Kornimate/medical-research-clean huggingface dataset:
follow up for patients with thyroid cancer planed for radioiodine scan or treatment

Conditions: Thyroid Cancer

Summary: the prevalence of thyroid cancer has increased in recent decades. patients with thyroid cancer need to choose between thyrogen® injection and eltroxin® withdrawal before radioiodine therapy or scan. this is a prospective, observational study, aiming to observe the difference of metabolic profiles between patients choose thyrogen® injection and eltroxin® withdrawal.

1. objective： to observe the difference between thyogen® injection or eltroxin® withdrawal on metabolic profile. 2. background and method:： the prevalence of thyroid cancer has increased in recent decades. patients with thyroid cancer need to choose between thyrogen® injection and eltroxin® withdrawal before radioiodine therapy or scan. this is a prospective, observational study, aiming to observe the difference of metabolic profiles between patients choose thyrogen® injection and eltroxin® withdrawal. inclusion ： patient number: 500人 inclusion criteria : 1. patients with diagnosis of thyroid cancer。 2. patients who need radioiodine therapy or scan。 exclusion criteria: 1. patients cannot cooperate with blood test.。 2. patients cannot cooperate with radioiodine therapy。 study design： prospective, observational study。 method： we will collect 20cc blood and 20 cc urine before and after radioiodine therapy during each visit (total 3 visits) and check lipid profiles, glucose profiles and inflammation markers. we will compare the difference between results of patients undergoing thyrogen® injection and eltroxin® withdrawal.

Eligibility criteria:
inclusion criteria: 1. patients with diagnosis of thyroid cancer。 2. patients who need radioiodine therapy or scan。 exclusion criteria: 1. patients cannot cooperate with blood test.。 2. patients cannot cooperate with radioiodine therapy。
clinical study of glaukos® trabecular micro-bypass system model is3 infinite vs. competitor

Conditions: Glaucoma; Glaucoma, Open-Angle

Summary: a study of the istent infinite product in the treatment of open-angle glaucoma vs competitor


Eligibility criteria:
inclusion criteria: * diagnosis of primary open-angle glaucoma (poag) or secondary pseudoexfoliative glacoma (pexg) or secondary pigmentary glaucoma (pg) exclusion criteria: * any other type of glaucoma including, but not limited to: traumatic glaucoma, angle recession glaucoma, uveitic glaucoma, neovascular glaucoma, angle closure glaucoma (acg) and glaucoma associated with vascular disorders

Keywords: glaucoma migs
phase 1 study of osi-930 in cancer patients

Conditions: Advanced Solid Tumors

Summary: open label, phase 1, dose escalation

multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose on both once daily (qd) and twice daily (bid) schedules. patients may continue to receive osi-930 until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.

Eligibility criteria:
inclusion criteria: histologically or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists. age \>/= 18 years, ecog ps 0-2, life expectancy \>/= 12 weeks prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed. prior tyrosine kinase inhibitor therapy is permitted. patients must have recovered from any treatment-related toxicities (with some exceptions) prior to registration. prior hormonal therapy is permitted provided it is discontinued prior to registration (with the exception of prostate cancer patients who have been on hormone therapy for at least 3 months). prior radiation therapy is permitted provided that it did not exceed 25% of bone marrow reserve and patients have recovered from the toxic effects. a minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive. anc \>/= 1.5 x 10\^9/l, plt \>/= 100 x 10\^9/l; bilirubin \</= 1.5 x upper limit of normal (uln), ast and alt \</= 2.5 x uln; creatinine \</= 1.5 uln accessible for repeat dosing and follow-up. patients must practice effective contraceptive measures throughout the study. provide written informed consent. exclusion criteria: symptomatic brain metastases which are not stable, require steroids, are potentially life-threatening or that have required radiation within the last 28 days. history of allergic reaction attributed to a similar compound as study drug. significant cardiac disease unless well controlled, poorly controlled hypertension. active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation. history of any psychiatric condition that might impair the patient's ability to provide informed consent or participate. concurrent anticancer therapy. use of cyp3a4 inducers/inhibitors during the 14 days prior to first dose. pregnant or breast-feeding females.

Keywords: advanced cancer non-small cell lung cancer small cell lung cancer uterine cancer ovarian cancer renal cancer head and neck cancer cervical cancer metastatic cancer colorectal cancer gastrointestinal stromal tumors
zk-epo given with prednisone in patients with metastatic androgen-independent prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate whether treatment with a new drug called zk-epothilone (zk-epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease psa (prostate-specific antigen) levels.

this study has previously been posted by berlex, inc. and schering ag, germany.berlex, inc. has been renamed to bayer healthcare pharmaceuticals, inc., schering ag germany has been renamed to bayer schering pharma ag, germany. bayer healthcare pharmaceuticals, inc.and bayer schering pharma ag, germany are the sponsors of the trial.

Eligibility criteria:
inclusion criteria: * must have evidence of confirmed metastatic prostate cancer * serum testosterone must be less than 50 ng/ml * disease must be progressing despite anti-androgen therapy * psa level must be elevated * additional criteria determined at screening visit exclusion criteria: * any previous cytotoxic chemotherapy for prostate cancer * use of any investigational drug in the last 4 weeks * symptomatic brain tumors requiring radiation to the brain * active infection * additional criteria determined at screening visit

Keywords: prostate cancer metastatic androgen-independent prostate cancer
treatment options in human epidermal growth factor receptor 2 (her2) positive metastatic breast cancer patients

Conditions: Neoplasms, Breast

Summary: this study will describe the treatment paradigm used over recent years in the clinical management of human epidermal growth factor receptor 2 (her2)+ metastatic breast cancer in hungary. this information will provide insight into real-world exposure and adherence to anti-her2 therapy containing regimens, and improve understanding of the reasons for discontinuation of this therapy. this is a retrospective, descriptive, cohort study of approximately 180 female patients diagnosed with her2-positive metastatic breast cancer in hungary. patients diagnosed with, or who progressed to, metastatic disease between 01 september 2009 and 01 september 2010 will be included. all patients will be followed until death, loss to follow-up or the end of the study period (30 september 2012). all data will be collected retrospectively from patient medical records. descriptive statistics of the demographic and clinical characteristics of her2+ metastatic breast cancer patients, including sites of metastases, the time from initial breast cancer diagnosis until diagnosis of metastatic disease, and her2 testing methodology and status of her2 will be described. further, descriptive statistics of the proportion of her2+ metastatic breast cancer patients who received anti-her2 therapy, the sequencing of different therapies, and the duration of therapies in the metastatic setting will be analysed. among the subset of women who receive lapatinib plus capecitabine, descriptive statistics of the timing of initiation of lapatinib plus capecitabine in the metastatic treatment pathway, time to treatment discontinuation and time to progression (ttp) on lapatinib plus capecitabine will be calculated. further, descriptive statistics of the type and duration anti-her2 therapies used prior to initiation of lapatinib plus capecitabine and, where relevant, after lapatinib+capecitabine will be performed.


Eligibility criteria:
inclusion criteria: * female patients aged 18 years or older at diagnosis of, or progression to, metastatic breast cancer * patients with a diagnosis of breast cancer with documented metastatic disease and with known date of metastatic disease * patients with a histologically confirmed her2+ breast cancer (her2 testing procedures per routine institutional practice; no tissue re-sampling will be performed. if conducted at another site, documented results must be available). exclusion criteria: * patients receiving care for another primary cancer during the study time period.

Keywords: her2 positive breast cancer treatment patterns
efficacy and safety of ascending dosages of moxidectin and moxidectin-albendazole against trichuris trichiura

Conditions: Trichuris Trichiura; Infection

Summary: the study rationale is to provide evidence on effective doses of moxidectin and/or moxidectin-albendazole in adolescents (16-18 years old) infected with trichuris trichiura. the study will take place on pemba island, tanzania.


Eligibility criteria:
inclusion criteria: 1. male and female subjects aged 16 to 18 years, inclusive 2. written informed consent/assent signed from parent/guardian 3. positive for t. trichiura by at least two slides of the quadruple kato-katz thick smears and infection intensities of at least 100 eggs per gram of stool (epg) 4. agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up). exclusion criteria: 1. presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment. 2. known or reported history of chronic illness such as hiv, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease. 3. prior treatment with anthelmintics (eg, diethylcarbamazine \[dec\], suramin, ivermectin or albendazole) within 4 weeks before planned test article administration. 4. received any investigational drugs or investigational devices within 4 weeks before administration of test article that may confound safety and/or efficacy assessments. 5. known or suspected allergy to moxidectin, ivermectin or albendazole or other compounds related to these classes of medication. 6. pregnant (urine testing) or breastfeeding women
diagnostic performance of ultrasound imaging technique for femoral condyle cartilage evaluation and osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study investigates the potential of the ultrasound imaging technique to diagnose the severity of knee osteoarthritis (oa). in parallel, measurements will also be conducted using magnetic resonance imaging (mri) and histology analysis as reference tools.

knee osteoarthritis (oa) is a common degenerative disease of synovial joint becoming more frequent with age. among techniques have been used to diagnose and classify the severity of knee oa, the imaging techniques, such as ultrasonography (us), provide physical quantitative informations for better understanding and assessing of the pathology of the knee joint. the present study aim to investigate the diagnostic performance of ultrasonography for femoral condyle cartilage evaluation using mri and histology analysis as reference tools. to validate this approach, evaluations are conducted to determine, whether the ultrasound speed of sound (us-sos) propagation is associated with the variation of the arthrosis stage, in order to improve the diagnosis of the surgeon. for this purpose, measurements are conducted using selected human cartilage samples with different stage of oa (early stage and advanced stage). this research is the first "preclinical" study of a new unlabelled medical device developed by cartimage medical sas. cartilage is a prospective, monocentric, unrandomized and uncontrolled study. this study doesn't modify the medical care of the patient.

Eligibility criteria:
inclusion criteria: * patient over 18 year old * knee osteoarthritis which total knee arthroplasty indication * who have signed a non-objection form. exclusion criteria: * person who refuse to sign a non-objection form * person deprived of liberty by judicial or administrative decision * person under legal protection or unable to express their consent * person hospitalized for psychiatric care

Keywords: knee osteoarthritis ultrasonography evaluation/ultrasound articular cartilage ultrasound speed of sound (us-sos) ultrasound time of flight (us-tof)
clinical/behavioral approach to overweight in latino youth

Conditions: Overweight; Pediatric Obesity

Summary: this randomized controlled trial tests the efficacy of a culturally and linguistically appropriate, evidence-based intervention to slow weight gain or promote weight loss among overweight 6-9 year old mexican-american children.

overweight and obesity is a serious problem for mexican-american children, due in part to poverty, acculturation, genetic predisposition or other factors. clinic-based weight control studies have shown promise, but often include convenience samples with few or no latino children. this randomized controlled trial tests the efficacy of a culturally and linguistically appropriate, evidence-based intervention to lower body mass index (bmi) or slow weight gain among overweight 6-9 year old mexican-american children randomly sampled from a large (36,192 pediatric patients) community clinic providing services to low and medium income families in a us-mexico border community (san ysidro, ca). intervention and measurement design and selection are based on a "socioecological model for latino health promotion". children and their parents will be randomly assigned to either a special intervention (si) or usual care (uc) group. the si group will participate in the following behavior change activities based on prevention plus and structured weight management approaches: 1. classes providing culturally-sensitive health education regarding healthy eating, increasing physical activity, decreasing sedentary behaviors, and effective parenting behaviors to model and reinforce children's health behaviors, instruction on how to modify both social and structural aspects of the home environment, and skills-building to navigate community resources; 2. clinical visits with a health educator and mid-level provider (mlp); 3. family visits with primary care providers (pcp); and 4. phone calls to reinforce goal setting. the uc group will receive standard health education for childhood obesity already provided by the community clinic. the primary outcome for the study is child bmi, which along with other changes in physical outcomes, child health behaviors and parenting behaviors will be evaluated at four time-points (baseline, 6-, 12-, and 18-months). the primary hypothesis is that the si group will demonstrate lower mean bmi than the uc group at the end of a 6 month intervention with a maximum difference occurring at 12 months, and will sustain this difference for an additional six months (18 months after baseline). secondary aims include examining intervention effects on children's energy balance, physical activity levels, sedentary behavior and parenting strategies related to their children's health behaviors.

Eligibility criteria:
inclusion criteria: * self-identify as latino * have made a clinic visit within past 24 months prior to enrollment in study * have a bmi % for age/gender between 75 - 99.9th * plan on living in target area for following 18 months * have transportation to participating clinic

Keywords: childhood obesity
a study of bci-838 and several bci-632 prodrugs in healthy volunteers

Conditions: Healthy

Summary: this study will evaluate the safety, tolerability and pharmacokinetics of bci-838, its metabolite bci-632 and several new pro-drugs in healthy male subjects.

the first phase of this study will evaluate the safety and tolerability of bci-838 following oral administration of single doses of bci-838 in healthy male subjects. the pharmacokinetics of bci-838 and its metabolite bci-632 following single ascending doses of bci-838 will be evaluated, as will the effect of food on the pharmacokinetics of bci-838 and its metabolite following single oral doses of bci-838 in healthy male subjects. the second phase of this study will evaluate and compare the relative bioavailability and pk of the metabolite bci-632 following single oral administration of several new pro-drug candidates in healthy male subjects.

Eligibility criteria:
inclusion criteria: * adult male healthy volunteer, 18-55 years of age * body mass index (bmi) between 18.0 to 30.0 kg/m2 inclusive * good general health as determined by medical history and physical examination with no clinically significant medical findings and no clinically relevant medical or surgical history and no acute or ongoing conditions within the past 30 days * able to participate and willing to give written informed consent and to comply with the study restrictions exclusion criteria: * clinically significant medical abnormality, chronic disease or history or presence of significant pulmonary, gastrointestinal, metabolic, cardiac, hepatic, renal or neurological disorder * history or current use of alcohol abuse or drug addiction * participation in a drug study within 60 days prior to drug administration. * participation in more than 3 other drug studies in the 10 months preceding the start of this study * donation or blood loss of more than 50 ml of blood within 60 days prior to the first drug administration. donation of more than 1.5 liters of blood in the 10 months preceding the start of this study * illness within 5 days prior to drug administration

Keywords: metabotropic glutamate receptors 2 and 3 antagonist mglur ketamine bdnf depression major depressive disorder mood disorder treatment resistant depression phase 1 safety, tolerability and pharmacokinetics study
a novel limb cryocompression system for prevention of chemotherapy induced peripheral neuropathy

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: the study aims to investigate the safety and tolerability of limb cryocompression in preventing of chemotherapy-induced peripheral neuropathy via a newly developed limb cryocompression device in healthy subjects and cancer patients. the limb cryocompression device will be tested for its safety in delivering limb cryocompression and efficacy in improving the preservation of peripheral nerves during chemotherapy.

the study consists of two parts. the first part of the study will consist of up to 18 healthy subjects to assess safety and tolerability of the new limb cryocompression device. the occurrence or lack of core hypothermia will be studied. the second part of the study will consist of 15 cancer patients recruited from the national university hospital. patients will undergo cryocompression over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy. cryocompression of the limbs will be administered using cooling wraps attached to a cooling device. the limbs will be cooled from the digits to the elbow/knee.

Eligibility criteria:
inclusion criteria: 1. for healthy subjects: * age 21-80 years * signed informed consent from patient or legal representative * no history of neuropathy * ecog 0 * no history of hospitalization in the past 6 months 2. for cancer patients: * age 21- 80 years * signed informed consent from patient or legal representative * scheduled to receive weekly paclitaxel chemotherapy * patients may receive other chemotherapy drugs alongside taxane e.g. platinum/herceptin. exclusion criteria: 1. for healthy subjects: * open skin wound or ulcers of the limbs * history of raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes * pregnant women 2. for cancer patients: * open skin wound or ulcers of the limbs * history of raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes * pregnant women

Keywords: chemotherapy-induced peripheral neuropathy cryocompression
janus kinase 1 in vitiligo & psoriasis

Conditions: Vitiligo

Summary: assessment of the level of jak1 in both vitiligo and psoriasis patients before and after treatment with nb-uvb which is considered a gold standard therapy for both diseases.


Eligibility criteria:
inclusion criteria: * age above 12 years of age. * psoriasis vulgaris or non-segmental vitiligo * patients who received no systemic or topical treatment at least 6 weeks prior to enrollment into the study. exclusion criteria: * psoriasis patients with erythrodermic psoriasis, pustular psoriasis or associated psoriatic arthritis * vitiligo patients with segmental or universal vitiligo were excluded from the study. * any patient with a photosensitive disorder or any contraindication to phototherapy exposure, e.g., history or presence of malignant or premalignant skin lesions.
effectiveness of three steps hysteroscopic repair of post caesarean isthmocele in patients with post menstrual spotting

Conditions: Abnormal Uterine Bleeding

Summary: isthmocele is one complications of repeat cesarean sections which is considered as a pocket .that accumulate menstrual blood causing post- menstrual spotting hysteroscopic resection of the edges of the isthmocele is considered the best treatment option available up to date. aim of the work: asses the effectiveness of three steps method resection using hysteroscopy of an isthmocele in patients complained of post -menstrual bleeding with confirmed presence of isthmocele. .

the incidence rate of cesarean deliveries has been dramatically increased in egypt.(1) isthmocele is one of the known complications of repeat cesarean sections.(2) post- menstrual spotting and many other gynecological complains have been correlated to this isthmocele which is considered as a pocket that accumulate menstrual blood. (3) hysteroscopic resection of the edges of the isthmocele is considered the best treatment option available up to date.(4) aim of the work: asses the effectiveness of three steps method resection using hysteroscopy of an isthmocele in patients complained of post-menstrual bleeding with confirmed presence of isthmocele. patients: 50 patients complained of post-menstrual bleeding with confirmed presence of isthmocele. after written consent, the patient will be subjected to three steps hysteroscopic resection of an isthmocele by removing the distal edge of the niche then the proximal edge and lastly ball cauterization of the floor of the pouch of the isthmocele. post-operative trans-vaginal ultrasound and follow up for 2 menstrual cycles.

Eligibility criteria:
inclusion criteria: * female * previous cesarean sections * complain post menstrual spotting exclusion criteria: * other genital tract abnormality * other uterine causes pf bleeding residual myometrial thickness less than 3mm