured by muga (multiple gated acquisition scan). * adequate kidney and liver function * adequate bone marrow function exclusion criteria: (the patient cannot meet any of the following criteria in order to be eligible for this study.) * prior regimens did not include herceptin. * pregnant or lactating. * conditions that would affect absorption of an oral drug * serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent. * severe cardiovascular disease or cardiac disease requiring a device. * active infection. * brain metastases. * concurrent cancer therapy or investigational therapy. * use of oral or iv steroids. * unresolved or unstable serious toxicity from prior therapy. * treatment with egfr (endothelial growth factor receptor) inhibitor other than herceptin.

Keywords: refractory
a case series evaluating a collagen wound dressing to treat wounds

Conditions: Wound

Summary: chronic wounds are a source of significant morbidity and escalated healthcare costs. the wound care professional has a myriad of modern wound dressings to choose from, each of which has benefits and drawbacks. an understanding of how a given dressing performs in healing a particular wound is crucial in order to determine a clinical mapping of wound dressings to wound types; such a categorization would lead to more efficient clinical decision making and better patient outcomes. this case series will evaluate the ability of a porcine-derived collagen dressing to improve healing of chronic lower-extremity wounds.


Eligibility criteria:
inclusion criteria: * has at least one of the following types of wounds below the knee: diabetic ulcer, pressure ulcer, venous ulcer, ulcer of mixed-vascular origin, traumatic wound, post-surgical wound * wound has been present for at least four weeks * wound is free of necrotic tissue or it is possible for necrotic tissue to be removed by typical debridement practices prior to or during treatment phase * wound has not healed after using at least one other type of advanced wound care treatment * wound size is between 1 and 100 cm2 * patient has adequate circulation, as demonstrated by biphasic or triphasic doppler waveform, measured within three months prior to study enrollment. if monophasic on exam, then non-invasive tests must display ankle brachial index greater than 0.8 and no worse than mild disease on segmental pressures. * wound is free of infection and absence of osteomyelitis. exclusion criteria: * pregnant, planning to become pregnant during the study timeframe, or breast feeding * has a known allergy to porcine products * has an allergy or sensitivity to any type of collagen * unable or unwilling to receive porcine collagen * wound is infected or there is presence of osteomyelitis * inability, in the opinion of the investigator to follow protocol requirements, attend follow up visits in a timely manner, or otherwise comply with the requirements of the protocol
open label study of su011248 in combination with trastuzumab for patients with metastatic breast cancer

Conditions: Breast Neoplasms

Summary: the current study is to evaluate: overall response rate for the combination of trastuzumab and su011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess pk in combination with trastuzumab and compare efficacy and safety.


Eligibility criteria:
inclusion criteria: * a diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease. * her2 positive disease (3+ by immunohistochemistry \[ihc\] or fish-positive) * candidate for treatment with trastuzumab. prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted. exclusion criteria: * prior treatment with \>1 regimen of cytotoxic therapy in the advanced disease setting. adjuvant chemotherapy is permitted * prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions. * prior treatment on a su11248 clinical trial. * uncontrolled brain metastases.

Keywords: breast cancer metastatic
europainclinicsstudy ix

Conditions: Failed Back Surgery Syndrome

Summary: prospective comparison between epiduroscopy procedure, racz catheter procedure and caudal epidural block in patients with fbss

i. epiduroscopy is an advanced proven diagnostic and therapeutic method for chronic radicular pain after spinal surgery. moreover, this method is frequently used in patients with chronic low back pain conditions without previous spine surgery also known as "virgin back". epiduroscopy allows by optical fiber technology and skiascopy imaging the exact examination of the epidural space and subsequently mechanical lysis (with advanced interventional options by laser, radiofrequency, balloon techniques etc.) and/or drug administration to the target point. ii. the racz catheter procedure is based on epidural neurolysis. it is used to release some of the adhesions or scar tissue which surround entrapped nerves in the epidural space of the spine. this state could be caused by chronic inflammatory adhesions or by healing mechanisms after spine surgery - scars. mechanical liberation of epidural space further allows better administration and targeting of drugs as corticoids or hyaluronidase. this technique is performed under fluoroscopy imaging. suitable epidurogram and skiascopy confirm appropriate catheter position during procedure. iii. the caudal epidural block involves placing a needle through the sacral hiatus to deliver medications into the epidural space. this approach to the epidural space is popular in managing a wide variety of chronic pain conditions in adults, especially chronic low back pain syndromes. fluoroscopy is considered as a gold standard of needle guidance during procedures in which caudal epidural injections are performed.

Eligibility criteria:
inclusion criteria: * patients aged between 20 and 80 * patients with fbss (at least 1 - up to 2 lumbar laminectomies) who has radiating pain (vas \>=5) on lower extremities * those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form exclusion criteria: * more than 2 lumbar laminectomies * patients without previous spine surgery * patients with a history of other spinal diseases (compression fracture, spondylitis, tumor) * women with a positive pregnancy test before the trial or who planned to become pregnant within the following 3 years * other patients viewed as inappropriate by the staff * disagreement with participation in the study