Kornimate/medical-research-clean huggingface dataset:
effect of the axillary lymphatic /vein reflux ratio on postoperative upper limb edema and dysfunction in breast cancer

Conditions: Breast Cancer Lymphedema

Summary: the purpose of this study is to compare the difference in the incidence of upper limb edema and dysfunction between the preponderant lymphatic reflux group (high ratio of axillary lymphatic reflux to axillary vein reflux) and the preponderant venous reflux group (low ratio of axillary lymphatic reflux to axillary vein reflux).


Eligibility criteria:
inclusion criteria: * age 18-69 years old, * regardless of gender, * breast masses were diagnosed by histology and pathology, stage ii -iii. * clinical palpation of axillary lymph nodes is positive, or * axillary lymph node puncture pathology is positive, or * the multidisciplinary treatment cooperation group (mdt) recommends axillary lymph node dissection, * good physical state score (0-1), * no severe organ complications, * no congenital or acquired diseases affecting the normal morphology and functional activities of the upper limbs, * informed consent, understanding and compliance with research requirements. exclusion criteria: * pregnancy or lactation, * inflammatory breast cancer, * clinical findings of metastatic lesions, * sentinel lymph node biopsy was negative, * history of upper limb or shoulder, chest, back trauma or surgery, * previous history of local radiotherapy, * history of other tumors, * vascular embolic disease, * those who are unable to comply with the clinical trial requirements for any reason.

Keywords: breast cancer axillary lymph node dissection post-mastectomy lymphedema upper limb dysfunction axillary lymphatic reflux axillary vein reflux
treatment study for actinic cheilitis comparing imiquimod 5% and photodynamic therapy

Conditions: Actinic Cheilitis

Summary: actinic cheilitis is a common precancerous lesion of the lip. the purpose of this study is to compare imiquimod 5% therapy and photodynamic therapy. the data will include effect data, histology (skin analysis), epidemiological data and follow-up data.

randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis. histological, efficacy, epidemiological and clinical data will be collected.

Eligibility criteria:
inclusion criteria: * clinical findings of actinic cheilitis. * histological findings demonstrating epithelial changes equal to or greater than mild epithelial dysplasia in severity (mild - moderate - severe). * age above 18. * willingness to take post-treatment biopsy. exclusion criteria: * disorders predisposing to photosensitivity (porphyria, sle). * pregnancy or nursing. * known allergy to any excipients in the study creams. * prescribed topical retinoids, 5-fluorouracil, cryodestruction, surgical excision and curettage.

Keywords: actinic cheilitis imiquimod 5% photodynamic therapy
effects of gabapentin versus placebo on buprenorphine detoxification of opioid-dependent individuals

Conditions: Opioid Dependence; Opioid Withdrawal; Opioid Detoxification

Summary: this study involves inducting treatment seeking opioid dependent participants onto buprenorphine. once the participant reaches a stable dose they will receive either placebo or gabapentin to determine if gabapentin helps ease withdrawal symptoms while the participant undergoes a 10-day buprenorphine detoxification.


Eligibility criteria:
inclusion criteria: * availability to attend clinic 6 days a week for approximately 30-60 minutes. * participants must fulfill dsm-iv criteria for opioid dependence. these criteria will be ascertained in the following manner: the physician will determine whether the individual is appropriate based on several clinical assessments that are routinely employed by methadone program physicians, including history and severity of opioid use, presence of track marks, prior treatment history, self-reported and/or observed signs and symptoms of opioid withdrawal. if any individual's degree of opioid dependence is questionable, that person will be excluded from further consideration as a participant. * participants must submit a urine negative for drugs of abuse other than opioids prior to starting the study. exclusion criteria: * unstable medical condition or stable medical condition that would interact with study medications or participation. * history of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression) * pregnancy or plans to become pregnant or inadequate birth control (adequate birth control includes abstinence, condoms, birth control pills, etc). * present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or drug (including maalox) that would have major interaction with drugs to be tested. * liver function tests greater than 3 times normal, bun and creatinine outside normal range, or thyroid function tests outside normal range. * ekg abnormalities including but not limited to: bradycardia (\ 450 msec); wolff-parkinson white syndrome; wide complex tachycardia; 2nd degree, mobitz type ii heart block; 3rd degree heart block; left or right bundle branch block. * physical dependence on alcohol or drugs other than opioids or tobacco (as determined by physician assessment).

Keywords: opioid dependent detoxification buprenorphine suboxone opiate
human umbilical cord mesenchymal stem cells (mscs) therapy in ards

Conditions: Acute Respiratory Distress Syndrome

Summary: acute respiratory distress syndrome (ards) is a devastating inflammatory and destructive disease in critical ill patients. preclinical studies have shown a promising perspective of mesenchymal stem cells (mscs) therapies in ards. but the safety and efficacy of umbilical cord mscs (ucmscs) have not yet been convinced in clinical trails. this study will explore the safety and life-rescue potential of ucmscs in refracotry ards.

this is a single arm study. according berlin definition (2012), moderate or severe adult ards patients who fail to improve oxygenation (pao2/fio2 increase over 20%) in the first 24h or 8h after diagnosis will be enrolled. a salvage package of 10\^6/kg suspended ucmscs in 100ml normal saline or only 100ml normal saline will be infused through central venous catheter. infusion associated events (iaes) in 24 hours will be closely monitored. compared with propensity score matched controls, mortality in 28 days as the primary outcomes. oxygenation index, ventilator parameters, lung injury biomarkers and clinical outcomes as secondary outcomes will be analyzed. this is a revised trail from its previous registered pilot rct, approved by ethic committe of stem cells trails (ecsct) of 3rd affiliated hospital of sun yat-sen university

Eligibility criteria:
inclusion criteria: 1. aged≥18 years old; 2. including all the criteria: (1) invasive ventilation, oi（pao2/fio2）\<200; (2) peep≥8cmh2o; (3) bilateral infiltration of lung in x-ray or ct; (4) in 1 week after onset; (5) still oi\<200 after protective ventilation or conservative fluid management. exclusion criteria: 1. any malignant disease; 2. cardiogenic pulmonary edema; 3. over 50% atelectasis either lung lobe in x-ray; 4. pregnancy or perinatal or lactation; 5. previous end stage respiratory disease; 6. more than 3 organs failure; 7. liver failure with meld(model for end-stage liver disease) score\>40; 8. stage iii or iv pulmonary hypertension; 9. none invasive arterial and central venous catheter; 10. concurrent deep venous thrombus or pulmonary embolism in 3 months; 11. cerebral hernia; 12. more than 96 hours after ards onset.

Keywords: refractory acuter respiratory distress syndrome mesenchymal stem cells salvage therapy
repetitive thinking in fibromyalgia and attentional bias

Conditions: Chronic Pain

Summary: theoretical models of chronic pain hypothesize a privileged treatment of pain-related information that would be the basis of avoidance behaviors in chronic pain. this privileged treatment, also called attentional bias, has been found experimentally in chronic pain. meta-analyses confirmed that but leaded the question of the difference found between bias in period of attention orientation and bias in period of maintained attention. one of the hypotheses is to consider one or more cognitive processes that would "fix" the attention around significant perceived problems and that would hinder the attentional disengagement and the reorientation of attention towards neutral or positive stimuli. in view of the scientific literature in psychopathology but also in chronic pain we think that the negative repetitive thoughts (rnt) variable is one of these processes. so the investigators want to better understand the difference of attentional bias at different moments of the attentional process by interrogating the repetitive thinking variable. more specifically the investigators test the attentional bias hypothesis in fibromyalgia. patient with fibromyalgia will be recruited at the pain center of chu-amiens. patients will complete different scales and also the visual probe task. first, the investigators hypothesize the attention bias for pain-related information in the fm group is correlated with the level of negative repetitive thinking in the maintained attention phase. second, the investigators hypothesize the attention bias is more important in the attention maintenance phase (1250 ms) than in the attention orientation phase (500 ms).


Eligibility criteria:
inclusion criteria: adults patients inclusion criteria: * 1990 acr criteria of fm * free and informed consent signed. * french mother tongue spoken, written, read. * major person. exclusion criteria: * adult major under protection. * patient with severe psychosis or depression or severe anxiety or impulsivity as -assessed by the clinician.

Keywords: repetitive negative thinking rumination fibromyalgia chronic pain attentional bias
comparison of safety and immunogenicity of pediacel™ and infanrix™ ipv+hib (penta) given in a 3 dose schedule in infants

Conditions: Pertussis; Diphtheria; Tetanus; Poliomyelitis; Haemophilus Influenzae Type b

Summary: pediacel™ is currently licensed in the uk for use as a 3 dose regimen for the active immunisation of infants against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by haemophilus influenzae type b. however there are currently no clinical data supporting the use of pediacel™ using a 3, 5, and 12 months of age vaccination schedule. this study is designed to provide safety and immunogenicity data to support the use of pediacel™ according to a 3, 5, and 12 months schedule.


Eligibility criteria:
inclusion criteria: * infants aged 80 to 120 days inclusive on the day of inclusion. * born at full term of pregnancy (\> 37 weeks) * informed consent form signed by the parent(s) or other legal representative according to local regulations * parent(s) or legal representative able to attend all scheduled visits and to understand and comply with the study procedures (able to read and write; access to a telephone). exclusion criteria: * rectal temperature ≥ 38.0°c * moderate or severe acute illness with or without fever * participation in another clinical trial in the 4 weeks preceding the first trial vaccination * having received any dtap, ipv, or hib vaccines prior to study initiation or any vaccination in the 4 weeks preceding the first trial vaccination * planned participation in another clinical trial during the present trial period * known history of diphtheria, tetanus, pertussis, h. influenzae type b infections, poliomyelitis * congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy * systemic hypersensitivity to any of the vaccine components (including neomycin, streptomycin, polymyxin b and formaldehyde) * history of a life-threatening reaction (such as encephalopathy, hypotonic hyporesponsive episode, severe fever, convulsions, etc.) to the trial vaccine or a vaccine containing the same substances * blood or blood-derived products (immunoglobulins) received in the past 4 weeks * vaccination planned in the 6 weeks following any trial vaccination * known hiv seropositivity * thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * history of seizures or progressive, evolving or unstable neurological condition * clinically significant findings on review of systems that might interfere with correct vaccination or which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.

Keywords: haemophilus influenzae type b; corynebacterium diphtheriae; clostridium tetani; bordetella pertussis; poliovirus types 1, 2 and 3; vero cell; influenza; diphtheria
acceleration of recovery from general anesthesia - efficacy of isocapnic hyperpnoea in obese patients undergoing isoflurane anesthesia

Conditions: Recovery Time From Isoflurane Anesthesia in Obese Patients

Summary: faster recovery from anesthesia is important for obese patients because they are at high risk of respiratory complications following tracheal extubation. isoflurane has several properties that make it a preferable agent for anesthesia in obese patients. its main limitation is a longer recovery time due to slower elimination in comparison to other agents. elimination of isoflurane from the lungs can be accelerated by increasing in patient's minute ventilation, which decreases the level of co2 in blood (hypocapnia).isocapnic hyperpnoea (ih) is a method allowing increased ventilation and therefore enhancement of the elimination of inhalation agents while maintaining a normal blood co2 level. the investigators will compare recovery time from isoflurane anesthesia in obese patients during standard anesthesia management protocol (control) to a group treated with ih.


Eligibility criteria:
inclusion criteria: elective gynecological or urological procedure, * bmi \> 35 kg/m², * asa i-iii, * signed informed consent. exclusion criteria: * lack of informed consent, * asa iv-v, * contra-indications to isoflurane anesthesia or other anesthetics included in the protocol, * history of cardiac or respiratory disease, * alcohol or drug abuse, * psychiatric illness and/or medications.

Keywords: isocapnic hyperpnoea obesity isoflurane recovery of obese patient from isoflurane anesthesia
diastolic function in myotonic dystrophy type 1

Conditions: Diastolic Dysfunction

Summary: myotonic dystrophy type 1 (dm1) is a neuromuscular disorder in relation with an unstable expansion of ctg repeat. patients with dm1 are at risk of arrhythmia and conduction disorders. mortality are mainly related to respiratory failure and sudden death. patients with dm1 may suffer from obesity, arterial hypertension, diabetes mellitus and sleep apnea. these comorbidities are classically associated with left ventricular diastolic dysfunction (dd) . the investigators aim to assess the prevalence of left ventricular diastolic dysfunction in patients with myotonic dystrophy type 1 , the distribution of dd grading as well as the long-term prognosis of dm1 patients with a left ventricular diastolic dysfunction.


Eligibility criteria:
inclusion criteria: * patients with genetic proven myotonic dystrophy type 1 * who experienced a doppler- echocardiography including an assessment of the left ventricular diastolic function exclusion criteria: * wall motion basal abnormalities * significant valvular disease
the lived experience of participants in an african randomised trial

Conditions: HIV; Cryptococcal Meningitis

Summary: there has been no previous qualitative study conducted in a low-income setting which has aimed to explore the experience of individuals who enrol into a clinical trial for the management of a life-threatening illness. the investigators plan to collect data from trial participants, their next-of-kin, and researchers working on a multi-site randomised controlled trial for the treatment of hiv-associated cryptococcal meningitis.

individuals recruited into clinical trials for life-threatening illnesses are particularly vulnerable and this is especially true in low-income settings. the decision to enrol may be influenced by existing inequalities, a poor healthcare infrastructure and the fear of death. where patients are confused or unconscious the responsibility for this decision falls on the relatives. the objectives of this study are to learn from the experience of participants, relatives and researchers involved in a randomised controlled trial, ambition (isrctn 72509687), which is testing a novel treatment approach for hiv-associated cryptococcal meningitis and is recruiting participants from multiple sites across sub-saharan africa. the investigators will collect data from trial participants and their relatives who provided consent on their behalf in gaborone, botswana; kampala, uganda and harare, zimbabwe. interviews will follow a narrative approach and encourage the drawing of timelines. this will be supplemented by direct observation of the research process at each of the three recruiting hospitals. in addition, interviews will take place with researchers from the african and european institutions that form the partnership through which the trial is administered. findings from the interviews will be prospectively fed back to the individual sites and trial management group to improve the ongoing trial.

Eligibility criteria:
ambition trial participants inclusion criteria: * enrolled onto the ambition trial and has completed at least six weeks of follow-up * not currently confused * willing and able to consent to the study exclusion criteria: * nil the next-of-kin of ambition trial participants inclusion criteria: * provided surrogate consent for an individual who was enrolled into the ambition trial * willing and able to consent to the study exclusion criteria: * nil ambition researchers inclusion criteria: * currently or previously employed on the ambition trial * willing and able to consent to the study exclusion criteria: * nil
brachial plexus birth palsy: reinforcement paradigm to augment recovery

Conditions: Brachial Plexus Palsy

Summary: infants who sustain an injury to the brachial plexus in the perinatal period are at high-risk for long-term neuromuscular deficits and prehensile dysfunction. if recovery is delayed because of slow axonal regrowth, disuse atrophy and secondary musculoskeletal deficits may develop. the investigators' hypothesis is that early, intensive intervention designed to foster muscle activation is essential to optimize outcomes after brachial plexus injury and may supplement rehabilitation and microsurgery. this proposal targets infants who are non-surgical candidates. yet, future studies will examine whether the investigators' experimental intervention can hasten recovery from microsurgery and will examine which post-operative time-point is best to employ it. the investigators' intervention shows promise to increase muscle activation and improve arm function in infants with brachial plexus birth palsy (bpbp) through contingent reinforcement based on a pilot study.

the investigator's study objectives are to (1) test the feasibility of a parent-lead in-home 2-week intervention for infants with bpbp; and (2) determine the effect size for the primary outcome measure(s) in preparation for a future definitive randomized controlled trial (rct). in this feasibility rct, the investigators will compare two in-home interventions in 3 to 12-month-old infants with upper trunk bpbp; n=12 per group: (1) experimental; and (2) dose-equivalent active control. for the experimental intervention, infants will trigger a musical toy to move and play via biceps contraction above a preset individual threshold. for the control intervention, toys will be available to play with, yet, there will be no reinforcement for biceps activation.

Eligibility criteria:
inclusion criteria: 1. age of 3 to 12 months with upper trunk brachial plexus birth palsy confirmed by an attending hand and upper extremity surgeon; 2. full-term at birth; 3. a minimum score of '1' (0-7 scale) in elbow flexion of affected arm (isometric contraction) based on the active movement scale (ams); 4. score ≥ 25th percentile on the motor subtest of the bayley scales of infant and toddler development, 3rd edition (bsitd-iii®); 5. ability to sustain attention/arousal for a 10 minute training period based on criteria from the neonatal behavioral assessment for an awake-alert state. exclusion criteria: 1. visual/auditory deficits; 2. nerve repair/shoulder surgery; 3. excessive crying during session(s); 4. shoulder, elbow, or wrist joint contractures \> 20° in the affected arm; 5. an inability to trigger the musical-toy to play at baseline.
a study to evaluate the tolerance and pharmacokinetics of tqb2618 injection in subjects with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: tqb2618 is a tim-3 receptor monoclonal antibody that binds to the extracellular domain of tim-3 outside the cell to block the binding of tim-3 to its ligand, thereby inhibiting the downstream signal transduction of tim-3 and deactivating tim-3 inhibition of immune cells. the purpose of this study was to evaluate the safety, tolerability, pharmacokinetic parameters and antitumor effects of tqb2618 injection in subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * 1. diagnosed as advanced malignant solid tumors and have failed standard treatments or lack effective treatments; 2. 18-75 years old; eastern cooperative oncology group (ecog) performance status score of 0 to 1; life expectancy ≥12 weeks; 3. has at least one measurable lesion; 4. the function of main organs is normal; 5. female patients of childbearing age must be negative in serum or urine hcg within 7 days before enrollment in the study, and must be non-lactating; patients should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 6. understood and signed an informed consent form. exclusion criteria: * 1. has autoimmune disease; 2. has received allogeneic bone marrow transplantation or solid organ transplantation; 3. has brain disease or brain metastases; 4. has cavity effusion; 5. has cardiovascular diseases; 6. has immunodeficiency diseases; 7. has liver disease; 8. has infection; 9. has diabetes; 10. has a history of psychotropic drug abuse or have a mental disorder; 11. have a history of severe allergy to macromolecular drugs or allergy to known components of tqb2618 injection; 12. has other malignant tumors within 2 years before the first medication; 13. has received other anti-cancer drugs or anti-cancer treatments, or major surgical operations within 4 weeks before the first medication; 14. has received any live vaccines or vaccines to prevent infectious diseases within 4 weeks before the first medication; 15. has received local radiotherapy within 1 week before the first medication; 16. toxicity (excluding hair loss) caused by previous anti-tumor therapy that has not recovered to ctc ae v5.0 level 1 or below; 17. has major wound, severe ulcer or fracture that has not healed before 1 day before the first medication; 18. has used systemic hormones, immune agonists, inhibitors, and regulators before 1 day before the first medication; 19. according to the judgement of the researchers, there are other factors that subjects are not suitable for the study.