Kornimate/medical-research-clean huggingface dataset:
dose range study of cd5789 in acne vulgaris

Conditions: Acne Vulgaris

Summary: to assess the efficacy and safety of different concentrations of cd5789 cream in participants with acne vulgaris for the purpose of dose identification.


Eligibility criteria:
inclusion criteria: * male or female participant, 12 to 35 years old with the following characteristics: * facial acne severity grade of the following: * stratum 1: iga score of 3 or 4 * stratum 2: iga score of 4 * stratum 3: iga score of 3 or 4 * a minimum of 30 non-inflammatory lesions and fulfills the criteria of one of the following strata: * stratum 1: a minimum of 20 but not more than 40 inflammatory lesions, and a maximum of one nodule on the face. * stratum 2: more than 40 inflammatory lesions, and up to four nodules on the face. * stratum 3: participants of japanese origin with at least 20 inflammatory lesions and up to four nodules on the face. * note: participants of japanese origin will not be included in stratum 1 or stratum 2. japanese origin is defined as all four grandparents were born in japan. exclusion criteria: * the presence of severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.) * any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the participant at significant risk (according to the investigator's judgment) if the participant participates in the clinical trial. * known or suspected allergies or sensitivities to any components of any of the study drugs. * current participation in any other clinical trial of a drug or device or past participation within the 30 days prior to the baseline visit.
cyclosporine a pretreatment and kidney graft function

Conditions: Brain Death; Kidney Transplantation

Summary: organ donors included in the study are randomized to a control group or an intervention group receiving 2.5 mg/kg of cyclosporine a before organ procurement. harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. according to the pretreatment of the transplant, delayed graft function during the first week was evaluated as well as kidney function at different timepoints and mortality during the first year after transplantation.

organ donors included in the study are randomized to a control group receiving a placebo or an intervention group receiving 2.5 mg/kg of cyclosporine a before organ procurement. in the operating theater organs are harvested. thereafter, harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. the management of transplanted patients is performed as usual. according to the pretreatment of the transplant, delayed graft function during the first week (need of at least one dialysis session) was evaluated as well as kidney function at different timepoints (slow graft function, estimated creatinine clearance on day 3 and 7, acute and chronic graft rejection), length of hospital stay and mortality during the first year after transplantation.

Eligibility criteria:
inclusion criteria: for organ donors: * male and females aged 18 to 80 years * brain death inclusion criteria for organ recipients: * male and females aged 18 to 80 years * indication of kidney transplantation * informed consent exclusion criteria: for organ donors: * contra-indication for multiorgan procurement (infections, cancer, etc) * preexistent chronic renal failure. * refusal for organ procurement by the donor (confirmed by the french national register or reported by the next-of-kin). exclusion criteria for organ recipients: * need for a double kidney transplantation. * need for a multiorgan transplantation

Keywords: preconditioning tissue and organ procurement cyclosporine a kidney transplantation delayed graft function
high-frequency trns for sleep disturbances in neurocognitive disorders due to vascular disease

Conditions: Sleep Disorders, Circadian Rhythm; Cognitive Impairment; Vascular Dementia

Summary: the investigators aim to 1) investigate and compare the safety, efficacy and sustainability of hf-trns, tacs and sham transcranial current stimulation (tcs) over left inferior parietal lobe (ipl) in mild neurocognitive disorder due to vascular disease (ncd-vascular) patients with sleep disturbances; 2) examine the relationship between the changes in sleep quality, cognitive function and brain morphometry. methods: chinese right-handed mild ncd-ad patients with sleep disturbances (aged from 60 to 90 years) will be randomly assigned to a 2-week intervention of either hf-trns, tacs, or sham tcs, with 10 participants per arm. before intervention, structural magnetic resonance imaging (mri) data is used to construct individual realistic head model. comprehensive assessments, including sleep quality, cognitive performance and blood pressure will be conducted at baseline, 2th week, 6th week and 12th week. program adherence and adverse effects will be monitored throughout intervention.

this study aims to investigate the feasibility, safety and efficacy of hf-trns and tacs over left ipl for sleep disturbances and cognitive dysfunction in mild ncd-vascular patients. it wills also test the program adherence, tolerability and adverse effects of this innovative neurotechonology. information will be helpful for in-depth understanding the relationship of "sleep disturbances-cognition" and guiding the further studies of sleep medicine and neurodegenerative diseases.

Eligibility criteria:
inclusion criteria: * chinese, right-handed, aged from 60 to 80 years. * with at least one cerebrovascular risk factor, e.g., a history of hypertension defined as systolic blood pressure (bp) 140 mm hg or higher, diastolic bp of 90 mm hg or higher; or receiving antihypertensive medication. * score of montreal cognitive assessment hong kong version (hk moca) range from 22 to 26 (lu et al., 2019). * with preserved functional abilities reflected by a functional assessment questionnaire score of 7 or lower (hajjar et al., 2020). * with a medial temporal lobe atrophy (mta) score \< 2 * no interference with independence in everyday activities. exclusion criteria: * previous diagnosis of dementia or stroke; * past history of bipolar disorders or psychosis; * physically frail affecting attendance to training sessions; * already attending regular training, such as cognitive behavioral therapy; * taking a psychotropic or other medication known to affect cognition (e.g. anti-dementia medication); * significant communicative impairments.

Keywords: aging transcranial current stimulation sleep disturbance randomized clinical trial
characterization of peripheral muscle function in patients with non-small-cell lung cancer

Conditions: Non-Small-cell Lung Cancer

Summary: rationale: with 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. this syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. however, despite the importance of cachexia in lung cancer, its mechanisms ans its relation with muscle function and effort tolerance are still unknown. aim: to explore muscle function, signaling pathways and its relationship to impaired functional capacity of patients with non-small-cell lung cancer(nsclc); depending of whether they have cachexic state at diagnosis. methods: this study will be conducted at the institut universitaire de cardiologie et de pneumologie de québec. 56 patients newly diagnosed of nsclc will be recruited and separated whether or not they have a cachexic state. the evaluation will need two visits separated by 5 days. during the evaluation the following tests will be done: * anthropometric measures * level of daily physical activity * pulmonary function test * maximal incremental cardiopulmonary exercise test on ergocycle * endurance test on ergocycle * muscle function tests * magnetic stimulation * quadriceps biopsy


Eligibility criteria:
inclusion criteria: * men and women with a primary lung cancer diagnosis exclusion criteria: * already have undertaken surgery, chemotherapy or radiotherapy treatment * having an other cancer in the last five years * taking anticoagulation therapy

Keywords: biopsy maximal incremental cardiopulmonary test muscle strength test magnetic stimulation
the management of transient loss of consciousness and suspected syncope in european emergency departments

Conditions: Syncope

Summary: prospective multi centre cohort study examining the clinical presentation, diagnostic tests, and management of adult emergency department (ed) patients presenting with transient loss of consciousness (tloc) either undifferentiated or thought to be of syncopal origin.

syncope is a common ed problem. the three underlying causes are reflex (simple faint), orthostatic hypotension (blood pressure fall on standing) and cardiac disease (structural heart disease or cardiac dysrhythmia). diagnosis is difficult and is not apparent in \~50% of patients after assessment. for the first time, european society of cardiology (esc) guidelines incorporating ed management of patients presenting with tloc, either undifferentiated or thought to be of syncopal origin, have been produced. however, very little is currently known about the use of diagnostic algorithms and management of this patient group in eds across europe. as a result, the application of guidelines and the management of tloc by european society of emergency medicine (eusem) members in different countries and hospitals, cannot yet be recommended for use in settings other than those where they have been successfully validated. this study aims to describe the prevalence, clinical presentation, current assessment, management strategies and esc risk categories of patients presenting with tloc (undifferentiated or thought to be of syncopal origin) to the ed, and will provide data to help identify the gaps in our knowledge and practice, and areas where further research and development work is required to fully implement european society of cardiology (esc) guidelines within european eds.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years old) assessed in the ed with tloc thought to be of syncopal origin. exclusion criteria: * inability to consent * patient in custody or prison * aged \<18 years * tloc thought to be due to neurological seizure (e.g., epilepsy/alcohol or drug withdrawal) or trauma

Keywords: syncope transient loss of consciousness emergency department
efficacy of preoperative intravenous iron in anaemic colorectal cancer surgical patients

Conditions: Anemia, Iron-Deficiency; Colorectal Cancer

Summary: iron deficiency anaemia is a common condition among colorectal surgical patient. untreated anaemia would lead to increase in blood transfusion, surgical complications and mortality. treatment with oral iron sulphate is poorly tolerated due to side effects. intravenous iron supplement provides an alternative way to rapidly replace iron deficit during the preoperative period among surgical patients. evidence is growing for its effect in rising hemoglobin level and reducing blood transfusion, at the same time supporting its safety profile. the investigators plan for a single-centered, randomized controlled trial to examine the effect of intravenous iron compared to standard care in terms of hemoglobin level/serum ferritin increment, need for blood transfusion, duration of hospital stay, quality of recovery and surgical complication rate, as well as safety profile among colorectal cancer surgical patients in hong kong. the investigator propose the following pilot rct for exploring the effect size and study process in conducting the above-mentioned large-scale rct.


Eligibility criteria:
inclusion criteria: * age \>18 years old with written informed consent * anaemia defined as: hemoglobin concentration \< 13g/dl (same cut-off for both male and female patients according to the international consensus statement on the perioperative management of anaemia and iron deﬁciency)2 * laboratory test confirmed iron deficiency: serum ferritin \<30mcg/l alone or serum ferritin 30-100mcg/l with tsat \< 20% exclusion criteria: * pregnancy or lactation * other known causes of anaemia apart from iron deficiency: untreated b12/folate deficiency, hemolytic disease, hemoglobinopathy/thalassemia, chronic renal failure on dialysis * presence of iron overload (serum ferritin \> 300g/dl or tsat \> 50%); known hemochromatosis * previous or ongoing iron replacement/use of erythropoietin within 12 weeks before recruitment * known hypersensitivity towards iron isomaltoside * significant liver function derangement (ast/alp exceeding three times upper limit of normal range) * participation in another ongoing interventional clinical trial(s) * patients with less than 3 weeks waiting time to surgery

Keywords: patient blood management
trial of pf-00299804 in patients with advanced refractory lung cancer

Conditions: Carcinoma, Non Small Cell Lung

Summary: to assess the safety and efficacy of pf-00299804 in patients with advanced lung cancer.


Eligibility criteria:
inclusion criteria: * advanced nsclc * prior treatment with and failure of at least one regimen of chemotherapy and erlotinib or gefitinib * prior treatment with no more than two chemotherapy regimens, including adjuvant treatment * measurable disease exclusion criteria: * chemotherapy, radiotherapy, biological or investigational agents within 4 weeks of baseline disease assessment * patients who lack of tolerance of erlotinib therapy * patients with known brain metastases * patients with demonstrated history of or presence of interstitial lung disease.
the effect of play on social and motor skills of children with asd

Conditions: Autism Spectrum Disorder

Summary: in this study, the investigators will compare effects of two types of 8-weeklong interventions: a) multimodal or b) general movement to facilitate social communication and motor skills of school-age children with autism spectrum disorder (asd). recently, the investigators have identified cortical dysfunction patterns as markers of imitation/interpersonal synchrony difficulties in children with asd using functional near-infrared spectroscopy. in this project, the investigators want to validate whether cortical markers can determine treatment responders and if such markers are sensitive to training-related changes. following training, the investigators expect to see a variety of behavioral and neural changes in both groups. if the study aims are achieved, the investigators will validate the use of cortical markers as a treatment response measure. this research will build evidence for the use of various movement interventions for school-age children with asd.

46 children with asd between 5 and 15 years of age will be randomly assigned to the multimodal or general play or seated play groups. each child will participate in 9 testing sessions (4 pretests, 3 posttests, and 3, 2-month follow-ups) and 8 weeks of multimodal or general intervention between pre-tests and post-tests. in the 8-week phase between the pre- and post-tests, each child will complete group-specific intervention-related activities with the expert clinician twice per week via telehealth or face-to-face interactions. each session will last for around 1-1.5 hours. if the study aims are achieved, the investigators will validate the use of cortical markers as a treatment response measure. findings from this research will offer evidence for the use of various movement interventions to promote motor, social communication, and cognitive skills in school-age children with asd.

Eligibility criteria:
inclusion criteria: * children with autism spectrum disorder (asd) between 5 and 15 years of age exclusion criteria: * significant hearing or vision impairment * significant behavioral problems * significant medical (cardiovascular or respiratory), orthopedic, or surgical problems that prevent study participation. * history of seizures. * significant mobility problems that prevent study participation.

Keywords: movement play social communication motor
clinical application and basic study of medicinal fractions-based herbal combinations

Conditions: Ischemic Stroke

Summary: the purpose of this study is to investigate the efficacy of fractions-based herbal combinations of clearing heat and promoting blood circulation treating acute ischemic stroke and the potential mechanism of it.

the interaction between fire-heat and blood stasis is a significant mechanism underlying pathogenesis and progress in acute ischemic stroke according to tcm theory.clinical therapeutic effects are achieved with wide application of ixeris of sonchifolia hance components (kdz injection) representing method of clearing heat and panax notoginseng saponins components (xueshuantong injection) representing method of promoting blood circulation.

Eligibility criteria:
inclusion criteria: * patients with acute ischemic stroke * patients with fire-heat syndrome * stoke onset within 48 hours * nihss scores range from 5 points to 25 points * age from forty to seventy-five,gender not limited * informed and signed the consent exclusion criteria: * cardiogenic cerebral embolism,stroke caused by other reasons or the unexplained * patients suitable for thrombolytic therapy(rt-pa, urokinase) * patients have received thrombolytic therapy * patients with serious diseases of heart,lungs,liver,kidneys * patients with bleeding or bleeding tendency recently * pregnant or lactating women * pre-existing neurological or psychiatric diseases that could confound the study results * patients be allergic to alcohol,ixeris of sonchifolia hance components (kdz injection) or panax notoginseng saponins components (xueshuantong injection) * patients have participated in other clinical trials within 3 months

Keywords: fire-heat syndrome blood stasis syndrome method of clearing heat method of promoting blood circulation medicinal fractions-based herbal combinations
glycophosphopeptical am3 a potential adjuvant in the treatment of sars-cov-2

Conditions: SARS-CoV-2 Infection

Summary: introduction: in late 2019, a novel human coronavirus was detected in wuhan, china, causing an outbreak of the severe acute respiratory syndrome - coronavirus 2 (sars-cov-2). the disease that sars-cov-2 causes was named coronavirus disease 2019 (covid-19). the virus rapidly spread throughout china and beyond, causing a public health challenge of global concern. today, the availability of safe and effective drugs to treat covid-19 remains limited, and symptomatic supportive treatments are the foundations of care. a natural glycophosphopeptical, am3 has been shown to effectively improve the progression of infectious respiratory diseases with no side effects. in this context, am3 could maintain an adequate immune status and serve as a therapeutic tool against covid-19. study aim: the effect of am3 supplementation on the progression of covid-19 patients. to evaluate the existence of significant differences between control and intervention groups in the progression of severe covid-19 disease. methods: double-blind randomized controlled clinical trial in collaboration with the health care management of soria. at the start of the trial, eligible patients will be randomized in a 1:1 ratio into two intervention and control groups. block randomization with participants based on gender will be used. 120 patients with a confirmed diagnosis of covid-19 by pcr and/or antigen testing will be randomized to the control group (placebo treatment) or experimental group (am3 treatment), respectively. patients will be randomly divided into two groups, the am3 supplementation group (n=60) and the control group (n=60). the intervention group will be administered 2 indistinct capsules of am3 (3 g/day of am3) for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach. the control group will be administered a placebo of identical appearance of 2 indistinct capsules for a single daily intake in the morning, same dose as the experimental group (3 g/day of placebo), for 30 consecutive days.


Eligibility criteria:
inclusion criteria: * ≥18 years * males and females * confirmed clinical diagnosis of covid-19 positive by real-time reverse transcription polymerase chain reaction (rt-pcr) and/or sars-cov-2 antigen test performed 120 hours prior to patient inclusion in the study * ldh 250-400 u/l * acceptance of informed consent signature * imc: 18.5-30 * patients not participating in other trials * no hepatic and renal disorders * possession of mental faculties to participate in the study exclusion criteria: * patients with rare and specific viral diseases such as hiv * patients undergoing chemotherapy during the last 2 months * any other condition/pathology diagnosed by the medical specialist that prevents them from participating in the trial * intake of vitamin complexes or functional foods

Keywords: covid-19 am3 treatment immunomodulation
digestive events in duchenne muscular dystrophy patients

Conditions: Duchenne Muscular Dystrophy

Summary: relation between clinical and genetic features and acute digestive events in duchenne muscular dystrophy patients

clinical data of the disease digestive events (pseudo occlusion, gastrostomy, cholecystectomy) nutritionnal parameters genetic of dystrophin (approved genetic nationnal data base, chu cochin, paris france)

Eligibility criteria:
inclusion criteria: * all duchenne muscular dystrophy patients in our center exclusion criteria: * none

Keywords: pseudo occlusion gastrostomy
immunization to prevent acute copd exacerbations

Conditions: Pneumococcal Infections; COPD

Summary: prospective multicenter observational study, to evaluate the impact of routine clinical practice vaccination with pcv13 on the reduction of the risk of moderate/severe copd exacerbations

patients with chronic obstructive pulmonary disease (copd) have been demonstrated to have an increased risk of pneumococcal disease. pneumonia is frequent among patients hospitalized for copd exacerbations and is associated with increased health care utilization and higher mortality. up to 50%-70% of exacerbations can be attributed to respiratory infections by viruses or bacteria, even more in the most severe patients. they are often associated with the colonization of airways by multiple bacteria or viruses of low virulence that in normal conditions are parts of the normal flora of the upper airway. current recommendations for immunization of patients with copd include vaccination against influenza and streptococcus pneumoniae. the aim of this study is to evaluate the potential benefits of immunization of copd patients with pcv13 and/or against influenza in terms of clinical benefits and quality of life.

Eligibility criteria:
inclusion criteria: 1. patient ≥18 years diagnosed with copd (any stage, the subgroups for the analysis would be based on copd severity grade) 2. ability to understand and complete the required qol questionnaires 3. at least 2 years of clinical history available that includes records of previous moderate/severe exacerbations, influenza and pneumococcal vaccination history comorbidities and previous treatments. 4. spirometry data (maximum 6 months old, or if not available at enrollment, to be performed as per normal clinical practice at visit 1 +/- one month) exclusion criteria: 1. impossibility to perform prospective follow up 2. present any immunocompromising condition 3. present any other respiratory diseases as co-morbidity (subjects with overlap syndromes copd-asthma will be excluded. mixed phenotype defined as: symptoms of increased variability of airflow and incompletely reversible airflow obstruction)

Keywords: pneumococcal infections copd exacerbations