Kornimate/medical-research-clean huggingface dataset:
induction chemotherapy and toripalimab for larynx preservation in resectable laryngeal/hypopharyngeal carcinoma

Conditions: Laryngeal Cancer; Hypopharynx Cancer; Laryngeal Neoplasms

Summary: the aim of this study is to define whether combination of induction chemotherapy and pd-1 inhibitor (toripalimab) improve the rate of larynx preservation, for patients with resectable laryngeal/hypopharyngeal carcinoma.

historically, induction chemotherapy could provide a chance of larynx preservation for approximate 60-70% of patients with locally advanced laryngeal/hypopharyngeal carcinoma. recently, phase i-ii clinical studies demonstrated excellent pathological response of induction pd-1 inhibitor with/without chemotherapy for locally advanced head and neck cancer. the aim of this study is to define whether combination of induction chemotherapy and pd-1 inhibitor (toripalimab) improve the rate of larynx preservation, for patients with resectable laryngeal/hypopharyngeal carcinoma.

Eligibility criteria:
inclusion criteria: * pathologically confirmed, resectable locally advanced laryngeal/hypopharyngeal squamous cell carcinoma (t2-4a, n0-resectable n3, m0); * age between 18-75 years; * signed inform consent; * had at least one measurable lesion according to recist 1.1 criteria * anticipated overall survival more than 3 months; * satisfactory performance status: ecog (eastern cooperative oncology group) scale 0-1; * normal organ function; * hbv dna\<500 iu/ml（or 2500 copies/ml）and hcv rna negative ; * male and no pregnant female, able to adapt birth control methods during treatment. exclusion criteria: * hypersensitivity to toripalimab, paclitaxel, nab-paclitaxel and cisplatin; * suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years; * severe, uncontrolled heart disease; * receive vaccine or live vaccine within 28 days prior to signing the informed consent; * equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent; * surgery or trauma within 28 days prior to signing the informed consent; * received other immune checkpoint inhibitors previously; * severe, uncontrolled infections within 28 days of prior to signing the informed consent; * active, known or suspected autoimmune disease; type i diabetes, hypothyroidism those only need hormone replacement therapy, vitiligo or inactive asthma who don't need systemic therapy can recruit; * history of interstitial lung disease; * hiv positive; * hepatitis b surface antigen (hbsag) positive and hbv-dna ≥500iu/ml, or 2500cps/ml; positive hcv rna; * other diseases which may influence the safety or compliance of the clinical trial, such as mental illness, or their family and society factors; * women of child-bearing potential who are pregnant or breastfeeding.

Keywords: induction chemotherapy checkpoint inhibitor pd-1 inhibitor toripalimab larynx preservation
postpartum hemorrhage after shenghua decoction treatment

Conditions: Postpartum Hemorrhage

Summary: a rare case of disastrous delayed postpartum hemorrhage after three days of shenghua decoction treatment.

a rare case of disastrous delayed postpartum hemorrhage after three days of shenghua decoction treatment.

Eligibility criteria:
inclusion criteria: * postpartum hemorrhage after shenghua decoction treatment. exclusion criteria: * nil

Keywords: postpartum hemorrhage
comparison of the effect of medication therapy in alleviating migraine with patent foramen ovale

Conditions: Patent Foramen Ovale; Migraine

Summary: migraine attack is an episodic disorder that affects approximately 12% of the population. previous studies have shown that 41-48% of migraineur have a combination of patent foramen ovale (pfo). clinical observational studies have been linking medication therapies which include anticoagulation and anti-platelet therapy with the effectiveness in improving migraine symptoms and reducing the frequency of attacks in patients combined with a pfo. however, it has been unclear whether the effectiveness of anticoagulation or anti-platelet therapy outweigh the conventional migraine medication therapy, as a result, we designed a multi-center randomized clinical trial aiming to examine the effectiveness of anticoagulation versus anti-platelet versus migraine medication therapy in migraine patients with pfo and provide a clinical guidance for migraineur.


Eligibility criteria:
inclusion criteria: 1. age 18-65 ； 2. diagnosed migraine by ichd-3 3. history of migraine longer than 1 year 4. tcd/tte/tee diagnosed patent foramen ovale 5. willing to participant and agree to follow-ups exclusion criteria: 1. migraine caused by other reason 2. had tia/stroke history 3. hypersensitive or hyposensitive to the study drug 4. with a history of anticoagulation or anti-platelet drug intake 3 month before randomization. 5. with a history of metoprolol intake 3 month before randomization, and migraine attacks did not reduced 50%.

Keywords: migraine patent foramen ovale medication therapy
the effect of abcc2 genetic polymorphism on neurotoxicity in gastrointestinal cancer patients receiving oxaliplatin

Conditions: Gastrointestinal Cancer

Summary: study the effect of genetic polymorphism (rs1885301, rs4148396 and rs3740066) in the membrane of multidrug resistance protein 2 (mrp2) encoded by atp-binding cassette c2 (abcc2) gene and its genetic expression levels on neurotoxicity in gasrtointestinal cancer patients reciving oxaliplatin-based chemotherapy.

several solutes carriers and atp-binding cassette transporters have been implicated in the influx or efflux of platinum-based chemotherapeutic agents such as cisplatin, carboplatin, and oxaliplatin. the atp-binding cassette (abc-) transporter superfamily contains several family members that may confer intrinsic or acquired multidrug resistance (mdr) by extruding anticancer agents or their metabolites from cells and suppression of such transporters may lead to sensitisation to cytostatic agents. multidrug resistance protein 2 (mrp2), encoded by the atp-binding cassette c2 (abcc2) gene , is an efflux pump located on the apical membrane of many polarized cells, which transports conjugate compounds by an atp-dependent mechanism like oxaliplatin. single nucleotide polymorphisms (snps) in genes involved in drug transport like abcc2 gene may lead to higher intracellular oxaliplatin accumulation in the dorsal root ganglia and thus increased risk of oxaliplatin-induced peripheral neurotoxicity (oxpn). enhanced abcc2 expression can lead to decreased cellular glutathione content. glutathione is needed for oxaliplatin detoxification via conjugation, and it was reported that low glutathione intra- cellular levels can cause increased oxaliplatin cytotoxicity. moreover, abcc2 mediates the export of the oxaliplatin-glutathione conjugated form, and abcc2 overexpressing cells were resistant to platinum derivatives.

Eligibility criteria:
inclusion criteria: 1. gastrointestinal cancer patients ( ≥ stages ii ) who receive oxaliplatin based chemotherapy ( folfox6 ) for adjuvant and metastatic setting. 2. eastern cooperative oncology group ( ecog ) performance ≤ 2. 3. adequate bone marrow functions ,liver functions and renal functions. exclusion criteria: 1. patients who have any clinical neuropathy. 2. pateints with diabetes mellitus. 3. serious comorbid systemic disorder incompatible with study. 4. pregnancy. 5. other primary tumors.

Keywords: neurotoxicity oxaliplatin genetic polymorphism
long-term safety and tolerability study of nktr-181 in subjects with chronic low back pain or chronic non-cancer pain

Conditions: Low Back Pain; Chronic Pain

Summary: the purpose of this 52-week open label study is to determine the long-term safety of a new opioid molecule, nktr-181, in patients with moderate to severe chronic low back pain or chronic non-cancer pain.

this is an open-label safety and tolerability study in which approximately 600 subjects will receive nktr-181 for up to 52 weeks. subjects may include newly enrolled subjects and subjects who have recently completed summit-07 study. this study will also investigate the pharmacokinetics of nktr-181 in patients with chronic low back pain or chronic non-cancer pain.

Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-nursing female aged 18 to 75 years old * clinical diagnosis of moderate to severe, chronic low back or non-cancer pain for at least three months * not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics * opioid analgesia is necessary * currently taking no less than 10 mg but no more than 60 mg of morphine sulfate equivalents (mse) per day of opioid analgesics for at least 7 days prior to entry * females of child bearing potential must be using a highly effective form of birth control. all subjects must agree to use double-barrier contraception during participation in this study and for at least 2 months after the last dose of the study drug. * willing and able to provide informed consent exclusion criteria: * history of hypersensitivity, intolerance, or allergy to opioids * surgical procedures in the last 4 weeks or plans to undergo surgical procedures during the study period * untreated moderate to severe sleep apnea * chronic migraines as the primary pain condition * cancer related pain
effect of light meal on pharmacokinetic and pharmacodynamics of aliskiren in patients with mild to moderate hypertension

Conditions: Hypertension

Summary: the purpose of this study is to determine the effect of a light meal on the pharmacokinetics and pharmacodynamics of aliskiren in patients with mild to moderate hypertension.


Eligibility criteria:
inclusion criteria: * male or female outpatients, 18 to 65 years of age with mild to moderate hypertension * patients who are eligible and able to participate in the study exclusion criteria: * severe hypertension * secondary form of hypertension. * type 1 or type 2 diabetes mellitus * serum potassium out side laboratory reference range * any history of hypertensive encephalopathy or cerebrovascular accident other protocol-defined inclusion/exclusion criteria may apply

Keywords: aliskiren, hypertension, renin-angiotensin-aldosterone system, pharmacokinetics, pharmacodynamics
effect of collagenase on healing and scarring

Conditions: Scarring; Impaired Wound Healing

Summary: a study to compare the rate of complete wound closure and quality of resulting scar at 3, 6 and 9 months, between dermatome-induced skin wounds treated with collagenase santyl ointment versus vehicle alone.


Eligibility criteria:
inclusion criteria: 1. provide written informed consent 2. willing to attend all required study visits exclusion criteria: 1. known hypersensitivity to clostridial collagenase 2. anticoagulants (blood thinners, including aspirin) within two weeks 3. congenital skin disorder which affects keratinocytes, elastin, or collagen 4. any dermatologic disease which may be aggravated or provoked by the wounding procedure 5. dark skin pigmentation to a degree which is very likely to obscure the assessment of vascularization post-wounding 6. at risk of keloid or hypertrophic scar formation 7. scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper arm area where the wound will be placed 8. any skin disorder which causes delayed healing 9. disrupted lymphatic drainage of the arm to be studied, or previously diagnosed thoracic outlet syndrome 10. taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs

Keywords: wound healing scarring collagenase santyl
focal salvage hdr brachytherapy for the treatment of prostate cancer

Conditions: Prostate Cancer

Summary: radiation therapy is considered a standard treatment option for the management of localized prostate cancer. among the 20-30% who recur, a proportion of them will present with an isolated local recurrence, meaning no distant metastases. if left untreated, it may serve as a source for subsequent metastases. salvage options available for isolated local recurrence include; temporary or permanent implantation of radioactive seeds into the prostate, complete removal of the prostate gland, use of low temperatures to treat the disease, and high frequency ultrasound to treat the disease. there are risks of complications associated with all these treatments, and there is presently no consensus as to which treatment is the best. therefore, the aim of this pilot study is to look at the feasibility and toxicities of focal treatment of the prostate using temporary implantation of radioactive seeds into the prostate which the investigators hope will be less since the entire prostate is not treated.


Eligibility criteria:
inclusion criteria: * biopsy-confirmed locally recurrent prostate adenocarcinoma \> 30months after the completion of xrt, sbrt, ldr or hdr brachytherapy boost with xrt, or ldr or hdr brachytherapy as monotherapy by a stereotactic transperineal biopsy * staging t2-weighted, dwi and dce-mri that demonstrates solitary recurrence confined to prostate, and correlates with stereotactic transperineal biopsy * staging ct or mri (abdomen and pelvis) and bone scan are negative for metastases * american urological association symptom index score (ie. ipss) \< 15 * baseline (post-xrt) serum psa \< 10 ng/ml * prostate volume as measured by transrectal ultrasound (trus) \< 50cc * ecog performance status 0-1 exclusion criteria: * any of the following prior therapies: transurethral resection of the prostate (turp), radionuclide (permanent or temporary implantation) prostate brachytherapy, prostatectomy or prostatic cryosurgery, hifu (high-intensity focused ultrasound), bilateral orchiectomy, chemotherapy for prostatic carcinoma * evidence of castrate resistance (defined as psa \> 3 ng/ml while testosterone is \< 1.7 nmol/l). patients could have been on combined androgen blockade with initial radiotherapy but are excluded if this was started due to psa progression.

Keywords: prostatic neoplasms brachytherapy salvage therapy recurrent prostate cancer
clinical protocol cern feasibility study

Conditions: Bacterial Vaginosis; Fungal Vaginal Infections

Summary: the goal of this clinical trial is to learn if the intravaginal cern device works to treat bacterial vaginosis and fungal vaginitis in premenopausal women. it will also learn about the safety of the device. the main questions it aims to answer are: does the device accomplish symptom resolution and negative diagnostic tests post-treatment? what medical problems do participants have when using the intravaginal device? participants will use the investigational intravaginal device for 5 consecutive days, participate in teleconferences and weekly follow-ups, attend in-clinic visits, and maintain a study diary.

the cern feasibility study is an interventional clinical trial designed to evaluate the cern medical device in the treatment of bacterial vaginosis and fungal vaginitis. the study assesses both the efficacy and safety of this innovative technology, which combines 450nm visible spectrum light with a natural photosensitizer (carboxy methyl cellulose and curcumin). the primary objective is to determine the device's effectiveness by measuring symptom resolution and negative diagnostic tests post-treatment. the secondary objective focuses on safety, monitoring adverse effects and patient tolerance during and after treatment. the study design involves recruiting up to 30 premenopausal women with culture-confirmed bacterial vaginosis or fungal vaginitis. participants are divided into two groups, in the bacterial vaginosis group, the device is used for 30 minutes daily for 5 consecutive days. and in the fungal vaginitis group, the device is used for 60 minutes daily for 5 consecutive days. following treatment, participants undergo a 45-day follow-up period, which includes daily telecom check-ins during treatment, weekly follow-ups, and a final assessment at 28 days post-treatment. adherence is tracked through daily diaries and telecom follow-ups, ensuring treatment compliance, effectiveness monitoring, and adverse reaction tracking. treatment success is determined by self-reported symptom resolution and negative diagnostic cultures, while safety is assessed through self-reported adverse events and clinical examinations.

Eligibility criteria:
inclusion criteria: * confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis exclusion criteria: * postmenopausal status, current use of intravaginal devices, concurrent medical therapy for fungal vaginitis or bacterial vaginosis, recent medical therapy for vaginitis in past 7 days, immunosuppressive medication ≤ 3 months before screening, radiation therapy ≤ 3 months before screening, known allergy to curcumin, acrylic, or silicone, major organ disease or clinically significant infection or conditions that may affect clinical assessment of vaginitis, pregnancy or plans for pregnancy, history of intolerance to intravaginal devices, symptomatic pelvic organ prolapse stage 2 or greater.
physical activity immediately after acute cerebral ischemia

Conditions: Ischemic Stroke; Physical Activity

Summary: stroke is the leading cause of adult disability in europe and united states and the second leading cause of death worldwide and affects more than 10,000 danes each year. studies in a late and stationary phase after stroke have shown that physical rehabilitation is of great importance for survival and physical ability of these patients, however many studies show that patients lie or sit next to their bed under hospitalization for more than 88.5 % of the daily hours. physical activity in stroke patients has never previously been measured immediately after debut of symptoms; furthermore there is no knowledge about the optimal dose of physical rehabilitation for these patients. accelerometers, small measuring devices, are a relatively new way to measure physical activity precisely, and hence it is possible to obtain an objective measure of how active stroke patients are in the first week after admission. the accelerometers measure a variable voltage, depending on the range and intensity of movement. they can measure movement dependent of the placement of the accelerometer, for instance over the hip, arm or leg. studies confirm their reliability, even in patients with abnormal gait, such as stroke patients. another approach of studying the effects of physical activity and rehabilitation is through the examination of biomarkers. studies have shown that biomarkers released during physical activity can inhibit biomarkers released after tissue injury in the brain, as seen after stroke. these brain biomarkers cause further damage and studies show that the higher the levels, the higher the damage. it is therefore obvious to examine whether physical activity rehabilitation can down regulate this destructive process in patients with stroke. clarification of physical activity in stroke patients immediately after debut of symptoms and examination of both the biochemical aspects of physical rehabilitation as well as the optimal dose of physical rehabilitation is of great importance for many patients, their relatives as well as of a great socioeconomic importance. the purpose of the project is to describe the amount and pattern of physical activity in stroke patients in the first week after admission. the investigators hypothesis is that patients are inactive for most of the time during hospitalization, activity being correlated with severity of stroke, but not with age, bmi and sex.


Eligibility criteria:
inclusion criteria: * patients admitted with acute ischemic stroke * age \> 18 years exclusion criteria: * symptoms attributable to other diseases than ischemic stroke * debut of symptoms \> 48 h prior to admission * consent not given \< 24 h of admission * pregnancy or lactation * isolation * bloodsampling generally not possible * allergy due to accelerometer wear * ulcers or other skin diseases in the area of accelerometer placement

Keywords: acute ischemic stroke accelerometer
the effects of tysabri treatment on vaccination response and lymphocyte subsets in subjects with relapsing forms of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the primary objectives of this study were: to evaluate the effect of tysabri® (natalizumab) on antibody responses after immunization with a neoantigen (keyhole limpet hemocyanin \[klh\]) and a recall antigen (tetanus toxoid \[td\]), and to evaluate the effect of tysabri on circulating lymphocyte subsets (cd3+, cd4+, cd8+, cd19+, and cd56+) over time in participants with relapsing forms of multiple sclerosis (ms). the secondary objective was to assess alpha4-integrin saturation and alpha4-integrin expression levels over time.


Eligibility criteria:
inclusion criteria: * able to give written informed consent * diagnosis of a relapsing form of ms and must fall within the therapeutic indication stated in the approved label for tysabri * aged 18-60 years, inclusive at the time of consent * free of signs and symptoms suggestive of any serious opportunistic infection, based on medical history, physical examination, or laboratory testing * must have a known history of tetanus toxoid immunization major exclusion criteria: * tetanus toxoid vaccination less than 2 years prior to screening * known hypersensitivity to tetanus-diphtheria vaccine or klh or any other administered vaccinations or their components (such as thimerosal) * known allergy to shellfish * history of active tuberculosis or undergoing treatment for tuberculosis * previous exposure to klh or vaccines containing klh components (e.g., cancer vaccines) * known history of human immunodeficiency virus (hiv), hepatitis c, or hepatitis b infection * history of, or available abnormal laboratory results indicative of any significant disease * history of malignancy * history of organ transplantation (including anti-rejection therapy) * history of severe allergic or anaphylactic reactions or known drug hypersensitivity * a clinically significant infectious illness within 30 days prior to the screening visit * prior exposure to tysabri, rituximab, any murine protein, or any therapeutic monoclonal antibody at any time * receipt of intravenous (iv) or intramuscular (im) immunoglobulin within 6 months of screening * live virus, bacterial vaccines, or any other vaccines within 3 months of screening * treatment with immunosuppressant medications within 6 months prior to screening * treatment with cyclophosphamide within 1 year prior to screening * treatment with immunomodulatory medications (interferon beta and glatiramer acetate) within 2 weeks prior to screening * treatment with systemic corticosteroids within 4 weeks prior to screening * treatment with any investigational product or approved therapy or vaccination for investigational use within 6 months prior to screening * women who are breastfeeding, pregnant, or planning to become pregnant during the study * female subjects who are not postmenopausal for at least 1 year, surgically sterile (does not include tubal ligation), or willing to practice effective contraception during the study

Keywords: ms multiple sclerosis relapsing forms of multiple sclerosis