Kornimate/medical-research-clean huggingface dataset:
dose-ranging study of ramosetron for the prevention of nausea and vomiting after gynecologic laparoscopic surgery

Conditions: Postoperative Nausea and Vomiting

Summary: many patients receiving opioid based analgesia after gynecologic laparoscopic surgery experience postoperative nausea and vomiting (ponv) despite prophylaxis and treatment with ht3 receptor antagonists. although a high dose of ramosetron can cause adverse effects such as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients is unknown. the aim of this study is to determine the effective dose of ramosetron for prophylaxis of ponv in a high-risk patients receiving intravenous opioid-based patient-controlled analgesia after gynecological laparoscopic surgery.


Eligibility criteria:
inclusion criteria: * patient between 20 and 70 of age with asa physical status ⅰ-ⅱ * patient scheduled for elective gynecological laparoscopic surgery. exclusion criteria: * hepatorenal disease * bmi \> 35 kg/m2 * allergy to ramosetron * gastrointestinal disease * vomiting within 24h * administration of antiemetics or opioids within 24h * qt prolongation (qtc \> 440ms) * pregnant * problem with communication
pro-coagulant markers and anticoagulant failure in cancer patients at risk for recurrence of venous thromboembolism

Conditions: Venous Thromboembolism; Deep-Vein Thrombosis; Pulmonary Embolism; Cancer

Summary: the presence of clots in the veins of arms and/or legs or lungs of cancer patients decreases their quality of life, delays their treatment and may cause death. the best way to avoid new clots is by giving blood thinners before clots are formed, but even some patients who are taking blood thinners may form blood clots. a major problem is that it is difficult to know which patients form clots while they are receiving blood thinners, a situation called treatment failure. several studies have shown that by doing blood tests that measure the formation of clots, the investigators could know if the patient is responding to the blood thinners. if this is proven, the investigators will be able to apply these tests to all patients.

therapeutic failure in cancer patients at high risk for recurrence of venous thromboembolism (vte) may be as high as 20% and the risk of death from a recurrent episode of pulmonary embolism is at least 8%. studies that have used pro-coagulant and thrombin generation markers support the notion that cancer is associated with a hypercoagulability state and that intensified doses of anticoagulation may be necessary to suppress this state. thus, it may be possible that by using these tests, we would identify the patients that do not respond to standard doses of anticoagulation. to date, only few small studies have evaluated the use of pro-coagulant markers in cancer patients but this data is promising. our study will measure pro-coagulant markers in cancer patients at risk for vte recurrence to determine if there is a relationship between the changes in the levels of pro-coagulant markers and vte recurrence while taking anticoagulation with low-molecular weight-heparin (lmwh). the evaluation of the pro-coagulant markers may enable new treatment strategies in cancer patients who fail their initial treatment. patients will be stratified by a risk model developed by our group and will be validate with this study. this new approach has the potential to improve the recovery of patients, to reduce death and disability due to clots in the veins of legs or arms and/or lungs.

Eligibility criteria:
inclusion criteria: * patients with any type of cancer (except basal cell and squamous cell carcinoma of the skin) and at any stage of the disease or treatment * confirmed newly diagnosed acute symptomatic vte (proximal dvt, pe, arm dvt, multiple sspe only) * planned treatment of vte with low-molecular weight heparin (lmwh) * age 18 years old or older. exclusion criteria: * planned cell transplant * patient receiving anticoagulation due to other clinical indications * patient who has received more than one therapeutic dose of lmwh * unable or unwilling to provide written, informed consent.

Keywords: venous thrombosis coagulation factors cancer blood
behavioral intervention trial for hiv-infected injection drug users

Conditions: HIV

Summary: the purpose of this study is to test whether a ten-session behavioral intervention for hiv-infected injection drug users is effective in reducing sex and injection risk behaviors that put others at risk for hiv infection, increasing access to or utilization of hiv primary health care, and increasing adherence to hiv medications.

inspire is a four-site (baltimore, miami, new york and san francisco) randomized control trial to develop and evaluate the efficacy of a ten-session intervention for hiv-positive injection drug users. the primary goals of the intervention are to: 1. decrease sex and injection risk behaviors that put others at risk for hiv infection, 2. increase access to or utilization of hiv primary health care, and 3. increase adherence to hiv medications. the intervention arm consists of 7 group sessions, 2 individual sessions, and one community experience. the control arm consists of 8 group sessions, aiming at controlling for demand (1st session) and attention (8 group sessions). behavioral assessments and blood draws (for viral load and cd4 testing) occur at baseline, 6, and 12 month follow-up; a 3 month assessment involves behavioral assessment only. 1161 participants took baseline. of these, 966 were randomized into the study, and 840, 807, and 821 participants took 3, 6, and 12 month follow-up assessments, respectively.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * self-identify as a person who has injected drugs in the last 12 months * self-identify as a person who has had sex with at least one opposite sex partner within the last 3 months * self-identify as hiv-seropositive * be confirmed as hiv seropositive through oral fluid (saliva) hiv testing * live in the geographic region under study, * agree to have their blood drawn for cd4 count and viral load testing * be willing to provide basic contact information (for follow-up) * be able to communicate in english * not have participated in the full-pilot of this intervention and not have enrolled previously in the present study. exclusion criteria: -

Keywords: iv drug users
latent myofascial trigger points in the craniocervical region

Conditions: Myofascial Pain Syndrome

Summary: myofascial pain is a clinical problem that has generated interest, debate and confusion for decades. according to studies anywhere between 33 and 97 % of patients with musculoskeletal pain visiting physicians and manual therapists are diagnosed with myofascial trigger points (mtrps). mtrps are localized, hyperirritable points that are associated with palpable nodules in taut bands (tb) of muscle fibres. mtrps can be classified into active and latent. latent mtrps demonstrate the same clinical characteristics as active mtrps but they do not provoke spontaneous pain. the myofascial trigger points (mtrps) are common in healthy subjects and in patients with musculoskeletal pain, and could produce sensitive disturbances and motor dysfunctions


Eligibility criteria:
inclusion criteria: * neck pain exclusion criteria: * myelopathy * fracture * infection * dystonia * tumor * inflammatory disease * fibromyalgia * or osteoporosis

Keywords: trigger points trigegeminal nerve pain
embedded palliative care in managing symptoms in participants with recurrent stage iii-iv thoracic malignancies and their caregivers

Conditions: Caregiver; Malignant Pleural Neoplasm; Metastatic Thymic Carcinoma; Recurrent Lung Carcinoma; Recurrent Thymic Carcinoma; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8

Summary: this trial studies how well embedded palliative care works in managing symptoms in participants with stage iii-iv thoracic malignancies that has come back and their caregivers. embedded palliative care may improve distress and anxiety in participants and caregivers.

primary objectives: i. to determine feasibility of embedding a palliative care (pc) physician within the james thoracic oncology clinic. ii. to assess patient and caregiver outcomes over a 12-month period within an embedded onco-palliative care clinic model. iii. to evaluate and describe clinician attitudes and beliefs regarding utilization of embedded palliative care as well as symptoms of provider burnout. iv. to analyze health care utilization among participants receiving embedded onco-palliative care. outline: participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit. after completion of study, patients are followed for up to 1 year.

Eligibility criteria:
inclusion criteria: * patients with advanced or metastatic cancer of the chest (lung, thymus, or pleura): stage iii or iv, recurrent disease * patients will receive therapy (chemotherapy, immunotherapy, targeted therapy or radiation therapy) at the ohio state university * new patients (defined as patients who have received no therapy for metastatic disease or have started treatment for metastatic disease within the last 30 days) or established patients with advanced cancer receiving anti-cancer therapy, no limit on prior therapies * patient and caregiver must be able to read and understand consent form * patients must designate a willing caregiver to participate although caregiver consent is not required for patient participation exclusion criteria: * patients who are already enrolled or have been previously enrolled in palliative care or hospice services as an outpatient. inpatient palliative care consultation prior to enrollment is permitted * patients who do not qualify for active anti-cancer therapy and opt to enroll in hospice services prior to study enrollment * patients who are unable to read or understand consent form * patients receiving primary systemic treatment outside of ohio state. outside radiation therapy is permitted
nutritional assessment in idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: in recent years nutritional status assumed increasing importance in the evaluation of chronic respiratory diseases, considering that their clinical course is often characterized by a progressive loss of weight and reduction of muscle mass.in regards to idiopathic pulmonary fibrosis (ipf), to date there are no studies that fully assessed the nutritional status of patients, nor the impact of the introduction of specific anti-fibrotic agents on the nutritional status of these patients. aim of this study is to assess the nutritional status of patients with ipf at the time of diagnosis and the impact of the introduction of specific anti-fibrotic agents, pirfenidone or nintedanib, on the nutritional status itself.

preliminary studies on idiopathic pulmonary fibrosis (ipf) seem to suggest that nutritional status has an impact on clinical outcomes, as already demonstrated in copd. however, few data regarding this subject are available for patients with ipf. primary aim of this study is to assess the nutritional status of patients diagnosed with mild to moderate ipf at the time of disease diagnosis. to do so, the investigators assess the prevalence of nutritional disorders at baseline through nutritional scores evaluated with specific questionnaires and through the identification of the following metabolic phenotypes (based on those previously applied in copd): cachexia, sarcopenia, normal nutritional status, obesity, sarcopenic obesity. secondary aims of this study are: * the evaluation of the impact of the introduction of an anti-fibrotic pharmacological agent (pirfenidone or nintedanib) on the nutritional status of patients (modification of metabolic phenotypes and nutritional scores) evaluated at 6 months from the initiation of antifibrotic therapy. * the assessment of calcium and vitamin d metabolism, by blood sampling, in patients diagnosed with mild to moderate ipf at the time of disease diagnosis and at 6 months from the initiation of antifibrotic therapy.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years; * diagnosis of ipf according to the ats / ers 2011 guidelines with multidisciplinary discussion exclusion criteria: * severe renal failure, defined as a gfr (glomerular filtration rate) lower than 30ml / min; * nyha class iv; * severe liver failure, defined as child-pugh score class c; * active solid or haematological neoplasms; * having already received (currently or in the past) therapy with pirfenidone or nintedanib; * inability to walk without help; * need for oxygen therapy at rest; * participation in other interventional experimental protocols with use of a medicinal product.

Keywords: nutritional status vitamin d
diagnosis of cervical lesions in women with unhealthy looking cervix

Conditions: Cervical Dysplasia

Summary: endocervix (cervical canal) is the cavity of the cervix and connects the external os with the internal os. it is fusiform in shape and has posterior and anterior oblique longitudinal ridges, the plicae palmatae. these are not exactly apposed but inter-lock like a zipper so that the canal is kept closed. the original squamous epithelium is clearly identified as a smooth, usually featureless covering of the cervix; its uniform pink color contrasts with the redness of the original columnar epithelium. it joins the latter at the original squamocolumnar junction. many clinicians encounter cervical lesions that may or may not be associated with cytologic abnormalities. such abnormalities as ectropion, nabothian cysts, and small cervical polyps are quite benign and need not generate concern for patient or clinician, whereas others, including those associated with a history of exposure to diethylstilbestrol, cervical inflammation, abnormal cervical cytology, and postcoital bleeding, should prompt additional evaluation. further, in some patients, the cervix may be difficult to visualize. several useful clinical suggestions for the optimal examination of the cervix are presented.


Eligibility criteria:
inclusion criteria: 1. suspicious cervix 2. age between 20 to 60 years exclusion criteria: 1. previously diagnosed cervical lesions. 2. pregnant women.
molecular basis of the growth axis in short stature

Conditions: Growth Hormone Deficiency

Summary: to examine the clinical genetic and biochemical characteristics of children with growth hormone deficiency.


Eligibility criteria:
inclusion criteria: * patient with growth hormone deficiency
pharmacokinetics, safety and efficacy of nemolizumab in participants with moderate-to-severe atopic dermatitis

Conditions: Moderate-to-Severe Atopic Dermatitis

Summary: the purpose of this study is to assess the pharmacokinetics (pk), efficacy, and safety of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * chronic ad that has been documented for at least 6 months for participants aged 2-6 years and at least 1 year for participants aged 7-11 years before the screening visit and confirmed according to the american academy of dermatology consensus criteria at the time of the screening visit * easi score \>=16 at both screening and baseline visits * iga score \>=3 at both screening and baseline visits * ad involvement \>=10% of bsa at both screening and baseline visits * peak (maximum) pp nrs score of at least 4.0 at both screening and baseline visits * agree to apply a moisturizer throughout the study from the screening visit daily, and liberally as needed; agree to apply an authorized topical corticosteroids (tcs) from the screening visit and throughout the study as determined appropriate by the investigator * participant and caregiver willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol * other protocol defined inclusion criteria could apply exclusion criteria: * body weight less than 10 kilogram (kg) * child in care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation * participants with a current medical history of chronic bronchitis * requiring rescue therapy for ad during the run-in period or expected to require rescue therapy within 2 weeks following the baseline visit * positive serology results for hepatitis b surface antigen (hbsag) or hepatitis b core antibody (hbcab), hepatitis c (hcv) antibody with positive confirmatory test for hcv (example; polymerase chain reaction \[pcr\]), or human immunodeficiency virus (hiv) antibody at the screening visit * history of lymphoproliferative disease, hypersensitivity (including anaphylaxis) to an immunoglobulin product and intolerance to low or mid potency topical corticosteroids * known or suspected immunosuppression * participants unwilling to refrain from using prohibited medications during the clinical trial. * other protocol defined exclusion criteria could apply

Keywords: atopic dermatitis nemolizumab cd14152
phase 2 extension trial in patients with relapsing-remitting multiple sclerosis (rrms)

Conditions: Multiple Sclerosis

Summary: the objective of this active-drug extension study is to evaluate the continuing safety and efficacy of ono-4641 (msc2430913a) in subjects with relapsing-remitting multiple sclerosis (rrms) who have completed an initial 26-week core study (ono-4641pou006 \[nct01081782\]).


Eligibility criteria:
inclusion criteria: * completed 26 weeks of double-blind phase of study ono-4641pou006 exclusion criteria: * presence of any dermatological abnormalities during study ono-4641pou006 that could increase the risk of the patient developing a skin cancer

Keywords: multiple sclerosis ono-4641 msc2430913a efficacy
diagnostic value of recto-perineal ultrasound in perianal fistula

Conditions: Perianal Fistula

Summary: perianal fistula is a common anal problem. it needs only surgery. mri is the best preoperative diagnostic tool, but it is demanding as it is expensive, time consuming and needs an experienced radiologist. so, we tried to find an alternative diagnostic tool which is cheaper, time saving and accurate and comparing its preoperative reports with intraoperative findings. study was held in surgery department in zagazig university hospitals from september 2023 to march 2024. it included 93 patients with perianal fistula who were diagnosed clinically and radiological by trans recto-perineal ultrasound and comparing pre-operative ultrasound findings with intra-operative surgical findings.


Eligibility criteria:
inclusion criteria: * perianal abscess and\\or fistula * patients who accidently discovered during transvaginal ultrasound. * age group between above 18 years old exclusion criteria: * informed consent refusal. * proved anal malignancy. * patients less than 18 years old

Keywords: recto-perineal ultrasound perianal fistula trans-sphincteric
affera global registry

Conditions: Atrial Fibrillation

Summary: the affera global registry is a prospective, global, multi-center, observational post-market registry (pmr). the purpose of this study is to describe clinical performance and safety data in a broad patient population treated with the affera platform.


Eligibility criteria:
inclusion criteria: * subject is ≥ 18 years of age or minimum age as required by local regulations * planned procedure using the commercially available affera platform * willing and able to comply with study requirements and give ic (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements exclusion criteria: * subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager * subject with exclusion criteria required by local law
brentuximab vedotin for newly diagnosed chl in chinese caya based on pet/ct assessment

Conditions: Classical Hodgkin Lymphoma; Child; Adolescent; Young Adult; Metabolic Response; Survival; Treatment; Brentuximab Vedotin; PET Scan

Summary: generally, pediatric patients tolerate acute toxicities but are vulnerable to late effects. thus, increasing chemotherapy intensity to achieve more rapid complete early response to limit radiation therapy is worth testing. in this cccg-hl-2024 study, brentuximab vedotin (bv) was used to replace vcr and bleomycin in the abve-pc regimen in the previous cccg-hd-2018 study, respectively, to form a bv-aepc regimen for the treatment of newly diagnosed classic hodgkin lymphoma (chl) in children, adolescents and young adults. on the premise of maintaining a 4-year event free survival (efs)\>90% in the low-, intermediate-and high-risk groups, increase the early assessment complete response rate (the overall early complete response rate increased by 20%, that is, from 54.0% to 74.0%) to further reduce the proportion of children receiving radiotherapy to benefit them.

in this cccg-hl-2024 study, brentuximab vedotin (bv) was used to replace vcr and bleomycin in the abve-pc regimen in the previous cccg-hd-2018 study, respectively, to form a bv-aepc regimen for the treatment of newly diagnosed classic hodgkin lymphoma (chl) in children, adolescents and young adults. bv is currently the most widely used "new drug" in childhood chl. for patients in the intermediate/high-risk group who did not achieve metabolic complete remission rate (cmr) at the early assessment based on pet/ct results, an intensive regimen of bv-dac-apc (bv-apc plus dacarbazine) was applied for 2 or 3 courses to further improve event-free survival without increasing long-term reproductive toxicity. for patients in the intermediate/high-risk group who did not achieve cmr after the bv-dac-aepc regimen, a modified check mate 744 regimen (pd-1 monoclonal antibody, bv,+/-bedamostine, autologous stem cell transplantation/radiotherapy) was applied to improve the cmr of patients before irradiation, hoping to reduce the primary treatment failure rate to almost zero.

Eligibility criteria:
inclusion criteria: * ages \>=2\~\<35 years at the time of enrollment; * patients with newly diagnosed, pathologically confirmed classical hodgkin lymphoma (hl) by at least 2 tertiary referral centers for pathology; * adequate organ function; * patients and/or their parents or legal guardians sign a written informed consent; exclusion criteria: * patients with nodular lymphocyte-predominant hl; * patients with an immunodeficiency that existed prior to diagnosis; such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible;patients known to be positive for hiv are not eligible. * patients who are pregnant; lactating females who plan to breastfeed. * patients who received systemic corticosteroids within 28 days of enrollment on this protocol