Kornimate/medical-research-clean huggingface dataset:
temsirolimus in combination with gemcitabine in previously untreated metastatic pancreatic cancer

Conditions: Pancreatic Adenocarcinoma

Summary: the purpose of this research study is to try to define the highest doses of temsirolimus and gemcitabine that can be used safely in combination to treat advanced pancreatic cancer. gemcitabine is a standard chemotherapy used for the treatment of pancreatic cancer.

* because this is a study to determine the highest doses of temsirolimus and gemcitabine that can be given safely together, groups of 3 subjects will be treated at gradually increasing doses of the drugs. each group of 3 subjects must complete 4 weeks of treatment (1 cycle) before the following group of 3 subjects can start treatment at the higher dose of drug. * temsirolimus will be given intravenously every week of the 28 day treatment cycle (days 1, 8, 15, 22). gemcitabine will be given intravenously every other week of the treatment cycle (days 1. 15). * during the study, participants will have weekly clinic visits where the following tests and procedures may be performed: physical exam; vital signs; urine test; blood tests. * a ct scan will be performed after every 2 cycles (8 weeks) to assess teh response of the tumor to the study treatment.

Eligibility criteria:
inclusion criteria: * previously untreated metastatic pancreatic adenocarcinoma, histologically proven. * measurable disease by recist criteria * ecog performance status 0 or 1 * male or female, 18 years of age or older * life expectancy of \>/= 12 weeks * ast and alt \</= 2.5 x uln * total bilirubin \</= 1.5 x uln * serum albumin \>/= 2.5g/dl * absolute neutrophil count \>/= 1500/mm3; platelets \>/= 100,000/mm3; hemoglobin \>/= 9.0 g/dl * serum creatinine \</= 1.5 x uln * subjects with diabetes must have adequate glycemic control, with fasting serum glucose \</= 1.5 x uln * female patients of childbearing age and male patients with partners of childbearing age must agree to use adequate birth control measures during the course of the study and for at least one month following withdrawal from the study exclusion criteria: * previously treatment with gemcitabine or chemoradiation * diagnosis of a second malignancy within the last 3 years, except for adequately treated basal cell carcinoma or squamous cell skin cancer * ongoing cardiac dysrhythmias of nci ctcae grade \>/= 2, atrial fibrillation, qtc prolongation to \> 450 msec for males and \>470 msec for females * known immunodeficiency disorders or active infections requiring treatment * pregnancy or breastfeeding * known brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease * prior radiation therapy or major surgery within 4 weeks of study entry * prior radiation therapy to \> 25% of the bone marrow * subjects receiving other experimental or alternative therapies during the course of the trial will be excluded * history of prior hypersensitivity to polysorbate

Keywords: metastatic pancreatic cancer
exploring the impact of hiv and art on knowledge, attitudes and practices in reproductive health in lilongwe, malawi

Conditions: HIV; AIDS

Summary: the aim of this study is to identify reproductive health priorities among individuals living with hiv.this study also seeks to explore factors that influence fertility, family planning, and sexual behavior among individuals with hiv who are receiving antiretroviral therapy (art).

the aim of this study is to identify reproductive health priorities among individuals living with hiv.this study also seeks to explore factors that influence fertility, family planning, and sexual behavior among individuals with hiv who are receiving antiretroviral therapy (art). this is a mixed method study in which subjects will participate in focused group discussions and complete a questionnaire. discussions will be 1-2 hours in length aimed to evaluate fertility intentions, family planning, and sexual health behaviors. data collected from the focus groups will be analyzed for common themes to generate questionnaires to assess reproductive health knowledge, attitudes and practices related to family planning, and fertility and sexual health among persons living with hiv.

Eligibility criteria:
focus group arm inclusion criteria: * client registered at either of the participating lighthouse clinics (kamuzu central hospital (kch) or bwaila hospital) * on antiretroviral treatment (art) for the past 6 months * sexually active within the past 6 months * hiv positive exclusion criteria: no exclusion criteria specified questionnaire arm inclusion criteria: * client registered at either of the participating lighthouse clinics (kamuzu central hospital (kch) or bwaila hospital) * sexually active within the past 6 month * hiv positive exclusion criteria: no exclusion criteria specified
tandem auto stem cell transplant with melphalan followed by melphalan and bortezomib in patients with multiple myeloma

Conditions: Multiple Myeloma; Auto Stem Cell Transplant

Summary: high dose chemotherapy with stem cell transplantation is commonplace in the treatment of multiple myeloma. this treatment uses a chemotherapy drug called melphalan that has been used in several thousand bone marrow transplant recipients worldwide for the same or similar disorders.

many patients with multiple myeloma receive 2 stem cell transplantations within a few months of each other as part of their treatment. usually the drug melphalan is used for both transplants. bortezomib is a drug that is used for treating multiple myeloma and has been used in combination with melphalan for stem cell transplantation for patients with multiple myeloma. the purpose of this trial is to study the effects of doing 2 transplants, first using melphalan and second using melphalan and bortezomib. the trial is aiming to find out if adding the bortezomib to the second transplant will increase the chances of staying in remission longer.

Eligibility criteria:
changed from: inclusion criteria: * confirmed diagnosis of multiple myeloma with either durie-salmon stage i, ii, or iii or iss stage i, ii or iii, less than 12 months since initiation of systemic therapy * ≥8x106 cd34+cells/kg available in cryopreservation in aliquots appropriate for tandem transplants * age: 18-75 years at time of transplantation * kps 70-100% * recovery from complications of prior therapies * gender: there is no gender restriction exclusion criteria: * diagnosis other than multiple myeloma * chemotherapy or radiotherapy within 8 days of initiating treatment in this study * prior autologous or allogeneic transplantation (except as enrolled into this study) * uncontrolled bacterial, viral, fungal or parasitic infections
impact of surgery on the treatment of supratentorial malignant gliomas in subjects aged 70 and over

Conditions: Malignant Glioma

Summary: the objective of this study is to evaluate the efficacy and safety of surgical resection in elderly patients 70 years or older with a supratentorial glioblastoma de novo. the sensitivity of magnetic resonance spectroscopy with perfusion sequences in the diagnosis of malignant glioma in the elderly will also be studied.

currently, the standard treatment for gliomas is based on surgical resection followed by radiation therapy. however in patients 70 and older, surgery is not systematic, before radiotherapy. moreover, at these ages, surgery is likely to be less well tolerated in general terms. the aim of this study is to try to determine the best treatment between radiation therapy associated with the surgical treatment and care by radiotherapy alone, after a brain biopsy. this is a randomized, two arms, multicenter, open study. in the two weeks following the radiological diagnosis of a lesion highly suggestive of a high-grade glioma, patients will be randomized to either arm surgery (partial or complete excision) + radiotherapy or in the radiotherapy alone arm. within 5 weeks after surgery (biopsy or excision), all patients will receive treatment with focal radiotherapy. a central review blades and mri data will be organized after the inclusion of patients. a maximum of 135 patients will participate in this trial.

Eligibility criteria:
inclusion criteria: * highly suggestive radiological aspect of a high-grade glioma * operability of the lesion, defined according to standard criteria of literature: lobar tumor, cortico-subcortical, well limited, without deep infiltration and without involvement of the basal ganglia. this operability is to reassess based on surgical experience and the ability to remove more or less completely a tumor of this type in a given location * age greater than or equal to 70 years * preoperative karnofsky index ≥ 50 * information given to the patient or his family and signed written consent. exclusion criteria: * existence of a cons-indication to mri * non operability of the lesion * unbalanced concomitant serious pathology that might be an indication against-formal anesthetic (asa 4-5) (see annex) * previous history of radiotherapy or chemotherapy prior to this injury * patient under guardianship or under judicial protection

Keywords: supratentorial gliomas surgery magnetic resonance spectroscopy elderly
efficacy of viusid® plus glizigen® in patients with papilloma virus esophageal

Conditions: Papilloma Viral Infection; Papillomavirus Infections; Esophageal Viral Wart; Esophageal Verrucous Carcinoma

Summary: a randomized, double-blind, phase ii clinical trial was conducted versus placebo in 110 patients with esophageal human papillomavirus. the experimental group will receive the viusid® plus glizigen® nutritional supplements, administered on an outpatient basis for 3 months. the control group will receive placebo from viusid plus glizigen placebo. it is expected that patients in the experimental group have a 30% higher rate of elimination of the virus than patients in the placebo group after treatment. the study will be conducted in the superior digestive tract consultation of the institute of gastroenterology of havana, cuba.

initially the study was planned as an adaptive study without seams, phase ii / iii for 150 patients. 75 in each therapeutic arm. the sample size was calculated with parameters of phase iii studies, but establishing an early stop rule, with an intermediate analysis. for the calculation it was taken into account that the expected percentage of elimination of the virus by spontaneous remission in immunocompetent patients, reported internationally is on average 35%. it is intended that in the group of patients to whom viusid® plus glizigen® will be administered, this figure is ≥ 65%. in other words, it is desired to reach a minimum difference of approximately 30% between both groups. considering a type i error of 5% (adjusted to 2.5% by an intermediate evaluation), a power of 90%, plus 5% of dropouts or losses to follow-up, the minimum number of patients to recruit is 150 patients in total , 75 in each therapeutic arm. however, by decision of the promoter the study was stopped with 55 patients in each arm, 110 patients in total. and established as a phase ii trial.

Eligibility criteria:
inclusion criteria: * older adults between 18 and 65 years of both sexes. * patients residing in the provinces of havana, artemisa and mayabeque. * voluntariness of the patient to participate in the study. informed and written consent. * women of childbearing age should have negative pregnancy test or use effective contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation. exclusion criteria: * pregnancy or breastfeeding. * contraindication to the performance of upper digestive endoscopy. * psychiatric conditions that do not favor the administration of treatment and follow-up. * history of hypersensitivity to another similar product. * severe acute allergic states. * patients with concomitant diagnosis of esophageal tumor or other causes of infectious esophagitis. * present an associated chronic illness in the decompensation phase (heart disease, diabetes, hypertension, renal failure, aidsl). * patients who are receiving another product under investigation.

Keywords: papillomavirus viusid glizigen papilloma virus esophageal antioxidant
wearable robotic functional assistance for stroke rehabilitation

Conditions: CVA (Cerebrovascular Accident)

Summary: this study aims to evaluate the effectiveness of using the myomo e100 wearable robotic rehabilitation system for increasing functional independence and long term rehabilitation of chronic stroke victims with a hemiparetic upper extremity.

this is a case controlled study for evaluation of the effectiveness of using the myomo e100 wearable robotic rehabilitation for upper arm therapy following stroke. the intervention for the study will be for the control group- 6-8 weeks of therapeutic exercise and functional training for a total of 18 hours of intervention, or the case group- 6-8 weeks of therapeutic exercise and functional training with the use of the ajb for a total of 18 hours of intervention. each session will be one hour in length. the length of the study and length of each session is per standard rehabilitation protocol that has been well documented in previous studies as well as the pilot study regarding the ajb. a pre and post test with a 3 month follow up of all measures will be included in the study. study procedures will focus on performing functional tasks using the e100.

Eligibility criteria:
inclusion criteria: * medically stable * cognitive awareness * weakness in upper arm * over 1 year post cva * not engaged in any other upper arm therapies exclusion criteria: * rashes, open wounds or skin sensitivity on arm * very high elbow tone (arm rigid in flexion or extension)

Keywords: robotics rehabilitation arm stroke weakness outpatient chronic
observational study on treatment satisfaction of levemir® versus protaphane® during "real-life" usage in germany

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this non interventional observational study is conducted in europe. the purpose of this non interventional observational study is to primarily investigate treatment satisfaction when using levemir® versus protaphane® in combination with oads in daily settings.


Eligibility criteria:
inclusion criteria: * written informed consent obtained from patient before first documentation of treatment in the observational study. * type 2 diabetes mellitus * patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control * no contraindication for use of protaphane® or levemir® exclusion criteria: * none
basiliximab for the treatment of acute graft-versus-host disease after allogeneic stem cell transplantation

Conditions: Graft vs Host Disease; Hematopoietic Stem Cell Transplantation

Summary: graft-versus-host disease (gvhd) contributes substantially to transplant-related morbidity and mortality. steroids remains first line therapy for acute gvhd but there is currently no consensus on second line therapy for those in whom steroids have been ineffective. basiliximab has been shown to be a safe and effective immunosuppresant in the prevention and treatment of rejection after renal transplantation and its role in acute gvhd prophylaxis and treatment has been described favourably. this is a randomized control trial to investigate its efficacy and safety in the management of acute gvhd post allogeneic stem cell transplantation (sct).


Eligibility criteria:
inclusion criteria: * grade ii to iv acute gvhd after sct exclusion criteria: * known allergy to basilixmab

Keywords: acute graft-versus-host disease post allogeneic stem cell transplantation
a study of ono-7428 in participants with unresectable advanced or recurrent solid tumors

Conditions: Solid Tumor; NSCLC

Summary: this study is to evaluate the tolerability and safety of ono-7428 in participants with unresectable advanced or recurrent solid tumors.


Eligibility criteria:
inclusion criteria: 1. participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors. \[backfill cohort only\] participants with histologically or cytologically confirmed stage iiib, iiic, iv, or recurrent nsclc according to uicc-tnm classification. 2. participants who are refractory or intolerant to standard therapy. 3. participants with a tumor type for which anti-pd-(l)1 antibodies have been approved and who have previously treated with anti-pd-(l)1 antibody containing regimen. 4. participants with eastern cooperative oncology group performance status 0 or 1. 5. participants with tumor tissue samples available for biomarker testing. exclusion criteria: 1. participants with a complication or history of severe hypersensitivity to any other antibody drugs. 2. participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease 3. participants with severe peritoneal dissemination. 4. participants with pericardial fluid, pleural effusion, or ascites requiring treatment. 5. participants with uncontrolled tumor-related pain. 6. participants with active or history of interstitial lung disease or pulmonary fibrosis.
a pilot study to evaluate the effect of pomegranate juice on semen parameters in healthy male volunteers

Conditions: Male Infertility

Summary: how daily consumption of pomegranate juice affects the concentration, morphology or motility of sperm in healthy men.

to determine, in this pilot study, whether daily consumption of pomegranate juice (pom) affects the concentration, morphology or motility of sperm in healthy men. the purpose of the present pilot study is to examine the hypothesis that pom may improve semen parameters in men.

Eligibility criteria:
inclusion criteria: * 12 healthy men aged 18-40 * normal sperm counts exclusion criteria: * history of undescended testes or surgery to the scrotal contents, * history of marijuana or alcohol abuse, hot tub usage at least 3 months prior to entry into the study * no alpha adrenergic medications within two weeks of entry into the study, * no anabolic steroid use, * no anticholinergic or antimuscarinic drugs, use of colchicine, cimetidine, sulfasalazine, antipsychotics, antidepressants, immunosuppressive drugs prior use of any chemotherapeutic drugs, or uti on screening visit.

Keywords: male infertility
influence of injury to the kaplan fibers in adult and pediatric patients with acl injury

Conditions: ACL-injury

Summary: the goal of this \[type of study: observational study\] is to \[detect concomitant kf and all injury in knees with acl injury using mri in both adult and pediatric patients and compare the effect of kf injury and multiple risk factors (concomitant injury to the all, medial collateral ligament \[mcl\], or anterior, central, or posterior part of the medial or lateral meniscus) on anterolateral rotatory laxity as measured by the pivot-shift test in a clinical setting.\]. the main question \[s\] it aims to answer are: \[does the main risk factor for a high-grade pivot shift after acute acl injury differ between pediatric patients and adults?\] \[does concomitant kf injury significantly affect the pivot-shift phenomenon in pediatric patients with acute acl injury?\] researchers will compare \[71 pediatric patients and 469 adults\] to see if \[main risk factor for a high-grade pivot shift after acute acl injury differs between pediatric patients and adults?\].


Eligibility criteria:
inclusion criteria: * unilateral acute primary acl tear, considered when the patient reported knee injury occurring less than 2 weeks before the examination; * bone bruising on the femoral condyles and tibial plateau identiﬁed on mri. exclusion criteria: * concomitant ligament (posterior cruciate ligament and/or posterolateral complex) procedures or realignment procedures; contralateral knee injury; * previous injury or surgery affecting the ipsilateral knee; * insufficient data from the electronic medical record system; * lack of kf visualization on mri.

Keywords: rotatory instability kaplan fiber injury anterolateral ligament meniscal injury magnetic resonance imaging anterior cruciate ligament
cystatin c: a biomarker of aki in aneurysmal subarachnoid haemorrhage patients

Conditions: Acute Kidney Injury

Summary: the goal of this observational study is to assess cystatin c as a predictive biomarker of early acute kidney injury in aneurysmal subarachnoid hemorrhage patients. the main question it aims to answer is: - does cystatin c biomarker can predict early acute kidney injury in aneurysmal subarachnoid hemorrhage patients? participants will be grouped into aki and non-aki groups based on rifle criteria and cystatin c biomarker will be tested to answer the study question.


Eligibility criteria:
inclusion criteria: * patient admission to hospital within 48 hours of subarachnoid haemorrhage onset. * subarachnoid haemorrhage caused by intracranial aneurysm rupture and is confirmed via computed tomography angiography (cta). * medical treatment, microsurgical clipping, or interventional endovascular treatment of aneurysm is performed within 48 hours of subarachnoid haemorrhage onset. exclusion criteria: * prior onset of subarachnoid haemorrhage or other neurological diseases such as ischemic stroke, hemorrhagic stroke, or severe head trauma. * systemic diseases, such as chronic liver diseases, chronic lung diseases, chronic heart failure, thyroid diseases and cancer. * renal impairment at time of admission (creatinine-based egfr less than 60 ml/min per 1.73 m2 body surface area). * patients who are hemodynamically unstable at time of admission. * mortality within 10 days after admission (duration of study).

Keywords: acute kidney injury delayed cerebral ischemia angiographic vasospasm aneurysmal subarachnoid hemorrhage
beach tennis and hypertension study

Conditions: Hypertension

Summary: the purpose of the present study was to evaluate the effect of a beach tennis session on 24-hour ambulatory blood pressure in adults with hypertension. the main hypothesis is that a single session of beach tennis would decrease ambulatory blood pressure compared with a non-exercise control session.

in this randomized crossover trial, participants performed randomly assigned two experimental sessions: a beach tennis session and a non-exercise control session. the beach tennis session started with a standardized 5-minute warm-up consisting of basic techniques, followed by three 12-minute beach tennis matches with 2-minute intervals between them. heart rate and rating of perceived exertion were continuously recorded during the beach tennis session, and enjoyment was measured after the beach tennis session. the control session was performed in seated rest. both experimental sessions lasted 45 minutes. ambulatory blood pressure was measured continuously for 24-hour after sessions.

Eligibility criteria:
inclusion criteria: * office blood pressure between 130-179 and 80-110 mmhg for systolic and diastolic blood pressure, respectively; * non-engaged in structured exercise programs in the last 3 months before the beginning of this study; * able to perform the proposed exercises. exclusion criteria: * underlying cardiovascular disease in the last 24 months such as acute myocardial infarction, angina, stroke or heart failure; * diseases that reduce life expectancy; * smokers; * bmi \>39.9 kg/m²; * diabetic proliferative retinopathy.

Keywords: exercise beach tennis sport training post exercise hypotension ambulatory blood pressure monitoring