Kornimate/medical-research-clean huggingface dataset:
effect of nph insulin, insulin detemir and insulin glargine on gh-igf-igfbp axis

Conditions: Diabetes Mellitus, Type 1

Summary: the objective is to describe the interaction of equal doses of nph insulin (neutral protamine hagedorn), insulin detemir and insulin glargine on igfbp-1 (insulin-like growth factor binding protein-1) production as well as immunoreactive and bioactive igf-i (insulin-like growth factor-i) after once-daily injection on three separate visits in type 1 diabetic subjects.

because of the importance of receptors activation and potential effects on the igf system, a head-to-head comparison of the eventual differential impact of intermediate-acting human insulin (nph), insulin detemir and insulin glargine on the growth hormone-insulin-like growth factor-insulin-like growth factor binding protein (gh-igf-igfbp) axis is relevant to be conducted for the safety assurance of insulin analogues. therefore, this study aims to investigate whether the serum insulin profile obtained by once-daily injection of long-acting insulin analog, insulin detemir or insulin glargine, has a different impact on igfbps production and igf-i concentrations (total igf-i) bioactivity and tissue-availability as compared to that seen during treatment with intermediate-acting human insulin, nph insulin.

Eligibility criteria:
inclusion criteria: 1. informed consent obtained before any trial-related activities. 2. diagnosis of diabetes mellitus according to who criteria; history and clinical course consistent with type 1 diabetes mellitus. 3. diagnosed with diabetes for more than 6 years and using continuous subcutaneous insulin infusion (csii) at least 6 months at time of inclusion. 4. total daily insulin dose between 0.4 and 1.4 units/kg (both values included) 5. hba1c between 6% and 9% (both values included). 6. age ≥ 18 years. 7. bmi between 18.5 and 28 kg /m2 (including both values). exclusion criteria: 1. known or suspected allergy to trial product(s) or related products. 2. recurrent major hypoglycaemic episodes. 3. heart: unstable angina pectoris, ami \< 12 months or heart insufficiency classified according to nyha iii-iv 4. blood pressure: severe uncontrolled hypertension with bp \> 180/110 mmhg, sitting 5. liver: impaired hepatic function corresponding to serum-alat or basic phosphatase \> 2 x upper reference limit of the local laboratory. 6. kidneys: impaired renal function corresponding to serum-creatinin \> 150 μmol/l according to the local laboratory. 7. any disease judged by the investigator to affect the trial. 8. pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.

Keywords: diabetes mellitus, type 1
same-day versus rapid art initiation in hiv-positive individuals presenting with symptoms of tuberculosis

Conditions: Human Immunodeficiency Virus (HIV) Infection

Summary: sadapt is a pragmatic, randomized, therapeutic-use trial comparing two approaches ("art first" versus "tb results first") for the timing of art initiation in plhiv with presumptive tb, but no signs of central nervous system (cns) disease, in a routine primary and secondary care setting in southern africa with regard to hiv viral suppression (vl \<400 copies/ml) 26 weeks after enrolment.

in this randomized controlled trial (rct) two different, guideline-approved algorithms for antiretroviral therapy (art) initiation in people living with hiv (plhiv) with presumptive tuberculosis (tb), but no signs of central nervous system (cns) disease will be compared. in one arm, same-day initiation (sdi) of art will be applied ("art first") for all participants independent of the status or results of initial tb investigations. in the other arm, an approach with deferral of art initiation until tb is excluded or confirmed and tb treatment initiated will be applied ("tb results first"). the direct comparison of the two approaches in a pragmatic, two-country rct conducted in a representative high-prevalence setting will provide evidence on the open question of optimal timing of art initiation in the large subgroup of plhiv with presumptive tb outside the cns.

Eligibility criteria:
inclusion criteria: * 12 years or older * hiv-positive * not taking art (naïve or reported no art intake since 90 days or more) * presenting with one or more tb symptoms according to w4ss * unknown tb status * planning to continue care at the study facility for at least 30 weeks * willing and able to consent (age 18 years or older) or assent with guardian consent (age 12 to 17 years) exclusion criteria: * medical condition requiring admission or referral to a higher level health facility at enrolment * symptoms or clinical signs suggestive for diseases of the cns * positive cryptococcal antigen test (crag) * reporting to be pregnant * taking tb treatment, tb preventive therapy (tpt) or treatment against cryptococcal meningitis

Keywords: tuberculosis (tb) infection acquired immunodeficiency syndrome antiretroviral therapy (art) immune reconstitution inflammatory syndrome people living with hiv (plhiv) same-day initiation (sdi) of art tb preventive treatment sub-saharan african countries hiv/tb-coinfection immune reconstitution inflammatory syndrome (iris)
treating smokers with mental illness

Conditions: Smoking Cessation; Cigarette Smoking; Schizophrenia; Psychotic Disorders; Major Depressive Disorder; Bipolar Disorder I; Bipolar II Disorder; Mental Illness

Summary: this is a smoking cessation study that will enroll smokers who have been diagnosed with a severe mental illness. the study will use a combination of intensive tobacco treatment counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting smoking over the course of six months.

at the baseline measurement visit, participants will be asked to complete a survey and an interview. they will be randomly assigned to either the intervention or control group. both groups will receive a smoking cessation manual and list of resources. the intervention group will also receive smoking cessation counseling and nicotine replacement therapy. both groups will be seen for in-person assessments again at 8 weeks and 6 months post baseline.

Eligibility criteria:
inclusion criteria: * have a severe mental illness diagnosis * be a daily smoker * be willing to reduce the number of cigarettes smoked per day leading to a quit attempt * want to try to quit smoking * be willing to use nicotine replacement therapy * be able to communicate in english exclusion criteria: * anyone who has had an active psychotic episode or been hospitalized due to suicidal ideation in the last six months * pregnancy * taking chantix or clozapine * having a terminal illness

Keywords: mental illness tobacco treatment
early prediction of hypocalcemia after thyroidectomy using postoperative second hour parathormone

Conditions: Hypocalcemia, Postoperative Parathormone

Summary: hypocalcemia is the most frequent complication in thyroid surgeries. diagnosing this complication earlier will reduce longer hospital stay and will lead to an earlier intervention. the purpose of the study is to evaluate postoperative second hour parathyroid hormone measurement as a predictor for early stage hypocalcemia.


Eligibility criteria:
inclusion criteria: * patients with multinodular goiter, graves, fine needle aspiartion biopsy with bethesda 3-4 undergoing total thyroidectomy exclusion criteria: * pregnant women * patients with thyroid cancer or previous neck dissection

Keywords: hypocalcemia, parathormone, bone density
a natural history study of infantile neuroaxonal dystrophy

Conditions: Neuroaxonal Dystrophy, Infantile

Summary: this study is a longitudinal and prospective study of the natural history of infantile neuroaxonal dystrophy (inad).

after obtaining informed consent, the study participants' relevant medical records will be collected and reviewed for this study. next, a clinic visit will be scheduled with the patient's family and an observing md/do/mbbs from a sponsor site to confirm and clarify information in the medical records. a baseline evaluation of clinical status will also be performed during this visit to serve as visit one in this longitudinal, prospective natural history study. subsequent visits will take place every 6 months, for up to 24 months. key components of this prospective study at each visit include a neurodevelopment exam tailored for inad, application of the chop-intend neurodevelopment scale, the hammersmith infant neurological examination and the modified ashworth spasticity scale as well as collection of monthly parental severity scoring and monthly home videos of activities of daily living (adls). data from this study will be pooled and presented in aggregate, without identification of individual subjects.

Eligibility criteria:
inclusion criteria: * male or female 18 months to 10 years of age * medical history consistent with the symptoms of classic inad (onset of symptoms between the ages of 6 months and 3 years) * homozygous or compound heterozygous pla2g6 variants * signed informed consent form (icf) prior to entry into the registry exclusion criteria: * diagnosis of atypical nad (anad) * additional underlying diagnosis with features that overlap with inad * unwilling or unable to allow medical record review * unwilling or unable to participate in serial assessments every 6 months (including deceased patients)

Keywords: pla2g6-related nbia inad pla2g6
randomized phase ii study of sol for untreated metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: this is a randomized, multicenter study designed to evaluate the progression free survival of the sol group (s-1, leucovorin, and oxaliplatin) compared with the mfolfox6 group (5-fu, l-lv and oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: * histologically proved adenocarcinoma (colorectal cancer). * age: 20 ≤ at enrollment. * no prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received s-1 or oxaliplatin containing treatment shall be excluded. * at least one measurable lesion by recist criteria exclusion criteria: * serious drug hypersensitivity. * prior history of peripheral neuropathy. * diarrhea . * simultaneously active double cancer.
post-operative pain relief in laparoscopic cholecystectomy

Conditions: Postoperative Pain

Summary: compare the analgesic efficacy of the combination of bupivacaine and morphine, bupivacaine and fentanyl and bupivacaine and ketamine in alleviating post operative pain following laparoscopic cholecystectomy.

laparoscopic cholecystectomy is comparatively advantageous over open cholecystectomy in pain management with shorter duration of hospital stays. pain management is medically pertinent for optimal care in surgical patients. although development and advancement in understanding of the patho-physiology of pain, analgesics, pharmacology and the development of better effective techniques for post-operative pain control, patients still continue to experience considerable discomfort. laparotomy results in parietal pain, whereas laparoscopy has a visceral component, a somatic component and shoulder pain secondary to diaphragmatic irritation because of co2 pneumo-peritoneum. postoperative pain associated with laparoscopic cholecystectomy, although less severe and of shorter duration than that after open cholecystectomy, is still a source of marked discomfort and surgical stress. the degree of the pain after laparoscopic procedures has multifactorial influence including the volume of residual gas, type of gas used for pneumo-peritoneum, pressure created by the pneumo-peritoneum and insufflated gas temperature. local anesthetic infiltration of the incision sites decreases postoperative opiate requirement and improves subjective pain scores but does eliminate the pain. earlier scientists have also reported several beneficial effects of the intra-peritoneal application of bupivacaine with morphine on postoperative pain management after laparoscopic cholecystectomy.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) classification i and ii * scheduled for elective laparoscopic cholecystectomy * under a standardized general anesthesia technique. exclusion criteria: * uncooperative, unwilling, * history of anaphylaxis to local anesthetics and/or opioids and the drugs to be used, * history of drug abuse, * anmorbidly obese patients, * asa classification iii, iv, v * d patients having any other significant co-morbidities * any other with psychiatric disease * pregnant women
ono-4059 study in patients with steroid-resistant pemphigus

Conditions: Pemphigus; Steroid-resistant Pemphigus

Summary: ono-4059-10:multicenter, placebo-controlled, randomized, double-blind, phase 3 study in patients with steroid-resistant pemphigus


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of pemphigus * patients with a re-increase in the pemphigus disease area index (pdai) score before oral corticosteroid tapering to 10mg/day of prednisolone (psl) equivalent exclusion criteria: * patients with an active infection * patients with malignancy * patients with past history of serious allergy or anaphylaxis
sarcoma study of morab-004 utilization: research and clinical evaluation

Conditions: Metastatic Soft Tissue Sarcoma

Summary: this study is being done to see if morab-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic soft tissue sarcoma.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age * be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period * have a histologically confirmed diagnosis of msts as defined by the 4 specified study subgrouped * have been treated in the metastatic setting with 0 to 2 prior systemic regimens for msts (systemic treatment regimens given in the neoadjuvant setting and maintenance therapies will not be considered as regimens in the metastatic setting for the purposes of this protocol. prior anthracycline-based regimen is allowable but not required. subjects with extra-skeletal small round blue cell sarcomas, including rhabdomyosarcomas, must have exhausted or be intolerant of standard first line anthracycline-based chemotherapy.) * have measurable disease, as defined by recist v 1.1 assess within 2 weeks of study entry and have radiologically documented disease progression greater than or equal to a 10% increase in the sum of the longest diameters of target lesions present within 6 months prior to randomization * have tumor tissue available for tem-1 biomarker studies * be willing and able to provide written informed consent exclusion criteria: * have received more than 2 prior systemic treatment regimens for msts * have received either gemcitabine or docetaxel in any previous treatment for msts (regardless of the line of treatment) * have a diagnosis of primary bone sarcoma of any histological type. * have a history of clinically significant heart disease, or clinically significant arrhythmia on ecg within the past 6 months * have a history of allergic reaction to prior monoclonal antibody or biologic agent * have received previous treatment with morab-004 (anti-tem-1) * have a medical condition with a high risk of bleeding (e.g., a known bleeding disorder, a coagulopathy, or a tumor that involves the major vessels) or have a recent (within past 6 months) history of a significant bleeding event * have undergone major surgical procedures or open biopsy, have significant traumatic injury within 30 days prior to the first date of study treatment, or have major surgical procedures anticipated during the study * have a serious non-healing wound, an ulcer (including gastrointestinal), or a bone fracture
comparing magnesium 2g versus 4g versus placebo in the incidence of treating aff rvr

Conditions: Tachycardia Atrial; Atrial Fibrillation; Atrial Flutter With Rapid Ventricular Response

Summary: the purpose of this prospective, randomized, double-blinded study is to further evaluate the safety and efficacy of varying doses of intravenous magnesium in the treatment of aff rvr.

intravenous magnesium has become a commonly utilized agent in the treatment of cardiac arrhythmias as an adjunct therapy to rate and rhythm control medications, such as its use in atrial fibrillation or atrial flutter with rapid ventricular response (aff rvr). though its benefit in the treatment of aff rvr has been well documented, a consensus on the optimal dosing of magnesium has yet to be achieved. only one randomized, controlled, double-blinded study has investigated the optimal dosing of magnesium.

Eligibility criteria:
inclusion criteria: * age \> 18 years or older * able to provide informed consent * primary diagnosis aff rvr greater than or equal to 120 bpm * diltiazem as rate control agent * english speaking exclusion criteria: * hemodynamically unstable patients (sbp \<90, map \<65) * impaired consciousness * end stage renal disease on hemodialysis or peritoneal dialysis * acute heart failure exacerbation based on clinical diagnosis, physician exam, bedside echo, and/or additional imaging * patient in aff rvr that is highly suspected to be a compensatory mechanism for an alternative clinical diagnosis * rhythms other than af, such as sick sinus syndrome or wide-complex ventricular response * acute myocardial infarction * pregnancy defined as a positive urine hcg (human chorionic gonadotropin) * contraindications to magnesium sulfate (including myasthenia gravis) * allergy or sensitivity to any study drugs * previously enrolled in this trial during a different patient encounter * withdrew from study
molecular associations with reproductive failure

Conditions: Spontaneous Abortions; Infertility

Summary: the overall hypothesis to be tested is: women with the molecular phenotype of highly skewed x chromosome inactivation are at increased risk of spontaneous abortion.

the overall hypothesis to be tested is: women with the molecular phenotype of highly skewed x chromosome inactivation are at increased risk of spontaneous abortion. we will investigate this hypothesis through two complimentary aims. in the background and significance section, we first present data on a 53-member pedigree segregating an x-linked recessive lethal defect that results in skewed x inactivation in the carrier females via secondary selection against those cells with the defective x chromosome active. we have characterized this deletion to be a 500 kb (approximate) deletion in distal xq28. moreover, the carrier females show a statistically significant increase in the frequency of spontaneous abortion as compared to non-deletion carrying relatives. secondly, in the preliminary studies section, we present data from a population based case-control study wherein highly skewed x chromosome inactivation is significantly correlated with idiopathic recurrent spontaneous abortion. this protocol attempts to elucidate the mechanism underlying this association. the first specific aim is to determine if women with highly skewed x chromosome inactivation are at risk of pregnancy loss. this will be accomplished through a prospective protocol, analyzing x chromosome inactivation patterns in pregnant women and investigating a possible association between x chromosome inactivation and pregnancy outcome. the second aim will study the nature of pregnancy loss in women with skewed x chromosome inactivation. this aim will correlate maternal x inactivation patterns with abortus karyotype.

Eligibility criteria:
inclusion criteria: * patients are prospectively ascertained women with either a new pregnancy (specific aim 1), or a spontaneous abortion (specific aim 2). * given our enrollment strategy, we anticipate enrolling women between the ages of 18 and 45. exclusion criteria: * the study is limited only to females. * children are not eligible to participate in this study. because the patient populations studied are (aim 1) women with primary infertility undergoing fertility treatment and (aim 2) women who have recently had a spontaneous abortion, the research topic is irrelevant to children.
prevention of delirium after bone marrow transplantation

Conditions: Delirium

Summary: the purpose of this study is to find out if using bright light sessions during bone marrow transplant can prevent people from developing confusion also known as delirium.

this is a pilot, double blind randomized study conducted in patients scheduled to undergo bone marrow transplant at the massachusetts general hospital. the goal of this study is to look at the usefulness of bright light therapy in the prevention of delirium in a population at high risk for developing this condition. delirium can develop in up to half of the people that undergo bone marrow transplant. symptoms include changes in level of alertness, confusion, and temporary problems with memory and attention. in severe cases, it can be accompanied by agitation, paranoia(overly suspicious), and hallucinations(seeing or hearing things that are not really there). bright light uses no medication and is often used to treat seasonal affective depression and multiple sleep disorders. the light boxes are portable and are placed in front of individuals for about 30 minutes every day.

Eligibility criteria:
inclusion criteria: * 18 or older * male or female * patients scheduled to undergo hsct * english speaking exclusion criteria: * previous history of bipolar affective disorder * on-going delirium * history of substance abuse/dependence within 6 months prior to hsct * history of invasive melanoma. patients with a history of basal cell carcinoma, melanoma in situ, or squamous cell carcinoma are permitted to enroll if the lesion(s) have been excised with negative margins * history of medical/dermatological conditions that make skin especially sensitive to light,such as systemic lupus erythematosus (sle) and/or porphyria * eye condition that makes eyes vulnerable to light damage * concomitant use of medications that increase sensitivity to sunlight, such as the herbal supplement st. john's wort * established primary insomnia

Keywords: delirium hematopoietic stem cell transplantation bone marrow transplantation bright light therapy
treatment of lambert-eaton syndrome with 3,4 diaminopyridine

Conditions: Lambert-Eaton Myasthenic Syndrome

Summary: the purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with lambert-eaton myasthenic syndrome (lems).

up to 15 patients over the age of 18 years with a diagnosis of lems are eligible to enroll if they are medically stable. they may receive 3,4 diaminopyridine in addition to other treatments and standard of care investigations for lems under supervision of the primary investigator. safety laboratory studies and ekgs will be obtained. the study has been approved by the university of pittsburgh irb. there is a local data-safety monitoring board. the investigator has a hold on enrolling new subjects.

Eligibility criteria:
inclusion criteria: 1. diagnosis of lems 2. over 18 years old 3. medically stable 4. if female and premenopausal, have a negative urine pregnancy test prior to starting the 3,4 dap, and, if premenopausal, be willing to practice an effective form of birth control such as "double-barrier contraception" during the study exclusion criteria: 1. known sensitivity to 3,4 dap 2. history of past or current seizures 3. history of severe asthma 4. believed by the investigator to be unable to comply with the protocol 5. unable to provide informed consent

Keywords: lambert-eaton myasthenic syndrome 3,4 diaminopyridine