Kornimate/medical-research-clean huggingface dataset:
growth hormone, cardiovascular risk, and visceral adiposity

Conditions: Obesity

Summary: this study will compare growth hormone levels and cardiovascular risk markers in normal weight and overweight women and men. in women and men with increased abdominal weight, growth hormone (gh) versus placebo will be administered and effects on cardiovascular risk, insulin resistance and body composition will be measured.

the purpose of this study is to measure growth hormone levels in women and men who are normal weight, overweight, and obese. growth hormone levels will be correlated with body weight, body composition, and markers of cardiovascular risk. in overweight or obese women and men with increased visceral adiposity and below average igf-1 levels, growth hormone versus placebo will be given for 6 months. effects of growth hormone treatment on weight, body composition, insulin resistance, lipids, and cardiovascular risk markers will then be assessed. study subjects will be followed for an additional six months for these endpoints.

Eligibility criteria:
inclusion criteria: * for growth hormone measurement part (for men and women): 1. for visceral adiposity arm: waist circumference greater than or equal to 88 cm for women or 102 cm for men, and bmi greater than or equal to 25 kg/m2 2. for lean controls: bmi 18.5 to 24.9 kg/m2 * for growth hormone treatment part (for men and women): 1. visceral adiposity (waist circumference greater than or equal to 88 cm for women and 102 for men, bmi greater than or equal to 25 kg/m2) 2. igf-i within the lowest 2 quartiles for age and gender 3. willingness to maintain current activity level and diet exclusion criteria: * diabetes mellitus (fasting plasma glucose greater than 126 mg/dl or 2-hour post-oral glucose tolerance test \[ogtt\] plasma glucose greater than 200) * taking the following medications in the last 3 months: weight loss or lipid-lowering agents, medications to treat diabetes mellitus or "pre-diabetes", oral contraceptives or estrogen-containing medications, other medications known to significantly affect weight * smoking * hematocrit below the lower limit of normal * amenorrhea for 3 months (in women) * pregnant or breastfeeding (in women) * polycystic ovary syndrome (in women) * weight that exceeds 280 pounds * sgpt greater than 2 times the upper limit of normal * history of malignancy, except for fully resolved basal cell carcinomas of the skin (specific aim 2 only) * radiation exposure greater than 1000 mrem over the last 12 months * previous diagnosis of cardiovascular disease * history of pituitary or hypothalamic disease, brain radiation, or childhood growth hormone deficiency * history of carpal tunnel syndrome that has not been surgically treated

Keywords: visceral obesity growth hormone cardiovascular risk insulin resistance
repeated-dose oral n-acetylcysteine for the treatment of parkinson's disease

Conditions: Parkinson Disease

Summary: the investigators are interested in evaluating the use of oral n-acetylcysteine (nac) as therapy for parkinson's disease (pd) and measuring changes in brain and blood chemistry.

the investigators are interested in evaluating the use of oral n-acetylcysteine (nac) as therapy for parkinson's disease (pd) and measuring changes in brain and blood chemistry. the investigators' hypothesis is that repeated oral dosing of nac will result in increased brain and red blood cell gsh concentrations in individuals with parkinson's disease (pd) and healthy controls. the specific aims are to 1.) measure plasma and blood (red blood cell) glutathione (gsh) and ratio of reduced gsh to oxidized glutathione (gssg) in individuals with pd and healthy controls at baseline and after four weeks of repeated high doses of oral nac (6000 mg/day) and 2) measure cortical gsh levels (as ascertained through mrs) in those with pd and healthy controls at baseline and four weeks during repeated high doses of oral nac (6000 mg/day) simultaneously with aim 1. this study will combine information from a medical history, a physical examination, and disease rating scales with results obtained using magnetic resonance spectroscopy (mrs) brain scans and pharmacokinetic studies from blood samples. this research will require 2 visits, one at baseline and one after approximately 28 days of therapy. participants will provide their medical history during the first visit, and undergo a physical examination and rating scale each visit (duration: 1 hour). the first visit including the brain scans and blood collection will require approximately 3 hours of time. the brain scan and pharmacokinetic studies for the second visit will require approximately 8 hours of time. in total the second visit will take roughly 9 hours.

Eligibility criteria:
inclusion criteria: 1. all participants must be 18 years or older 2. all enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent 3. individuals with medically stable parkinson's disease (in the opinion of the investigator) 4. all participants must not have taken antioxidants nac, glutathione, coenzyme q-10, vitamin c, or vitamin e for 3 weeks prior to the study 5. absence of dementia in all subjects exclusion criteria: 1. inability to undergo mri scanning without sedation and other mri counterindications, such as metal in the body (see section 7.3) 2. medically unstable conditions as determined by the investigators 3. pregnant or lactating or those women of child-bearing age that are not using acceptable forms of contraception 4. diagnosis of asthma that is presently being treated with any medication, or past history of asthma/bronchospasm resulting in an emergency room visit, hospitalization or treatment 5. unable to adhere to study protocol for whatever reason
a study of tarceva (erlotinib) in elderly patients with advanced non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this study will compare the efficacy and safety of tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer. patients will be randomized to receive either tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). the anticipated time on study treatment is until disease progression.


Eligibility criteria:
inclusion criteria: * adult patients, \>=70 years of age * non-small cell lung cancer * naive to prior chemotherapy or specific immunotherapy * presence of at least 1 measurable lesion exclusion criteria: * active non-controlled infection or disease * cns metastases * any other malignancies (other than adequately treated basal cell cancer of skin, or in situ cancer of the cervix)
irinotecan versus only best supportive care for gastric cancer

Conditions: Stomach Neoplasm; Neoplasm Metastasis

Summary: the median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 2.5 months. there are no data which a possible benefit of second line therapy. for this reason a trial which investigates a possible benefit or chemotherapy compared to best supportive care as second line treatment is urgently necessary. irinotecan shows response rates of 20% in the first line therapy with high rates od disease stabilization. there are few trials investigating irinotecan in the second line setting. response rates of 20% are reported in tis setting. irinotecan is supplied without costs from the company pfizer.

metastatic gastric cancer, progressive disease after one palliative chemotherapy arm a: irinotecan 250/350 mg/m2 q3w 1. cycle:250mg/m2/ 30min 2. cycle:if no toxicity\>2° ctc, nor leuko-thrombopenia\>3° occured, dose is increased to 350mg/m2 arm b. best supportive care

Eligibility criteria:
inclusion criteria: * patient with histologically proven adenocarcinoma of stomach or the gastro-esophageal junction * patient with distant metastases laparoscopically proven operative incurability of an locally advanced gastric cancer or patient with a tumor recurrence after gastrectomy * patient with progressive disease under a palliative first-line chemotherapy or progressive disease within 6 months after termination of a first-line chemotherapy, defined as objective progression by imaging techniques according to who criteria * age 18 and 75 years * sufficient liver function, defined as serum-bilirubin \<1,5 mg/dl (1,5 upper normal limit), alt und ast \< 3x upper normal limit * sufficient renal function, defined as serum creatinine \ 60ml/min calculated according to crockroft-gault * contraction for patient with reproductive potential * karnofsky-index \>60% * measurable or evaluable tumor manifestation exclusion criteria: * tumor progression later than 6 months after termination of first-line chemotherapy * ki 50% or less * patient who have already received a second line chemotherapy for the metastatic setting (adjuvant chemotherapy and one line of palliative chemotherapy os allowed, biologic prior therapies are allowed) * prior or current second malignancy despite of basal carcinoma of the skin and curatively treated carcinoma in situ of the cervix * uncontrolled infection * cns metastases * other severe medical illness * prior major surgery less than 2 weeks ago * parallel treatment with another experimental therapy * parallel treatment with another therapy aiming at tumor reduction * chronic diarrhea, subileus * chronic inflammatory bowel disease or intestinal obstruction * pretreatment with irinotecan

Keywords: gastric cancer metastatic irinotecan
dexpramipexole sad/mad study

Conditions: Amyotrophic Lateral Sclerosis

Summary: this phase 1 study will explore the safety, tolerability, and pharmacokinetics of single doses ranging from 300 to 600 mg and multiple daily doses ranging from 225 mg to 300 mg bid dexpramipexole in healthy volunteers.

preclinical and clinical data to date support the exploration of doses of dexpramipexole higher than 150 mg twice daily for their effectiveness in slowing the progression of als. exploration of doses of dexpramipexole higher than 150 mg twice daily is justified by preclinical and clinical data that suggest that higher doses could potentially be more effective in slowing the progression of als than the dose of dexpramipexole currently being explored in phase 3 studies (150 mg twice daily). this is a phase 1, single-center, blinded, randomized, placebo controlled, ascending-dose study consisting of 2 parts; part a (single-ascending dose \[sad\]) and part b (multiple ascending dose \[mad\]). the study will explore safety, tolerability, and pharmacokinetics of single doses ranging from 300 to 600 mg and multiple daily doses ranging from 225 mg to 300 mg bid dexpramipexole in healthy volunteers.

Eligibility criteria:
inclusion criteria: * must give written informed consent. * adult males/females aged 18 to 55 years inclusive and between 19 and 30 kg/m2 body mass index (bmi), inclusive at screening. * subjects who are healthy as determined by prestudy medical history, physical examination and 12-lead ecg. * subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 1 month (females) or 3 months (males) after their last dose of study treatment. * normal systemic blood pressure defined as a systolic blood pressure of 90 to 140 mmhg and a diastolic blood pressure of 50 to 90 mmhg. exclusion criteria: * history of cardiovascular disease (e.g., hypertension, arrhythmia, heart failure, long qt syndrome, or other conditions/diseases causing prolongation of the qt/qtc interval). * a prolongation of qt/qtc interval (e.g., repeated demonstration of a qt/qtc interval \>450 ms before study treatment administration) at screening, admission or pre-dose on day 1. * any clinically important abnormalities in resting ecg that may interfere with the interpretation of qtc interval changes at screening, admission or pre-dose on day 1. * prior exposure to dexpramipexole. * treatment with pramipexole or any dopamine agonist within 1 year. * treatment with another investigational drug or approved therapy for investigational use within 30 days, or 5 half-lives (whichever is longer), or in follow up for any other drug, biologic, or device study. * currently active infection or serious infection (e.g., pneumonia, septicemia) within the 2 months prior to day -2 as determined by the investigator. * female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
do oral contraceptives protect against acl injuries in female athletes

Conditions: Ligament Injury

Summary: the purpose of this research study is to examine the impact of one type of commonly used birth control pill on blood levels of relaxin and measure changes in knee movement to determine whether there are changes in joint instability (indicating the knee is less stable) that may predispose female athletes to injury. women not on hormonal birth control will also be enrolled to analyze differences between athletes on and not on birth control and to evaluate typical relaxin levels and knee laxity when birth control pills are not used.


Eligibility criteria:
inclusion criteria: * female * 18 years of age or older * currently playing basketball, soccer, or volleyball at loyola marymount or pepperdine * if not currently on coc, regular menstrual cycle occurring every 21-35 days exclusion criteria: * previous acl injury * underlying neuromuscular disease * medical contraindication to coc use * history of pregnancy * desire to conceive in the next year

Keywords: anterior cruciate ligament birth control oral contraceptive
telecoaching plus a portion control device for weight management in the primary care setting

Conditions: Obesity

Summary: the purpose of this study was to evaluate the impact of telecoaching conducted by a counselor trained in motivational interviewing paired with a portion control device for obese patients receiving care in a certified patient-centered medical home. the investigators will conduct a randomized, controlled clinical trial evaluating the effectiveness of a telecoaching intervention with a portion control device.

the intervention will be provided during a 3-month period with follow-up through 6 months after randomization. body mass index (bmi) and waist circumference measurements will be collected at baseline and at 6, 12, 18, and 24 weeks. participants will also complete measures assessing eating behaviors and physical activity at baseline and at 12 and 24 weeks.

Eligibility criteria:
inclusion criteria: * men or women ≥ 18 years and ≤ 55 years of age * a bmi of ≥ 30 and ≤ 44.9 kg/m2 * motivated to lose weight * able to participate fully in all aspects of the study; * have been provided with, understand, and have signed the informed consent. exclusion criteria: * unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia * a history of a gastric bypass procedure or planned gastric bypass * baseline systolic blood pressure \> 180 or diastolic \> 100 * another member of their household already participating in this study * current treatment with another investigational drug for obesity (within 30 days of study entry) * are pregnant or lactating * history of anorexia or bulimia * current binge eating disorder as assessed by the patient health questionnaire eating disorder module (phq-ed) * schizophrenia or bipolar disorder or have a phq-2 ≥ 337 * have been diagnosed with cancer within the past 5 years * are currently participating in a program specifically to lose weight or are on a weight loss medication (last 30 days)
effect of early administration of albumin 20% versus crystalloid

Conditions: Septic Shock

Summary: sepsis and septic shock are global health problems, leading to a high mortality rate. they are often associated with extremely low blood pressure and multiple organ dysfunctions, which are the main causes of death in critically ill patients. fluid resuscitation is one of the most critical treatments for patients with sepsis and septic shock. an early administration of an appropriate fluid to patients is considered the most effective way to increase blood pressure, improve tissue perfusion, and save their lives. crystalloid fluids are a subset of intravenous solutions composed of mineral salts and other small, water-soluble molecules, including normal, isotonic or hypertonic saline, and various buffered solutions.

crystalloid fluids are a subset of intravenous solutions composed of mineral salts and other small, water-soluble molecules, including normal, isotonic or hypertonic saline, and various buffered solutions. colloid solutions are composed of various amounts of substances, for instance, albumin, hydroxyethyl starch, dextran, and gelatine. although the current international guidelines from the surviving sepsis campaign recommend crystalloids to perform the initial resuscitation, and the replacement with albumin on patients who require substantial amounts of crystalloids, the choice of the best type of resuscitation fluids is still under debate. albumin, in addition to its oncotic functions, has a variety of other properties, including binding and transport of various endogenous molecules, anti-inflammatory and anti-oxidative effects, and modulation of nitric oxide metabolism.these properties are particularly relevant in critically ill patients, especially in patients with sepsis.

Eligibility criteria:
inclusion criteria: * presence of septic shock that meets all the following criteria: clinically possible, probable, or microbiologically confirmed infection according to the definitions of the international-sepsis- forums (isf), despite adequate volume therapy, vasopressors are required to maintain mean arterial pressure (map) ≥ 65 mmhg for at least 1 hour, serum lactate concentration \> 2 mmol/l (18 mg/dl) despite adequate volume therapy. * onset of septic shock less than 24 h prior to study inclusion. * women of childbearing age: negative pregnancy test exclusion criteria: * moribund conditions * end of life decisions * previous participation to this trial or any other interventional clinical trial * known hypersensitivity to albumin or any component of the trial drug * clinical conditions, where albumin administration may be unfavourable * breast feeding
analgetic effect of two solutions of intracameral anesthesia during cataract surgery in patients

Conditions: Cataract; Analgesia; Ophthalmological Disorder

Summary: purpose: the aim of the study was to compare the analgetic effect of two solutions of intracameral anesthesia in patients undergoing cataract surgery and assess the factors influencing the patients' postoperative activities. methods: in this prospective, single-blind, randomized study, a group of 62 patients undergoing cataract surgery received mydrane (mydrane group) or a combination of 1% solution of lignocaine and 0.025% solution of adrenalin (reference group) as an intraocular anesthetic. the analgetic effect of these two anesthetic methods was evaluated using psychological tools - visual analog scale for pain (vas pain) and brief pain inventory-short form (bpi) on the next day after the surgery.


Eligibility criteria:
inclusion criteria: * age above 18 years * best corrected visual acuity (bcva) of 0.2 logmar or worse * and agreement for taking part in the study exclusion criteria: * depressive disorder or expected compliance problems (known psychiatric disease) * epilepsy * ongoing treatment with hypnotics or psychotropic drugs (including opioids) within a week before admission * daily analgesic treatment * intake of additional rescue medications due to the pain after surgery * omitting postoperative visit * no consent to complete the survey * the patients who later needed additional medications for pain relief
efficacy of tele-rehabilitation intervention on hand, cognitive functions & depression of hemiparetic patients

Conditions: Hemiparesis

Summary: information and communication technologies (ict) are used in telerehabilitation to deliver rehabilitation treatments to patients in their homes or other locations.

thirty hemiparetic patients with mild hand dysfunction of both sexes participated in the study (age range was 45- to 55-year-old); 15 patients in the control group (gb) received a selected hand rehabilitation program, whereas 15 patients in the study group (ga) received telerehabilitation intervention. the 9hpt (nine-hole peg test), fmue (fugl meyer upper extremity), moca (montreal cognitive assessment scale), rehacom system, and the beck depression inventory questionnaire were used to evaluate the patients in both groups before and after the treatment program began.

Eligibility criteria:
inclusion criteria: * patients between the ages of 45 and 55 were included in this study. * both men and women were among the patients. patients with duration of illness between three to six months. * according to the modified ashworth scale (mas), the patients' hand spasticity ranged from grade 1 to +1. * the patients had a fugl myer upper extremity score of at least nine, indicating mild hand function. on the beck depression inventory questionnaire, the patients' score ranged from 17 to 20 (borderline clinical depression). every patient had good vision and hearing. * the patients successfully filled out the consent form and completed the assigned activities. * in order to enable video communication while at home, patients need to have at least ten years of education to be able to use a smart device that is connected to the internet, such as a laptop, phone, or tablet. * in addition to medical care, the patients shouldn't receive any other kind of treatment. * the patients should be able to communicate and obey commands with ease. - - the patients' mmse scores were over 21, indicating good cognitive abilities. exclusion criteria: * individuals with unstable medical conditions, such as unstable angina, symptomatic heart failure, or uncontrolled diabetes mellitus or hypertension. - --- patients who are unable to utilize the video communication device, have moderate to severe impairment of hand functions, or have any other pathology impacting hand function except stroke. * patients who have visual or hearing impairments. * patients who have communication issues or who have trouble understanding or obeying instructions. * individuals who have seizures or psychological disorders. * patients who have not had a stroke but have another illness that impairs cognitive function. * individuals who have a history of stroke or other neurological conditions.

Keywords: tele-rehabilitation hand functions cognitive functions depression hemiparesis
cemented vs non-cemented semiendoprosthesis in the treatment of proximal femoral fractures

Conditions: Hip Fracture; Proximal Femoral Fracture

Summary: the hip semiendoprosthesis is an acceptable method to treat the proximal femoral fractures. traditionally, the cemented version of the semiendoprosthesis has been used for this indication. however, the cementing carries a risk of fat embolism during the pressurization of the cement. the fat embolism can be avoided when using the non-cemented semiendoprosthesis. in this study we want to find out whether there are any differences in the treatment results between the cemented and non-cemented semiendoprostheses when treating the proximal femoral fractures.


Eligibility criteria:
inclusion criteria: * a proximal femoral fracture exclusion criteria: * rheumatoid arthritis * pathologic fracture * severe dementia (preventing the informed consent)

Keywords: hip hip endoprosthesis hip fracture femoral fracture bone cement non-cemented