Kornimate/medical-research-clean huggingface dataset:
effect of single-dose pf-05175157 on metabolic and cardiopulmonary parameters

Conditions: Healthy

Summary: this study is designed to assess the effect of one single dose of pf-05175157 on metabolic and cardiopulmonary parameters before, during and after treadmill exercise in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects of non child bearing potential only, between the ages of 18 and 40 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests). * body mass index (bmi) of 18 to 28 kg/m2; and a total body weight \>50 kg (110 lbs). * subjects with maximum effort studies (peak rer \>1.05) and normal exercise capacity as defined by peak vo2 ≥80% and ≤120% of predicted and no evidence of inducible ischemia or significant arrhythmia at the time of peak aerobic capacity testing 3 (±1) days prior to initiation of the study. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * history of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of screening or positive cotinine test at screening or day -3 (±1). * dry eye symptoms

Keywords: cardiopulmonary exercise testing metabolic parameters diabetes mellitus type 2
n-acetyl cysteine for the prevention of oral mucositis after autologous hematopoietic cell transplantation.

Conditions: Mucositis; Transplant-Related Disorder

Summary: oral mucositis (om) is a major source of morbidity in patients undergoing hematopoietic cell transplantation (hct). n-acetyl cysteine (nac) is an antioxidant, widely used as mucolytic agent or antidote of acetaminophen overdose hepatotoxicity. we intend to explore the safety and efficacy of nac in the prevention of om after high-dose chemotherapy and autologous hct in a phase iii, randomized, open label and multi-center study.


Eligibility criteria:
inclusion criteria: * patients with multiple myeloma and lymphoma in partial response and complete remission. * undergoing high-dose chemotherapy with autologous transplantation. exclusion criteria: • known sensitivity to nac
wearable sensors to detect atypical muscle activation in young infants

Conditions: Neuromuscular Disorders; Motor Development; Muscle Tone

Summary: the purpose of this study is to see if wearable sensor technology can be used to evaluate muscle activity and/or identify atypical muscle tone in infants up to 48 weeks postmenstrual age (8 weeks corrected age). these sensors are placed on the surface of the skin and record data about a child's body movements and muscle activity.


Eligibility criteria:
inclusion criteria: * for infants with low tone: * hospitalized in the nicu * and \>38 weeks post-menstrual age * and abnormal normal brain imaging or apgar score \<7 at five minutes with umbilical cord ph (if obtained) \<7.15 * and 2 or more warning signs for muscle tone or posture using the hnne short form * and legal guardian able and willing to give written consent and comply with study procedures * for infants with typical tone: * born at 38-41 weeks of gestation * and hospitalized after birth in the nicu or well newborn nursery * and infants with appropriate for gestational age birth weight * and hnne exam (short proforma) normal with no warning signs for any parameter * and legal guardian able and willing to give written consent and comply with study procedures. exclusion criteria: * infants of both low tone and typical tone cohorts: * missing or incomplete limbs (such as from amputation or congenital limb defects). * open wounds or skin breakdown on the limbs or torso. * presence of known genetic syndrome or congenital anomalies requiring surgery or affecting function * use of sedative medications (may include phenobarbital if level stable and therapeutic) * legal guardian unable to give written consent and comply with study procedures. * does not receive medical clearance from a physician to participate in the study if the individual is receiving inpatient care.

Keywords: early detection wearable sensors
study of organ perfusion with custodiol-n solution compared with custodiol solution in heart transplantation

Conditions: Heart Failure

Summary: the objective of this investigation is to demonstrate non-inferiority in outcome of custodiol-n against custodiol in heart transplantation.


Eligibility criteria:
inclusion criteria: donor criteria: * deceased donors should fulfil the criteria for organ donation (scd) patient criteria * recipients awaiting their first transplant * recipients ≥ 18 and \>/= 65 years * recipient's signed informed consent * waiting list exclusion criteria: donor criteria: * not applicable patient criteria: * recipients participating in another interventional study * pregnant or lactating patients * history/demonstration of hiv antibodies or aids * multiorgan transplantation * transmedics pump * the explantation team is affiliated another clinic than transplantation team
dilute bleach compresses for radiation dermatitis

Conditions: Radiation Dermatitis

Summary: this study is looking at the safety of applying dilute bleach compresses to patients receiving radiation therapy and the impact of these dilute bleach compresses on the frequency and severity of skin changes that occur during radiation therapy. the names of the study interventions involved in this study are: * di-dak-sol: dilute bleach compresses * white petrolatum ointment

this is a planned open-label prospective clinical trial to determine the safety of applying dilute bleach compresses to pediatric patients being treated for rhabdomyosarcoma and other soft tissue and bone sarcomas with radiation therapy (rt). this study is interested in finding out whether dilute bleach compresses are safe to apply and evaluating their impact on the frequency and severity of skin changes that occur in children who are receiving radiation therapy for cancer treatment. this information may help treat other patients receiving radiation therapy for cancer treatment in the future. the research study procedures include screening for eligibility and study treatment including weekly evaluations and follow up visits participants will receive study treatment throughout their radiation therapy and for one week after. they will be followed for one month after the completion of radiation. it is expected that about 12 people will take part in this research study. .

Eligibility criteria:
inclusion criteria: * diagnosed with a rhabdomyosarcoma or other sarcoma requiring rt * 12 to 25 years of age * scheduled for a rt planning session (ct simulation) * have a scheduled rt start date within 1 to 2 weeks from the ct simulation * will be receiving doses of radiotherapy greater than at least 36 gy * subjects may participate in other studies, including therapeutic trials. * ability to comply with at-home dilute di-dak-sol compresses for final week of dilute di-dak-sol compresses following radiation treatment. * ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document. exclusion criteria: * patients who are pregnant, which may result in discontinuation of rt * presence of inflammatory skin lesions in the radiation field that could interfere with assessment

Keywords: radiation dermatitis
impact of belt position on the results of peep titration by eit during ards

Conditions: ARDS

Summary: ards is a frequent reason for hospitalization in intensive care. in order to improve its management, doctors seek to limit the mechanical ventilation-induced injuries (vili) that can occur. peep is a parameter that plays a role in the appearance of vili, and its adjustment can be optimized by eit. the eit is a non-invasive, non-irradiating, real-time monitoring device, today widely used for the optimization of ventilation in patients intubated for ards. the positioning of the eit belt at different chest heights could influence the result of the peep titration.

the aim of this study is to test the hypothesis that the position (2nd intercostal space or 5th intercostal space) of the eit (electrical impedance tomography) belt significantly influences the result of peep (positive expiratory pressure) titration.

Eligibility criteria:
inclusion criteria: * occurrence of moderate to severe ards (pao2/fio2 ratio ≤ 200 mmhg) within 72 hours following intubation * criteria for moderate to severe ards for less than 72 hours * passive ventilation in controlled assisted ventilation (no spontaneous ventilation) * consent of next of kin exclusion criteria: * age \< 18 years * ecmo * pneumothorax * pacemaker or implantable defibrillator * chest trauma in the last 3 months * skin peeling (burned, lyell) * intracranial hypertension * uncontrolled shock (noradrenaline \>5 mg/h) * pregnant woman * adult patient protected within the meaning of the law * lack of social security

Keywords: ards mechanical ventilation eit
sacroiliac orthopedic blocking and cervical spine function

Conditions: Musculoskeletal Diseases

Summary: this study seeks to determine if the correction of a sacroiliac lesion can produce a functional change in cervical spine. reduction of a sacroiliac joint lesion may alter cervical spine function.


Eligibility criteria:
inclusion criteria: * young adults currently enrolled at logan college exclusion criteria: * recent cervical spine injuries or surgeries * surgical hardware in the cervical spine or pelvis * any cervical condition that would make rom \& strength testing painful.

Keywords: this study seeks to determine if the correction of a sacroiliac lesion can produce a functional change in cervical spine.
mental practice impact on gait and cortical organization in spinal cord injury (sci)

Conditions: Incomplete Spinal Cord Injury

Summary: spinal cord injury (sci) is a disabling condition that impairs fundamental abilities, such as ambulation, respiration, and toileting. compromised ambulation is a common, devastating impairment following sci. yet, despite the fundamental desire to walk, no conventional rehabilitation regimen reliably improves ambulation after sci, and many sci patients do not have reliable transportation access, decreasing community integration and access to needed services, including rehabilitation. little is also known about the subtle neural events that may predict motor recovery in incomplete sci patients. this study will test a novel, safe, easy to implement technique that has shown promise in improving gait in incomplete sci patients. the investigators expect that this study will confirm the efficacy of this technique, by showing that it increases the speed and efficiency of walking. this outcome is expected to produce a therapy that improves outcomes and health, and reduces care costs, for community dwelling patients with incomplete sci.


Eligibility criteria:
inclusion criteria: * age \> 18 years old; * incomplete sci (asia grade c or d), experienced \> 1 year prior to enrollment; * motor grade of \> 1 \< 3 in the quads, hamstrings, and hip flexors, and ability to ambulate with at least a maximal assist; * range of motion in the lower limbs within functional limits; * motor function in at least half of asia key lower extremity muscles with strength \ 3/5; * able to ambulate at least 10 meters with 1 person assistance and/or assistive device; * medically stable (ie, no bladder infection; decubiti); (8) stable dosage of antispasticity medications for duration of study exclusion criteria: * excessive spasticity in the lower limbs as measured by a score of \> 3 on the modified ashworth spasticity scale; * excessive pain in the lower limbs as measured by a score of \> 5 on a visual analog scale or \> 8/10 with a clarified scaled picture graph; * moderate to severe osteoporosis, as indicated by the patient's physician; * heterotropic ossification, as indicated by the patient's physician; * psychological conditions that would contraindicate participation in the program and no abnormalities of attention, with minimum cognitive capacity present sufficient to participate in mp; * fracture or fracture history in the lower limbs (individuals with a remote history of fractures may be included at discretion of the study physical therapists at each site); * enrolled in any form of rehabilitation; * for subjects to be administered fmri, implant containing electrical circuitry, generating electrical signals, or having moving metal parts, metal pins or plates above the waist, orthodontic braces, or other positives on a standard checklist of mri exclusion criteria used by the radiology department; * pregnant; * dsm-iv major depressive episode symptom criteria of \> 5/9 as exclusion threshold instead of cesd;
auriculotherapy - pain management of aspiration abortion

Conditions: Abortion in First Trimester

Summary: primary objective: to assess whether usual care plus auricular acupressure with beads reduces subject-reported maximum pain during first trimester vacuum aspiration compared to usual care plus placebo. secondary objective: to assess whether usual care plus auricular acupuncture with pyonex™ needles reduces subject-reported maximum pain during first trimester vacuum aspiration as compared to usual care plus placebo. this assessment will replicate the previous trial and strengthen the evidence that auricular acupuncture is beneficial for aspiration abortion pain exploratory objective: to assess whether usual care plus either auricular acupressure with beads or auricular acupuncture with pyonex™ needles reduces subject-reported anxiety scores during first trimester vacuum aspiration as compared to women receiving usual care plus placebo.

most first trimester aspiration abortions are performed in the outpatient setting with a paracervical block and nonsteroidal anti-inflammatory drugs (nsaids) as the only analgesics. yet first trimester aspiration pain control is often inadequate with 26-32% of women reporting that they experienced severe pain. moderate sedation and general anesthesia are not readily available, and investigations on opioids and anxiolytics have consistently found them ineffective for first trimester aspiration abortion pain. in 2018, the national academies of sciences, engineering, and medicine (nasem) recommended research to improve pain relief. limited data indicate that acupuncture is valuable in dysmenorrhea and for labor pain, conditions in which pain may be similar to that experienced during aspiration abortion. this randomized trial will recruit women seeking first trimester aspiration abortion. this study will evaluate two types of auriculotherapy applied to selected acupoints on the external ear. the study treatments are acupressure using gold beads and acupuncture using pyonex needles; both are applied to the ear using adhesive disks. a control group will receive the adhesive disks alone. all participants will receive usual care for their aspiration abortion procedure, including a paracervical block and ibuprofen for pain management. the investigators will query the participants regarding pain and anxiety immediately after their procedure, in person, on the day of their procedure.

Eligibility criteria:
bullets inclusion criteria: * pregnant up to 13 weeks gestation * seeking aspiration abortion for any first trimester induced abortion, abnormal pregnancy, early pregnancy loss, retained products of conception, or molar pregnancy * english- or spanish-speaking * willingness to be randomized into one of the three arms. exclusion criteria: * allergy to adhesives or gold * allergy or intolerance to ibuprofen or 1% lidocaine (paracervical block) * congenital anomaly or infection of the ear.

Keywords: auriculotherapy abortion pain management
artificial intelligence identified dyskalemia using electrocardiogram (aide)

Conditions: Hyperkalemia; Hypokalemia

Summary: this is a randomized controlled trial (rct) to test a novel artificial intelligence (ai)-enabled electrocardiogram (ecg)-based screening tool for improving the diagnosis and management of potassium abnormalities.


Eligibility criteria:
inclusion criteria: * patients in emergency department. * patients recieved at least 1 ecg examination. exclusion criteria: * patients recieved dyskalemia-related treatment before ecg examination. * the patients recieved ecg at the period of inactive ai-ecg system.
dopaminergic neurotransmission in schizophrenia, patients at risk and healthy subjects

Conditions: Schizophrenia

Summary: this study is an investigation of the dopaminergic neurotransmission in patients with schizophrenia, patients at risk for the development of schizophrenia, and healthy controls using an iodobenzamide-single photon emission computed tomography (ibzm-spect) imaging technique under amphetamine challenge.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia (currently unmedicated) * subjects at risk for the development of schizophrenia (prodromal symptoms) * healthy subjects * written informed consent exclusion criteria: * neurological or severe somatic disorders * women during pregnancy or lactation * occupational exposition to radiation \> 15msv * medication known to interfere with ibzm * contraindications for the use of amphetamine challenge

Keywords: ibzm-spect amphetamine challenge schizophrenia dopaminergic neurotransmission persons at risk for the development of schizophrenia healthy subjects
study for the treatment of the bone marrow edema:core decompression vs bone marrow concentrate (bmc) vs bone substitute

Conditions: Bone Marrow Edema

Summary: randomized, controlled, three-arm, double-blind study : control group, treated with core decompression technique vs subchondral plasty by injecting i-factortm vs injections of autologous bmc.

the clinical trial is a randomized, controlled, three-arm, double-blind study, involving up to 120 patients. eligible subjects will be randomly allocated to one of the three treatment groups: control group, treated with core decompression technique, study group 1, treated with subchondral plasty by injecting i-factortm, and study group 2, treated by injections of autologous bmc.

Eligibility criteria:
inclusion criteria: 1. male or female patients between 18 and 75 years; 2. symptomatic subchondral bone marrow lesions of femoral condyles (grade ≥ 1 according to the worms mri score); 3. failure after at least two months of a conservative treatment; 4. single bme areas involving a single compartment of the knee; 5. availability of the patients to participate actively in the rehabilitation protocol and follow-up clinic and radiology; 6. signature of informed consent. exclusion criteria: 1. patients incapable of discernment; 2. history of allergy to calcium phosphates; 3. patients with malignancies; 4. patients with rheumatic diseases; 5. patients with diabetes; 6. patients suffering of metabolic disorders of the thyroid; 7. patients with history of abuse of alcohol, drugs or medication; 8. patients with advanced osteoarthritis (kellgren-lawrence grade\> 3); 9. body mass index\> 35; 10. bme that involve more than one compartment; 11. patients with trauma in the 6 months prior to the intervention. -

Keywords: bone marrow edema mesenchymal stem cells
million veteran program return of actionable results

Conditions: Cardiovascular Disease

Summary: the purpose of the million veteran program- return of actionable results (mvp-roar) study is to develop a process to return medically actionable genetic results to living mvp participants nationwide and to determine the impact of doing so on medical management and outcomes and veteran quality of life.

the million veteran program - return of actionable results (mvp-roar) study is a randomized controlled trial of immediate vs. delayed (after 6 months) return of medically actionable, clinically confirmed genetic testing results. mvp participants with a medically actionable variant in their mvp chip genotype data will be contacted and offered the opportunity to receive clinical confirmation of this result through a research protocol. first, a non-randomized pilot trial will be conducted among 10 eligible mvp participants, followed by a randomized controlled trial of immediate vs. delayed clinical confirmation and reporting, delivered to participants nationwide via telegenetic counseling. three hypotheses will be tested: hypothesis 1 (ldl-c change): ldl-c reduction after 6 months will be greater in the immediate results arm compared to the delayed results arm (primary outcome) hypothesis 2 (ldl-c target): the proportion of participants meeting clinically significant ldl-c targets (\<100mg/dl for primary prevention and \<70 mg/dl for secondary prevention) at 6 months will be greater in the immediate results arm than in the delayed results arm (secondary outcome) hypothesis 3 (pharmacotherapy): the proportion of participants with an intensification of lipid-lowering pharmacotherapy will be greater in the immediate results arm than in the delayed results arm (secondary outcome)

Eligibility criteria:
inclusion criteria: * living enrollee in mvp * is identified to have a pathogenic or likely pathogenic variant in the gene(s) of interest in mvp genotype data exclusion criteria: * previously underwent genetic testing for the condition of interest * is incarcerated * is pregnant
ultrasound assessment of changes in the diameter of the common carotid artery after increasing the preload of the heart

Conditions: Critical Illness; Fluid Responsiveness

Summary: passive leg raise (plr) and fluid challenge are useful tools in assessing the fluid responsiveness. however, they require continuous monitoring of cardiac output, which is usually an invasive technique and in some cases not always available. vascular ultrasound can be an alternative to cardiac output monitoring in a fluid status evaluation. the common carotid artery (cca) is an easily accessible vessel. it has recently been noted that the diameter of this artery changes after an intravenous fluid bolus. it is possible that the change in the diameter of the common carotid artery during passive leg raise and fluid challenge can be a predictor of fluid responsiveness.


Eligibility criteria:
inclusion criteria: * mechanically ventilated patients with circulatory failure, who are monitored with picco and need fluid responsiveness assessment exclusion criteria: * contraindication for the volume administration (hydrostatic pulmonary edema or other evidence of fluid overload) * contraindication for plr test (e.g. after trauma) * lack of possibility to examine the carotid arteries * bilateral carotid surgery in the past * bilateral anatomical defects of the carotid arteries * unstable cardiac rhythm (e.g. atrial fibrillation)

Keywords: passive leg raise fluid challenge common carotid artery