Kornimate/medical-research-clean huggingface dataset:
double-blind randomized crossover trial to access electrocardiogram effects of hpn-100

Conditions: Drug Toxicity

Summary: arm 1: primary objective: • to determine the safety and tolerability of multiple ascending, supratherapeutic doses of hpn-100. arm 2: primary objective: • to assess the effects of steady-state levels of hpn-100 metabolites (4 phenylbutyric acid \[pba\], phenylacetic acid \[paa\], and phenylacetylglutamine \[pagn\]) on 12-lead electrocardiogram (ecg) parameters in healthy male and female subjects with the primary endpoint being the time-matched change from baseline in the qt interval corrected for heart rate (hr) based on an individual correction method (qtci).

assess the effects of steady-state levels of hpn-100 metabolites (4-phenylbutryic acid (pba), phenylacetic acid (paa), and phenylacetylglutamine (pagn) on 12-lead electrocardiogram (ecg) parameters in health male and female subjects with the primary endpoint being the time-matched change from baseline in the qt interval corrected for heart rate(hr) based on an individual correction method (qtcl). study acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria: * must be in good health * negative hepatitis panel and negative hiv antibody screens * females must be non-pregnant, non-lactating, and either postmenopausal or agree to to use adequate contraceptive methods throughout the study * males must either be sterile or willing to use adequate contraceptive methods throughout the study * willing and able to comply with all trial requirements * able to comprehend and willing to sign an informed consent form (icf) exclusion criteria: * history or clinical manifestations of significant allergic, metabolic, hepatic, renal, endocrine, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders * history of hypersensitivity or allergies to any drug compound * history of stomach or intestinal surgery or resection * history or presence of an abnormal ecg * history of alcoholism or drug addiction within 1 year * use of any tobacco-containing or nicotine-containing products within 3 months * participated in any other clinical trial of an investigational drug (or a medical device) within 30 days * use of any prescription medications/products other than contraceptives within 14 days * use of any over-the-counter, non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days * test positive for drug(s) of abuse, ethanol, or cotinine * have donated blood or blood components within 30 days * have received blood products within 2 months * have a history of unexplained syncope * have a family history of unexplained sudden death
the effects of intravenous heme arginate on heme oxygenase-1 expression (ho-1) and oxidative stress in the human heart

Conditions: Myocardial Ischemia

Summary: ischemia reperfusion injury may be attenuated by ho-1 induction. our previous data confirmed strong ho-1 induction in peripheral blood cells following heme arginate infusion in healthy humans. furthermore, we could demonstrate the amelioration of experimental ischemia reperfusion injury in the calf musculature by heme arginate in healthy subjects as measured by functional mri. therefore, we propose that ho-1 induction in the human heart may be a suitable target to mitigate cardiac ischemia-reperfusion injury. the ho-1 induction will be assessed in a clinical trial by myocardial biopsy prior to and after aortic cross-clamping in subjects with or without preceding heme arginate treatment in two different dosages. the ho-1 expression will also be measured in the clinical trials in peripheral blood mononuclear cells. as additional outcome, levels of myoglobin, creatine-kinase and troponin t and reactive oxygen species will be measured in plasma according to standard laboratory procedures.


Eligibility criteria:
inclusion criteria: * signed informed consent * men and women aged between 40 and 85 years (inclusive) * body mass index \< 35 kg/m2 * ability to communicate well with the investigator in the local language and to understand and comply with the requirements of the study exclusion criteria (any of the following): * known hypersensitivity to the study drug or any excipients of the drug formulation * treatment with another investigational drug within 3 weeks prior to screening * history or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug * severe renal failure (glomerula filtration rate \< 30 ml/min) * moderately or severe impaired left ventricular function (ejection fraction \< 40%) * moderately or severe impaired right ventricular function * systolic pulmonary pressure \> 45 mmhg * acute or recent (\<7 days) myocardial infarction * child bearing potential

Keywords: carboxyhemoglobin neutrophil reactive oxygen species reperfusion injury
facilitating parent adaptation to pediatric transplant: the p-scip trial

Conditions: Childhood Cancers

Summary: the investigators have developed a parent social-cognitive processing intervention (p-scip) to help decrease distress among parent caregivers of children undergoing hematopoietic stem cell transplant (hsct). the investigators will evaluate the efficacy of p-scip in reducing short- and long-term distress and parenting stress among 300 parents of children undergoing hsct. p-scip will be delivered during the child's inpatient hsct hospitalization and is specifically designed to improve parent social (e.g., sharing concerns) and cognitive (e.g., acceptance) processing of the transplant experience. the intervention includes five in-person sessions that are accompanied by an interactive cd-rom. the cd-rom complements the materials in the in-person sessions and provides parents with the opportunity to enhance and deepen their cognitive and social processing of the hsct experience. the intervention will be tested against best-practices psychosocial care (bpc) available in four enriched pediatric hsct settings across the united states. p-scip will be provided to both spanish- and english-speaking parents. participants will complete measures of psychological distress, well-being, and social and cognitive processing at the time of hsct, two, six and twelve months after hsct. research questions will address the effects of p-scip versus bpc on parent psychological adaptation and social and cognitive processing, as well as evaluate parent personal resources as well as child medical course variables that contribute to intervention response. the investigators will also examine barriers to participation in the intervention by comparing barriers to participation among parents who refuse participation in the trial and parents who accept.


Eligibility criteria:
inclusion criteria: * biological or foster parent of children under 19 years of age who are scheduled for hsct within the next month * participant is the primary caregiver * participant must have phone service * caregiver speaks, reads, and writes english or spanish (spanish is for childrens hospital los angeles and columbia university only) exclusion criteria: * pediatric patient has a diagnosis of medulloblastoma or other cancer of the brain

Keywords: hematopoietic stem cell transplant bone marrow transplant children parents counseling depression
gait re-education program in subjects with parkinson´s disease

Conditions: Parkinson Disease

Summary: randomized controlled study that will include participants diagnosed with parkinson's disease in mild or moderate stage with altered gait pattern who will be randomized following a simple randomization procedure in which one group will perform an intervention based on a gait re-education program called "tapiz fisior"- motor control and learning added to a conventional physiotherapy program; and the other group will perform only a conventional physiotherapy program. the evaluators will be unaware of the patient's treatment status.

all participants interested in participating in the present study will be part of the research project. once recruited, they will be randomly assigned to two intervention groups: a and b. group a (control group) will perform a conventional physiotherapy treatment 2/3 sessions per week of 30 minutes duration; on the other hand, group b (intervention group) will perform the treatment of group a and a therapeutic supplement of 2-3 sessions per week of about 30 minutes. during the research period, several measurements of the variables studied will be taken: one before the intervention, one immediately after the end of the intervention, and another measurement 12 weeks after the end of the intervention. the treatment will be carried out and supervised at all times by qualified physiotherapists, who will explain to you what the treatment consists of, the days you should attend, and the schedules. no adverse effects are expected from this therapy that could pose a risk for health.

Eligibility criteria:
inclusion criteria: * older than 50 years. * diagnosed parkinson disease. * not to be institutionalized. * barthel index scores of ≥ 60. * ability to communicate and to get up and walk at least 10 m (33 ft) exclusion criteria: * medical criteria for contraindication of treatment. * severe behavioral problems that hinder participation in the training program.
integrative oncology for patient symptoms

Conditions: Oncologic Complications; Symptoms and Signs

Summary: the use of complementary and integrative medicine (cim) among oncology patients is widespread, with a large body of research-based evidence supporting the ability of these therapies to alleviate symptoms related to cancer and its treatment. organizations such as the american society for clinical oncology and the european society for medical oncology have included cim modalities in their treatment guidelines, and many of today's leading cancer centers include cim in their supportive care service. the proposed study will prospectively examine the impact of a cim treatment program on the symptom burden, quality of life and function of patients undergoing active oncology treatment. a total of 750 patients will undergo an integrative oncologist (ip) consultation followed by a series of 8 cim treatments consisting of either acupuncture or touch-related therapies (reflexology, shiatsu, tuina, etc.) with the goal of relieving their symptoms. patients will be allocated to one of the two study treatment arms: the "patient-preference arm", for patients who specify their preference for either acupuncture or touch therapy; and the "randomized treatment arm", for those with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup. patients will be asked to complete the following study questionnaires before and after the treatment regimen: the european organization for research and treatment of cancer quality of life questionnaire (eortc qlq-c30); the edmonton symptom assessment system (esas); and the measure yourself concerns and wellbeing (mycaw) tool. the primary study outcome will be the change in eortc global health-status / quality of life scores, from pre- to post-treatment. secondary study outcomes will include eortc qlq-c30 functional and symptom scales, single items assessing additional symptoms commonly reported by cancer patients, and perceived financial impact of the disease; esas severity scores for 10 quality-of life related items; and mycaw severity scores for the 2 most significant symptoms, as well as post-treatment narratives. other secondary outcomes to be assessed include the safety of the study treatments (adverse effects); adherence to conventional treatment regimen; and narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * undergoing active oncology treatment * fully understand the study plan * agree to sign the study informed consent form. exclusion criteria: * not fulfilling all of the study criteria * not interested in attending all 8 weekly cim treatments sessions

Keywords: integrative medicine integrative oncology acupuncture touch therapy wellbeing
clinical study for the evaluation of the efficiency of a device for the diagnosis of an internal rectal prolapse, a pelvic floor ptosis and for the determination of an internal hernia into the douglas pouch

Conditions: Internal Rectal Prolapse; Pelvic Floor Ptosis; Internal Hernia Into the Douglas Pouch

Summary: the purpose of this study is to determine if the device is supplying sufficient diagnosis results of an internal rectal prolapse, of a pelvic floor ptosis and for the determination of an interal hernia into the douglas pouch, as well as to determine the technical success of using the device at the patient.

existing diagnosis methods are inadequate, inaccurate, complicated or can only made intraoperatively. the new device should enable a fast and easy examination procedure well tolerated by the patients. the diagnosis results, received with the device, should assist in the accurate selection of patients for operations as well as to avoid any unnecessary operations.

Eligibility criteria:
inclusion criteria: * female patients * patients with ods-symptome-score according longo of \>7 * existing results about a perceptible and seeable internal rectal prolapse, pelvic floor ptosis and an internal hernia into the douglas pouch * patients who correspond to to the asa 1 - asa 2 criteria exclusion criteria: * male patients * female patients with inflammable or malign diseases of the urogenital tract as well as of the anorectal area and after rectum operation * female patients with diarrhea * pregnant patients because of the x-ray examination * female patients who get anticoagulants * serious cardiopulmonary disorders * disorders of the blood coagulation * female patients who correspond to the asa 3 to asa 4 criteria
stated-preferences in knee arthroplasty

Conditions: Arthritis; Knee Osteoarthritis; Arthropathy of Knee

Summary: the primary objectives of this study are to apply best-practice stated-preference methods to quantify patient preferences for benefit-risk tradeoffs associated with arthroplasty treatment options for end-stage osteoarthritis of the knee. duke will develop and administer stated-preference surveys to adult patients (ages 40-80) with knee pain to collect preference data, estimate the relative importance of treatment features and outcomes, and estimate maximum acceptable risks for given benefits and minimum acceptable benefits for given harms. this study proposal describes plans for the patient stated-preference survey.


Eligibility criteria:
inclusion criteria: * age 40-80 * knee pain exclusion criteria: * inability to read, understand and give effective english consent
hypnosis for smoking relapse prevention

Conditions: Smoking

Summary: a majority of smokers who quit return to smoking within three months of their quit date. this study is a randomized trial to investigate the effectiveness of hypnosis versus behavioural counseling to promote maintenance of abstinence or relapse prevention in quitting smokers. the hypothesis is that hypnosis will be at least as effective as behavioral counseling in preventing relapse to smoking in smokers who are able to quit for at least three days.

we will enroll 520 current smokers in the study. all subjects will participate in an initial smoking cessation intervention involving brief counseling and nicotine replacement therapy. participants who are able to achieve at least 3 consecutive days of abstinence will be randomized to one of two relapse prevention interventions. the participants in study arm 1 will receive a hypnosis intervention designed to facilitate relapse prevention. participants in study arm 2 will participate in empirically-supported behavior relapse prevention counseling, utilizing the national cancer institute's forever free materials. both interventions will be conducted in two 60-minute individual sessions scheduled one week apart in addition to counseling phone calls on their quit date and after relapse prevention treatment. outcomes for the two study arms will be compared by assessing biochemically-validated point-prevalence smoking status at 9 weeks(end of treatment), 26 weeks and 52 weeks. hypnosis for relapse prevention is designed to sustain the ex-smokers commitment to remain abstinent, to provide a review of behavioral skills to resist the temptations to smoke, and to encourage attempts to quit again if relapse occurs.

Eligibility criteria:
inclusion criteria: * currently smoking at least 5/cigarettes per day during the past week * willingness to participate and give informed consent * aged 18 and above exclusion criteria: * contraindications to nicotine replacement * pregnancy, lactation * unstable psychiatric disorders * current (last 3 months)substance use disorder * terminal illness * current use of smoking cessation medication

Keywords: smoking
effects of implementing a high potassium diet in heart failure patients

Conditions: Heart Failure

Summary: this study evaluates the safety and physiologic effects of increasing dietary potassium intake in individuals with heart failure.


Eligibility criteria:
inclusion criteria: * all patients classified as having hf, both systolic and diastolic. * new york heart association class ii-iii symptoms. * treatment with an beta blocker, ace inhibitor, or angiotensin receptor blocker without any adjustment over the previous month * intake at baseline of ≤ 3 servings of fruits and vegetables per day. servings defined by health canada's food guide. exclusion criteria: * patients with an episode of decompensated heart failure, acute coronary syndrome, or revascularization within the previous 3 months of study inclusion. * patients receiving insulin therapy * glomerular filtration rate \< 40ml/min/1.73 m2 * pregnancy and lactation (women of childbearing potential will be included but will have to have a negative pregnancy test prior to inclusion). * inability to provide informed consent.

Keywords: potassium nutrition
assessing the use of mobile technology in adult asthma patients

Conditions: Asthma

Summary: this is a prospective, remote observational study of adults with persistent asthma who are managed on inhaled corticosteroids.

the study consists of one interventional group and all 104 subjects will be included in this group. all subjects will be provided with the herotracker package, which includes: 1. herotracker sensor that counts dosage and monitors real-time medication adherence 2. breathesmart mobile application that sends subjects real-time alerts and allows patients respond to questionnaires / surveys.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent * male and female adults (aged ≥ 18 years) * diagnosis of asthma for at least 6 months * ics (inhaled corticosteroid) use for at least 3 months * use of a pressurized metered dose inhaler (pmdi) compatible with the herotracker * possess a compatible smartphone (ios 8.0 or higher and android 4.3 or higher) exclusion criteria: * currently pregnant or planning to become pregnant during the study period * primary language other than english (breathesmart mobile app is currently available only in english)

Keywords: patient adherence mobile application mobile health digital therapeutics digital health
pilot study of perioperative docetaxel, oxaliplatin, and 5-fluorouracil (flot) in gastroesophageal adenocarcinoma

Conditions: Gastric Adenocarcinoma; Esophageal Adenocarcinoma

Summary: gastric or gastroesophageal junction adenocarcinoma is commonly treated with chemotherapy before and after surgery. the chemotherapy regimen used in our institution, called dcf (docetaxel,cisplatic, 5-fluorouracil) is active, resulting in tumor reduction and dysphagia relief. however, it is toxic, causing approximately half of patients severe inflammation of the mucosa (lining) of the mouth and gut. this results, in turn, in mouth sores, vomiting and diarrhea. similar regimen called flot (5-fu, oxaliplatin,docetaxel) appears to be at least equally active, but less toxic. our ultimate plan is to perform a randomized comparison of dcf and flot. before embarking upon this, we are conducting this pilot trial in 10 subjects with the flot regimen. if less than 5 patients develop severe mouth sores, vomiting or diarrhea, plans will be made to proceed with the next trial, a randomized comparison of dcf and flot

data about occurrence of diarrhea and mouth sores will be recorded through the use of quality-of-life questionnaires

Eligibility criteria:
inclusion criteria: * histological diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction (gej), or lower third of the esophagus. * the tumor must be deemed by the team to be potentially resectable. this includes imaging studies (detailed below) to clinically stage the tumor and rule out the presence of metastatic disease, and includes a preoperative laparoscopic evaluation. * stage ib (t1n1 only), ii, iiia, iiib, and iv (t4n1 only) * life expectancy greater than 3 months * ecog performance status of 0-2 (i.e. restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work). * adequate hematologic reserve: platelet count greater than or equal to 100,000 microlitre, wbc greater than or equal to 2000 microlitre, * creatinine clearance greater than or equal to 30 ml/min, ast \& alt less than or equal to 2 uln, alkaline phosphatase less than or equal to 2.5 uln, bilirubin less than or equal uln exclusion criteria: * prior systemic therapy for gastric cancer * prior docetaxel-containing chemotherapy * pre-existing medical conditions precluding treatment, including any contraindication for major surgery * pregnancy or lactating mothers. women of childbearing age must use contraception during and for 3 months following treatment * inability to give informed consent * inability to maintain nutrition by oral consumption of food alone must have additional enteral feeding. * macroscopic disease noted at laparoscopy * ecog peformance status of 3 or higher * unwillingness to undergo investigations and/or treatment as outlined on the study

Keywords: gastric esophageal adenocarcinoma
marcaine post-operative pain study

Conditions: Effect of Drug

Summary: the study examines the efficacy of marcaine in post-operative pain reduction for patients receiving breast reduction surgery. patients who consent will be randomized to which breast receives a marcaine injection and the other breast will have saline injected. pain will be assessed one time post-operatively using a 1-10 pain scale.


Eligibility criteria:
inclusion criteria: * must be receiving bilateral breast reduction surgery exclusion criteria: * unilateral breast reduction surgery