Kornimate/medical-research-clean huggingface dataset:
docetaxel combined with cisplatin as first line in patients with metastatic non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer Metastatic

Summary: this is a phase ii, open-label clinical study prospectively enrolling 40 metastatic patients with non small cell lung cancer. the study will enroll patients at king abdulaziz medical city, riyadh. sub-sites will be open for patient accrual in selected centers in the kingdom.

the cisplatin/docetaxel is established standard in the first line management of metastatic non small cell lung cancer in the united states, europe and asia. however, the safety and efficacy of this regimen was not studied systematically in middle eastern population. the aim of this study is to study the efficacy and safety of this regimen in our patient population

Eligibility criteria:
inclusion criteria: * histologically or cytologically proven non-small cell lung carcinoma * stage iv metastatic non-small cell lung carcinoma or stage iii with malignant pleural effusion. * patient should not be eligible for customization chemotherapy (if available at participating institutions). * having at least one measurable lesion * patient has life expectancy of 12 weeks or greater. * age \> 18 years. * no prior systemic treatment for metastatic lung cancer. adjuvant treatment given more than 1 year ago is acceptable. * who performance status 0-2 (see appendix iii ) * adequate organ function: * hematology: neutrophils \> 2 x 10 9 /l, platelets \> 100 x 10 9 /l * hepatic function: total bilirubin \< 1.25 times the upper normal limits, asat (sgot) \< 2 times the upper normal limits * renal function: creatinine \ 60min/ml. * able to comply with scheduled follow-up and with management of toxicity * signed informed consent from patient or legal representative * negative urine pregnancy test (if indicated) exclusion criteria: * pregnant or lactating women or women of childbearing potential using inadequate contraception. * uncontrolled brain metastatic disease. (cns disease that is stable \> 4 weeks after radiotherapy in lieu of steroids reduction is eligible). * symptomatic peripheral neuropathy \> grade 1 according to the nci common toxicity criteria version 3 * other serious illness or medical condition: * unstable cardiac disease requiring treatment * history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures * active uncontrolled infection * concurrent treatment with other experimental drugs. participation in another clinical trial with any investigational drug within 30 days prior to study screening * concurrent treatment with any other anti-cancer therapy * contraindication of steroid drug administration * past (up to 5 years) or concurrent history of other neoplasm except curatively treated non- melanoma skin cancer or in situ carcinoma of the cervix

Keywords: lung cancer
burn validation study

Conditions: Burns; Wound Heal; Wounds and Injuries

Summary: the purpose of this study is to validate the algorithm for burn healing assessment by the spectral md deepview device which would provide burn healing potential assessment.


Eligibility criteria:
inclusion criteria: willing and able to give informed consent or have a legally authorized representative (lar) able to do so; life expectancy \> 6 months; thermal burn mechanism (flame, scald, or contact); the study burn(s) occurred less than 72 hours prior to the time of first imaging; and minimum burn wound size for adult or pediatric patients is 0.5% tbsa per region for adult subjects: have 2 - 4 regions of their clinical burn(s) that meet the criteria for a study burn. for pediatric subjects: have 1 - 4 regions of their clinical burn(s) that meet the criteria for a study burn exclusion criteria: burn pattern distribution isolated to head, face, neck, hands, feet, genitalia, and/or joints; subject has burns involving \> 50% total body surface area (tbsa); sepsis at the time of enrollment; immunosuppression/radiation/chemotherapy \< 3 months prior to enrollment; concurrent use of investigational products with a known effect on the burn sites; and/or any condition that in the opinion of the investigator may prevent compliance with the study requirements or compromise subject safety.
irish programme for stratified prostate cancer therapy

Conditions: Prostate Cancer

Summary: the purpose of the trial is to investigate new clinical tests that could predict what treatments work best for certain patients with advanced prostate cancer by identifying markers and indicators present in blood and tissue which correlate with treatment response.

prostate cancer (pca) is a complex disease and not all patients respond to every treatment available. this study aims to investigate new clinical tests based on simple and routine blood tests to allow men with pca and their doctors to choose the correct treatment for their metastatic pca. in this way, only men likely to respond to the specific treatment will be chosen, sparing unnecessary or prolonged treatment for those who will not respond and allowing them to avail of alternative therapies likely to have more benefit. this is termed personalised therapy. the study will perform research on biological elements present in the blood including deoxyribonucleic acids (dna), ribonucleic acid (rna), protein and circulating tumour cells (ctcs) which are cancer cells that have spread beyond the prostate gland and can be found floating in the blood. clinical data will be correlated to research findings to form conclusions on personalised therapy. additional optional sub studies include; magnetic resonance imaging (mri) with a biopsy of another tumour in a different site of their body such as bone, lung or liver (metastatic biopsy), metastatic biopsy only and biopsies of the fluid of solid part of the bone. these optional components provide more detailed information on prostate cancer and how men are responding to treatment. the research results from these optional sub studies will be correlated with the research analysis from the blood samples and clinical data and will help to make treatment decisions.

Eligibility criteria:
inclusion criteria: 1. stage 4 mpca as confirmed by ct/mri or by bone scan 2. patient with visceral disease and/or bone lesions (excluding patients who only have nodal disease), who have commenced or are about to commence adt and whose disease has not shown any evidence of castration resistance (cohort 1) or patient with castrate-resistant disease at time of treatment change (cohort 2) 3. stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 28 days prior to recruitment 4. life expectancy of at least 6 months 5. ability to give written informed consent obtained before any study-related procedures 6. age ≥ 18 years and male exclusion criteria: 1. diagnosis of or treatment for another systemic malignancy within 2 years before study entry.\* 2. any evidence of residual disease from a previously diagnosed malignancy. \*patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
analysis of velmanase alfa (lamzede®)'s effects in the body of children with alpha-mannosidosis under the age 3

Conditions: Alpha-Mannosidosis

Summary: the goal of this observational study is to learn the effects of the drug velmanase alfa (lamzede®) in the bodies of children under the age of 3 with alpha-mannosidosis. the main questions it aims to answer are: * study the effect of velmanase alfa on a marker of the disease called glcnac(man)2 after one year of therapy * explore how the child's body reacts to velmanase alfa during the therapy the parents or legal guardians of participants will be asked to provide the results of analyses performed in the routine clinical setting related to the participant's general health and the administration of velmanase alfa. additional data will be extracted from other observational sponsored studies/registries, compassionate use programs, investigator-initiated studies (iis), and published case reports (presented in the literature) if existing.


Eligibility criteria:
inclusion criteria: * subjects with the provision of informed consent from their legal guardians (lar) * have a confirmed diagnosis of alpha mannosidosis * have initiated treatment with velmanase alfa between birth to at least six weeks before turning 3 years of age * have information on the disease marker glcnac(man)2 obtained: before velmanase treatment initiation (ideally max 6 month before), and at least one post-treatment sample, collected following at least six weeks of treatment. - participants treated with lamzede, 1 mg/kg body weight, via weekly intravenous infusions. exclusion criteria: participants who have undergone prior hematopoietic stem cell transplantation (hsct) or other investigational therapies for treating alfa mannosidosis (supportive treatments acceptable).
effectiveness of chemotherapy in metastatic or recurrent carcinoma cervix

Conditions: Metastatic Carcinoma to the Uterine Cervix; Recurrent Carcinoma Cervix; Cervix Carcinoma Recurrent

Summary: experience with substituting carboplatin for cisplatin is limited in advanced and recurrent cervix cancer and there has been no counterpart to gog 158, which documented therapeutic equivalency of cisplatin/paclitaxel and carboplatin/paclitaxel for treatment of ovarian cancer, performed in a cervix cancer population.

this trial will be a prospective, randomized phase ii pilot study. consecutive patients of metastatic, recurrent or refractory carcinoma cervix enrolled in gynecology clinic at irch, aiims will be taken into study after taking informed consent. patients will be randomized into two arms. each arm shall contain 20 patients. the patients shall receive paclitaxel and carboplatin q3wk in first arm and paclitaxel and carboplatin q1 wk in second arm.

Eligibility criteria:
inclusion criteria: 1. histologically proven case of squamous or adenocarcinoma or adenosquamous carcinoma 2.ecog performance status 0,1 and 2 3.adequate hematologic, renal and liver functions 4.informed consent 5.measurable disease by ct scan or usg abdomen or mri - exclusion criteria: 1. ecog performance status 3 or 4 2. impaired blood counts: those patients with an absolute neutrophil count \<1,500/μl, platelet counts \<100,000/μl, will be ineligible. 3. impaired renal /liver functions as indicated by: serum bilirubin \>1.5× normal, ast level more than 3× normal, alkaline phosphatase level more than 3× institutional normal, or a serum creatinine level more than 1.2 mg/dl. patients with serum creatinine level of more than 1.2 mg/dl but less than 1.5 mg/dl are eligible if creatinine clearance is 70 ml/min were eligible if a creatinine clearance determination was more than 50 ml/min. 4. h/o prior chemotherapy for metastatic disease, 5. h/o concurrent or past malignancy other than carcinoma cervix, 6. cns metastasis, or 7. bilateral hydronephrosis that could not be alleviated by ureteral stents or percutaneous nephrostomy. -

Keywords: recurrent or metastatic carcinoma cervix chemotherapy
vaso-inotropic score and ecmo-va support in post-cardiotomy cardiogenic shock.

Conditions: EMCO-VA

Summary: veno-arterial extracorporeal membrane oxygenation (va-ecmo) is a well-established lifesaving treatment for refractory cardiogenic shock, with or without concomitant respiratory failure. va-ecmo is usually started in presence of refractory low cardiac output syndrome following cpb weaning. currently, there is no consensus about the best timing for implantation and initiation of va-ecmo in this setting. some publications have suggested that vis score could be used to determine the necessity of va-ecmo in cardiologic area. it was demonstrated that a vis score between 20 and 40 may be a cut-off value to discuss the implantation of va-ecmo. post cardiotomy shock is a very interesting setting because the timing of cardiogenic shock is known and several bias are more controlled than in medical area. based on the well-established ability of vis score in predicting mortality, we will investigate the role of the vis score as a determinant for early va-ecmo implantation in patients suffering of post-cardiotomy cardiogenic shock.


Eligibility criteria:
inclusion criteria: * age over 18 years * cardiac surgery with cardiopulmonary bypass * post cardiotomy cardiogenic shock * ecmo-va implanted in or exclusion criteria: * lvad * heart transplantation * incomplete data in relation to outcomes * cardiac arrest
impact of hip activation compared to hip plus balance training on the forward-step-down test

Conditions: Control of Frontal Plane Biomechanics; Patellofemoral Pain Syndrome

Summary: the purpose of this research is to determine the impact of a hip activation home exercise program (hep) compared to a hip activation + single leg balance hep on performance of the forward-step-down test (fsdt) in healthy females. participants will be assigned to the control (hip activation hep only) or experimental (hip activation + single leg balance hep). following the pre-test data collection, participants will complete their hep for 8 weeks. they will return to the lab for post-test measurements.


Eligibility criteria:
inclusion criteria: * first or second year students at the institutions's school of allied health professions * healthy * female exclusion criteria: * participating in another research study * current knee pain or pathology on the dominant leg * known diagnosis of vestibular impairment * known pregnancy
preservation versus excision of denonvilliers fascia in l-panp surgery

Conditions: Rectal Cancer

Summary: tme (total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. however, the damage of pelvic autonomic nerve following with tme principle will lead to high incidence of urinary and sexual function disorder. panp (pelvic autonomic nerve preservation) surgery played a role in decreasing incidence of urinary and sexual function disorder. however, 32%-44% patients still suffered from urinary and sexual function disorder when underwent open (o-panp-tme) or laparoscopic panp tme surgery (l-panp-tme). in the early stage of work, the investigators performed preservation of denovilliers' fascia in l-panp-tme to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. the results showed that preservation of denovilliers' fascia in l-panp-tme significantly decreased incidence of urinary and sexual function disorder. in order to further confirm the early work, the investigators design a randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between preservation and excision of denovilliers' fascia in l-panp-tme.


Eligibility criteria:
inclusion criteria: 1. age from over 20 to under 60 years; 2. primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy; 3. mid-low rectal cancer (distance from anal edge≤12cm); 4. ct1-3, n0-3, m0 at preoperative evaluation according to the ajcc cancer staging manual seventh edition; 5. expected curative resection through l-panp; 6. performance status of 0 or 1 on ecog (eastern cooperative oncology group) scale; 7. asa (american society of anesthesiology) score class i, ii, or iii; 8. written informed consent; 9. urinary and sexual function normal preoperatively exclusion criteria: 1. severe mental disorder; 2. history of previous pelvic surgery; 3. enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging; 4. history of other malignant disease within past five years; 5. history of unstable angina or myocardial infarction within past six months; 6. history of cerebrovascular accident within past six months; 7. history of continuous systematic administration of corticosteroids within one month; 8. contraindication of heart, brain, lung, etc dysfunction; 9. requirement of simultaneous surgery for other disease; 10. emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer; 11. rectal cancer invades surrounding tissues; 12. existence of genuine incontinence or severe stress incontinence preoperatively
a study of vemurafenib and gdc-0973 (cobimetinib) in participants with brafv600e mutation-positive metastatic melanoma

Conditions: Malignant Melanoma

Summary: this open-label, dose-escalation study of vemurafenib in combination with cobimetinib will evaluate the safety, tolerability and pharmacokinetics in participants with brafv600 mutation-positive metastatic melanoma. participants with previously untreated, brafv600e mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are eligible. participants will be assigned to different cohorts with escalating oral doses of vemurafenib and cobimetinib. this study consists of 2 stages, stage 1 (dose escalation stage \[des\] and cohort expansion stage \[ces\]) and the anticipated time on study treatment is until disease progression, unacceptable toxicity or any other discontinuation criterion is met.


Eligibility criteria:
inclusion criteria: * participants with histologically confirmed melanoma (unresectable stage iiic and stage iv metastatic melanoma, as defined by american joint committee on cancer \[ajcc\]) * measurable disease per response evaluation criteria in solid tumors (recist) version (v) 1.1 * eastern cooperative oncology group (ecog) performance status of less than or equal to (\</=) 1 * participants must 1. be previously untreated for locally advanced/unresectable or metastatic melanoma or 2. previously treated but without prior exposure to any braf or mek inhibitor therapy or 3. progressed on vemurafenib while participating in a phase i (including clinical pharmacology studies), ii, or iii clinical study or expanded access programs (eap) immediately prior to enrollment in this study or 4. progressed on vemurafenib administered in a postmarketing setting immediately prior to enrollment in this study. * life expectancy \>/=12 weeks exclusion criteria: * history of prior significant toxicity from another raf or mek pathway inhibitor requiring discontinuation of treatment * palliative radiotherapy within 2 weeks prior to first dose of study drug treatment * experimental therapy within 4 weeks prior to first dose of study drug treatment except vemurafenib * major surgery within 4 weeks of first dose of study drug treatment or planning a major surgery during the study
fractional laser assisted delivery of sculptra® for the treatment of striae

Conditions: Striae Distensae

Summary: this study evaluates the efficacy of treatment of striae distensae using the combined modality of fractional laser and poly-l lactic acid (sculptra).

striae distensae (sd) is a form of scarring that can oftentimes be quite disfiguring and emotionally distressing to individuals. fractional laser therapy has been used by doctors to treat stretch marks by stimulating collagen growth. poly-l lactic acid also promotes collagen growth in the areas injected. the combination of laser and poly-l lactic acid might provide the optimal treatment modality for sd by decreasing the appearance of atrophic scars.

Eligibility criteria:
inclusion criteria: * subject has bilateral striae alba * subject has stable body weight for at least 6 months with fitzpatrick skin type 1-4 exclusion criteria: * subject has striae rubra * pregnant * history of adverse effects to phototherapy * subject has single sided lesions * subject has immunosuppression * subject has radiation therapy to the study area * subject has topical or oral steroid use or chemotherapy within the last 6 months * history of keloids or hypertrophic scar

Keywords: stretch marks fractional laser therapy poly-l lactic acid sculptra
steroid resistance in pediatric immune thrombocytopenic purpura

Conditions: Pediatric Mmune Thrombocytopenic Purpura

Summary: to predicting steroid resistance on children newly diagnosed with immune thrombocytopenic purpura

immune thrombocytopenia (itp, platelet counts \&lt; 100 × 109/l) is the most common acquired childhood bleeding disorder, clinically characterized by a low platelet count in the absence of other thrombocytopenia causes \[1,2\]. the estimated incidence of itp is 100 cases out of a million people per year; about half of these cases occur in previously healthy children, where it represents the most frequent blood disorder \[3\]. most children present with a typical history of acute purpura and bruising after a mild viral infection \[4\]. in severe cases, intracranial hemorrhage (the most 0.5% serious complication, but also the rarest occurring in adults), gastrointestinal hemorrhage in 1.5 % of children, and genitourinary hemorrhage may occur \[5\]. the international working group on itp defines itp according to the following clinical phases \[6\]. these are as follows: newly diagnosed itp is in the first three months post-diagnosis. persistent itp is for 3-12 months. chronic itp is for \&gt; 12 months. refractory itp is the failure to restore count of platelet after splenectomy. for children requiring therapy but without life threatening bleeding, corticosteroids are the recommended first line therapy over ivig or anti-d \[2\]. guidelines from the american society of hematology recommend a 5-7-day course of prednisone dosed at 2-4 mg/kg/day \[2\]. seventy-five percent of children respond to steroids, with platelets recovering to hemostatic range by 2-7 days \[7\]. if a more rapid rise in platelets is desired, iv methylprednisolone may be used. studies comparing outcomes between anti-d versus methylprednisolone \[8\] and comparing methylprednisolone with dexamethasone \[9\] showed similar response rates with minor side effects in all groups. a study shows that 98% of patients with corticosteroid exposure experienced one or more side events, and 38% of patients need to stop or reduce corticosteroid therapy \[10\]. this research aims to develop a new prediction model to evaluate whether newly itp patients are at high-risk of corticosteroid resistance, and help clinicians to choose better therapy so we divide patients to two groups, steroid response and steroid resistance.

Eligibility criteria:
inclusion criteria: * all patients diagnosed as acute immune thrombocytopenic purpura based on clinical manifestations and laboratory investigations from age of 1 years to age of 18 years. gender: both six exclusion criteria: * children with immune thrombocytopenic purpura below age of 1 years and above 18 years, patient with thrombocytopenic purpura with secondary causes, and chronic itp