Kornimate/medical-research-clean huggingface dataset:
decitabine combined with unrelated cord blood transplantation for elderly patients with aml

Conditions: Acute Myeloid Leukemia

Summary: acute myeloid leukemia (aml) is a clonal disease caused by genetic mutations in hematopoietic stem progenitor cells. unfortunately, advanced age (\>60 years old) is considered to be one of the most important adverse prognostic factors for aml, and older patients are unable to tolerate high-dose chemotherapy, due to various complications and organ dysfunction. based on the results of the previous research, we will carry out the pretreatment regimen of decitabine + cytarabine in elderly patients with aml who have achieved disease treatment through induction therapy, and continue the transplantation program of unrelated-blood cord blood. by assessing the patient's dfs,os,rfs and safety to determine whether the regimen is suitable for the consolidation treatment of elderly acute myeloid leukemia, further clarify the efficacy of this regimen compared with traditional consolidation therapy, and initially confirm the effect of combined with unrelated cord blood transplantation in the treatment of acute myeloid leukemia.

a prospective,multicenter,open,single-arm clinical study.the research process is divided into three phases: the screening phase, the treatment phase, and the follow-up phase. the treatment phase includes pre-transplant pretreatment, cord blood transplantation, and consolidation therapy.

Eligibility criteria:
inclusion criteria: 1. aml patients diagnosed by bone marrow morphology and immunology; 2. exclusion of apl by bone marrow morphology or molecular level; 3. a patient who has obtained bone marrow cytology remission after inductive treatment; 4. aged from 60 to 75 years; 5. liver and kidney function: blood bilirubin ≤ 35μmol / l, ast or/alt \<2 times the upper limit of normal (uln), serum creatinine;≤ 150μmol / l; 6. the function of heart is normal; 7. physical condition score 0-2 (ecog score); 8. get informed consent signed by patient or family member. exclusion criteria: 1. apl patients, treatment-related aml; 2. retreatment of patients; 3. allergies to any of the drugs involved in the protocol; 4. there are obvious contraindications to chemotherapy drugs; 5. liver and kidney function is obviously abnormal, exceeding the inclusion criteria; 6. serious heart disease, including myocardial infarction, cardiac insufficiency; 7. suffering from other organ malignant tumors at the same time ; 8. active period of tuberculosis patients and hiv-positive patients; 9. suffering from other blood system diseases at the same time; 10. pregnancy or breastfeeding; 11. cannot understand or follow the research plan; 12. a history of intolerance or allergies to similar drugs; 13. patients under 60 years of age or over 75 years of age; 14. participate in other clinical researchers at the same time; 15. there are other situations that hinder the conduct of the study.

Keywords: aml,elderly patients,decitabine,unrelated cord blood
distal renal denervation

Conditions: Hypertension, Resistant to Conventional Therapy

Summary: objective of this study is to evaluate whether a distal mode of endovascular renal denervation with the treatment performed primarily in segmental branches of renal artery is more effective than conventional mode of the intervention with the treatment equally distributed within its main trunk for the treatment of drug-resistant hypertension.

recent spectacular failure of renal denervation (rdn) therapy in symplicityhtn-3 trial in fact might be easily predicted from the very beginning. conventional rdn done as 4-6 point treatments equally distributed within main trunk of renal artery (ra) may only be effective if renal plexus tightly surrounds the artery throughout its whole course with equal longitudinal and circumferential density of the nerve fibers. while this idea itself is unnaturally idealistic also a number of surgical studies demonstrated that proximally majority of renal nerves go at a distance from ra obliquely to its course and join the artery mainly in its distal part (fan-shaped renal plexus with wide base directed toward aorta and apex converging to renal gate). we developed a distal mode of rdn targeting segmental branches of ra and conducted a single-center double-blind randomized controlled parallel group study to compare its efficacy and safety to those of conventional rdn in patients with drug-resistant hypertension.

Eligibility criteria:
inclusion criteria: * systolic bp is equal or greater than 160 mmhg or diastolic bp is equal or greater than 100 mmhg, * stable (\>3 months) treatment with full doses of at least 3 antihypertensive drugs including a diuretic, * given written informed consent exclusion criteria: * secondary hypertension * 24h-mean systolic bp \<135 mmhg, * estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m2, * extended disease of renal artery, * any other clinically important disorders/comorbidities significantly increasing risk of endovascular intervention (investigator's assessment)

Keywords: hypertension, catheter ablation, renal nerves
long term results after sleeve gastrectomy

Conditions: Obesity

Summary: today sleeve gastrectomy is the most performed bariatric procedure worldwide. since 2005 it is gaining popularity as a single procedure. long term data is scarce. in this retrospective study long term follow-up in relation to weight loss, comorbidities, re-do and revisional surgery is getting analyzed.

today sleeve gastrectomy is the most performed bariatric procedure worldwide. since 2005 it is gaining popularity as a single procedure. long term data is scarce. re-do and revisional surgery in form of re-sleeve, gastric bypass (mini -gastric bypass, roux-en y gastric bypass) and biliopancreatic diversion (bpd) is described in the current literature due to weight regain and reflux. the investigators want to analyze the frequency of this re-do/revisional surgery and want to compare weight loss and improvement in comorbidities.

Eligibility criteria:
inclusion criteria: * s.a. sleeve gastrectomy since 2007 exclusion criteria: -

Keywords: sleeve gastrectomy long-term follow-up gastroesophageal reflux disease after sleeve revisional surgery
dermacyd silver floral (lactic acid) - compatibility.

Conditions: Hygiene

Summary: primary objective: to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product dermacyd silver floral


Eligibility criteria:
inclusion criteria: * phototype skin i,ii, iii e iv * integral skin test in the region * willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion exclusion criteria: * lactation or pregnancy * use of antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection * disease which can cause immunosuppresion, such as diabetes, hiv * use of antihistamines 30 days before selection * personnel history of atopy * history of sensitivity or irritation for topic products * cutaneous active disease (local and/or general) which can modify the study results * use of new drugs and/or cosmetics during the study * cutaneous reaction * previous participation in studies using the same product in test * volunteer which has immunodeficiency congenital or acquired * relevant history or confirmation of alcohol or other drugs abuse * intolerance detected or suspected for some component of the sample tested * medecin or sponsor employees or their close family. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
study of treatment with nilotinib in adult patients with imatinib - resistant or - intolerant chronic myeloid leukemia in blast crisis, accelerated phase or chronic phase

Conditions: Chronic Myeloid Leukemia

Summary: maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the \[camn107a2109\] study


Eligibility criteria:
inclusion criteria: 1. patients currrently participating in novartis study camn107a2109 2. imatinib - resistant or intolerant - philadelphia chromosome-positive cml in chronic (cml-cp)accelerated phase (cml-ap) or in blast crisis (cml-bc) 3. males or females ≥18 years of age 4. who performance status of ≤ 2 5. patients must have the following laboratory values: alt and ast ≤ 2.5 x uln or ≤ 5.0 x uln if considered due to tumor exclusion criteria: 1. impaired cardiac function; use of therapeutic coumarin derivatives 2. patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days 3. patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control 4. patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose of chemotherapy 5. ,.patients who have received imatinib or dasatinib at least 3 days prior to beginning of study drug or who have not recovered from side effects of such therapy

Keywords: leukemia adult chronic myeloid leukemia imatinib nilotinib
bounce to health: a healthy lifestyle program

Conditions: Childhood Obesity; Obesity; Physical Activity; Health Knowledge, Attitudes, Practice; Health Behavior

Summary: the primary purpose of the bounce study is to assess the effectiveness of a four-week family-based healthy lifestyle summer program in reducing adiposity indicators in hispanic and african american girls and boys (ages 9-14 years old).

the secondary aims of this study are to examine post-intervention changes in eating patterns, body image disturbances, unhealthy weight control practices, and fitness levels. the investigators hypothesize that at the post-bounce summer intervention, children will exhibit significant decreases in adiposity indicators (percent body fat and waist circumference), sweetened drinks and fried foods consumption, and an increase in physical fitness (aerobic capacity and minutes of moderated-vigorous physical activity) when compared to their baseline values after controlling for demographic, acculturation characteristics.

Eligibility criteria:
inclusion criteria: * both parental guardians (mother and father) and target child must be of hispanic or african american descent * child must be between the ages of 9-14 years * child must be overweight/obese as defined by a body mass index percentile for age- gender specific between the 85th-100th percentile * child must have no physical disability or medical conditions that interfere with their participation in an exercise program * children must have no extensive diet restrictions that would hinder their participation in the bounce nutrition component (e.g., unable to eat solid foods) * all children will be required to submit evidence of a medical examination conducted by a health professional * parental guardians and child must be available to participate for the duration of the bounce summer exclusion criteria: * child and parental guardians are not hispanic or african american * child is not between the ages of 9-14 years * child is underweight or normal weight (bmi \ 100 percentile) * child or mother are pregnant or physically unable to participate * child has extensive diet restrictions that would hinder their participation in the bounce nutrition component (e.g., unable to eat solid foods) * child does not have submitted evidence of a medical examination conducted by a health professional note: we will encourage both maternal and paternal guardians to participate in the measurements and interventions. however, if the paternal guardian refuses to participate or there is no father figure present in the family, maternal guardian-child pairs will be still eligible to participate in this study. if the children are of mixed race, but identify themselves as hispanic or african american and at least one of their parents is either hispanic or african american, they will be still eligible to participate.
switching osteoporosis patients currently on oral bisphosphonate to zoledronic acid

Conditions: Osteoporosis

Summary: the purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.


Eligibility criteria:
inclusion criteria: * post-menopausal women between 45 and 79 years of age * must be osteopenic/osteoporotic * treatment with oral bisphosphonate for at least 1 year exclusion criteria: * any woman of child bearing potential * treatment with other bone active agents other protocol-defined inclusion/exclusion criteria may apply.

Keywords: osteoporosis, osteopenia, post-menopausal, zoledronic acid
a study to evaluate and compare injections of autologous dermal and epidermal cells into the balding scalp of subjects with hair loss (ca-0002899)

Conditions: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness

Summary: evaluate the ability of injections of ji gami(tm) and ji gami(tm) do to induce hair growth in male and female subjects with hair loss.


Eligibility criteria:
inclusion criteria: * male and female volunteers 18 to 65 years old, inclusive * hair loss consistent with ≥ grade iii-vertex, iv, va, v, and vi, based on norwood-hamilton scale providing there is bridging of hair in the anterior edge of the vertex circle. * have no clinically significant disease or abnormal laboratory results taken at the screening visit. exclusion criteria: * known sensitivity to dmem/f-12 or any component of the study material. * known hypersensitivity to clindamycin hydrochloride, amphotericin b or streptomycin sulfate. * subjects who have used minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening. * a history of drug or alcohol abuse within 1 year of study enrollment. * clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator. * any clinically significant abnormal laboratory parameters. * a positive result at screening for human immunodeficiency virus (hiv 1 or 2), hepatitis b or c, htlv i/ii. * dermatologic condition in donation and/or study areas. * prior surgery in the treatment area. * insufficient hair or scarring in the donor area that might impact cell growth. * any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.

Keywords: androgenetic alopecia male pattern baldness female pattern baldness hair loss baldness
standard post market clinical follow-up (pmcf) study wsa @ hzo

Conditions: Hearing Loss, Sensorineural

Summary: the purpose of the study is to follow-up on a released low-risk device as part of standard pmcf activities

this is a comparative study which is conducted monocentric at hoerzentrum oldenburg, germany. the focus is to test a released hearing aid and compare this to the subject's own hearing aids with a minimum of 16 mild-to-moderate sensorineural hearing impaired adult subjects. the subjects, all of them native german speakers, have 2 appointments of 1-2 hours including a fitting procedure with real-ear measurements and some standard speech tests and undergo two 2-weeks home trials (with questionnaires).

Eligibility criteria:
inclusion criteria: * hearing loss should fall within fitting range of study hearing aid * they should be experienced hearing aid users * air-bone-gap should be less or equal to 20 db hearing loss (hl). * sensorineural hl, mild-to-moderate * hl corresponding to the fitting range of the hearing aid * healthy (outer) ear * older than 18 years * german is mother tongue * able to understand the instructions * willing to participate in laboratory tests and to wear the hearing aids at home for 2 weeks * informed consent exclusion criteria: * contraindication for hearing aid treatment * fluctuating or rapidly progressing hearing loss * "central" hearing problems * limited mobility * limited dexterity (in handling the hearing aid) * known psychological problems

Keywords: hearing aid freiburger matrix test ssq ioi-ha
early active controlled motion (eacm) rehabilitation protocol post open reduction and internal fixation (orif) of scaphoid fractures: a pilot study

Conditions: Scaphoid Fixation

Summary: there is poor research supporting the benefits of early active controlled motion (eacm) protocols post operative scaphoid fixation. advances in surgical fixation technique for scaphoid fractures should allow for start of earlier mobilization, however there is little evidence in the literature that supports the use of these protocols within the early phases of healing. the study uses a pre-experimental design with purposeful sample population recruitment.


Eligibility criteria:
inclusion criteria: * date of injury and diagnosis: scaphoid fracture less than 3 weeks old * waist fractures in the middle 1/3 and distal pole 1/3 of scaphoid bone. * surgical procedure includes orif with screw fixation and/or percutaneous pin with screw fixation. * to be included in the study the patient needs to have started rehab within the first 10 days after surgery date. exclusion criteria: * proximal pole scaphoid fracture * past medical history of diabetes and other peripheral vascular disorders. * history of osteopenia and osteoporosis. * previously failed orif of scaphoid * neurovascular or nerve lesion to the involved upper extremity * cognitive deficits related to memory, attention span, judgment as documented in the emr or need for a legal guardian to be a medical proxy
meat derivative and satiating compound effect on satiety

Conditions: Overweight

Summary: the purpose of this study is to evaluate the satiating effects of a meat derivative and a satiating compound on overweight subjects (bmi ≥25 and \<30 kg / m2).

a randomized, parallel, controlled and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of a meat derivate and a satiating compound in a group of healthy overweight subjects. the investigators included 20 participants between 18 and 65 years (bmi ≥25 and \<30 kg / m2). all volunteers will be randomized into 3 study groups, and participants will receive the 2 study products during the 3 experimental phases.

Eligibility criteria:
inclusion criteria: * men and women from 18 to 65 years old. * body mass index (bmi) ≥25 and \<30 kg/m2. * adequate cultural level and understanding for the clinical trial. * subjects willing to consume all food present in the brunch type meal. * signed informed consent. exclusion criteria: * subjects with bmi ≥30 or \ 30 g/day) * subjects diagnosed with diabetes mellitus. * subjects with dyslipidemia on pharmacological treatment. * subjects with hypertension on pharmacological treatment. * subjects with hyper/hypothyroidism. * subjects with established diagnosis of eating disorder. * smokers or those subjects with high alcohol consumption (\> 2-3 servings/day in men and\> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer). * subjects under pharmacological treatment (except oral contraceptives). * subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet. * subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients. * subjects with severe chronic diseases (hepatic, kidney, ...) * subjects with intense physical activity. * subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption. * subjects with a diagnosis of celiac disease or a gluten intolerance. * subjects who consume regularly oral supplements (i.e. omega-3) * pregnant or breastfeeding women. * women with menstrual irregularities (absence of menstrual cycle at least 2 months).

Keywords: satiety meat derivative fiber visual analogue scale parallel
imaging with 11c-erlotinib pet/ct to identify responders to erlotinib treatment in nsclc

Conditions: Lung Cancer

Summary: new treatment strategies have been developed in lung cancer targeting the epidermal growth factor receptor (egfr). patients with an activating mutation in the egfr have high responds rates to the treatment and should be treated with a egfr inhibitor as first line of treatment. some wild type patients do as well respond but selection of these patients is more difficult. erlotinib has been labeling with 11c and used as a new pet tracer. accumulation of the tracer (11c-erlotinib) in tumors has showed promising results for selection of responders. the investigators now want to conduct a larger clinical study to evaluate if accumulation of tracer on a pre-treatment 11c-erlotinib pet/ct can predict responds to erlotinib.


Eligibility criteria:
inclusion criteria: * lung cancer patients with non-small cell histology and stage iv disease who are candidate for erlotinib treatment as first/ second/ third line of treatment exclusion criteria: * pregnancy * severe dyspnoea
efficacy of oocyte activation with two types of ca2+ ionophore.

Conditions: Infertility, Female

Summary: this study is a prospective ranzomized analysis including 372 human oocytes from 44 women. half of the oocytes from the same patient will be randomly allocated to induce oocyte activation using two protocols: in protocol nº 1 we will use ionomycin (prepared solution), protocol nª2 a23187 (gm508 cultactive gynemed) will be applied. non treated oocytes will serve as control. oocyte fertilization rates, embryo development and embryo quality will be analyzed. obstetrics variables of offspring will be also followed and compared.

background: oocyte non-activation (oad) is the main cause of fertilization failure in intracytoplasmic sperm injection (icsi) cycles. oocyte activation involves a series of consecutive events that take place in the oocyte during fertilization, triggered by the action of sperm-specific phospholipase c zeta (plcz) that causes an increase in the amount of free ca2+. this increase, as well as its transient elevations in space and time, is species-specific. defects in this pattern of ca2+ release and oscillation are attributed to most cases of oad. several strategies have been described and applied to achieve artificial oocyte activation (aoa), which use mechanical, electrical, or chemical stimuli, among which the use of calcium ionophores such as ionomycin and a23187 (calcimycin) predominates. documented fertilization and pregnancy rates appear to be improved in patients with previous low fertilization rates or total fertilization failures after using icsi-aoa compared to conventional icsi. however, the lack of well-designed studies, the heterogeneity of the population undergoing aoa, and the scarcity of results comparing different aoa protocols make it difficult to assess the clinical efficacy and safety of the technique. study question: in patients with prior fertilization failure or low fertilization rates (30% or less), does aoa improve reproductive outcomes compared to conventional icsi in patients with prior fertilization failure? and if it does, which protocol is more efficient?

Eligibility criteria:
inclusion criteria: * own oocyte patients who have had previous fertilization failure in previous cycles. * own oocyte patients with fertilization rate in previous cycles less than or equal to 30% of the microinjected oocytes. exclusion criteria: * oocyte recipient patients * sperm bank sperm recipient patients * patients who after oocyte decumulation have less than 2 mature oocytes.

Keywords: artificial oocyte activation fertilization failure calcium ionophore ionomycin calcimycin fertilization rate