Kornimate/medical-research-clean huggingface dataset:
contrast volume reduction during pci with the use of a new assisting software package

Conditions: Coronary Stenosis; Coronary Occlusion

Summary: the new software package is intended to assist the physician in imaging the coronaries during percutaneous coronary interventions. this study investigates the amount of contrast used during percutaneous coronary interventions with the aid of the new software package. the results of the study will be compared with control group data (before the new software package was installed or after it was removed) to define a possible contrast reduction.


Eligibility criteria:
inclusion criteria: * subject undergoing a percutaneous coronary intervention. * subject 18 years of age or older, or of legal age to give informed consent per state or national law. exclusion criteria: * subject undergoing an emergency treatment * primary angioplasty for acute st segment elevation myocardial infarction. * subject with contrast allergies * subject with severe kidney disease (e-gfr \< 40 by modification of diet in renal disease (mdrd)/cockcroft gault clearance formula and/or upon decision by investigator) * subject participates in a potentially confounding drug or device trial during the course of the study. * prisoners, people who cannot legally give consent, pregnant women and breastfeeding women.
single-patient expanded access protocol for tradipitant in a single patient with gastroparesis

Conditions: Gastroparesis; Diabetic Gastroparesis

Summary: primary objective: to treat a single patient with gastroparesis who has requested expanded access with tradipitant

this is a single-patient extended access treatment protocol to be conducted in the united states. investigator-physician has determined patient satisfies expanded access inclusion criteria and has requested expanded access to tradipitant. patient will be given open label tradipitant 85 mg to be taken twice daily at 12 hour intervals for long term treatment. patient can fill out daily web-based symptom diaries on a voluntary basis and report any adverse events to investigator-physician. primary objective: -to treat a single patient with gastroparesis who has requested expanded access with tradipitant secondary objectives: * to monitor the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis in this single patient * to monitor the safety of tradipitant in a patient with gastroparesis by assessing adverse events in this single patient

Eligibility criteria:
inclusion criteria: * identified subject who requested expanded access * diagnosed with gastroparesis * demonstrated delayed gastric emptying * presence of moderate to severe nausea * patient does not qualify for or does not have access to other clinical trials with tradipitant; exclusion criteria: * another active disorder or treatment which could explain or contribute to symptoms of gastroparesis * a positive test for drugs of abuse at the screening or evaluation visits; * exposure to any investigational medication in the past 60 days other than tradipitant * gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year * any other reason as determined by the investigator which may lead to an unfavorable risk-benefit ratio to treatment;

Keywords: gastroparesis idiopathic diabetic tradipitant nausea vomiting stomach motility functional nk-1 antagonist neurokinin 1 receptor substance p expanded access
a study to examine apl-130277 in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: the primary objective of this study is to evaluate the efficacy, tolerability and safety of single treatments of apl-130277 in 16 patients with parkinson's disease (pd)


Eligibility criteria:
inclusion criteria: 1. male or female ≥18 years of age. 2. clinical diagnosis of idiopathic pd 3. receiving stable doses of l-dopa +/- other adjunctive pd therapy for at least 4 weeks before study participation. 4. at least one off episode per day and a total daily off time of \> 2 hours duration. 5. experience predictable off episodes in the morning on awakening prior to receiving morning dose of levodopa. 6. stage i to iii on the hoehn and yahr scale in the "on" state. 7. if female and of childbearing potential, must agree to use one of the following methods of birth control: 8. willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study. 9. able to understand the consent form, and to provide written informed consent. exclusion criteria: 1. atypical or secondary parkinsonism 2. changes in l-dopa or other pd drug dosing regimens 4 weeks before the screening visit. 3. past treatment with any form of apomorphine within 30 days of dosing day 1 (patients who stopped apomorphine for reasons other than lack of efficacy or tolerability issues may be considered for the trial). 4. female who is pregnant or lactating. 5. contraindications to apokyn or hypersensitive to apomorphine hydrochloride or any of the ingredients of apokyn (notably sodium metabisulfite), or tigan®. 6. participation in any other clinical trial within 14 days of the screening visit. 7. receipt of any investigational (i.e., unapproved) medication within 30 days of the screening visit. 8. currently taking, or likely to need to take at any time during the course of the study 9. currently taking dopamine antagonists or depleting drugs excluding anticholinergics and/or antihistamines with anticholinergic effects. 10. drug or alcohol dependency in the past 6 months. 11. clinically significant orthostatic hypotension. 12. malignant melanoma or a history of previously treated malignant melanoma within 5 years. 13. clinically significant medical surgical or laboratory abnormality in the judgment of the investigator. 14. psychiatric disorder, including but not limited to dementia or any disorder that, in the opinion of the investigator requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult. 15. dementia that precludes providing informed consent. 16. potential for lack of compliance and follow-up in the judgment of the investigator. 17. any other condition, current therapy, or prior therapy (within 30 days of the screening visit), which, in the opinion of the investigator, would make the subject unsuitable for the study. 18. previous neurosurgery for pd. 19. donation of blood or plasma in the 30 days prior to dosing. 20. presence of cankers or mouth sores.

Keywords: parkinson's disease
analgesic effect of ultrasound-guided bilateral modified-thoracoabdominal nerves block through a perichondrial approach

Conditions: Laparoscopic Cholecystectomy

Summary: this study will define the postoperative analgesic effect of ultrasound-guided bilateral modified-thoracoabdominal nerves block through perichondrial approach (m-tapa) and compare the control group in patients undergoing laparoscopic cholecystectomy.

laparoscopic cholecystectomy is the most common laparoscopic procedure and causes moderate to severe postoperative pain. the m-tapa block was described by tulgar et al. for postoperative analgesia of abdominal surgeries. however, studies showing the analgesic efficacy of this block are lacking. in this prospective interventional trial, the investigators aim to define the efficacy of m-tapa block for laparoscopic cholecystectomy surgeries under general anesthesia. this study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. after randomization, the patients in the group m-tapa will receive bilateral m-tapa block at the beginning of the operation defined by tulgar et al or no intervention (group n). an anesthesiologist who performed m-tapa block will not involve in the data collection. other health care workers who will involve in the evaluation of postoperative pain scores, vital parameters, nausea and vomiting, anti-emetic and opioid consumption will be blinded to group assignment.

Eligibility criteria:
inclusion criteria: * patients' age between 18 and 70 years with american society of anesthesiology (asa) physical status i-ii, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study exclusion criteria: * presence of coagulation disorder * refuse to participate * infection at the injection site of the block * known allergy to local anesthetics * advanced hepatic or renal failure * can not communicate in turkish * history of abdominal surgery or trauma * conversion of laparoscopic to open surgery * consumption of any pain killers within the 24 h before the operation * chronic opioid consumption * pregnancy * alcohol or drug abuse * body mass index (bmi) ≥ 35 kg m-2.

Keywords: modified-thoracoabdominal nerves block acute pain laparoscopic cholecystectomy
early versus late administration of insulin glargine in t1dm during fasting ramadan

Conditions: Type1diabetes; Fasting; Insulin

Summary: to compare different timing of insulin glargine administration (early-6 pm versus standard bedtime-10 pm) as part of standard of care in patients with type1 diabetes who wish to fast the month of ramadan.

the investigators aim to compare the effectiveness and safety of two management strategies currently used in basal insulin adjustment for treatment of type1 diabetes (t1dm) during fasting the holy month of ramadan. primary objective: to determine if taking basal insulin glargine at 6 pm is associated with less rates of hypoglycemia -(we will consider glucose level of 70 mg/dl ( 3.9 mmol/l) and below as the level of hypoglycemia ) - compared to bedtime timing (10-12pm) during fasting ramadan in patients with t1dm secondary objectives: 1. to estimate the difference between the two groups in glucose variability 2. to estimate the difference between the two groups in number of days they needed to brake their fast 3. to assess the difference in glycemic control between the two groups 4. to estimate the difference between the two groups in overnight and daytime hyperglycemia. 5. to estimate the difference between the two groups in rate of severe hyperglycemia and /or dka it is a multi-center open label randomized study that will take place in the diabetes/endocrine clinics at national guards hospitals in four cities (jeddah, riyadh, alhasa, and dammam) variables to be assessed: 1. patient's demographics including (age, gender, type and duration of diabetes), and baseline measurements (weight, height,bmi, ...). 2. rate of hypoglycemic events (as per smbg records and cgm) in both groups 3. number of days fasting was broken in both groups 4. rate of severe hyperglycemic episodes (bg\>250mg/dl) or dka in both groups 5. mean blood glucose for the month of ramadan as calculated from sum of each patient's 7-point blood sugar home measurements in both groups. 6. mean 24-hour blood glucose as measured by a continuous glucose monitoring devise in both groups. 7. mean fasting blood glucose for the month period as calculated from patients home blood sugar measurements in both groups. 8. mean 2-hour post-prandial blood glucose for the as calculated from patients home blood sugar measurements in both groups. 9. fructosamine and hba1c level before and after ramadan in both groups results of this study will help fill a current gap of knowledge and may also contribute to the development of future guidelines for the management of type1dm during ramadan.

Eligibility criteria:
inclusion criteria: 1. dm type 1 2. age \> 14 years 3. diagnosis of type 1 dm of more than 6 months. 4. committed to do smbg exclusion criteria: 1. renal and hepatic impairment 2. adrenal insufficiency 3. pregnancy 4. alcohol consumption 5. any diagnosed psychiatric disease

Keywords: type1 diabetes fasting insulin glargine ramadan hypoglycemia
validation of digital heart rhythm devices in the detection of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the validation study aims to evaluate the performance of four state-of-the-art digital heart rhythm devices (preventicus®, fibricheck®, apple watch®, 6l kardia mobile®) for the detection of atrial fibrillation.


Eligibility criteria:
inclusion criteria: * the patient is an ambulatory cardiology patient. * the patient is at least 18 years old. * the patient is sinus or in atrial fibrillation. * the patient is able to perform the study procedures together with the study assistant. exclusion criteria: * patients with a pacemaker * inclusion in another clinical trial that may influence the results of this trial * the patient is unable to comprehend the informed consent.
brief behavioral therapy for insomnia(bbti) in middle-aged and older adults with chronic insomnia

Conditions: Chronic Insomnia; Older Adults; Sleep Hygiene

Summary: this study aims to investigate whether a four-week bbti program can effectively improve chronic insomnia and reduce overall stress in middle-aged and elderly individuals.

this study will be conducted a single-group pre-test and post-test design, aiming to recruit 80 subjects who will undergo a four-week bbti intervention. participants will be selected from sleep counseling patients referred by sleep specialists. inclusion criteria include: 1) individuals aged 40 years and above; 2) experiencing sleep disturbances; 3) willing to participate in the research project and provide informed consent. cognitive impairment will exclude. the intervention consists of four weeks of bbti. during the first week, participants will receive face-to-face sleep assessments and sleep hygiene education. in the second week, a phone interview will be conducted to assess the patient's progress and provide appropriate relaxation techniques. unsatisfactory responses to sleep restriction therapy or stimulation control methods will be addressed through face-to-face interviews in the third week. the fourth week will involve an overall review and evaluation conducted via a telephone interview.

Eligibility criteria:
inclusion criteria: * individuals aged 40 years and above, * experiencing sleep disturbances, * willing to participate in the research project and provide informed consent exclusion criteria: ●cognitive impairment

Keywords: brief behavioral treatment for insomnia chronic insomnia older adults sleep hygiene
efficacy of bilateral ultrasonic guided sphenopalatine ganglion block in maxilofacial cancer surgeries

Conditions: Maxillofacial Tumors

Summary: patients will be randomly allocated according to computer - generated tables to one of two groups, group (a) ultrasonic guided sphenopalatine block using local anasthetic, group (b) ultrasonic guided sphenopalatine block using saline. before induction anesthesia the following will be assessed, time needed to perform the technique, time till onset of the block, distribution of the block (opthalmic, maxillary, mandibular) by needle brick.intra and post- operatively the following will be assesse the quality of operative filed every 30 min intra-operatively using a pre- defined average category scale (acs) (from 0 to 5), end tidal sevo flurane concentration will be recorded intra- operatively every 5 minutes, the total amount of nitroglycerine used to achieve the target map and frequency of propranolol usage will be recorded,emergence time, postoperative vas score and amount of meperdine used for rescue analgesia.


Eligibility criteria:
inclusion criteria: * adults patients of asa physical status i and ii, aged 20-70 year who will be scaduled for maxillo - facial cancer surgeries exclusion criteria: * patients with disfigurement and disturbed anatomy that will not allow easy access to the sphenopalatine ganglion, bleeding disorders, history of hepatic, renal or cardiopulmonary dysfunction, patients receiving drugs affecting coagulation or cardiovascular active medication are excluded also patients having infection or allergies to local anesthetics
isoniazid (inh) treatment based on elispot assay

Conditions: Kidney Transplant Recipient

Summary: it has been recommended that all transplant recipients undergo a tuberculin skin test (tst) before transplantation. however, the ability of tst to diagnose latent tuberculosis infection (ltbi) in transplant candidates has been reported to be suboptimal because of high rates of false-negative and false-positive results. the enzyme-linked immunospot assay (elispot) detecting interferon-gamma secreting t-cells for diagnosing tuberculosis infection gave promising results in immunocompromised patients as well as in immunocompetent patients. the investigators will perform a randomized, open-label, prospective trial of isoniazid (inh) prophylaxis based on elispot assay for ltbi in renal transplant recipients.

our previous data have shown that elispot assay was more sensitive to detect ltbi in renal transplant recipients than tst (kim sh, et al. transplant infect dis 2010 jan 25 \[epub ahead of print\]). however, further studies are eagerly awaited to determine the efficacy of isoniazid (inh) prophylaxis based on elispot assay for ltbi in renal transplant recipients. all adult patients admitted for renal transplantation between may 2010 and april 2013 at the asan medical center, seoul, south korea, will be prospectively enrolled. inh (300 mg/day for 9 months) prophylaxis group and no prophylaxis group (control group) will be randomly assigned to all patients with a baseline positive elispot assay regardless of the results of tst. the investigators will compare cumulative probability of developing active tb after transplantation between inh prophylaxis group and control group as primary outcome. secondary outcomes will be adverse drug reactions, rejection episodes, graft survival, and mortality.

Eligibility criteria:
inclusion criteria: * 16 years or more * kidney transplant recipients exclusion criteria: * patients who do not receive isoniazid treatment due to abnormal liver function (i.e. child-pugh score b or c) * patients who have clinical risk factors for latent tuberculosis infection 1. close contact with a person with pulmonary tb within the past year 2. abnormal chest radiography and no prior prophylaxis 3. a history of untreated or inadequately treated tb 4. new infection (i.e. a recent conversion of tst to positive status) * if kidney transplant donor has these clinical risk factors for latent tuberculosis infection, the transplant recipient from this donor will be excluded from this study.

Keywords: kidney transplantation tuberculosis elispot isoniazid
dual-task obstacle crossing training in ambulatory subjects with spinal cord injury

Conditions: Injuries, Spinal Cord

Summary: is dual-task obstacle crossing training more efficiently than single-task obstacle crossing training on the improvement of walking ability, balance ability, and lower extremity muscle strength in ambulatory subjects with spinal cord injury

to compare immediate effects of dual-task and single-task obstacle crossing training in ambulatory subjects with spinal cord injury

Eligibility criteria:
inclusion criteria: * independent ambulatory subjects with * traumatic causes or non-progressive diseases * sub-acute and chronic stage of injury (at least 3 month after injury) * body mass index (bmi) between 18.5-29.9 kg/m2 * walk independently for at least 17 meters with or without assistive devices (functional independence measure locomotor (fim-l) scores 5-7) * able to read thai exclusion criteria: * pain in the musculoskeletal system with a pain scale more than 5 out of 10 on a the visual analog scale (vas) * deformity in the joints that affect ambulatory ability * unable to understand the commands and tests used in the study

Keywords: spinal cord injury dual-task obstacle crossing
lactoferrin versus ferrous sulphate for treatment of iron deficiency anaemia during pregnancy

Conditions: Iron Deficiency Anemia of Pregnancy

Summary: this study evaluates the efficacy and tolerability of lactoferrin in contrast to ferrous sulphate in the context of iron deficiency anemia with pregnancy. half of participants will receive lactoferrin, while the other half will receive ferrous sulphate.

lactoferrin and ferrous sulfate are used to treat iron deficiency anemia in pregnancy. ferrous sulphate is the most commonly used treatment for iron deficiency anemia. lactoferrin is a new generation oral iron that has long been recognized as a member of the transferrin family of proteins and an important regulator of the levels of free iron in the body fluids and has the ability to enhance iron binding. preliminary evidence suggests that lactoferrin may represent a promising new strategy for oral iron replacement.

Eligibility criteria:
inclusion criteria: * pregnant women with single fetus * hb count \< 11g/dl * ferritin level \< 12 ng/dl * gestational age (14 - 30 weeks) exclusion criteria: * associated chronic medical disorder (ckd, liver disease, peptic ulcer and chronic blood loss). * associated bleeding disorder * anaemia requiring blood tranfusion (hb \< 7g/dl) * hypersensitivity to iron preparations * haemoglobinopathies (g6pd, thalassemias, sickle cell disease)

Keywords: iron deficiency anemia of pregnancy - lactoferrin
establishing the safety and efficacy of reloxaliase in patients with enteric hyperoxaluria

Conditions: Enteric Hyperoxaluria

Summary: the purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.

this is a phase 3, global, multi-center, randomized, double-blind, placebo-controlled study. this study is designed to determine the short- and long-term efficacy of reloxaliase in terms of reducing urinary oxalate excretion and clinical benefits compared to placebo.

Eligibility criteria:
inclusion criteria: 1. provided informed consent 2. age 18 years or older 3. has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy) 4. urinary oxalate ≥ 50 mg/24 hr 5. has at least 1 documented kidney stone within 2 years exclusion criteria: 1. acute renal failure or estimated glomerular filtration rate (egfr) \< 30 ml/minute/1.73 m2 2. has a known genetic, congenital, or other cause of kidney stones 3. unable or unwilling to discontinue vitamin c supplementation \>200mg daily 4. cannot establish baseline kidney stone burden

Keywords: kidney stone hyperoxaluria enteric hyperoxaluria oxalate kidney calcification