Kornimate/medical-research-clean huggingface dataset:
telecare in type 1 diabetes (t1d) patients treated by insulin pump

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to determine whether telecare can be used for efficient management of adults with type 1 diabetes mellitus using insulin pump, in lieu of frequent clinic visits.

1. objectives 1. to evaluate the effect of telecare on glycemic control for patients with type 1 diabetes (t1dm). 2. to assess the cost of telecare to maccabi, the patient and the economy. 3. to assess patients' quality of life and satisfaction with telecare intervention. 4. to assess the effect of telecare intervention on insulin adjustment to consumed carbohydrates. 2. working hypothesis telecare can be used for efficient management of t1dm in adults using insulin pump, in lieu of frequent clinic visits. 3. methodology a randomized controlled prospective trial for one year. intervention group: each patient will transmit glucometer and pump data electronically via a web site (medtronic carelink internet site www.carelink.minimed.com) to diabetes team and will receive feedback by telephone. frequency of data transfer will be directly related to patients' metabolic control. in addition to data transmission patient of the intervention group will be arriving during the intervention year for 3 clinic visit at the following time point : 0, 6 and 12 month. control group: 3-month routine clinic visits 4. significance of the proposed research (its uniqueness and innovation) telecare potentially offers a method for efficient continuous care management of patients with t1dm using insulin pump in lieu of clinic visits. it enables real time responses of clinical personnel and increases patient involvement. this trial will be the first telecare intervention lasting for one year to determine if treatment is as efficient as face to face visits, thus enabling cost reduction and time saving without affecting the quality of care. .

Eligibility criteria:
inclusion criteria: * patients with t1d lasted \>1 year, age 22 and up, using insulin pump * patients possessing a mobile phone and internet access exclusion criteria: * patients with severe target organ damage * patients with mental retardation * patients with eating disorders * pregnant patients or patients planning pregnancy

Keywords: diabetes mellitus, type 1 adult insulin infusion systems telecare
autologous mesenchymal stem cells transplantation in women with premature ovarian failure

Conditions: Premature Ovarian Failure

Summary: stem cells (sc) are the foundation cells for every organ, tissue and cell in the body. they are undifferentiated "blank" cells that do not yet have a specific function. under proper conditions, they begin to develop into specialized tissue and organs. they are self-sustaining and can replicate themselves for long periods of time. they have the remarkable potential to develop into many different cell types in the body. they serves as a sort of repair system for the body, they can theoretically divide without limit to replenish other cells as long as the person is still alive. premature ovarian failure (pof) is the loss of ovarian function in women less than 40 years. it is associated with sex steroid deficiency, amenorrhea, infertility and elevated serum gonadotropins. pof occurs in 1 % of women. in majority of cases the underlying cause is not identified. management essentially involves hormone replacement and infertility treatment. this work aimed to evaluate the therapeutic potential of autologous msc transplantation in women suffering from premature ovarian failure.

sample of 60 ml is aspirated from the bone marrow of the iliac crest and prepared in the lab and injected in the ovaries through laparoscopy. endometrial fractional biopsy was taken, stained with h\&e stain and by ih staining by stem cell marker oct4. immunohistochemical expression of stem cell marker oct4 was evaluated before and after transplantation according to edessy stem cell scoring (ess). participants were followed up monthly for a period of six months by hormonal (fsh, lh and e2), clinical (resuming menstruation), us (folliculometry), histopathological (hp), and ih expression of stem cell marker oct4 of the endometrial biopsy (stem cell positivity according to ess) outcome.

Eligibility criteria:
inclusion criteria: * post-menarche female less than 40 years old. * follicle-stimulating hormone (fsh) more than or equal to 20 iu/l. * female with normal karyotyping. * agree to sign the designed consent for the study. exclusion criteria: * pregnancy and lactation. * autoimmune diseases. * breast cancer, ovarian cancer. * female with abnormal karyotyping (e.g. turner syndrome, fragile x syndrome....). * hypersensitivity to any gonadotropin-releasing hormone (gnrh) analogs. * patients with secondary ovarian failure (e.g. hypothalamic causes) * those with major medical problems such as malignancy, hepatitis, etc.

Keywords: primary infertility primary amenorrhea sex steroid deficiency premature ovarian failure (pof)
neuropsychological profiles of pediatric obsessive compulsive disorder (ocd)

Conditions: Obsessive Compulsive Disorder (OCD)

Summary: the neuropsychological profiles of children treated with standard cbt for ocd are evaluated.

the neuropsychological profiles of children treated with standard cbt for the treatment of ocd will be compared at pre-treatment and post-treatment. children between the ages of 8 and 16 years who have a primary diagnosis of ocd will be participants. treatment will last 12 weeks.

Eligibility criteria:
inclusion criteria: * children 8-16 years old who have a primary diagnosis of obsessive compulsive disorder exclusion criteria: * risk of suicidal or homicidal behavior * presence of another psychological disorder as the primary disorder * psychotic disorder, bipolar disorder, pervasive developmental disorder, thought disorder, uncontrolled adhd, eating disorder, substance use disorders, school refusal behavior characterized by missing more than 25% of days in most recent term, does not speak english, youth does not have at least one parent who speaks english

Keywords: children ocd cbt neuropsychological profiles
irofulven in treating patients with persistent or recurrent, refractory endometrial cancer

Conditions: Endometrial Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of irofulven in treating patients who have persistent or recurrent refractory endometrial cancer.

objectives: i. assess the antitumor activity of 6-hydroxymethylacylfulvene in patients with persistent or recurrent, refractory endometrial carcinoma. ii. determine the nature and degree of toxicity of this treatment in these patients. outline: this is a multicenter study. patients receive 6-hydroxymethylacylfulvene iv over 5 minutes on days 1-4. treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 2 years and then every 6 months for 3 years. projected accrual: approximately 19-51 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed endometrial carcinoma refractory to curative therapy or established treatments clinically or histologically confirmed persistent or recurrent disease bidimensionally measurable disease (ascites or pleural effusions not considered measurable) not eligible for higher priority gog protocol patient characteristics: age: 18 and over performance status: gog 0-2 life expectancy: not specified hematopoietic: platelet count at least 100,000/mm3 absolute neutrophil count at least 1,500/mm3 hepatic: bilirubin normal renal: creatinine no greater than 1.5 mg/dl or creatinine clearance greater than 60 ml/min cardiovascular: no clinically uncontrolled dysrhythmia or signs of ischemia per ecg no congestive heart failure requiring medication no uncontrolled hypertension other: no significant active infection no other prior or concurrent malignancy within the past 5 years except nonmelanomatous skin cancer prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 3 weeks since prior chemotherapy and recovered no more than 1 prior chemotherapy regimen allowed (either single or combination cytotoxic drug therapy) no prior 6-hydroxymethylacylfulvene no prior chemotherapy for other malignancy endocrine therapy: not specified radiotherapy: at least 3 weeks since prior radiotherapy and recovered no prior radiotherapy for other malignancy surgery: at least 3 weeks since prior surgery and recovered

Keywords: recurrent endometrial carcinoma
a study of ncs-01 in patients with acute ischemic stroke

Conditions: Ischemic Stroke

Summary: this is an initial phase1/2 dose-finding, randomized, multi-center study to evaluate the safety and tolerability of ncs-01 in patients with acute ischemic stroke. all patients will be randomized within 48 hours of stroke onset. this study will be conducted in 2 stages.


Eligibility criteria:
inclusion criteria: * males and females, age 18 to 85 years inclusive * clinical evidence of acute ischemic unilateral cerebral infarction * - evidence of neurologic deficits as defined by nihss 6 to 18 or nihss \< 6 with fugl-meyer upper extremity subtotal 6 to 40 inclusive * women of child bearing potential who agrees to take acceptable birth control as described in the icf * provide written informed consent before participation, either by patient or a legal representative exclusion criteria: * progressive neurologic deficit * an inability to undergo an mri scan * any malignancies within the last 5 years * previous organ transplantation * participation in another clinical trial with an investigational drug, device or biologic within the preceding 3 months * women of childbearing potential with a positive pregnancy test * already dependent in activities of daily living (rankin scale 3 or more) before the present acute stroke * known hypersensitivity, allergy or intolerance to the similar biologic interventions * any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives judged by investigator based on medical history, physical examination, laboratory tests and/or ecg
prevalence of abnormal pap smear

Conditions: Cervix Cancer

Summary: this study aims to evaluate prevalence of abnormal pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic.

this study aims to evaluate prevalence of abnormal pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic. participating women will be subjected to accurate history taking regarding age, parity, body mass index, contraceptive use, menstrual history, and duration of marital life, frequency of previous marriages if any, and the status of cervix by per-vaginal examination of the patients. the patient put in dorsal lithotomy position and place the feet in stirrups or on foot rests . then, the physician will insert a cusco speculum into the vagina to hold vaginal wall open . the specimens will be collected as follows; firstly, the speculum will be inserted without lubricant. any mucous, discharge or blood will be removed with dry cotton. a wooden spatula will be used for sampling ectocervix which will be rotated 360 degrees. for sampling endocervix, a brush or a swab will be rotated only 90 degrees as the circumferential bristles will be in contact with the entire surface the moment the brush is inserted. the samples will be applied to the slides which will be encoded and immediately fixed in 95% ethanol and the samples will be transferred to pathology department to be stained by the standard papanicolaou stain . the bethesda system will be used for cytological interpretation.

Eligibility criteria:
inclusion criteria: * non pregnant sexually active women aged from 21 to 60 years old. * patients who didn't have their pap smear done in last 3 years . * patient who had previous abnormal pap smear and coming for follow up. exclusion criteria: * women who were diagnosed cervical cancer that was treated. * women who underwent total hysterectomy. * women who are pregnant. * patients whose pap smear was done in last 3 years with reassuring results.
tecfidera slow-titration study

Conditions: Multiple Sclerosis

Summary: the primary objective of the study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the incidence of dimethyl fumarate (dmf \[tecfidera\])-related gastrointestinal (gi) adverse events (aes) in participants with multiple sclerosis (ms). the secondary objective of this study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the average severity and duration of gi symptoms over 12 weeks of dmf treatment in this study population.


Eligibility criteria:
key inclusion criteria: * diagnosis of ms consistent with locally labeled indication for dmf * no prior treatment with dmf * female subjects of childbearing potential who are not surgically sterile and male subjects must practice effective contraception during their participation in the study * have had a recent complete blood count (cbc), including lymphocyte count, that does not preclude participation in the study, in the judgement of the investigator key exclusion criteria: * have a recent history or ongoing gi illness (e.g., peptic ulcer, irritable bowel syndrome) or any other current condition with gi signs and symptoms (e.g., nausea, vomiting, abdominal pain, or diarrhea) that may interfere with assessment of study endpoints * have other major comorbid conditions that preclude participation in the study, as determined by the investigator * participant is pregnant, breastfeeding, or planning a pregnancy during the study period * are receiving concomitant disease-modifying therapies for ms including, but not limited to, natalizumab, interferon beta, glatiramer acetate, fingolimod, alemtuzumab, teriflunomide, or laquinimod at screening * history of severe allergic or anaphylactic reactions or known drug hypersensitivity * note: other protocol defined inclusion/exclusion criteria may apply
comparing relative motion splint with static splint after hand extensor tendon repair

Conditions: Hand Tendon Injury

Summary: different splints are used after hand extensor tendon repair (including relative motion splint, static splint, etc.) there is no consensus regarding the benefits of either one. the aim of this study is to compare clinical outcomes after using different orthoses and rehabilitation methods after hand extensor tendon repair. patients are randomly assigned after signing consent to either immobilization with a static splint or a relative motion splint. patients are examined after 2 and 5 months postoperatively for finger range of motion, grip strength, and dash questionnaire.


Eligibility criteria:
inclusion criteria: * patients with hand extensor tendon tear in zones 4-7 after surgical repair, that are able to sign a consent form. exclusion criteria: * patients that did not arrive for a follow-up meeting after 2 months.
the pleiotropic effects of atorvastatin when combined with common antihypertenisve medications.

Conditions: Hypertension

Summary: the purpose of this study is to compare the effects of the cholesterol medication taken with each blood pressure medication alone on heart disease risk factors including blood pressure, cholesterol, inflammation, blood sugar control, blood vessal function, and other heart disease risk factors.


Eligibility criteria:
inclusion criteria: * mild hypertension and high cholesterol exclusion criteria: * diabetes and heart disease
individual dosage selection of irinotecan (cpt-11) based on ugt1a1 genotype in metastatic colorectal cancer patients

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to investigate the influence of dose selection of cpt-11 on toxicity, response and pharmacokinetics according to ugt1a1 genotype in colorectal cancer patients.

genetic polymorphisms of ugts result in reduced enzyme activity and increased toxicity. ugt1a1\*28 and ugt1a1\*6 are reported to increase cpt-11-related toxicity in asian patients. moreover, the area under concentration curve (auc) ratio of sn-38g to sn-38 is decreased in asian patients having ugt1a1 \*28 or ugt1a1\*6. this implicated that the current standard dose of cpt-11 would be overdosing for homozygous ugt1a1\*28/\*28, \*6/\*6 or \*28/\*6 patients. the study is designed to investigate the role of prospectively dose reduction of cpt-11 in toxicity, tumor response and pharmacokinetics for homozygous ugt1a1 patients, and compare these parameters to standard dose of cpt-11 for wild-type, heterozygous or homozygous ugt1a1 patients.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed colorectal cancer patients who received no prior chemotherapy or failed to 1st line treatments 2. at least one measurable lesion by response evaluation criteria in solid tumors (recist) criteria 3. aged 18 years or older 4. ecog performance status of ≤ 2. 5. anticipated life expectancy of ≥ 3 months. 6. ugt1a1 genotype tested. categorized into wild (ugt1a1\*1/\*1), hetero (ugt1a1\*1/ \*28, ugt1a1\*1/ \*6), and homo (ugt1a1\*28/\*28, ugt1a1\*6/\*6, ugt1a1\*28/\*6). 7. adequate organ function, including bone marrow, kidney and liver. * anc ≥ 1.5×109/l and hemoglobin ≥ 9g/dl and platelet count ≥ 100×109/l * serum total bilirubin ≤ 1.5 x uln, alkaline phosphatase ≤ 2.5 x uln, serum alt and ast ≤ 2.5 x uln (serum alt and ast ≤ 5 x uln, if liver metastases are present) * serum creatinine ≤ 1.5 x uln or clcr \> 60 ml/min 8. written informed consent can be obtained prior to their participation in the trial. exclusion criteria: 1. pregnant or breast feeding women. 2. subjects who have previously received cpt-11 treatment. 3. serious concurrent complication, severe active infection. 4. subjects with chronic diarrhea, acute or sub acute intestinal obstruction. 5. subjects with uncontrolled cns metastasis or epilepsia or severe psychiatric disorders. 6. subjects who are regarded to be unsuitable for this trial by the investigator. 7. subjects who are participating in other clinical trials.

Keywords: colorectal cancer irinotecan ugt1a1 genotype neutropenia diarrhea response pharmacokinetic
neurostimulation for the relief of acute bronchoconstriction

Conditions: Asthma

Summary: the goal of this study is to validate design for the resolve™ stimulator and proximity electrode and the associated procedure to quickly and safely place an electrode into the neck, in the vicinity of the vagus nerve by a physician in either the emergency department or other appropriate hospital inpatient setting (e.g., icu). the secondary goal is to confirm that the electrical signal being delivered via this electrode rapidly counters bronchoconstriction and improves airway flow.

the present study is to evaluate the safety of a new neurostimulator device, the resolve stimulator and proximity lead™, which comprises an external electrical signal generator coupled to temporary electrode that is percutaneously inserted in the neck. sponsor believes, based on animal testing data provided as well as consultations with physicians who regularly treat patients suffering from attacks of acute bronchoconstriction in er and inpatient hospital settings, that this device could be used in the skilled care hospital setting to help rapidly relax the smooth muscle in the airway, relieving a clinically significant portion of the bronchoconstriction suffered by patients experiencing moderate to severe asthma attacks, allowing more effective delivery of inhaled medications to restore the patient to his or her baseline respiration status.

Eligibility criteria:
inclusion criteria: * male / female, age 18-65 * subject declares a medical history of asthma or sufficient prior clinical experience/records exists to confirm the subject has received a diagnosis of bronchoconstriction * completed \>1 hrs of conventional breathing and related medication treatments without improvement in fev1 to \> 70% predicted * able to give informed consent exclusion criteria: * scaring / abscess other problems with neck at electrode placement site * known or suspected carotid artery disease (i.e. bruits or history of stenosis) * suspected or confirmed coagulopathy * suspected or confirmed sepsis * irregular heart rate, rhythm * receiving pressors to maintain blood pressure * presently implanted electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant * allergy to local anesthetics used for placement of the lead * history of lung cancer, emphysema, chronic obstructive pulmonary disease, or other comorbidity that might otherwise compromise the expected air flow volumes in the lungs * at risk of imminent respiratory collapse * lung function: fev1 \< 40% predicted * signs and symptoms: extreme symptoms at rest, accessory muscle use, chest retraction * alert state: drowsy, confused * treatment with anti-cholinergic medications within 4 hours of enrollment

Keywords: bronchoconstriction neuromodulation neurostimulation vagus nerve stimulation vagal nerve stimulation nvns vns non invasive gammacore
genetic epidemiology of sarcoidosis

Conditions: Lung Diseases; Sarcoidosis

Summary: to determine if hereditary susceptibility predisposes african americans to sarcoidosis and to identify sarcoidosis susceptibility genes in african americans.

background: sarcoidosis is a multisystem, granulomatous inflammatory disease of unknown etiology. hereditary susceptibility to sarcoidosis is suggested by reports of familial clustering and a higher prevalence in certain ethnic groups, particularly african-americans. over four hundred kindreds been reported in the medical literature and these investigators have recently described 101 families and shown that african americans have a higher prevalence rate of familial sarcoidosis than caucasians (19 percent vs. 5 percent). the reasons why sarcoidosis clusters in families or the role of genetic factors in this disease are not known. design narrative: the study was carried out in african american families ascertained through 400 african american sarcoidosis patients evaluated at the henry ford health system. they were tested for association of sarcoidosis with markers for candidate genes using the affected family-based control method and tested for possible environmental risk factors and genetic mechanisms of disease transmission by performing a segregation analysis in african american families. a strong association of one or more of the candidate genes with sarcoidosis or an indication of major gene segregation for the disease, provided the basis for future linkage studies. investigating the hereditary susceptibility of sarcoidosis was best done in african americans, because of the greater severity and occurrence of disease in this population. once the reasons for familial aggregation of sarcoidosis are determined, the etiology of this disease will be better understood and it should be possible to design new approaches to prevention and treatment. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) recor

Eligibility criteria:
no eligibility criteria