Kornimate/medical-research-clean huggingface dataset:
a safety and effectiveness study of aroplatin in patients with advanced solid malignancies

Conditions: Esophageal Neoplasms; Hepatocellular Carcinoma; Colorectal Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms; Neoplasms

Summary: to determine the rate of response and the duration of the response following therapy with aroplatinin patients with advanced solid malignancies.

primary objective: * determine response rate (rr; complete and partial response \[cr, pr\]) and duration after therapy with aroplatin™ in patients with advanced solid malignancies. secondary objective: * determine the safety and tolerability of aroplatin

Eligibility criteria:
inclusion criteria: * advanced solid malignancies; * amenable to therapy with dach platinum agents; * measurable disease (recist criteria); * ecog performance score of 0-2; * adequate hematopoietic, liver and renal function; * adequate cardiac function (maximum of class ii, nyha); * women of childbearing potential must have a negative urine or serum pregnancy test; * signed written informed consent; * subjects must be willing to be followed during the course of treatment/observation and follow-up. exclusion criteria: * no other active malignancies; * no prior therapy with oxaliplatin; * no known brain metastases; * active, uncontrolled infection or other serious medical illnesses; * not using or have used any investigational therapy during four weeks before start of protocol treatment.

Keywords: esophageal neoplasms esophagus neoplasm esophagus cancer esophageal cancer esophageal tumors esophagus tumors neoplasms, esophageal hepatocellular carcinoma carcinoma, hepatocellular hepatoma colorectal neoplasms colorectal cancer colorectal carcinoma colorectal tumor neoplasms, colorectal ovarian neoplasms ovary neoplasms ovary cancer ovary carcinoma ovarian cancer ovarian carcinoma neoplasms, ovarian pancreatic neoplasms pancreatic cancer pancreas neoplasms pancreas cancer neoplasms, pancreatic neoplasms, pancreas and other solid tumors
investigating the safety and efficacy of shr6508 injection in the treatment of secondary hyperparathyroidism in hemodialysis patients : a multicenter, long-term clinical trial

Conditions: Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis

Summary: this is a multicenter, single-arm, long-term safety and tolerability trial. a total of 300 subjects with chronic kidney disease on hemodialysis are planned to be enrolled.


Eligibility criteria:
inclusion criteria: 1. subject is 18 years of age or older 2. subject understands the study procedures and agrees to participate in thestudy by giving written informed consent. 3. subject must be receiving regular hemodialysis for at least 12 weeks 4. bmi ≥18 kg/m2 and ≤35 kg/m2 5. ipth≥ 300pg/ ml exclusion criteria: 1. subject has received a a history of malignant tumor within 5 years prior to screening 2. subject has a history of unstable angina, congestive heart failure (nyha class iii or iv), acute myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening. 3. postdialysis systolic blood pressure\>180 mmhg and/or diastolic blood pressure\>110 mmhg 4. allergy to the investigational drug (shr6508 injection) and any of its components or excipients 5. subject has a history of drug use or excessive alcohol use within 6 months prior to screening 6. female subjects who were pregnant or lactating 7. other reasons for not participating as deemed by the investigator
phase ii study of trk-820 soft capsules - intractable pruritus in patients with chronic liver disease -

Conditions: Pruritus With Chronic Liver Disease

Summary: the efficacy and safety of trk-820 are to be evaluated in the treatment of intractable pruritus in patients with chronic liver disease by administering 2.5, 5 and 10 microg of this drug or placebo for 28 days in four groups with a design of randomized, double-blind, parallel-group comparison. in addition, the plasma concentrations of trk-820 and its primary metabolites are to be determined.


Eligibility criteria:
inclusion criteria: * chronic liver disease is present; and the patient's general condition is judged by the physician to be stable with no prospect of an abrupt change in pathophysiology. * it can be confirmed by either of the following that treatment of pruritus with antihistamines or antiallergics has not been adequately effective in such patients: exclusion criteria: * malignant tumors * depression, integration dysfunction syndrome (schizophrenia), or dementia * hepatic encephalopathy, or hepatic cirrhosis in which ascites or esophageal or gastric aneurysm cannot be controlled * alcoholic liver disease * atopic dermatitis, chronic urticaria, or other skin disease producing generalized pruritus that is judged by the physician to affect the assessment of pruritus associated with chronic liver disease in this study * allergy to opioid drugs * drug dependence or alcohol dependence * chronic renal failure
tele health monitoring service for patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease, COPD

Summary: the aim of this study is to evaluate the effect of monitoring patients with chronic obstructive pulmonary disease (copd) after a hospitalization for copd exacerbation or pneumonia. the patients are randomized to receive either standard treatment and follow up, or standard treatment and follow up, plus tele monitoring of key clinical parameters and symptoms for six months.

telemedicine is a relatively new approach for the management of chronic obstructive pulmonary disease (copd) disease. telemedicine, for monitoring disease exacerbation, is the focus area of our research. the patient monitoring offers the possibility of early initiation of treatment of patients who has evidence of copd exacerbation or pulmonary infection. the self-monitoring of potential exacerbation is started after a hospitalization, and is done by the patient on a daily (not on weekends) basis initially. after one month the monitoring is made at least three times weekly during the rest of the intervention period of six months. with the help of the monitoring equipment, the patient answers a short series of health related questions, and makes simple measurements of oxygen saturation, heart rate, lung function and weight. data is sent to the hospital, and here the staff can assess the data and respond to them the same day, with a phone call to the patient, if the patient's condition has changed. the selected telemonitoring-equipment, consists of a monitoring systems for the assessment of key clinical parameters and symptoms. all patients, in the intervention group as well as in the control group, are trained in the use of a standardized self-treatment plan. it is expected that the monitoring of symptoms and signs will support patient empowerment. the investigation is planned to assess the clinical and economic effects of the intervention.

Eligibility criteria:
inclusion criteria: * chronic obstructive pulmonary disease copd with fev1/fvc (forced expiratory volume in 1 second / forced vital capacity) below 70% at all times during the study. fev1 below 51% during inclusion and during the further study. inclusion takes place during a hospitalization, with exacerbation in pulmonary symptoms. exclusion criteria: * not able to give written or oral consent * terminal disease, such as cancer * unstable heart disease, such as coronary infarction within the last to month * disabling psychiatric disease * asthma * inability to use the equipment * severe language barriers * drug abuse * alcohol abuse
developing and pilot testing an opioid tapering protocol

Conditions: Chronic Pain; Opioid Use; Analgesia

Summary: this study proposes to pilot test an intervention to facilitate opioid pain reliever (opr) tapering in primary care. the intervention will incorporate a clinician embedded within primary care to follow tapering dose schedules to support providers as well to deliver a psychosocial curriculum to support and engage patients. in a pilot randomized controlled trial (rct), the study will examine the preliminary efficacy and feasibility of the manualized, protocol-based tapering intervention ("tappro") compared to usual care. as there is no standard definition or outcome for tapering, the primary efficacy outcome is a decrease in opr dose over six months. separately, the study proposes a clinically meaningful dose reduction (greater than or equal to 30 percent) as a secondary outcome. the central hypotheses' are that a tapering intervention with patient and provider support is feasible in a primary care setting and can result in greater dose reduction when compared to usual care.

in a 12-week randomized controlled trial based in a primary care outpatient clinic, the study will recruit 60 patients on moderate to high dose chronic opioid therapy for whom providers recommend opioid tapering and randomize 1:1 to an opioid tapering protocolized intervention (tappro) or to usual care. over three months, participants in the tappro arm will visit with a clinician on the telephone on a biweekly basis in order to facilitate opioid prescribing and tapering and a pain self-care and coping curriculum. in the control arm, participants will see their primary care providers as per usual and decisions on opioid prescribing and tapering will be made by the primary care providers. participants will be assessed throughout the study with questionnaires, urine drug screens, prescription database review, and medical record review.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. chronic prescription opioid use (\>3 monthly prescriptions from the clinic within prior 6 months) 3. morphine milligram equivalents (mme) ≥50 4. poorly controlled pain (peg pain score ≥ 5/10) 5. providers considering opioid taper but no reductions in opioid dose over the past 6 months. exclusion criteria: 1. active cancer or other serious progressive illness, by medical review and by self-report 2. moderate or severe opioid use disorder, as per dsm-v 3. inability to give informed consent 4. active suicidal ideation.

Keywords: opioid tapering chronic pain
a study investigating the efficacy and safety of sepranolone in women with menstrual migraine

Conditions: Menstrual Migraine

Summary: the objective of this phase 2 proof.of concept study is to evaluate the efficacy and safety of sepranolone (uc1010) in preventing menstrual migraine attacks in adult women with migraine occurring between day -2 and day 5 of the menstrual cycle. patients will be taking sepranolone or placebo (blinded to patient and study doctor) during the two week preceding the menstruation for three menstrual cycles. effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using an electronic diary using validated scales for assessment of menstual migraine symptoms. sepranolone is identical to an endogenous steroid.

the objective of this phase 2 proof-of-concept study is to evaluate the effect and safety of two doses of sepranolone (uc1010) in preventing menstrual migraine attacks in adult women with migraine occurring between day -2 and day 5 of the menstrual cycle in comparison to placebo. study treatment will be self-administrated as subcutaneous injections during the luteal phase of three consecutive menstrual cycles. effect will be assessed by comparison of symptoms recorded daily by the patients using an electronic migraine diary and a validated rating scale for assessment the physical and functional impact of menstrual migraine symptoms (mpfid). preceding the treatment period, the diagnosis of menstrual migraine will be established by verifying menstrual migraine in at least two out of three menstrual cycles of daily symptom ratings by the patients. this period will also constitute the baseline data. the effect of study medication will be assessed as the change in symptoms from baseline to during treatment. the reduction in average number of menstrual migraine days per menstrual cycle during the treatment period cycles vs. the three menstrual cycles of baseline will constitute the primary endpoint. the study will also include a follow-up (no treatment) cycle before patients final visit. the study is conducted in three european countries (sweden, finland and denmark) and will randomize 84 patients.

Eligibility criteria:
inclusion criteria: * have menstrual migraine according to the international classification of headache disorders, 3rd edition (ichd-3) verified in three menstrual cycles * have a regular menstrual cycle of 24-35 days cycle, * use double barrier contraception, intrauterine device (iud), be truly sexually abstinent, or subject or her partner has been surgically sterilized, exclusion criteria: * more than 10 headache days per month on average during screening phase * steroid hormonal treatment during previous three months * ongoing treatment with antiepileptic drugs or benzodiazepines * significant medical or psychiatric condition * be pregnant or plan a pregnancy within the study period
expansion of the weigh smart pediatric group family oriented weight management program through the use of telehealth

Conditions: Pediatric Obesity

Summary: there has been a steep rise in the prevalence of obesity among children and adults in the united states. the weigh smart program, a family based weight management program was developed in 2005 with significant improvement in the severity of obesity among children in the baltimore are participating in the group program with limited impact outside the region due to transportation. trial of the group program (nutrition, exercise) delivered via telehealth through fruit street on the eastern shore and western maryland with use of noninvasive lifestyle tracking options (drink water aquarium app for water consumption and fitbit- steps, sleep monitoring) provides novel options for expansion of family- based lifestyle intervention to underserved areas. investigators plan as a pilot study to assess the sensitivity of noninvasive measures for the detection of sleep apnea (pediatric sleep questionnaire (psq) and fitbit re: sleep data) in comparison to clinically indicated polysomnography among children with clinical suspicion for sleep apnea.

. trial of the group program (nutrition, exercise) delivered via telehealth through fruit street to families of overweight and obese children between 7-17 years of age referred from selected pediatric practices on the eastern shore of maryland and western maryland with use of noninvasive lifestyle tracking options (drink water aquarium app for water consumption and fitbit charge 3- steps, sleep monitoring) provides novel options for expansion of family- based lifestyle intervention to underserved areas. investigators plan as a pilot study to assess the sensitivity of noninvasive measures for the detection of sleep apnea (pediatric sleep questionnaire (psq) and fitbit charge 3 sleep data) in comparison to clinically indicated polysomnography among children with clinical suspicion for sleep apnea.

Eligibility criteria:
inclusion criteria * children who are overweight/obese (7-17 years of age) * children must be referred by selected maryland eastern shore and western maryland pediatric practices to mount washington pediatric hospital weigh smart. families must provide informed consent at the weigh smart visit and have access to either a tablet, laptop or smart phone device to participate. exclusion criteria * children outside of the age range * children not seen by maryland eastern shore or western maryland pediatric providers who are part of the intervention group * children who do not have internet access either by smart phone or tablet to allow telehealth participation * children who are unwilling to participate in group program and followup local visits
human bone graft in epiphysiodesis

Conditions: Leg Length Differences; Primordial Gigantism

Summary: this observational study is to document the application of human bone graft in the surgical treatment (epiphysiodesis) of leg length discrepancy or primordial gigantism and its subsequent healing process.


Eligibility criteria:
inclusion criteria: * planned epiphysiodesis to stop the growing of a bone indicated by leg length discrepancies or primordial gigantism * age 10-18 years * written consent to participate in the study after previous written and oral education (additional consent for the participation of minors in the study after prior written and oral education by at least one parent) exclusion criteria: * insufficient knowledge of the german language * foreseeable compliance issues * neoplastic diseases, malignant bone tumors, rheumatoid arthritis * patients with non-treated pre-existing conditions, which could be the cause of leg length differences * active osteomyelitis * ulcerations in the area of the skin of the surgical area * immunosuppressive drugs that can not be discontinued

Keywords: human bone graft screw epiphysiodesis leg length inequality primordial gigantism
outlook quality of life intervention

Conditions: Cancer; Congestive Heart Failure; Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to determine whether discussions of life story, forgiveness, and future goals improve quality of life for patients with serious illness.

this is a pilot randomized control trial to evaluate the feasibility of the outlook intervention. 36 veterans with advanced cancer, congestive heart failure (chf) or chronic obstructive pulmonary disease (copd) will be randomly assigned to one of three intervention groups and complete a brief battery of pre-test measures. subjects in the first group ("treatment") will meet with a facilitator three times for a period of 45 min-1 hour. in the first session, subjects will be asked to discuss issues related to life review. in the second session, participants will be asked to speak in more depth about issues such as regret, forgiveness and things left undone, in the final session, subjects will focus on heritage and legacy. the subjects in the second group ("attention control") will meet with a facilitator three times for a period of 45 min- 1 hour and listen to a non-guided relaxation compact disk (cd). the third group of participants ("true control") will be exposed to no intervention or attention control. one week and two weeks later, participants in all groups will receive post-test measures administered by a blinded interviewer.

Eligibility criteria:
inclusion criteria: patients with advanced cancer, chf or copd. exclusion criteria: cognitive impairment, inability to speak, non-english speaking

Keywords: quality of life
combined effect of tdcs and motor or cognitive activity in patients with alzheimer's disease

Conditions: Alzheimer Disease (AD)

Summary: the goal of this clinical trial is to evaluate the effectiveness of combining tdcs with motor or cognitive activities on cognitive functions in patients with ad. second aim is to investigate if tdcs has a different impact if it is combined with motor or cognitive activities.


Eligibility criteria:
inclusion criteria: * mini mental state examination (mmse) major or equal to 15; * good level of compliance; * acetylcholinesterase inhibitor treatment (e.g., donepezil, rivastigmine); * no modifications of medication during the last four months. exclusion criteria: * behavioral disorders (e.g., aggressiveness); * alcohol abuse; * orthopedic pathology with risk of falls to the ground; * respiratory pathology; * severe auditory or visual deficits uncorrected; * history of epileptic fits; * anti-epileptic medication; * metallic body implants; pacemaker; * psychiatric, neurologic, systemic or metabolic disorders.

Keywords: transcranial direct current stimulation motor activity cognitive stimulation alzheimer's disease
a study of incmga00012 in squamous carcinoma of the anal canal following platinum-based chemotherapy (pod1um-202)

Conditions: Squamous Cell Carcinoma of Anal Canal

Summary: the purpose of this study is to assess the efficacy of incmga00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (scac) who have progressed after platinum-based chemotherapy.


Eligibility criteria:
inclusion criteria: * ability to comprehend and willingness to sign a written informed consent form. * confirmed diagnosis of locally advanced or metastatic scac. * must have received (or been intolerant to or ineligible for) at least 1 prior line of platinum-based chemotherapy and received no more than 2 prior systemic treatments. * must have measurable disease by recist v1.1. * eastern cooperative oncology group performance status of 0 to 1. * if hiv-positive, then all of the following criteria must also be met: cd4+ count ≥ 300/μl, undetectable viral load, and receiving highly active antiretroviral therapy. exclusion criteria: * receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug; 6 weeks for mitomycin c. * radiotherapy within 14 days of first dose of study treatment with the following caveats: 28 days for pelvic radiotherapy, 6 months for thoracic region radiotherapy that is \> 30 gy. * prior treatment with programmed cell death protein 1 (pd-1) or programmed cell death ligand protein 1 (pd-l1)-directed therapy. * active autoimmune disease requiring systemic immunosuppression. * known central nervous system (cns) metastases and/or carcinomatous meningitis. * known active hepatitis infection. * active infections requiring systemic therapy. * is pregnant or breastfeeding or is expecting to conceive or father children within the projected duration of the study, from screening through 6 months after the last dose of study drug.

Keywords: squamous carcinoma of the anal canal anti-pd-1 antibody igg4 monoclonal antibody incmga00012
reduction of abdominal obesity and insulin resistance in women

Conditions: Obesity

Summary: the purpose of the study was to assess the effects of equivalent diet- or exercise-induced weight loss and related insulin resistance in abdominally obese women.


Eligibility criteria:
inclusion criteria: * premenopausal women exclusion criteria: * smokers and diabetics

Keywords: obesity, exercise, diet, insulin resistance
study of the consumer use of a new home test to measure sperm concentration

Conditions: Fertility, Male; Sub-Fertility, Male

Summary: the objective of the study is to evaluate the agreement in measurement of sperm concentration in human semen between lay users with trak and a recognized reference method. the study will also include the measurement of matched samples by trak when tested by healthcare professionals trained in use of the trak device.


Eligibility criteria:
inclusion criteria: subjects (donor/tester) * generally healthy (apart from fertility or reproductive care), ambulatory, and have absence of chronic conditions or treatments, except those related to fertility and reproductive care * 20 - 50 years of age inclusive * male sex (subjects providing and/or testing human semen specimens) * for males providing human semen specimens, either healthy subjects or men receiving health care for any one or more of the following reasons: * partner in a couple having difficulty conceiving * diagnosed with male factor infertility * post-vasectomy patients * post-vasectomy reversal patients testers only * be able to provide signed informed consent * 20 - 50 years of age inclusive exclusion criteria: * any medical or personal issue that would impair the ability of the subject to adhere to the protocol (e.g. substance abuse, neurological disorders) * patients currently taking investigational drugs or who are active participants in a treatment trial for any condition * unable to speak, understand, or write english * mental illness that would interfere with understanding during the discussion of informed consent or that would compromise ability to follow the study protocol including, but not limited to, review of the trak™ instructional booklet, semen specimen collection, and semen specimen testing.

Keywords: male fertility male infertility fertility sperm sperm concentration