Kornimate/medical-research-clean huggingface dataset:
open-label study of oral treprostinil in digital ulcers

Conditions: Systemic Sclerosis

Summary: this open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine sr in subjects with ssc and digital ulcers.


Eligibility criteria:
inclusion criteria: * eligible subjects who completed assessments for the final visit of the previous tde-du-201 controlled trial and who signed appropriate informed consent were eligible to enroll in this extension study. * if a female of childbearing potential, the subject must have agreed to continue practicing an acceptable method of birth control (i.e., surgical sterilization, approved hormonal contraceptives, barrier methods \[such as a condom or diaphragm\] used with a spermicide, or an intrauterine device). exclusion criteria: * have had any change in clinical status that, in the opinion of the investigator, would pose a safety risk for participation in this extension study; * have been found to be unable to complete study assessments in the previous controlled trial; * have prematurely discontinued study drug during the previous study due to clinical worsening or treatment related adverse events.

Keywords: systemic sclerosis scleroderma digital ulcers vasculopathy
exercise and quality of life in leukemia patients

Conditions: Acute Leukemia

Summary: the purpose of this study is to evaluate the impact of an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep disturbances among acute leukemia patients. the investigators hypothesize that exercise will reduce fatigue in acute leukemia patients.

the purpose of this randomized, prospective, longitudinal study is to evaluate the impact of an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep disturbances outcomes among acute leukemia patients. the study will include 2 groups for a total sample size of 30: n=15 control group and n=15 intervention group. each patient enrolled in the intervention arm will participate in an exercise program for the duration of their hospitalization, 4-6 weeks on average during the first treatment (induction chemotherapy).

Eligibility criteria:
inclusion criteria: * newly diagnosed with acute leukemia by pathology report * admitted for induction chemotherapy within in the previous 96 hours or +/- 3 days from initiation of induction chemotherapy * an expected hospital stay of 3-4 weeks or longer * participation in the study must be approved by the physician directly responsible for the patient's care while at university of north carolina -hospitals * age \>21 years of age * willing and able to provide, signed informed consent * willing and able to use a computer to complete study questionnaires * ability to understand and speak english exclusion criteria: the criteria below will be determined by the patient's physician and a review of the patient's medical history. if any of the exclusion criteria are observed, the patients will be informed and excluded from participating in the study. participation in this study will involve the same risks as any exercise regimen. given the potential risks involved, patients will be screened for exclusion based upon the following criteria: * cardiovascular disease (unless the disease would not compromise the patient's ability to participate in the exercise rehabilitation program) * acute or chronic respiratory disease that would compromise the patient's ability to participate in the exercise rehabilitation program * acute or chronic bone, joint, or muscular abnormalities that would compromise the patient's ability to participate in the exercise rehabilitation program * inability to understand and speak english * dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent * another active malignancy * patients will also be excluded if they have active bleeding, acute thrombosis, ischemia, hemodynamically unstable, and uncontrolled pain.

Keywords: health related quality of life
the correlation of the cervical symptoms with intubation quality and airway assessment

Conditions: Cervical Pain; Cervical Disease

Summary: cervical spine disorders can cause neck pain with or without neurological dysfunction. the most common cause of acute and chronic neck pain is cervical degenerative changes. surgical decision of cervical pathology is made by anamnesis, neurological examination and imaging methods. airway management can be difficult for patients presenting for cervical spine surgery. in addition, these patients may have severe cervical spine instability or spinal cord level myelopathy and may develop serious neurological complications associated with the intubation technique. videolaringoscopes, which have become widely used with the developing technology, provide a better view than direct laryngoscopy in terms of cervical immobilization during intubation. therefore, videolaryngoscope is preferred for cervical pathologies. nowadays, the use of videolaryngoscope is recommended in patients with airway difficulty. neutral position is important for intubation of patients with cervical pathology and it is highly recommended in the literature to evaluate these patients as difficult airways. all cervical patients are intubated with videolaryngoscope in investigator's clinic. the aim of this study was to evaluate how long the duration of cervical pathology affects airway anatomy and how it affects airway management during anesthesia. on the other hand, airway-related measurements will be performed by mri and ultrasonography (usg), which is routinely evaluated in the diagnosis process, and it will be aimed to evaluate these measurements in terms of their effects on intubation quality. at the end of the study, all evaluations were analyzed and it was aimed to compare the effects of other evaluated parameters (such as usg and mri measurements) on intubation difficulty level, with cervical pathology duration being primary.


Eligibility criteria:
inclusion criteria: - elective cervical surgery exclusion criteria: * patients undergoing emergency surgery * cervical tumor patients * patients with cognitive dysfunction * patients with previous cervical surgery * pediatric patients * cervical trauma patients * the presence of cervical spondylitis, spondylodiscitis

Keywords: videolaryngoscopy quality of intubation cervical pathology difficult airway
painful hiv neuropathy and alpha-lipoic acid

Conditions: HIV; Peripheral Neuropathy

Summary: hiv is associated with painful peripheral neuropathy. disability is often significant. alpha-lipoic acid's antioxidant properties may have benefit in this condition.

hiv is associated with painful distal peripheral polyneuropathy in up to 35-50% of those without aids and in more than 70% of those with advanced disease. the condition is progressive but may be halted with disease remission. disability is often significant. peripheral nerve axons and sensory neuron cell bodies in the dorsal root ganglia are the principal targets of the process leading to symptoms. alpha-lipoic acid occurs naturally in every cell of the body. in high concentrations it acts as an anti-oxidant which regenerates other anti-oxidants and promotes glutathione synthesis. clinical studies for diabetic neuropathy have shown significant benefit at daily oral doses that are well-tolerated. this placebo-controlled study is designed to evaluate the effects of daily oral alpha-lipoic acid supplements (600mg, three times per/day) plus standard medical care in the treatment of painful hiv-associated neuropathy over a 24-week period in adult subjects. possible benefits of the study include reduction in pain and disability, reduced use of medications, and enhanced cellular metabolism.

Eligibility criteria:
inclusion criteria: * hiv-seropositive * distal peripheral sensory neuropathy as diagnosed by a neurologist with pain or paresthesia, with or without numbness or weakness * able to understand and participate in protocol activities * able to give informed consent * under the care of a unc id clinical physician for at least 2 months * able to document pain characteristics, use of pain medications, and other assessment instruments and characteristics * on stable antiretroviral therapy (or none) for 12 weeks prior to enrollment * no changes in peripheral neuropathy pharmacologic treatment for 12 weeks prior to enrollment exclusion criteria: * any significant cognitive impairment or psychosis * pregnancy or anticipated pregnancy (women of child-bearing potential must agree to use birth control for the duration of the study) * undergoing any current treatment for malignancy, including chemotherapy or radiation therapy within the past year * concurrent or prior use of a-la * known non-hiv risk factors for peripheral neuropathy, such as dm, b12/folate deficiency; thyroid dysfunction; hx of exposure to lead, mercury, arsenic, thallium (prior diagnostic tests permitted), other heavy metals or complex hydrocarbons * use of metronidazole, isoniazid or other furantoins * suspected or documented thiamin deficiency * active alcoholism * allergy to a-la * hx of 'significant' use of anti-oxidant supplements during the two months prior to study entry

Keywords: hiv peripheral neuropathy alpha-lipoic acid ala complementary therapies
multicenter clinical trial of buprenorphine - 3

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to test the efficacy and safety of buprenorphine.

12 different sites for a total of 736 subjects (60 at pizarro, 70 at west la tx center, 15 in the 1 year extension)

Eligibility criteria:
inclusion criteria: m/f, ages 21-50. opiate dependence according to dsm-iv criteria. self-reported use within the last 30 days. agreeable to conditions of the study and signed informed consent. exclusion criteria: psychiatric disorder that requires medication therapy. history of seizures. pregnant and/or nursing women. dependence on etoh or benzodiazepines or other sedative-hynotics. acute hepatitis. other medical conditions that deem participation to be unsafe.

Keywords: buprenorphine opioid
cpx-351 real-world effectiveness and safety study

Conditions: Acute Myeloid Leukemia

Summary: cpx-351 real world effectiveness and safety study (crest uk) is a real-world evidence study designed to collect data on the potential benefits and/or risks of vyxeos liposomal (liposomal daunorubicin/cytarabine; cpx-351) in routine clinical practice in the united kingdom (uk).

this is a retrospective, non interventional, multi-centre, single arm, observational study designed to assess patients with newly diagnosed, therapy-related acute myeloid leukaemia (t-aml) or acute myeloid leukaemia with myelodysplasia related changes (aml-mrc) who have been treated with vyxeos liposomal (liposomal daunorubicin/cytarabine; cpx-351) in routine uk clinical practice and managed as per standard local practice.

Eligibility criteria:
inclusion criteria: * aged ≥18 years at the start of treatment of aml with vyxeos liposomal * pathological diagnosis of t-aml or aml-mrc according to world health organization criteria (with at least 20% blasts in the peripheral blood or bone marrow) * patient has received at least one infusion of vyxeos liposomal, prescribed as per the smpc * patient signs an informed consent form or is included in accordance with an informed consent waiver exclusion criteria: * treatment with vyxeos liposomal as part of a clinical trial or managed access program * prior treatment intended for induction therapy of aml; only hydroxyurea is permitted for control of blood counts

Keywords: acute myeloid leukemia cpx-351 vyxeos liposomal
effect of high altitude exposure, acclimatization and re-exposure on sustained attention in lowlanders

Conditions: Effect of High Altitude

Summary: prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on global cognitive function.

baseline measurements will be performed in santiago de chile, 520 m, over the course of 3 days. participants will then travel by commercial airline (2 h flight) and by bus (2 h ride) to the alma base camp located at 2900 m near san pedro de atacama, northern chile. participants will stay there for the next 7 nights and they will be spend the days (6 total; 6-8 h daily) at the telescope station at 5050 m while undergoing testing as described above at the first and the last day at 5050m. daily transports from 2900 to 5050 m will be by car (1 h ride, one way). after the first 7 day altitude sojourn participants will return to the santiago area (520 m) for a 7 day recovery period. a second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Eligibility criteria:
inclusion criteria: * born, raised and currently living \<1300m * no overnight stays at altitudes \>1500m 4 weeks before the study exclusion criteria: * previous altitude intolerance \<3000m * pregnancy * health impairment, which requires regular treatment

Keywords: high altitude attention cognitive function acclimatization sleep
effect of covid-19 vaccination on male

Conditions: COVID-19 Pandemic

Summary: we will assess the effect ofcovid19 vaccination on the reproductive and sexual function of the male egyptian

coronaviruses are a group of rna viruses that primarily affect the respiratory system and cause the common cold, fever, and coughs in mammals and birds. however, in some cases, coronaviruses are associated with more serious and lethal conditions, such as pneumonia, bronchitis, and severe acute respiratory syndrome . severe acute respiratory syndrome coronavirus 2 (sars-cov-2) originating from wuhan, china, led to a global health crisis. sars-cov-2 had infected more than 450 million people, resulting in more than 6.6 million deaths. the world health organization (who) declared coronavirus disease 2019 (covid-19), the infectious disease caused by sars-cov-2, a pandemic, and many states enacted strict rules, such as border closures, transportation restrictions, and quarantine. quality and satisfying sexual life have a positive effect on the social and daily relationships as well as on the intimate life of many individuals. the who summarizes the definition of sexual health as the physical, emotional, mental, and social well-being of an individual. on the other hand, sexual dysfunction can be described as any condition preventing the individual from being satisfied by the sexual activity at any stage of the sexual relationship. the renin-angiotensin system (ras), also ace 2 and tmprss2 play an important role in the cellular entry for sars-cov-2. because the male genital system presents high ace 2 expression, the importance of this pathway increases in covid-19 cases. as the covid-19 pandemic has affected the male genital system in direct or indirect ways and showed a negative impact on male reproduction ozer baran and aykut aykac et al reported that the fear of infection and transmission of the disease to the partner that occurs during the covid-19 pandemic manifests itself in the form of a decrease in the frequency and quality of sexual intercourse. a covid 19 vaccine is a biotechnology product intended to provide acquired immunity against corona virus disease 2019 (covid 19) as of 1st june 2020, there were 124 candidate vaccines that were being developed for the prophylaxis of covid-19. of these, 10 vaccine candidates had entered phase1, combined phase 1/2 or phase 2 human clinical trials in adults

Eligibility criteria:
inclusion criteria: * male patients receive covid 19 vaccinations. age from 20 to 55 years exclusion criteria: * patients complaining of ed or any sexual dysfunction before vaccination. * patients with history of male infertility before vaccination. * patients who have pyschological disorders or any other systemicdiseases
electromyographic activity of preterm newborns submitted to hammock positioning

Conditions: Infant, Premature, Diseases

Summary: to compare and analyze the effects on the electromyographic activity of preterm newborns placed in the hammock position with the activity of newborns not placed in this position.

randomized clinical trial, according to consort standards, with newborn preterm gestational age \<34 weeks and birth weight \<1500 g, admitted to the intensive care unit. newborns will be randomized. those selected for the control group (cg) will be placed in the incubator following the service routine. babies in the intervention group (ig), will be positioned supine in a hammock in the incubator, with the appropriate postural adjustments. the evaluation of muscle activity will be carried out through surface electromyography. evaluations shall be performed immediately before the intervention; immediately after 24 hours of intervention; and within 24 hours without intervention, in order to compare the values before and after the intervention of the two groups, as well as if the effects of the intervention are maintained after its removal.

Eligibility criteria:
inclusion criteria: * preterm infants with gestational age \<34 weeks * free from mechanical ventilation in the last 48 hours prior to electromyographic evaluation * not in use of supplemental oxygen at the time of assessment exclusion criteria: * apgar score of less than seven in the fifth minute * previous history of perintraventricular hemorrhage grade iii and / or iv * congenital infection * congenital heart defects * neonatal obstetric traumas * gastroesophageal reflux disease * genetic syndromes * congenital malformations * sepsis with meningitis * orthopedic and musculoskeletal alterations
the quantitative study of the habenula based on multi-channel cascaded neural network and the establishment of the prediction model of the curative effect in patients with depression

Conditions: Depression

Summary: depression is the second leading cause of disease burden in our country. it has serious effects on the physical and mental health of human beings, and about 30% of patients with depression are unresponsive or respond poorly to antidepressant treatment. clinical practice is in a tough position of wanting objective measures of assessing depression. the applicant and her team have devoted many years to the basic and clinical research on habenular nucleus (hb) accumulating a significant amount of experience from animal experiments and patients' magnetic resonance (mr) studies. these studies have demonstrated that the habenular nucleus is the key target area that is responsible for the pathophysiological changes in depression as well as its treatment. small volumes and unsatisfactory contrast have been knotty problems in the mr imaging of hb. in addition, time-consuming manual segmentation and lack of quantitative standards in conventional studies has impeded the advancement of hb research. fortunately, the development of high-resolution multi-parametric quantitative mr imaging and the extensive use of artificial intelligence (ai) technology in medical imaging can just provide powerful support for the imaging, segmentation and quantification of hb. this project proposes to use high resolution mr anatomy of hb combined with multimodal fusion to 1) construct a model for automatic 3d segmentation of hb mr images based on the densely connected multichannel dilated convolutional neural networks; 2) sift out the quantitative imaging signatures related to the antidepressants' efficacy using the radiomics methodology, and in combination with clinical information, construct an individualized prediction model for treatment efficacy. overall, this study focuses on the translation of basic research to clinical application in the hope of providing quantifiable objective imaging markers in clinical practice, facilitating clinical decision-making and bringing about individualized precise diagnosis and treatment.


Eligibility criteria:
inclusion criteria: * premiere depressed patients exclusion criteria: * drug therapy modality change、incomplete mr image data

Keywords: depression habenula convolution neural network segmentation curative effect prediction
the organ protection of astragalus in subjects with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: metabolic syndrome have the damages on tissues and organs in heart、kindey and vessels. in this study, prospective randomized, controlled, parallel designed ,different doses of astragalus mongolia, gansu longxi produce treat on the ms patients, and then use real-time quantitative pcr and western blotting to detect the index of oxidative stress 、angiotensin-converting enzyme 2 mrna expression and proteins.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older, meet the diagnostic criteria of ms 2. non-allergic with the astragalus 3. agree to conduct clinical trials and those who signed the informed consent exclusion criteria: 1. patients with resistant hypertension 2. renal disease requiring dialysis 3. heart failure nyha ⅲorⅳ; 4. complications of diabetes 5. arteritis 6. cancer 7. thyroid disease 8. unstable coronary heart disease 9. peripheral vascular disease 10. acute cerebral vascular disease11.pregnancy、 planned pregnancy 11. patients with anti-oxidants 12. acute infection 13. other organic dysfunction, such as the liver, respiratory system, blood system, and other rheumatic diseases.

Keywords: 5-10 gram astragalus per day
a phase i study of subcutaneously administered proleukin (aldesleukin) in hiv-infected patients

Conditions: HIV Infections

Summary: to determine the mtd and dose-limiting toxicities of recombinant interleukin-2 (aldesleukin; proleukin) administered subcutaneously in hiv-seropositive patients. to identify a tolerable subcutaneous regimen that will replicate the immunologic improvement demonstrated in the outpatient polyethylene glycolated il-2 and high-dose continuous infusion il-2 studies. to evaluate the incidence and level of anti-il-2 antibody formation to subcutaneously administered proleukin in this patient population.

patients will receive subcutaneous proleukin, and the mtd will be determined.

Eligibility criteria:
inclusion criteria patients must have: * documented hiv infection by elisa and western blot. * cd4 count \> 200 cells/mm3. required: * fda-approved antiretroviral therapy for at least 2 months prior to study entry.

Keywords: interleukin-2 acquired immunodeficiency syndrome aids-related complex