Kornimate/medical-research-clean huggingface dataset:
autologous tumor infiltrating lymphocytes (gt101 injection) in patients with recurrent or metastatic cervical cancer

Conditions: Adult

Summary: this is a phase ii, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of autologous tumor infiltrating lymphocytes (gt101 injection) compared with gemcitabine in participants with recurrent or metastatic cervical cancer.


Eligibility criteria:
inclusion criteria: * 1. the patients (or legally authorized representative) patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (icf) approved by an institutional review board/independent ethics committee (irb/iec) ,must have the ability to understand the requirements of the study); * 2. the patient must be 18 to 70 years of age at the time of consent; * 3. must have a confirmed diagnosis of malignancy of their receptive histologies or cytology: unresectable recurrent or metastatic cervical carcinomas and previously received≥ 1 prior systemic therapy; * 4. eastern cooperative oncology group (ecog) performance status score of 0 or 1; * 5. expected survival time of ≥ 12 weeks; * 6. adequate normal organ and marrow function; * 7. before tumor resection, the confirmatory imaging of disease progress since last treatment should be documented. * 8.patients must have measurable disease measured by response evaluation criteria in solid tumors (recist) 1.1 criteria (in addition to the resected lesion). exclusion criteria: * 1.patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring painkiller must already have had a stable pain management options at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry; * 2.patients who have psychiatric disorders, alcohol, drug or substance abuse; * 3.women who are pregnant or breastfeeding, or planning to become pregnant within 1 year after cell infusion; * 4.participate in other clinical trials within 4 weeks prior to screening, or planning to participate in this study and other clinical trials at the same time; * 5.any other conditions that would make the patient unsuitable candidate for the study at the discretion of the investigator.
assessment of digital imaging as a tool for diagnosing psoriasis, hand rashes and unusual moles

Conditions: Dermatitis; Nevus; Psoriasis

Summary: this study will evaluate whether digital photography is a reliable tool for diagnosing hand rashes, psoriasis and unusual moles. the findings will help determine if this method can be used in the national health and nutrition examination survey (nhanes), which monitors disease in the united states. employees of the national institutes of health 19 years and older may enroll in this study. participants will complete a brief questionnaire that includes information on skin type, history of skin conditions (moles, cancer, rashes, psoriasis), and demographic information such as name, age and sex. they will be examined by a dermatologist, who will note in writing the appearance of any hand rashes, unusual moles, or psoriasis. if any areas suspicious for skin cancer are found, the participant will receive this information in writing, along with advice about where to go for treatment. a total of six photographs will then be taken of the participant's arms, legs, hands and back. the face will not be photographed, and the participants will not be identifiable.

this validation study is designed to evaluate the sensitivity, specificity, validity and reliability of digital photography of the skin as a prevalence assessment tool in preparation for the national health and nutrition examination survey, 2001 (nhanes iv). nhanes is charged with monitoring disease in the u.s. population, which is affected frequently by skin disorders and disease. the three skin disorders proposed for study in nhanes iv are atypical nevi, psoriasis, and hand dermatitis. this selection is based on the expected impact of these diseases on the u.s. population, including a prevalence of 3-10%, associated risk of melanoma in the case of atypical nevi, and associated disability in the cases of psoriasis and hand dermatitis. this skin disease section of nhanes, as currently planned for 2001, includes an imaging component with four standardized photographs to be obtained from each survey participant (sp). the selection of the regions to be photographed is designed to maximize the information obtained, while preserving patient privacy and is based on the known distribution of clinical findings of the three conditions, as well as nhanes logistical limitations. this validation study is a cooperative effort between the niams extramural programs, the nci intramural program, and the national center for health statistics.

Eligibility criteria:
must have employee status at the national institutes of health. age greater than 18 years. able to understand and sign consent. patients who are wheelchair bound and are unable to have images of their back and lower extremities taken safely will be excluded from photography since this portion of the examination requires an ability to stand. however, they will still be eligible to participate in the skin cancer screening.

Keywords: epidemiology nhanes photography prevalence skin disease healthy volunteer
pain phenotyping in patients with neuropathic pain after spinal cord injury

Conditions: Spinal Cord Injuries; Pain, Neuropathic; Nociceptive Pain; Neuropathy

Summary: the development of neuropathic pain is one of the most debilitating sequels after a spinal cord injury (sci). the overall aim of this study is to investigate potential underlying pathophysiological mechanisms of neuropathic pain after sci. the functionality of the nociceptive pathway in humans as well as its plastic changes following sci will be inferred with sophisticated sensory and pain phenotyping using quantitative sensory testing (i.e., psychophysical measures), objective neurophysiological measures of pain processing and the recording of pain-related autonomic responses (i.e., galvanic skin response, cardiovascular measures and pupil dilation). in addition, the interplay between the somatosensory and autonomic nervous system and its association with the development and maintenance of neuropathic pain after sci will be investigated.


Eligibility criteria:
inclusion criteria: * spinal injury cohort - general inclusion criteria: * aged between 18-80 years * traumatic and non-traumatic etiology * para- and tetraplegic sci * complete and incomplete sci * sci with and without neuropathic pain * additional inclusion criteria for longitudinal study: * sci since less than one month * additional inclusion criteria for cross-sectional study: * sci since more than one year * control cohorts with peripheral neuropathy: * general inclusion criteria: * aged between 18-80 years * neurological disorder affecting the peripheral nervous system (i.e., peripheral neuropathy) * peripheral neuropathy with or without neuropathic pain * additional inclusion criteria for longitudinal study: * peripheral neuropathy since less than one month * additional inclusion criteria for cross-sectional study: * peripheral neuropathy since more than one year * control cohorts without neuropathy / healthy volunteers * general inclusion criteria: * aged between 18-80 years * no medical condition affecting the peripheral and/or central nervous system (e.g., pain, systemic disease, psychological disorder) exclusion criteria: * inability to follow study instructions * pregnancy * medically manifested psychological disorder * medical condition affecting the peripheral and/or central nervous system other than the desired experimental condition (e.g., additional peripheral neuropathy in the sci cohort)
salivary melatonin levels and sleep quality in patients with burning mouth syndrome

Conditions: Burning Mouth Syndrome; Melatonin

Summary: burning mouth syndrome is an idiopathic condition characterized by symptoms burning and / or pain of the oral mucosa with an orderly clinical finding. so far not found a unique way of treatment. it is a diagnosis that impairs the quality of life of patients, and consequently it can affect the quality of sleep. melatonin is a hormone secreted from pineal gland and regulates the day-night rhythm of man, and whose production in the body decreases aging. the level of melatonin in saliva correlates well with the level of melatonin in plasma, therefore they are advantages of determining from saliva painlessness and non-invasiveness of the procedure itself. the purpose of this study was to compare the level of melatonin in saliva and the quality of sleep with help of the epworth sleepiness scale in patients with burning mouth syndrome and control groups of patients without subjective oral disorders and with an orderly clinical finding.


Eligibility criteria:
inclusion criteria: * female patients * primary burning mouth syndrome * without oral lesions exclusion criteria: * secondary burning mouth syndrome * male gender * patients with oral lesions
comparing how burn wounds and scars heal in children using chitosan and silver dressings

Conditions: Burns Degree Second; Pediatric

Summary: burns are among the most common types of trauma worldwide, ranking fourth after traffic accidents, falls, and violence, and account for an estimated 265,000 deaths annually (who). most burn injuries result from heat exposure, though other causes include friction, chemicals, and electricity. effective burn treatment aims to promote wound healing by supporting tissue regeneration and maintaining optimal conditions such as moisture, oxygenation, and low bacterial load. in slovenia and across europe, silver-based dressings are commonly used for burn care. while they are known to support wound healing, their effectiveness in reducing scar formation remains unclear. chitosan-based hydrogels, by contrast, offer promising benefits due to their natural biocompatibility, antibacterial action, and support for tissue repair, though clinical data are still limited. this study aims to compare the effectiveness of chitosan-based and silver-based dressings in burn wound healing, focusing on healing time, scar formation, cost-efficiency, and patient experience. scar outcomes will be assessed using the validated posas (patient and observer scar assessment scale).


Eligibility criteria:
inclusion criteria: 1. age between 6 months and 17 years old 2. having a first or second-degree superficial burn that does not require excision and grafting 3. patients with a burn of less than 20% of the total body surface area (tbsa) 4. admission within 72 hours of burn injury 5. first line of therapy is burnshield® dressing for the first 48 hours 6. clean non-infected wound as diagnosed by the attending physician 7. informed consent of the patient or caregiver exclusion criteria: 1. causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite) 2. diabetes mellitus 3. significant cardiac, pulmonary, or renal insufficiency 4. severe hematologic disease, malignancy, hypo-immunity 5. wounds noted to be contaminated or infected 6. systemic inflammatory response syndrome (sirs) or sepsis 7. moderate or severe respiratory tract or lungs burn injuries 8. previous treatment efforts such as previous debridement, silver sulfadiazine ointment or other topical agents (e.g.: oil, toothpaste, betadine, rivano) 9. being pregnant or breastfeeding 10. known sensitivity or allergy to one of the dressings or its components.

Keywords: chitosan-based dressing silver-based dressing
combination treatment with btl-899 and hpm-6000uf devices

Conditions: Pelvic Floor Disorders

Summary: this study will evaluate the clinical efficacy of the btl-899 and hpm-6000uf devices in combination for non-invasive strengthening of the core muscles and overall improvement in quality of life in elderly patients.

the study is a prospective, multicenter single-arm, open-label, interventional study. the subjects will be enrolled and assigned into a single study group. subjects will be required to complete seven (7) treatment visits and two (2) follow-up visits - 1 month and 3 months after the final treatment. at the baseline visit, medical history will be assessed. inclusion and exclusion criteria will be verified, and informed consent will be signed. digital photographs will be taken, waist circumference will be measured, abdominal muscle strength will be measured with a pressure biofeedback device. the two devices will be used separately in two different treatments. however one treatment visit can comprise both treatments. the btl-899 will be applied over the abdomen, and the device will induce visible muscle contractions along with mild heating of the muscles. four (4) treatments once a week will be delivered. the hpm-6000uf device will induce pelvic floor muscle contractions. six (6) treatments 2-4 days apart will be delivered. there will be three (3) visits where both treatments will be applied consecutively, starting with btl-899, followed by the therapy with hpm-6000uf.

Eligibility criteria:
inclusion criteria: * healthy male or female subjects aged 60 years or older (postmenopause when female), * bmi ≤35kg/m2 seeking treatment for strengthening their pelvic floor or abdominal muscles * subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the informed consent form. * subjects willing and able to abstain from partaking in any concurrent treatments on abdomen and pelvic floor other than the study procedures during study participation. * willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs taken. exclusion criteria: * electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators) * metal implants in the treated area * drug pumps * malignant tumor * pulmonary insufficiency * injured or otherwise impaired muscles in the treated area * cardiovascular diseases * disturbance of temperature or pain perception * hemorrhagic conditions * septic conditions and empyema * acute inflammations in the treated area * systemic or local infection such as osteomyelitis and tuberculosis * contagious skin disease * elevated body temperature * poor healing and unhealed wounds in the treatment area * following recent surgical procedures when muscle contraction may disrupt the healing process * graves' disease

Keywords: core strength abdominal muscles pelvic floor muscles quality of life
the effects of different dentin hypersensitivity treatment methods on quality of life

Conditions: Dentin Hypersensitivity

Summary: the aim of this study was to evaluate the effects of a self etch adhesive resin and two desensitizing agents(calcium phosphate, 5% glutaraldehyde) in treatment of dentin hypersensitivity on the quality of life of individuals.

this in-vivo study was done among 69 participants who reported at least one sensitivite tooth(schiff sensitivity score \>1) as a result of the clinical examination. participants were randomly divided into three treatment groups(n=23): i. tetracalcium phosphate and dicalcium phosphate containing desensitizer (teethmate desensitizer) ii. %35 hydroxyethyl methacrylate and %5 glutaraldehyde containing desensitizer (gluma desensitizer) iii. self-etch adhesive resin (hybrid bond) these materials used in treatment of dentin hypersensitivity in 6 months clinical follow-up and the effects on the quality of life of individuals were evaluated with dentine hypersensitivity experience questionnaire (dheq).

Eligibility criteria:
inclusion criteria: * not having any systemic disease, * 18 years and older, * at least one tooth complaining of dentin hypersensitivity (schiff score\> 1), * the acceptance of the volunteers participating in the research. exclusion criteria: * active periodontal disease, * periodontal surgery for the last 3 months, * use of desensitizing toothpaste or mouthwash in the last 3 months, * long-term use of analgesic and anti-inflammatory drugs, * having a history of allergies, * women during pregnancy or breastfeeding, * parafunctional habits (bruxism, teeth grinding etc.), * the presence of caries, pulpitis or restoration in teeth, * tooth tissue loss due to erosion, abrasion and abfraction, * congenital anomalies, * cracked teeth were not included in the study.

Keywords: dentin hypersensitivity desensitizing agent adhesive resin
intertransverse process block for postoperative acute pain after coronary bypass surgery

Conditions: Postoperative Pain; Coronary Artery Bypass Grafting (CABG) Surgery; Sternotomy

Summary: this prospective, randomized controlled trial aims to evaluate the effect of bilateral intertransverse process block (itpb) on acute postoperative pain in patients undergoing coronary artery bypass grafting (cabg) via median sternotomy. patients will be randomly assigned to receive either itpb or placebo (saline) injection prior to surgery. postoperative pain scores, opioid consumption, and recovery quality will be assessed during the first 24 hours following extubation.

coronary artery bypass grafting (cabg) is associated with significant postoperative pain due to sternotomy and tissue manipulation, which may impair recovery, increase opioid consumption, and prolong hospital stay. regional anesthesia techniques are increasingly used as part of multimodal analgesia strategies to minimize opioid-related side effects. the intertransverse process block (itpb) is a novel regional technique that targets the dorsal rami of spinal nerves and may provide effective bilateral analgesia in thoracic procedures with a favorable safety profile. this prospective, randomized, triple-blind controlled study aims to investigate the effect of preoperative bilateral itpb on postoperative acute pain, opioid consumption, and recovery quality in adult patients undergoing elective cabg via median sternotomy. patients will be randomized to receive either itpb with 0.25% bupivacaine or a placebo (saline) injection under ultrasound guidance. postoperative outcomes, including numeric rating scale (nrs) pain scores, rescue analgesic use, total opioid consumption, and quality of recovery-15 (qor-15) scores, will be collected within the first 24 hours following extubation. the results of this study may support the incorporation of itpb into routine analgesia protocols for cardiac surgery patients.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * elective coronary artery bypass grafting (cabg) via median sternotomy planned * able to provide written informed consent * able to communicate symptoms reliably with the research team exclusion criteria: * emergency cabg surgery * infection or open wound at the injection site * coagulopathy * hepatic or renal failure * reoperation cases * incomplete or missing data

Keywords: intertransverse process block coronary artery bypass grafting postoperative pain cardiac surgery median sternotomy
interaction between rimonabant and cyclosporine and tacrolimus

Conditions: Renal Transplantation

Summary: the major cause of premature death in renal transplant recipients is cardio-vascular disease. in addition, obesity is becoming a major problem in this patient population. rimonabant does not only seem to have weight reducing properties but also weight reduction independent effects on insulin sensitivity and endothelial function, two important cardio-vascular risk factors. rimonabant therefore is an interesting drug for the treatment of transplanted patients. present data also indicate that rimonabant does not interact with essential immunosuppressive drugs (csa and tac) indicating that it most probably is safe to administer to this patient population. however this needs to be investigated in a proper manner.

renal transplant recipients are treated with life-long immunosuppressive therapy in order to prevent acute rejection episodes. the calcineurin inhibitors (csa and tac) are the back-bones in the immunosuppressive treatment and they have a very narrow therapeutic index. it is therefore essential to assure that new drug to be used in transplanted patients do not interact with csa and tac. even though rimonabant is metabolized via the same enzyme as csa and tac (cyp3a4) previous in vitro and in vivo studies with relevant probe drugs in healthy volunteers do not indicate the presence of any relevant pharmacokinetic interaction. however, to be absolutely sure that it is safe to administer rimonabant in transplanted patients a 12-hour pharmacokinetic interaction investigation is included for 16 patients in the present pilot study (8 patients on csa and 8 patients on tac).

Eligibility criteria:
inclusion criteria: * renal transplant recipient with stable renal function (less than 20% deviation in serum creatinine the last 2 months). * renal transplant recipient currently on csa or tac and prednisolone based immunosuppression. * bmi \> 30 kg/m2 or \>27 kg/m2 in combination with one or more cardio-vascular risk factors. * \> 18 years of age. * male patient, or female patient without childbearing potential (surgically sterilized or postmenopausal) or, if female of childbearing potential, is not lactating, has a negative pregnancy test at screening and is willing to utilize an effective method of contraception throughout the study period and for 90 days following discontinuation of the study drugs. * signed informed consent. exclusion criteria: * diabetes mellitus * severe liver disease. * depressive-, anxiety- or sleeping disorders. * estimated gfr \< 25 ml/min. * epilepsy. * skin disorders that may influence laser doppler flowmetry investigations. * pregnant or nursing mothers. * concomitant treatment with cyp3a4 inhibitors (www.cyp450.no) with interaction potential according to the investigator.

Keywords: obese calcineurine inhibitor pharmacokinetics interaction