Kornimate/medical-research-clean huggingface dataset:
efficacy and tolerability of novel a2a agonist in treatment of diabetic neuropathic pain

Conditions: Diabetic Neuropathic Pain

Summary: the purpose of this study is to evaluate the efficacy and tolerability of bvt.115959 in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study.

the planned study is an exploratory study which aims to provide proof of the efficacy of bvt.115959 in the reduction of the symptoms of pain. thus, the primary objective is to evaluate the anticipated analgesic properties of bvt.115959 in patients with diabetic neuropathic pain and to confirm its activity against placebo. the study will evaluate the efficacy and tolerability of oral bvt.115959 7 mg administered three times a day (t.i.d.) versus a matching placebo in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study and who are being maintained on stable analgesia throughout the study. eligible subjects will be randomized in a ratio of 2:1 (bvt.115959: placebo). the study consists of a 1-week screening/baseline period, a 4-week treatment period and a 1 week follow-up period.

Eligibility criteria:
inclusion criteria: * a diagnosis of type 1 or 2 diabetes mellitus and documented painful, symmetrical, sensorimotor polyneuropathy for at least 6 months * either no analgesic medication or on stable analgesic medication for at least 4 weeks exclusion criteria: * female patients who are fertile and of child-bearing potential * clinically significant or unstable hepatic, respiratory, renal, hematologic, cardiovascular or peripheral vascular disease * painful conditions that may confound the evaluation of neuropathic pain

Keywords: diabetic neuropathy, painful adenosine a2a receptor
peripheral tissue perfusion in intensive care

Conditions: Acute Circulatory Failure

Summary: tissue perfusion has been identified as an early prognosis factor in patients admitted to intensive care. however, little is known about the effects of different hemodynamic interventions performed in clinical routine on peripheral tissue perfusion. the aim of this work is to study the kinetics of crt and local skin blood flow following therapeutic intervention (fluid challenge, vasopressor or inotropic drug).

sepsis is today a major cause of morbidity and mortality worldwide. septic shock, the most serious manifestation of the infection, affects 2 to 20% of intensive care patients. despite appropriate antibiotic therapy and improved resuscitation strategies based on early treatment, volume expansion and rational use of vasopressors, the mortality rate of shock states remains too high, between 40 and 50%. over the past two decades, great advances have been made in the understanding the pathophysiology of septic shock. microcirculatory abnormalities have been identified as the main cause of organ hypoperfusion and visceral failure leading to death. in addition, several studies in animals and humans have highlighted a discordance between systemic hemodynamic parameters and alterations of small vessels during shock suggesting that microvascular blood flow and tissue perfusion should be analyzed in patients with acute circulatory failure in association with blood pressure and cardiac output. capillary refill time (crt), is an easy-to-use, easy-to learn tool to evaluate peripheral tissue perfusion. crt is a strong predictive factor of organ failure severity and poor outcome in critically ill patients with sepsis. a recent randomized trial reported promising results regarding the use of crt to guide resuscitation. however, little is known about the impact of treatment on crt. the aim of this work is to study the kinetics of crt and local skin blood flow following therapeutic intervention (fluid challenge, vasopressor or inotropic drug).

Eligibility criteria:
inclusion criteria: * patients in intensive care unit with acute circulatory failure related to sepsis or cardiac failure requiring therapeutic intervention exclusion criteria: * agitation * hemorrhagic shock * severe skin lesions

Keywords: tissue perfusion capillary refill time skin blood flow fluid challenge inotrope
viral dynamics and transmission of influenza, rsv and sars-cov-2 in children

Conditions: SARS CoV 2 Infection; RSV Infection; Influenza

Summary: viral respiratory tract infections are very common in children. they contribute to missed time in school, work disruption for caregivers and can also cause severe illness requiring hospitalization and rarely death. in the 2022-2023, influenza, rsv and sars-cov-2 viruses infected a large number of children which strained the pediatric healthcare system in many jurisdictions. unfortunately, there continues to be limited data on duration of infectiousness and transmission risk of these viruses to inform public health decisions during times when there is significant circulation of these viruses.


Eligibility criteria:
inclusion criteria: viral dynamics (primary outcome): * the child must be less than 18 years of age * have a positive pcr sample for influenza, rsv or sars-cov-2, * have any one of the symptoms listed to meet testing eligibility: fever, cough, shortness of breath, decreased or loss of taste or smell, muscle aches/joint pains (unusual, long lasting, not related to injury), extreme tiredness (unusual fatigue not otherwise explained), sore throat, runny or stuffy/congested nose, headache (new, unusual, long-lasting), nausea/vomiting and/or diarrhea, and * be within 5 days of symptom onset household testing inclusion criteria (secondary outcome): -any individual in the same household (i.e. household contacts, defined as residing at the same address) as the individual testing positive by pcr for influenza, rsv or sars-cov-2 classroom testing inclusion criteria (secondary outcome): -any individual in the same classroom (i.e. classroom contacts) as the individual testing positive by pcr for influenza, rsv or sars-cov-2 (i.e. case identified through the ths program) exclusion criteria: viral dynamics (primary outcome): -participants will be ineligible if they are more than 5 days from symptom onset
the role of intestinal flora in the pathogenesis of fd and the intervention of xiangsha liujunzi

Conditions: Functional Dyspepsia

Summary: functional dyspepsia (fd) is a common digestive system disease in clinic. although it has not reached the level of life-threatening, it seriously affects the quality of life of patients. the pathogenesis of fd mainly involves gastric motility disorder and visceral hypersensitivity. at present, there are gastric motility promoting drugs and gastric acid inhibiting drugs, but they can not achieve satisfactory therapeutic effect. traditional chinese medicine has a good clinical effect on fd, but the specific mechanism is not clear. with the gradual deepening of intestinal flora research, it provides a useful tool for elucidating the mechanism of action of traditional chinese medicine compound. the role of intestinal flora in the pathogenesis of fd, especially in the pathogenesis of symptoms, has not been studied, and the mechanism of spleen-strengthening and motility-promoting effects of xiangsha liujun has not been studied from the perspective of intestinal flora. in this study, 16s rrna high-throughput sequencing technology was used to observe the difference of intestinal flora between fd patients and normal people, and then to observe the effect of xiangsha liujun on intestinal flora of fd patients. the aim of this study was to explore the role of intestinal flora in the pathogenesis of fd and to elucidate the therapeutic mechanism of xiangsha liujunzi by regulating intestinal flora of fd patients, so as to provide support for follow-up clinical and experimental studies.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of functional dyspepsia by rome iv . ② clinical diagnosis of spleen deficiency and qi stagnation by ctm. ③ must be able to swallow potion. exclusion criteria: * gastric ulcer * duodenal ulcer. * gastroesophageal reflux disease . * chronic gastritis with hp (+). * chronic pancreatitis. * diabetes. * chronic renal insufficiency. * hematological disease. * tumor or aids. * pregnant or lactating women.

Keywords: xiangshaliujunzi,functional dyspepsia，intestinal flora
enbrel versus placebo with radiation therapy to combat fatigue and cachexia

Conditions: Lung Cancer; Prostate Cancer; Neoplasm Metastasis; Bone Cancer

Summary: patients who receive radiation therapy often have fatigue or a decrease in feeling well causing a "wasting" away. for patients with advanced disease of lung cancer, prostate cancer, or cancer that has spread to the bone, it is hoped that this drug may decrease this. if patients feel better during treatments they can complete the therapy without any breaks in treatment. for treatment to be most effective, it should be given in the amount needed, on a particular schedule.

subjects will be placed in a group to receive either the drug enbrel, or a placebo. the radiation therapy treatments are as they would be given if the person was not on a research study. the selection of the group a patient is in is done by random, like flipping a coin. the doctor is not able to influence which group anyone is selected for. as is done routinely, radiation therapy is given monday through friday for about 4 to 6 weeks.the injections of enbrel or placebo are given two times a week. the enbrel or placebo is given as an injection directly under the skin with a small needle.

Eligibility criteria:
inclusion criteria: * advanced lung, prostate, or bony metastasis for cancer * performance status (ps) of 3 or less * good lab test results with albumin of at least 2.5 * radiation therapy of at least 4000gy in 4 weeks exclusion criteria: * poor ps * planned radiation therapy for less than 4 weeks or 4000gy * limited disease

Keywords: bone metastasis radiation therapy lung cancer prostate cancer advanced lung cancer receiving radiation therapy advanced prostate cancer receiving radiation therapy any cancer with bone mets receiving radiation therapy
use of focalin for fatigue in sarcoidosis

Conditions: Sarcoidosis

Summary: patients diagnosed with chronic sarcoidosis with fatigue for more than 6 months. sarcoidosis and its treatment can greatly affect your quality of life. many patients suffer from fatigue (feeling tired), lack of focus and concentration, in ability to organize their daily activities, and memory loss. these commonly reported symptoms often get in the way of everyday life.

this is to be a double blind, randomized trial with cross over of 12 patients with chronic sarcoidosis on stable systemic therapy. patients will be screened for fatigue using a modified snap and facit-f scores. patients will be in the study for 20 weeks. objective of study: to determine the effect of dexmethylphenidate hydrochloride, (d-mph)(focalin) on fatigue in sarcoidosis. the is a common complaint in sarcoidosis, related to the chronic inflammatory nature of the disease. it may also related to therapy for the disease.

Eligibility criteria:
inclusion criteria: * diagnosis of sarcoidosis using standard criteria * disease for more than one year * complain of fatigue which has been present for more than six months. * over 18 years of age exclusion criteria: * pregnancy * change in therapy for sarcoidosis in prior three months * history of ventricular arrythmias * patients with a history of anxiety disorder, glaucoma, motor ties or a family history of tourette's syndrome. * patients who are currently receiving or have received monoamine oxidase inhibitors within 14 days prior to study entry.

Keywords: sarcoidosis sarcoid
study evaluating inotuzumab ozogamicin (cmc-544) plus rituximab in diffuse large b-cell non-hodgkin's lymphoma

Conditions: Lymphoma, B-Cell

Summary: the purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (asct) in patients with relapsed/refractory diffuse large b-cell non-hodgkin's lymphoma.


Eligibility criteria:
inclusion criteria: * cd20/cd22-positive diffuse large b-cell nhl that has relapsed after 1 or 2 prior therapies; one prior therapy must include anthracyclines and one must include rituximab in combination with chemotherapy * relapsed/disease progression within 12 months after start of prior therapy and/or secondary international prognostic index (sipi) score greater than 1 * eligible for autologous stem cell transplant (asct) exclusion criteria: * prior allogeneic hematopoietic stem cell transplant * within 6 months prior to test article: autologous transplant, treatment with anti-cd22 antibodies, radio-immunotherapy * veno-occlusive disease or sinusoidal obstruction syndrome, chronic liver disease, systemic vasculitides, current or chronic hepatitis b or c infection

Keywords: diffuse large b-cell lymphoma inotuzumab ozogamicin autologous stem cell transplant
employment and quality of life in patients with malignant melanoma

Conditions: Malignant Melanoma of Skin; Quality of Life; Work Ability

Summary: within the first year after diagnosis, data on employment and quality of life will be collected and evaluated in patients with malignant melanoma


Eligibility criteria:
inclusion criteria: * first diagnosis of malignant melanoma stage 0 to stage iiic within the last 6 weeks * written informed consent exclusion criteria: * diagnosis of malignant melanoma stage iv * inability to follow the protocol
efficacy of chinese ocular exercise on visual acuity and ocular accommodation in myopic teenager

Conditions: Myopia

Summary: to assess whether chinese ocular exercise is effective in altering distant and near visual acuity, ocular accommodation and visual symptoms in myopic teenager, and thus might have the possibility of slowing myopia progression in teenager through a weak but long-term effect.

myopia is a public health problem worldwide, especially in some asian countries like china, singapore, and japan. chinese ocular exercise, originating in 1963 with the theory of traditional chinese medicine, is a kind of massage on acupuncture points around the eye to prevent myopia and alleviate visual fatigue. the exercise has been spread as a community ritual and living habit of primary and high school students for nearly half a century. however, the prevalence of myopia in chinese children increased remarkably in recent years. therefore, the efficacy of chinese ocular exercise on preventing myopia or alleviating visual fatigue is widely questioned. evidence from clinical trials of high level is needed to clarify that whether chinese ocular exercise is effective in slowing and preventing myopia progression, or at least in part in easing the symptoms related to myopia and visual fatigue.

Eligibility criteria:
inclusion criteria: 1. visual acuity: 20/20 or better in each eye; 2. spherical error ranging from +0.5 d to -6.0 d and astigmatism less than 1.5 d in each eye, anisometropia less than 1.0 d between the two eyes contact lens 3. no strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development exclusion criteria: 1. currently using other interventions to control myopia progression (acupuncture, massage, drugs, ear needles and so on) 2. unable to cooperate with the ocular examination and questionnaire survey
post market clinical follow-up study for the pamira icd lead family

Conditions: Heart Failure; Tachyarrhythmia

Summary: confirm clinical safety and performance of the pamira lead to support the regulatory post market strategy in europe and other regions and validating promotional claims by * demonstrating clinical safety * evaluating performance based on sensing and pacing assessment * collecting additional data of interest to assess other aspects such as the handling and usability


Eligibility criteria:
inclusion criteria: * standard indication for icd or crt-d therapy according to clinical guidelines * planned for de novo implantation of a biotronik icd or crt-d in combination with pamira * ability to understand the nature of the study and willingness to provide written informed consent * ability and willingness to perform all follow-up visits at the study site * ability and willingness to use the cardiomessenger and acceptance the biotronik home monitoring® concept exclusion criteria: * mechanical tricuspid valve prosthesis or a severe tricuspid valve disease * known dexamethasone acetate intolerance * cardiac surgical post-implantation procedure planned within 12 months (including interventional procedures like ablation, valve replacement, heart transplant etc.) * less than 18 years old * pregnant or breast feeding * participating in another interventional clinical investigation * life-expectancy less than 12 months
the impact of an evidence-informed spinal cord injury activities of daily living educational manual

Conditions: Spinal Cord Injuries

Summary: this study argues that providing evidence-based occupational therapy patient education is vital in order to optimize rehabilitation outcomes. the planned trial aims to evaluate the sadl-em intervention for people with sci compared with standard treatment.

this is a parallel randomized clinical trial with two study arms, intervention and control. ninety patients treated in three inpatient rehabilitation settings will be randomly allocated to two study groups. both groups will receive standard care. the intervention group will also receive a copy of the sadl-em from their treating occupational therapist during an individual session. assessment on admission (baseline measure) and after six weeks of admission will use the scim-sr as the primary outcome measure. secondary outcomes include the scim-iii, private religiousness practices scale, organizational religiousness short-form, additional domains of adl covered by the educational manual, and adherence to the intervention. the effect will be determined using repeated-measures anova.

Eligibility criteria:
inclusion criteria: * confirmed sci diagnosis by computed tomography or magnetic resonance report. * asia: a, b, and c * age between 18 and 65 years old. * stable medical condition. * time elapsed after sci is not more than 6 months. * minimum time of stay in the inpatient rehabilitation unit is six weeks. * active involvement in the rehabilitation program. * sufficient comprehension (read/write) of the arabic language. exclusion criteria: * unconfirmed diagnosis. * patients who have communication and/or cognitive disorders such as global aphasia and memory deficit. * patients with a disturbed level of awareness such as coma or lethargy. * time elapsed since sci is more than 6 months. * asia: d and e * unstable medical condition. * patients who have other cause(s) of disability in addition to sci such as stroke or amputation. * age less than 18 or more than 65 years old. * time of stay in the inpatient rehabilitation unit is less than six weeks. * inactive involvement in the rehabilitation program. * patients with progressive disease or a psychiatric condition that would interfere with active participation in the rehabilitation programs. * patients with cardiovascular contraindications. * persons who become walking ambulatory during the inpatient period. * persons with complete tetraplegia c4 or above. * persons on a mechanical ventilator.

Keywords: occupational therapy educational intervention activities of daily living spinal cord injury clinical trials
study evaluating the safety of rovalpituzumab tesirine for third-line and later treatment of subjects with relapsed or refractory small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: a single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (dll3) expressing small cell lung cancer by evaluating the frequency of high grade (\>= grade 3) select treatment-emergent adverse events (teaes).


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1. * minimum life expectancy of at least 12 weeks. * laboratory values meeting the criteria specified in the protocol. * histologically or cytologically confirmed small cell lung cancer (sclc) with documented disease progression after at least 2 prior systemic regimens, including at least one platinum-based regimen. * delta-like protein 3 (dll3)-expressing sclc based on central immunohistochemistry (ihc) assessment of banked or otherwise representative tumor tissue. * measurable disease as described per protocol. * in participants with a history of central nervous system (cns) metastases, documentation of stable or improved status based on brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of study drug, off or on a stable dose of corticosteroids. exclusion criteria: * documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with new york heart association class iii - iv within 6 months prior to first dose of study drug. * recent or on-going serious infection. * history of other invasive malignancy that has not been in remission for at least 3 years. * history of exposure to a pyrrolobenzodiazepine (pbd)-based drug or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation. * known hypersensitivity to biopharmaceuticals produced in chinese hamster ovary cells. * documented history of capillary leak syndrome. * grade 2 or higher pleural or pericardial effusion within 4 weeks of investigational drug start, or earlier history of recurrent grade 2 or higher effusions with ongoing requirements for pericardiocentesis or thoracentesis.

Keywords: cancer small cell lung cancer relapsed small cell lung cancer remitting small cell lung cancer delta-like protein 3 (dll3) dll3 expressing small cell lung cancer rovalpituzumab tesirine
polish registry of takotsubo syndrome

Conditions: Takotsubo Syndrome

Summary: polish registry of takotsubo syndrome


Eligibility criteria:
inclusion criteria: all patients with takotsubo syndrome exclusion criteria: -
exercise with music for icu survivors

Conditions: Critical Illness; Intensive Care Unit Syndrome

Summary: this project will test whether the individualized music-enhanced exercise playlist (exercise with music intervention) can prevent further physical and psychological deterioration and motivate icu survivors to more actively participate in their rehabilitation.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * length of icu stay \>5 days (excludes patients with less comorbidity) * within 72 hours of icu discharge (standardizes time to begin intervention) * ability to independently move upper and lower extremities (required to participate in intervention) * ability to speak english or spanish exclusion criteria: * documented mental incompetence * dependent status pre-icu admission (katz, activity daily living scale) * evidence of delirium using the confusion assessment method (cam) * hearing impairment * documented "comfort measures only" in the electronic medical record * prior residence in a long-term care facility * unstable hemodynamics

Keywords: rehabilitation exercise music intervention