Kornimate/medical-research-clean huggingface dataset:
rhtsh, radioiodine uptake and goiter reduction following 131i therapy in patients with benign nontoxic nodular goiter

Conditions: Nodular Goiter

Summary: the study aims at clarifying (in a randomized, double-blinded design): 1. whether stimulation with 0.1 mg rhtsh 24, 48 or 72 hours before induction of a 131i-tracer dosis increases the 131i uptake in patients with atoxic multinodular goitre and to study which time interval is the most optimal (part i) 2. whether patients suffering from atoxic multinodular goitre obtains a corresponding goitre reduction compared with a control group when stimulating with 0.1 mg rh tsh 24, 48 or 72 hours before 131i therapy and when reducing the thyroid radiation dose to 50 gy (part ii) the two studies will be carried out successively on the same patient population. the 131i uptake will be carried out first followed by the i therapy itself. the patients are compared with a placebo-treated control group going through the same course of treatment, but the 131i dosis will be 100 gy (standard treatment). after the 131i therapy, all patients are followed during one year with a regular ultrasound scan of the thyroid gland and control of the metabolic status. the patient satisfaction is monitored by the use of a visual-analogue-scale.


Eligibility criteria:
inclusion criteria: * age over 18 years * apart from benign non-toxic goiter no other serious illness * signed proof of participation exclusion criteria: * treatment with levothyroxine * former 131i-therapy * a thyroid volume above 100 ml or a retro-clavicular component * unsafe contraception * pregnancy or breastfeeding * participation in another clinical trial * previous allergic reaction toward rhtsh * suspicion of malignancy in the thyroid gland either by clinical examination, laboratory findings (a raised serum calcitonin or ionized calcium)or by fine-needle aspiration biopsy * physically or mental condition making it impossible to participate * acute ischemic heart attach within the last 3 months * alcohol and/or drug addicts

Keywords: nontoxic nodular goiter 131i therapy thyroid radioiodine uptake optimal time-interval reduced 131i activity goiter reduction
evaluation of the impact of stress on ivf outcome

Conditions: Stress, Physiological; Infertility; Stress, Psychological

Summary: the purpose of this study is to determine if physiological measures of stress, measured by the non-invasive oto device, are significantly correlated with ivf outcome.

the oto device is a wearable device that utilizes multiple methods of electrophysiology to identify the impact of stress on humans. the device consists of the oto sensor, a belt with two electrode pads worn around the chest, one electrode placed on the thenar of the dominant hand and one electrode placed on the forehead; the sensor pairs with the oto app via bluetooth. it tracks 54 physiological properties including temperature, hrv, amplitude frequency analysis (afa) of ecg and dc potential. this data is analyzed by the proprietary oto expert system which creates the overall conclusions on levels of stress, functional reserves, adaptive capacity and level of readiness to additional stressors. physiological data will be collected from the study participant using the oto device for the duration of one ivf and frozen embryo transfer (fet) cycle. study participants will complete questionnaires online related to perceived stress at the beginning and the end of study participation. study participant's ivf cycle treatment and outcome data will be collected and analyzed in conjunction with the physiological data collected with the oto device.

Eligibility criteria:
inclusion criteria: * women age 25-40 years old * planning to undergo their first ivf cycle with frozen embryo transfer at one of the participating fertility clinics * have access to the internet and own a smartphone * ability and willingness to wear the oto device for a few minutes each morning during their ivf and fet cycle * able to read and speak english exclusion criteria: * medical history of cardiac arrhythmias * history of cardiac surgery within a year of study enrollment

Keywords: ivf in-vitro fertilization oto inception stress omegawave infertility fet frozen embryo transfer
nadolol versus propranolol in children with infantile hemangiomas

Conditions: Infantile Hemangioma

Summary: the purpose of this study is to assess the efficacy and safety of oral propranolol versus nadolol in patients with infantile hemangiomas (ih) in a randomized, controlled, double-blinded study.

the study objective is to compare the efficacy and safety of oral propranolol in comparison with oral nadolol in patients with ih. patients will be randomly assigned to either propranolol or dose equivalent nadolol. the duration of the study will be 24 weeks, however, patient will be monitored for up to 1 year post study enrolment. both efficacy and safety will be closely monitored and captured.

Eligibility criteria:
inclusion criteria: * 1-6 months corrected age * written parental informed consent * at least one of the following: * size: hemangioma \>1.5 cm on the face or \>3 cm on other body parts * causing or with potential for functional impairment (e.g. amblyogenic ih, ulcerated hemangioma) * causing or with potential for cosmetic disfigurement (e.g. nasal tip, glabella location) exclusion criteria: * contraindications to beta-blockers * hypotension * bradycardia * hypoglycemia * cardiac disease associated with decreased ejection fraction and/or \> second degree heart block * bronchospasm (including bronchial asthma) * allergic rhinitis * corrected gestational age less than 1 month at screening * patients with phaces cerebral arteriopathy at risk of stroke * patients and/or breastfeeding mothers receiving treatment with anti-arrhythmic agents, calcium channel blockers, ace inhibitors, inotropic agents, vasodilators, hypoglycemic agents, neuroleptics, antiacids, benzodiazepines, thyroxine, warfarin * patients treated with an oral beta-blocker or other agent (e.g. systemic steroids, vincristine) within 2 weeks from randomization * patients treated with topical timolol within 1 week from randomization * vascular tumors other than infantile hemangioma (e.g. pyogenic granuloma, hemangioendothelioma)

Keywords: hemangioma, propranolol, nadolol
the evaluation of the effect of preoperatively applied throat lozenge

Conditions: Anesthesia; Pain, Postoperative

Summary: purpose:the aim of this study is to evaluate the effect of preoperative throat lozenge on pain relief in the postoperative period of the mucosal damage caused by intubation in patients who underwent operations in the head and neck region under general anesthesia. methods: 60 patients were included in this study who were hospitalized in the inpatient service of the oral and maxillofacial surgery department, this study was single-blind and performed by the same practitioner. throat lozenge (strepsilis) was given to patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes).the postoperative sore throat was evaluated by vas scale (0=no pain, 10=unbearable pain), and cough and hoarseness were evaluated with a four-point likert scale (0=absent, 3=severe) at 1, 4, 6, 12, and 24 hours.

before the operation, blood sugar, urea, creatinine, electrolytes, prothrombin time, active partial thromboplastin time, and liver enzyme levels were determined in all patients. hemoglobin and hematocrit determinations were made. electrocardiography and chest radiographs were taken. patients whose biochemical tests were within normal limits were included in our study. the study was single-blind and performed by the same practitioner. throat lozenge (strepsilis) was given to 30 patients, and sugar dragee in the same size and shape was given to 30 patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes). in order not to cause any complications, sugar patients were sucked and told not to chew. before the initiation of general anesthesia, height, weight, intubation time, mallampati score and asa classification, the name of the operation, the start and end time of the operation, smoking, tube number, and whether spasms occurred were recorded. patients taken to the service in the postoperative period were rested by wearing an oxygen mask. postoperative sore throat vas scale (0 = no pain, 10 = unbearable pain), cough, and hoarseness were assessed at 1, 4, 6, 12, and 24 hours with a four-point likert scale (0 = absent, 3 = severe).

Eligibility criteria:
inclusion criteria: being over 18 years old having asa i and ii scores clinical diagnosis of alzheimer's disease must be able to swallow tablets exclusion criteria: being over 60 years old complex intubation cases insulin dependent diabetes thyroid disease

Keywords: pain anesthesia and analgesia orthognathic surgery
bicarbonate and lipocalin in systemic inflammatory response syndrome (sirs) study

Conditions: Systemic Inflammatory Response Syndrome; Oliguria; Renal Impairment

Summary: the investigators will determine the feasibility, safety and efficacy of intravenous sodium bicarbonate in reducing progression to overt acute renal failure in patients with the systemic inflammatory response syndrome, and low urine output or early acute renal impairment as defined by serum neutrophil gelatinase-associated lipocalin (ngal).

the investigators hypothesise: 1. in patients with sirs and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high ngal level is feasible. 2. in patients with sirs and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high ngal level is safe. 3. in patients with sirs and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high ngal level leads to signs or trends of efficacy as measured by serum creatinine derived indices.

Eligibility criteria:
inclusion criteria: * consent obtained * diagnosis of sirs. requires any two of: temperature \> 38°c or \ 90 beats/min or respiratory rate \> 20 breaths/min. paco2 \ 12,000 cells/mm3, \ 10% immature neutrophils * elevated lipocalin level * arterial line already in place * central venous catheter already in place * age ≥ 18 years * within 24 hours of admission to the icu exclusion criteria: * unlikely to remain in icu for \>72 hours * moribund patient * pre-existing ckd, transplant or esrd * receiving (or about to receive) continuous renal replacement therapy for acute renal failure at time of enrolment * diagnosis of acute gn, ain, vasculitis or post-renal aetiology * known/suspected study allergy to sodium bicarbonate * enrolling physician concern about patient enrolment

Keywords: sodium bicarbonate serum neutrophil gelatinase associated lipocalin renal impairment renal failure systemic inflammatory response syndrome defined by serum ngal ≥ 100 ng/ml.
protect-timi 30 trial

Conditions: Unstable Angina

Summary: the primary purpose of this study was to compare the efficacy and safety of bivalirudin to eptifibatide (with or without unfractionated heparin or enoxaparin)given to subjects at high risk for heart attack and other cardiovascular complications who will undergo surgery to open up blocked arteries in the heart.

platelet inhibitor drugs

Eligibility criteria:
inclusion criteria: * chest paing/discomfort that occurs at rest and lasts at least 10 minutes and have at least one of the following high-risk features: * diabetes * elevated cardiac proteins in the blood (indicating acute coronary syndrome) * be willing and able to give informed consent exclusion criteria: * uncontrolled hypertension * cardiac episode (heart attack) within the previous 24 hours before randomization into the trial * prior heart surgery (pci) within the previous 2 weeks before randomizing in the trial * any electorcardogram (ecg) finding that make the holter monitor for ischemia unable to read

Keywords: gp iib/iiia inhibitors eptifibatide anti-thrombotic agents
effects of coenzyme q10 in psp and cbd

Conditions: Progressive Supranuclear Palsy; Neurological Disorders

Summary: to compare the efficacy, safety and tolerability of coenzyme q 10 versus placebo in patients with atypical parkinsonian syndromes corticobasal degeneration (cbd) and progressive supranuclear palsy (psp) ).


Eligibility criteria:
inclusion criteria: * patients fulfilling the diagnostic criteria of psp and cbd (above) and who were diagnosed within the past 5 years * age \> 40 * subjects receiving anticholinergics, amantadine, dopamine agonists, carbidopa/levodopa, eldepryl, or comtan must be on a stable dose for at least 30 days prior to baseline visit. * patients agreeable to participate in the study. exclusion criteria: * prior or concurrent therapy with anticholinergics, amantadine,a dopamine agonist,carbidopa/levodopa or comtan within 30 days of the baseline visit. * parkinsons disease or any other atypical parkinsonism; parkinsonism due to drugs. * history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant. * previous use of coenzyme q10 within 60 days of the baseline visit.

Keywords: coq10 psp cbd
a multi-center clinical trial to determine the impact of a mobile health application on rheumatoid arthritis shared decision making

Conditions: Rheumatoid Arthritis

Summary: the overall goal is to improve shared decision-making (sdm) about treatment options and thereby enhance disease outcomes and health-related quality of life (hrqol) for patients with rheumatoid arthritis (ra). the objective of this study is to engage patients in using the arthritispower application on a weekly basis during the time between clinic appointments for collection of data on self-reported disease activity and patient-reported outcomes (pros), and to display the data using an ipad to the patients and their rheumatology health care providers (hcps) at the point of care for sdm.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. fulfillment of the acr/eular 2010 classification criteria for ra \[9\]. 3. moderate or high disease activity, according to cdai ≥ 10, at the baseline visit. 4. intent to modify dmard therapy (i.e., adding a dmard, switching to a new dmard, or changing dmard dosage) by the patient and hcp. exclusion criteria: 1. current or previous use of arthritispower™ by the patient. 2. lack of access to an arthritispower™ compatible device (e.g., smartphone, tablet, or computer) 3. inability or unwillingness to participate with using the arthritispower™ app for this study
efficacy and safety of antidepressant augmentation with lamotrigine

Conditions: Depression

Summary: this study reports a clinical trial evaluating lamotrigine safety and efficacy as an antidepressant augmentation agent in treatment resistant depression, therefore adding more empirical evidence to the limited number of studies on the use of lamotrigine.

objective: this study reports a clinical trial evaluating lamotrigine safety and efficacy as an antidepressant augmentation agent in treatment resistant depression, therefore adding more empirical evidence to the limited number of studies on the use of lamotrigine. method: a double-blind pilot study was conducted with 34 nonbipolar, nonpsychotic patients who had dsm-iv major depressive disorder and were resistant to at least 2 antidepressants. the subjects were on taking antidepressant therapy and were randomly assigned to receive placebo or lamotrigine as an adjunct therapy for 8 weeks. they were evaluated on a biweekly basis in order to access assess the efficacy and the safety of the drug.

Eligibility criteria:
inclusion criteria: * they were selected according to a clinical interview based on dsm-iv criteria for major depressive disorder in single or recurrent episodes, with moderate to severe intensity. besides * they also had a history of treatment-resistant depression stage ii or above according to the criteria of by thase and rush11 * failure to respond to treatment with at least 2 antidepressants of different classes * at the maximum tolerated dose for at least 6 weeks and absence of psychotic symptoms exclusion criteria: * pregnant or lactating women or those capable of getting pregnant that who were not using contraceptive methods were excluded as well as patients with severe clinical diseases or organic mental disorder * further exclusion criteria were acute depression with risk of suicide * psychosis * and bipolar disorder as well as personality disorders and disorders related to alcohol and other drugs

Keywords: treatment augmentation resistant depression lamotrigine
safety and efficacy study using rexin-g for breast cancer

Conditions: Breast Cancer

Summary: the goal of the adaptive trial design is to confirm the over-all safety of rexin-g and to determine the optimal dosing regimen for rexin-g that would document the significant clinical benefits required to support a phase ii registration protocol for recurrent or metastatic breast cancer.

the clinical trial incorporates a phase ii component that will evaluate the efficacy of rexin-g using an adaptive trial design. each treatment cycle will be six weeks: four weeks of treatment and two weeks of rest. unlike a standard phase i protocol, eligible patients may have repeat cycles after the safety data and objective tumor response/s are recorded. continued rexin-g treatment will enable the targeted nanomedicine to catch up with tumor growth, halt disease progression, and reduce tumor burden. the treatment strategy is to achieve tumor control as quickly as safely possible. the goal of the adaptive trial design is to confirm the over-all safety of rexin-g and to determine the optimal dosing regimen for rexin-g that would document the significant clinical benefits required to support a phase ii registration protocol for breast cancer.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed recurrent or metastatic breast cancer that is refractory to standard chemotherapy and that is measurable. 2. adequate hepatic function: total bilirubin \ 3.0 mg/dl. there must be no substantial ascites. pt and ptt must be within normal limits. 3. performance status must be \< 1 (ecog 0-1) with a life expectancy of at least 3 months. 4. hemoglobin \> 9 gms% 5. absolute granulocyte count \> 1000/ul, and platelet count \> 100,000/ul. 6. serum creatinine of less than 1.5 mg%. 7. there must be no plans for the patient to receive further cancer therapy from the date of enrollment until the completion of the 6-week follow-up visit. 8. accessibility of peripheral or central iv line 9. age \> 18 years 10. patients will be off chemotherapy for a minimum of 4 weeks prior to initiation of therapy and should have recovered to grade 1 or less toxicity. 11. the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. prior malignancy, except for non-melanoma skin cancer, stage 1 breast cancer, cis of cervix from which the patient has been disease-free for 5 years. 2. woman who are pregnant or nursing 3. fertile patients unless they agree to use barrier contraception (condoms and spermicide jelly) during the vector infusion period and for six weeks after infusion. male patients must agree to use barrier contraception. 4. patients who are transfusion dependent (more than one transfusion per month) 5. patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol. 6. patient who do not meet the inclusion criteria.

Keywords: breast cancer rexin-g gene therapy
vascular effects of triglyceride-rich lipoproteins

Conditions: Postprandial Period; Lipemia; Vasodilation; Vascular Resistance; Nitric Oxide

Summary: many types of cardiovascular disease begin when the layer of cells lining blood vessels (endothelial cells) start to function abnormally. this causes white blood cells (monocytes) to enter the blood vessel wall and eventually form lesions. fats from foods we consume are carried in the blood for 3-8 hours after a fatty meal in small particles known as chylomicrons (cm) and chylomicron remnants (cmr). the overall aim of this project is to investigate the idea that n-3 polyunsaturated fatty acids (pufa) protect against heart disease by modifying the effect of cmr on endothelial cells and monocytes. we hypothesize that n3-pufa carried in cmr reduce detrimental events which promote blood vessel damage and activate protective mechanisms to improve the function of arteries.


Eligibility criteria:
inclusion criteria: * healthy males * non-smokers * aged 35-70 years * fasting tag concentrations ≥1.2 mmol/l. exclusion criteria: * reported history of cvd (myocardial infarction, angina, venous thrombosis, stroke), impaired fasting glucose/uncontrolled type 2 diabetes (or fasting glucose ≥ 6.1 mmol/l), cancer, kidney, liver or bowel disease. * presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption. * history of substance abuse or alcoholism (previous weekly alcohol intake \>60 units/men) * current self-reported weekly alcohol intake exceeding 28 units * allergy or intolerance to any component of test meals * unwilling to restrict consumption of any source of fish oil for the length of the study * weight change of \>3kg in preceding 2 months * body mass index \ 35 kg/m2 * fasting blood cholesterol \> 7.8 mmol/l * current cigarette smoker. * current use of lipid lowering medication

Keywords: n-3 pufa endothelial cells nitric oxide oxidative stress blood pressure vasodilation lipemia unsaturated dietary fats
evaluation of pregnancy associated plasma protein a (pappa) as a biomarker in breast cancer.

Conditions: Breast Cancer

Summary: this work aims to: 1. evaluation of the role of pregnancy associated plasma protein a( pappa ) in diagnosis \& early detection of breast cancer. 2. evaluation of the relationship between ( pappa ) levels and stages of breast cancer.


Eligibility criteria:
inclusion criteria: * female patients with breast cancer who were diagnosed by histopathological studies and did not receive any treatment. exclusion criteria: * patients who received chemotherapy or radiotherapy. * patients with known other organ malignancy.
an open-label, long-term safety study of linaclotide in patients with chronic constipation or irritable bowel syndrome with constipation

Conditions: Irritable Bowel Syndrome With Constipation; Chronic Constipation

Summary: the objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (cc) or irritable bowel syndrome with constipation (ibs-c).

participants include randomization-ineligible (ri) patients from the lead-in double-blind trials mcp-103-302 (nct00938717) or mcp-103-303 (nct00730015), or rollover (ro) patients from the lead-in double-blind trials mcp-103-302 (nct00938717), mcp-103-303 (nct00730015), and from the phase 2 double-blind studies mcp-103-004 (nct00306748), mcp-103-005 (nct00258193), and mcp-103-201 (nct00402337), or mcp-103-202 (nct00460811).

Eligibility criteria:
inclusion criteria: * patients must have * entered study mcp-103-303 or mcp-103-302 and at minimum completed the pre-treatment period or * completed one of the following studies: mcp-103-004, mcp-103-005, mcp-103-201, mcp-103-202 * sexually active patients of childbearing potential agree to use birth control * females of childbearing potential must have a negative urine pregnancy test prior to dosing * lactating females must agree not to breastfeed * patient must meet protocol criteria for cc or ibs-c exclusion criteria: * patient must not use protocol-defined prohibited medicine * patient is planning to receive an investigational drug at any time during the study * patient has an unresolved adverse events or a clinically significant finding on a physical examination, 12-lead electrocardiogram, or clinical laboratory test