Kornimate/medical-research-clean huggingface dataset:
a study of tirzepatide (ly3298176) in participants after a lifestyle weight loss program

Conditions: Obesity; Overweight

Summary: this is a study of tirzepatide in participants with obesity. the purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. the study will last about 2 years (29 visits).


Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease * history of at least one unsuccessful dietary effort to lose body weight exclusion criteria: * diabetes mellitus * change in body weight greater than 5 kg within 3 months prior to starting study * obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity * history of pancreatitis * family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men-2) * history of significant active or unstable major depressive disorder (mdd) or other severe psychiatric disorder within the last 2 years * any lifetime history of a suicide attempt

Keywords: diet exercise metabolism and nutrition disorder behavioral modification
dual mobility cup: does it improve patient's satisfaction after total hip arthroplastry?

Conditions: Patient Satisfaction; Hip Osteoarthritis

Summary: although the success of total hip arthroplasty, many patients were dissatisfied postoperatively. patient's reported outcome measures become of a great importance in assessment of the results after joint replacement. the aim of this prospective study is to evaluate and compare postoperative patient's satisfaction after implantation of two commonly used different designs of total hip arthroplasty.

the investigators conducted a prospective comparative study carried out on 180 patients suffering of hip arthritis between 2011 and 2018. they were randomized into two groups of homogenous demographic and clinical data. group a was treated by cementless t.h.a. with a large head while group b received cementless t.h.a. with a dual mobility cup. clinical evaluation and preoperative patient's expectation were assessed and compared to the postoperative satisfaction.

Eligibility criteria:
inclusion criteria: * unilateral hip arthritis * age up to 65 years * body mass index (bmi) up to 35 * modified charnley comorbidity classification equal to a exclusion criteria: * neurological deficit (e.g. parkinsonism, stroke) * bone type c not fit for cementless fixation * poly-arthritis, active inflammatory arthritis (e.g. rheumatoid arthritis) * any patient with psychiatric disorders

Keywords: hip arthroplasty satisfaction dual mobility cup
omega-3 polyunsaturated fatty acids and non-muscle invasive bladder cancer

Conditions: Non-Muscle Invasive Bladder Cancer

Summary: the investigators hypothesize that omega-3 polyunsaturated fatty acids (n-3 pufas) might have a role in prevention of the recurrence of non-muscle invasive bladder cancer (nmibc). the patients who are suffering from high-risk nmibc will be randomly allocated into two groups: the first group (n-3 pufas group): 55 patients will receive omega-3 plus twice daily for one year after transurethral resection of bladder tumor (turbt). the second group (control group): 55 patients will receive placebo twice daily for one year after turbt. all patients will receive intravesical bacillus calmette-guérin (bcg) immunotherapy and they will be followed up for two years. the chemopreventive effect of n-3 pufas on the recurrence of nmibc after turbt will be studied via magnetic resonance imaging (mri), inpatient cystoscopy, histopathological examination and molecular studies of the resected bladder tissues.

the investigators hypothesize that omega-3 polyunsaturated fatty acids (n-3 pufas) might have a role in prevention of the recurrence of non-muscle invasive bladder cancer (nmibc). the patients who are suffering from high-risk nmibc will be randomly allocated into two groups: the first group (n-3 pufas group): 55 patients will receive omega-3 plus (1200 mg) orally, twice a day for at least 12 months. the treatment will start after transurethral resection of bladder tumor (turbt), as soon as the histopathology will be obtained. the treatment will be discontinued if recurrence develops, unacceptable or serious adverse events occur or according to the patients' request. the second group (control group): 55 patients will receive placebo twice daily for one year after turbt. patients and care providers will be blinded to the medication given. all patients will receive intravesical bacillus calmette-guérin (bcg) immunotherapy and they will be followed up for two years. the chemopreventive effect of n-3 pufas on the recurrence of nmibc after turbt will be studied via magnetic resonance imaging (mri), inpatient cystoscopy, histopathological examination and molecular studies of the resected bladder tissues.

Eligibility criteria:
inclusion criteria: - patients who are at high risk for recurrence of nmibc after turbt based on the following tumor characteristics: * stage ta (g3, multifocal, or ≥ 2 occurrences within 12 months, including the current tumor), * stage t1 (any grade) and/or, * carcinoma in situ (cis), * without any indication for radical cystectomy. exclusion criteria: - patients with: * ≥ t2 bladder cancer, * evidence of nodal metastasis, * associated upper tract urothelial carcinoma (utuc) or * those who refuse.

Keywords: non-muscle invasive bladder cancer; transurethral resection of bladder tumor; omega-3 polyunsaturated fatty acids.
a study of ly3009120 in participants with advanced cancer or cancer that has spread to other parts of their body

Conditions: Neoplasms; Neoplasm Metastasis; Melanoma; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms

Summary: the main purpose of this study is to see how safe the investigational drug known as ly3009120 is and whether it will work to help people with advanced cancer or cancer that has spread to other parts of the body.


Eligibility criteria:
inclusion criteria: * advanced or metastatic cancer * other available therapies have failed to cure the cancer * the cancer that has no proven effective therapy * the cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required) * able to swallow capsules exclusion criteria: * have active cancer in the brain or spinal cord * have an active infection of any kind (fungal, viral, or bacterial) * have a cancer of the blood * are pregnant or breastfeeding * have some types of eye problems or impairments
clinical evaluation of white spot lesions treated by s-prg and icon

Conditions: White Spot Lesion

Summary: randomized with (1:1) prospective, double-blind, controlled trial. subjects will be randomized to receive s-prg and the control group receives icon.

interventions: - all the procedures will be performed by the same clinician. diagnodent will be used to assess the fluorescence loss of wsls and the adjacent sound enamel. wsls in permanent teeth will be treated according to the manufacturer's instructions with: * group i (control group): 20 teeth will be treated with icon. * group ii ( experimental) : 20 teeth will be treated with prg barriercoat. observation: - the treatment methods will be assessed immediately after the intervention, 3 months,6 months, and one year. the data will be collected for evaluation of the difference in color and fluorescence loss between the treatment groups, by using diagnodent devices, over different time intervals. ethical considerations: the research protocol is approved by the ethical committee, faculty of dental medicine, al-azhar university and the enrolled patients should sign a written consent form.

Eligibility criteria:
inclusion criteria: * patients within 20-40 years of age. * each patient has 4 or more wsls. * mild and moderate wsls according to gorelick's scale. * good oral hygiene and willing patients who can attend the study visits. * a symmetrical number of permanent teeth in each arch (mesial to second molars). exclusion criteria: * active carious lesions. * facial surface restorations. * intrinsic and extrinsic stains. * patients who have a significant medical history or if they smoke. * criteria for discontinuation; mortality and acquiring severe debilitating disease

Keywords: white spot lesions icon s-prg diagnodent
second-line endocrine treatment followed by capecitabine versus capecitabine followed by endocrine treatment in patients with metastatic er positive breast cancer

Conditions: Breast Cancer

Summary: this trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. it is anticipated that the time on study (which is the time between randomization and the discontinuation of the second treatment in the sequence) will be similar for both arms of the study. the quality of life during this period, however, could be better in the patient group receiving the most effective first agent in the sequence. if this proves to be true, the conventional wisdom that endocrine therapy should be continued until no further endocrine options remain, must be abandoned.

this is a randomized phase ii/ii study. patients are randomized for the sequence capecitabine-hormonal therapy versus hormonal therapy- capecitabine. at progression the patient should receive the other protocol treatment (e.g. if the patient was randomized to capecitabine, at progression the treatment should be switched to hormonal treatment).

Eligibility criteria:
inclusion criteria: 1. written informed consent. 2. proven infiltrating breast cancer with distant metastases or inoperable locally advanced disease. 3. positive estrogen receptor (≥ 10% positive nuclei at immunohistochemistry). progesterone and her-2 neu receptor have to be known. 4. - progressive disease during first line hormonal therapy (either tamoxifen or aromatase inhibitor) for metastatic or inoperable locally advanced disease. simultaneous use of lh-rh analogs is allowed. or - recurrence of disease (m1) during adjuvant hormonal therapy (either tamoxifen or aromatase inhibitor). 5. no prior chemotherapy for metastatic disease 6. willing and able to participate in quality of life investigation - exclusion criteria: 1. other malignancy except carcinoma in situ, unless the other malignancy was treated 5 or more years ago with curative intent without the use of chemotherapy or radiation therapy. 2. pregnancy or breast feeding women. 3. contra-indications to the use of capecitabine 4. known cns metastases

Keywords: metastatic er positive pd during/after first line hormonal treatment
investigation of the safety of intranasal glulisine in down syndrome

Conditions: Down Syndrome

Summary: this study is a single center, randomized, double-blind, placebo-controlled, cross-over pilot study designed to assess the safety of intranasally (in) delivered glulisine versus placebo in patients with ds. subjects will be randomized into this cross-over study and within subject comparisons conducted between single treatment of intranasal insulin glulisine and single treatment of intranasal placebo. all subjects will also receive a single treatment of placebo prior to randomization to ensure adherence to study procedures.


Eligibility criteria:
inclusion criteria: * male or female aged 35-80 years with a down syndrome diagnosis that is confirmed by karyotype. * vital signs must be within normal limits for their age. (medically treated hypertension will be allowed). * must have an electrocardiogram free of clinically significant findings. * must have an authorized representative to provide written informed consent. * level of speech and comprehension of verbal commands are sufficient to understand and to answer simple requests. * must have a reliable caregiver or family member who agrees to accompany the subject to all visits, provide information about the subject as required by this protocol. * must be independent for activities of daily living. * must tolerate the initial in treatment of placebo and adhere to study procedures. exclusion criteria: * any current psychiatric or neurologic diagnosis other than down syndrome or down syndrome with dementia that is judged to impact cognition. * subjects who currently meet or have within the past five years met dsm-iv (diagnostic and statistical manual) criteria for drug or alcohol abuse or dependence. * subjects residing in a skilled nursing facility or subjects who are anticipated to enter a nursing home within the next 6 months. (subjects may reside in group homes, assisted living, or other residential settings where they do not require 24 hour skilled nursing.) * subjects receiving any experimental drug for down syndrome within the past 30 days of screening visit. * subjects with significant allergies to or other significant intolerance insulin. * presence of active seizure disorder. * presence of significant aggression or agitation that may impact participation with testing and in administration. all subjects must have npi-c aggression and agitation subscore ≤ 4 (severity ≤ 2; frequency ≤ 2). * significant cerebrovascular disease with modified hachinski score\>4. * subjects who may not be able to comply with the protocol or perform the outcomes measures due to significant hearing or visual impairment or other issues judged relevant by the investigators. * subject has been diagnosed with any form of diabetes mellitus, actively takes insulin, or has hba1c \> 6.1% at screening.
turkish validity and reliability of the uw concerns about pain scale

Conditions: Chronic Low-back Pain

Summary: brief summary: the aim of this study was to determine the turkish validity and reliability of ''uw concerns about pain scale'' developed by dr. amtmann.

chronic pain is a common condition, affecting an estimated 20% of people worldwide. the biopsychosocial model of chronic pain is the most current accepted approach to understanding the complexity of pain and disability. one of the most important psychosocial factors in this approach is pain-related self-efficacy, which is defined as the individual's confidence in their ability to tolerate pain and participate in daily activities despite pain. the aim of this study is to determine the turkish version, validity, and reliability of ''uw concerns about pain scale''. 60 people with chronic low back pain will include in the study. in order to determine the reliability of the scale, the intraclass correlation coefficient (icc) will be used to determine the level of the relationship between the results of the first and second measurements. cronbach's alpha coefficient will be used for the homogeneity of the questions in the scale. for construct validity, the correlation coefficient will be used to determine the agreement between the turkish version of pain catastrophizing scale and, turkish version of "fear avoidance beliefs questionnaire" and the ''uw concerns about pain scale''.

Eligibility criteria:
inclusion criteria: 1. to be between 18-65 years old 2. having a complaint of low back pain for at least 6 months 3. low back pain severity to be 3 points or above according to the numerical graded pain scale. exclusion criteria: 1. using antidepressant-derived drugs 2. having a history of spinal surgery

Keywords: concerns
a study in patients with myasthenia gravis in china

Conditions: Myasthenia Gravis

Summary: this study is a multi-center, prospective cohort study designed to characterize current clinical practice, clinical and patient-reported outcomes (pros), disease prognosis, treatment patterns and healthcare resource utilization for chinese patients with myasthenia gravis (mg). this study will enroll patients with mg as diagnosed by physician. approximately 1,200 mg patients are intended to be recruited from approximately 40 sites across majority of regions in china. the clinical and pros included mgfa class, mgfa pis, mg-adl (activities of daily living), qmg (quantitative mg score), mg qol-15r, eq-5d etc. all mg patients enrolled will be followed up every 6 months until end of 2027.


Eligibility criteria:
inclusion criteria: this study will enroll patients of all ages who are diagnosed with mg of all mgfa classifications by physicians. 1. patients must have the following data to be enrolled in this study: * mgfa classification * mg-adl score 2. mg patients or their legal guardians/representatives are able to sign the informed consent form (icf). exclusion criteria: 1. patients aged ≥18 years with ocular myasthenia gravis (mgfa class i) lasting for more than 2 years; 2. patients who are currently participating in an interventional clinical trial cannot be enrolled in this study.

Keywords: myasthenia gravis generalized myasthenia gravis refractory myasthenia gravis prospective study observational study cohort study patient registry chinese
irinotecan-eluting bead (debiri) for patients with liver metastases from colorectal cancer

Conditions: Colon Cancer Liver Metastasis

Summary: this is a multicentre, open labeled, single arm study to determine effectiveness and safety of chemoembolization with irinotecan-eluting bead(debiri) in the treatment of unresectable liver metastases in patients with colorectal cancer after chemotherapy failure.


Eligibility criteria:
inclusion criteria: 1. patients over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give informed consent, will be eligible. 2. patients with primary colorectal lesions removed, and negative extrahepatic metastasis 3. patients with at least one measurable liver metastases, with size \> 2cm or less than 5 liver metastases,with size smaller than 10cm. 4. patients have received at least six cycle system chemotherapy based irinotecan or oxaliplatin and got a failure outcome; or patients who are intolerance of operation. 5. no intervention therapy was received for liver lesions during one year. 6. life expectancy of \> 3 months 7. child-pugh's grade a or b (no more than 7 score). 8. eastern cooperative oncology group (ecog) performance status score of \< 2 9. signed, written informed consent exclusion criteria: 1. patients with extrahepatic metastasis 2. patients has received tace,ablation and iodine seed implantation for liver lesions during one year. 3. with obvious arterio-venous fistula 4. patients suffered with other cancer(except for cured basal or squamous cell skin cancer or cervical carcinoma in situ) 5. hematologic function: leukocytes \<3000cell/mm3, platelets\<50000/mm3, with no hypersplenism. 6. adequate renal function (creatinine ≤ 2.0mg/dl) 7. alanine transaminase(alt) and/or glutamic oxalacetic transaminase(ast) \>5 times upper limit of normal(uln) 8. international normalized ratio (inr) \>1.5, or being treated by anticoagulants, or being suffered hemorrhagic disease. 9. with serious heart, kidney, bone marrow, or lung, central nervous system diseases. 10. with recent infections and received antibiotics. 11. other conditions place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation.
probiotics to prevent nec - a historical control study

Conditions: Necrotizing Enterocolitis

Summary: probiotics is given routinely to infants admitted to the department of neonatology during the first 3 days of life with gestational age less than 30 weeks since march 2010. the incidence of necrotizing enterocolitis bell stage ii and iii will be assessed blindly from clinical records. it is hypothesised that the incidence of nec will decrease. infants admitted from 1 march 2010 to 28 february 2013 will be compared to infants admitted 1 dec 2007 to 30 nov 2009 will be compared.


Eligibility criteria:
inclusion criteria: * gestational age less than 30 weeks * admission during the first 3 days of life

Keywords: necrotizing enterocolitis probiotics preterm infant
identification of genetic and cellular markers associated with vascular endothelial modifications in cutaneous arteriovenous malformations

Conditions: Cutaneous Arteriovenous Malformations

Summary: cutaneous arteriovenous malformations (avm's) rare congenital high-flow vascular malformations in which arteries and veins are directly connected through a complex web of abnormal arteries and veins instead of a normal capillary network. arterial feeders and enlarged draining veins directly connect through arteriovenous fistulas that create the "nidus". the natural history of avms is organized into a clinical staging system: during the first phase of quiescence, the arteriovenous malformation mimics a capillary malformation. after many years, the avm may enlarge with loco-regional expansion and tissular destruction. at the ultimate stage, avm may impact the heart function. they are considered non malignant but can expand and become a significant clinical risk when extensive. the management of these high flow avm remains often problematic. complete and large surgical excision of the nidus after hyperselective embolization is the only potential therapeutic solution but this, is often difficult if not impossible. there is no pathogenetic hypothesis for the development of these malformations. histopathological examination (performed only on surgical resection specimen) is poor and does not provide sufficient evidence to assess the evolutivity or the severity of the mav. recent data hypothesize that these vascular malformations are associated with alterations of the vascular endothelium caused by genetic abnormalities involved in the control of angiogenesis and vascular homeostasis. the detection of these anomalies allows the search for cellular and genetic markers that might be useful to optimize the clinical classification, staging, predicting the evolution of these defects and some understanding of its pathophysiological mechanisms. to our knowledge, no studies to identify cellular markers / genetic and endothelial associated with the development of cutaneous avms have been published to date.


Eligibility criteria:
inclusion criteria: * male or feminine subject * subject of 10 and more years old, * subject weighing more than 55 kg. patients: * subject presenting a cutaneous artério-venous deformation there outside of any other deformation or known vascular tumor. * subject presenting no other susceptible pathology to influence endothéliaux markers (renal insufficiency, inflammatory pathology chronicles, infections, pathologies cardiovascular, diabetes, evolutionary tumoral pathology). volunteers: * unhurt subject of deformation or vascular tumor. * subject presenting no other susceptible pathology to influence endothéliaux markers(scorers) (renal insufficiency, inflammatory pathology chronicles, infections, pathologies cardiovascular). exclusion criteria: * subject of less than 10 years old * subject weighing less than 55 kg * subject presenting another type(chap) of vascular vascular deformation or tumor