Kornimate/medical-research-clean huggingface dataset:
effect of delayed cord clamping on haematological status in low birth weight infants

Conditions: Low Birth Weight; Perinatology; Iron Status; Cord Clamping

Summary: delayed cord clamping (dcc, clamping after cessation of pulsations in the cord around 2-3 min after delivery) is effective in increasing (low birth weight) infant haemoglobin and iron status until six months after birth, without increasing the risk of polycythaemia or other adverse events. we hypothesize that this intervention will also benefit low birth weight infants in south africa.


Eligibility criteria:
inclusion criteria: * pregnant mothers with sfh measurements below the cutpoint are eligible for inclusion. we aim to include infants with a birth weight below 2500 grams, but the actual birthweight can only be assessed after birth. we therefore accept an error of 500 grams (20%) and will include newborns up to 3000 grams. birthweight will be measured after randomisation and study treatment. exclusion criteria: 1. twin pregnancy 2. history of postpartum haemorrhage (pph) 3. (gestational) diabetes 4. pre-eclampsia 5. abruptio placentae 6. caesarian section 7. necessity of early clamping due to tight nuchal cord 8. need for resuscitation immediately after birth 9. major congenital abnormalities
a study to evaluate the efficacy and safety of faricimab (ro6867461) in participants with diabetic macular edema (yosemite)

Conditions: Diabetic Macular Edema

Summary: this study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (q8w), in participants with diabetic macular edema (dme).


Eligibility criteria:
inclusion criteria: * documented diagnosis of diabetes mellitus (type 1 or type 2) * hemoglobin a1c (hba1c) of less than or equal to (≤) 10% within 2 months prior to day 1 * macular thickening secondary to diabetic macular edema (dme) involving the center of the fovea * decreased visual acuity attributable primarily to dme * ability and willingness to undertake all scheduled visits and assessments * for women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment exclusion criteria: * currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to day 1 * uncontrolled blood pressure, defined as a systolic value greater than (\>)180 millimeters of mercury (mmhg) and/or a diastolic value \>100 mmhg while a patient is at rest * currently pregnant or breastfeeding, or intend to become pregnant during the study * treatment with panretinal photocoagulation or macular laser within 3 months prior to day 1 to the study eye * any intraocular or periocular corticosteroid treatment within the past 6 months prior to day 1 to the study eye * prior administration of ivt faricimab in either eye * active intraocular or periocular infection or active intraocular inflammation in the study eye * any current or history of ocular disease other than dme that may confound assessment of the macula or affect central vision in the study eye * any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than dme in the study eye * other protocol-specified inclusion/exclusion criteria may apply
repetitive transcranial magnetic stimulation for "voices"

Conditions: Schizophrenia

Summary: objectives: i. determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia.

protocol outline: this is a randomized, double blind study. patients are randomized to one of two treatment arms. group i: patients receive 9 sessions of active transcranial magnetic stimulation (rtms) which consists of 8 minutes of rtms during session 1, 12 minutes duration during session 2, and 16 minutes duration during sessions 3-9. the total duration of stimulation is 132 minutes. each session was given on a separate day and in general each session occurred on consecutive days with the exception of weekends. group ii: patients receive 9 sessions of sham stimulation, which consists of 8 minutes of sham stimulation during session 1, 12 minutes duration sham stimulation during session 2, and 16 minutes duration sham stimulation during sessions 3-9. the total duration of sham stimulation is 132 minutes. each session was given conducted on a separate day and in general each session occured on consecutive days with the exception of weekends. this study provided pilot data supplying the basis for our current study - nct00308997 -- see our website for details

Eligibility criteria:
protocol entry criteria: inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder based on dsm-iv version of scid * auditory hallucinations of spoken speech occurring at least 5 times per day where subject able to discern verbal content * right-handed * at least 4 weeks on stable antipsychotic medication exclusion criteria: * history of seizure (unless due to drug withdrawal or medication that is no longer prescribed) * history of epilepsy in first degree relatives * estimated iq less than 80 * unable to provide informed consent * significant unstable medical condition * current treatment with clozapine or bupropion * cochlear implants or other metal in the head (surgical, etc.) * history of cardiac arrhythmia * cardiac pacemaker * active drug or alcohol abuse within prior 6 weeks * pregnancy

Keywords: neurologic and psychiatric disorders rare disease schizophrenia
volume restoration of plantar pad with a hyaluronic acid dermal filler in metatarsalgia

Conditions: Metatarsalgia

Summary: aim of this study is to evaluate the decrease of plantar pain of forefeet due to restoration of plantar pad tissue density and of cushioning function with an hyaluronic acid dermal filler as mechanical-supplementation in subjects with metatarsalgia further use of high heel shoes

this will be an open and single center study. there will be 4 study visits in total for each subject. each subject will participate for a period of maximum 6 months.

Eligibility criteria:
inclusion criteria: * female subject aged 30 years or older, * subject with pain sensation under metatarsal heads, further to use of high heels shoes at any moment of the day whatever the onset time, * subject with no previous injections under the metatarsal heads of forefeet. exclusion criteria: * subject with a personal history of allergic/anaphylactic reactions including hypersensitivity to crossed-linked hyaluronic acid and to lidocaine or amide local anesthetics * subject with cutaneous infection on either foot or with history of autoimmune diseases or auto-inflammatory diseases, * subject who wishes to wear orthotic supports (shock-absorbing insoles or arch supports, etc...). * subject with history of bleeding disorders or or erysipelas of the lower limbs, * subject with chronic inflammatory pain of the feet due to other non-mechanical causes, such as plantar fasciitis, arthritis, gout, morton's neuroma.
thalassaemia severity

Conditions: Thalassaemia

Summary: this study aims to develop a nuanced understanding of thalassemia severity in upper egypt by integrating various clinical parameters beyond transfusion frequency. by doing so, it seeks to enhance patient management and ultimately improve quality of life for those affected by this condition.

thalassemia syndrome classified as hemoglobinopathies, represent one of the most prevalent classes of single-gene disorders globally. the mutations in the hbb gene lead to variable impacts on the production of globin proteins, which in turn affects the overall function of hemoglobin. the genetic variants contribute significantly to the diverse clinical presentations and severity of thalassemia. traditionally, thalassemia has been categorized into major, intermediate, and minor based on the frequency of blood transfusions required for survival it has been observed that anemia may not be the sole determinant of thalassemic disease severity, other factors are also responsible for overall clinical status. accordingly, clinical conditions of the thalassemia patient, cannot classified based on the transfusion status. phadke et al. (2006), proposed a classification that considers multiple parameters beyond transfusion status . similarly, sripichai et al , (2008) classified hbe/β-thalassemia into the 3 categories of mild, moderate, and severe. another classification was also introduced by thalassemia international federation (tif) , which 'was bit modification sripichai et al 2008 . despite these advancements, existing classifications still tend to simplify thalassemia into three categories globally, an estimated 1-5% of the global population are carriers of a genetic thalassemia mutation.although the epidemiology of the various clinical forms remains poorly recognized, the disease is known to be highly prevalent in the area extending from sub-saharan africa, through the mediterranean region and middle east, to the indian subcontinent and east and southeast asia.thus, \&gt;90% of patients with these disorders live in low- and middle-income countries

Eligibility criteria:
inclusion criteria: - children and adolescents aged from 18 month to 18 year old. those with thalassemia exclusion criteria: * non thalassaemia children

Keywords: thalassaemia severity score
optical diagnosis versus laser measurement of polyps' size during colonoscopy and implications for surveillance

Conditions: Colorectal Polyp

Summary: recent updates of the guidelines on polyp surveillance of the american society of gastrointestinal endoscopy (asge) and european society of gastrointestinal endoscopy (esge) increasingly focus on size of polyps as an important indicator of malignant transformation to colorectal cancer (crc). however, the interobserver variability in polyp size assessment between optical diagnosis of endoscopists and pathologists is considerable. this may lead to incorrect surveillance intervals in patients at risk for developing colorectal cancer, which may increase the risk of post-colonoscopy crc (pccrc). this study aims to assess the precision of a new laser-based measurement system (accumeasure, vtm technologies ltd.) for polyps during colonoscopy.

objective: the main objective is to compare the precision of polyp size measurement by accumeasure to biopsy forceps assisted measurement. secondary objectives are to assess: time needed for measurement and learning curve, endoscopists advised surveillance intervals based on both measurement methods, and safety. study design: multicenter, randomized, parallel group, endoscopist blinded study, including the measurement of 138 polyps during standard colonoscopy. with a polyp detection rate of approximately 40%1, this results in up to 345 patients/colonoscopies to be included. enrollment will conclude once 138 polyps are included in the study. study population: all adult patients with screening or surveillance colonoscopies will be asked for informed consent. polyps smaller than 25mm found during colonoscopy are considered eligible for inclusion. up to 3 polyps per patient can be included in this study. intervention: optical assessment will be performed upon identification of the polyp. then, measurement with accumeasure and biopsy forceps will be performed in a randomized order. the endoscopist will remain blinded to the accumeasure measurement outcomes, to avoid a learning effect that could influence subsequent measurements.

Eligibility criteria:
inclusion criteria: * • adult patients (\>18 years) * scheduled for screening, surveillance, or diagnostic colonoscopy * polyps of all forms ≤ 25mm as assessed by the endoscopist exclusion criteria: * • therapeutic colonoscopy; * inflammatory bowel disease (ibd); * american society of anesthesiologists (asa) score of \>3; * inadequately corrected anticoagulation disorder or anticoagulation medication use; * inability to provide informed consent; * inadequate bowel preparation (boston bowel preparation scale score \[bbps\] \<2 per segment); * no polyps identified during colonoscopy or only small (\<5mm) hyperplastic rectal polyps; * intraprocedural complications, not caused by the study device.

Keywords: screening colonoscopy surveillance
evaluating the efficacy and safety of vardenafil in patients erectile dysfunction solely secondary to spinal cord injury

Conditions: Erectile Dysfunction

Summary: investigate efficacy and safety of vardenafil in patients with spinal cord injury


Eligibility criteria:
inclusion criteria: * males ≥18 years with erectile dysfunction (ed) solely as a result of traumatic spinal cord injury (sci) for ≥6 months with demonstrated 50% failure in intercourse attempts during the 4-week run-in period. * stable heterosexual relationship for at least 1 month. exclusion criteria: * subjects with unstable medical or psychiatric conditions or using prohibited concomitant medications * primary hypoactive sexual desire * history of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month * nitrate therapy * other exclusion criteria apply according to us product information or summary of product characteristics

Keywords: erectile dysfunction traumatic spinal cord injury vardenafil
clinical protocol of sensitized acupoint changes in knee osteoarthritis patients

Conditions: Microdialysis

Summary: based on the research background and the preliminary research basis of the research group, in order to answer the material basis and micro-physical environment change characteristics of knee osteoarthritis sensitization acupoints and provide scientific basis for in-depth study of sensitization of acupoints. this study plans to use knee osteoarthritis as a research vehicle, and use microdialysis combined with high performance liquid chromatography to analyze the local material basis and key indicators of common sensitization points in knee osteoarthritis.

this trial is a single-centre, normal controlled, parallel group, clinical trial. the trial is an explorative, pilot trial designed to reveal the change of the main material group in sensitized acupoints caused by knee osteoarthritis, and provide the key signal substance and its changing characteristics of knee osteoarthritis sensitized acupoints.

Eligibility criteria:
inclusion criteria: meets the diagnosis criteria of knee osteoarthritis. age between 45 and 70 years. meets imaging examination x-ray kellgren and laerence classification standards grade i-iii. patients who meet the criteria for early or mid-term stage of knee osteoarthritis. discontinue use of pain medications and hormone drugs during the trial. the patient's vital signs are stable, can read his own medical history, and can cooperate with the relevant examination and treatment. signed the informed consent voluntarily. exclusion criteria: seriously patients with surgical indications associated systemic arthropathies, e.g. rheumatoid arthritis and gout heart failure bleeding diathesis liver failure knee arthroplasty there are diseases that may seriously endanger life, such as cardiovascular and cerebrovascular diseases, renal and liver failure, hematopoietic system diseases, etc. patients with mental illnesses that cannot be completed or are not suitable for treatment and examination patients who received treatment including traditional chinese medicine, western medicine, acupuncture, massage and physiotherapy within the past month patients on steroids history of intra articular injection of steroid within last six months joint irrigation or arthroscopy has been performed within the past year have had knee arthroplasty at the same time participate in other studies

Keywords: knee osteoarthritis sensitized acupoints microdialysis high performance liquid chromatography（hplc）
fio2 closed loop control ventilation

Conditions: Wounds and Injuries; Respiratory Failure

Summary: a randomized, multi-center trial involving critically-ill patients comparing conventional, manual control of inspired oxygen (fio2) within a target range, with a computer-controlled, closed-loop fio2 delivery using a continuous ventilator.

the trial will use a proportional-integral-derivative (pid) type controller for automatic adjustment of fio2 to maintain the spo2 within a target range, based on continuous use of pulse oximetry. intubated subjects will be randomized to either manual control of fio2 or closed-loop control of fio2, during a 12-hour period. the pclc is designed to respond to acute hypoxemia (spo2 \<88%) within seconds while preventing hypoxemia and minimizing exposure to excessive inspired oxygen levels.

Eligibility criteria:
inclusion criteria: * the subject's legally authorized representative will provide signed and dated informed consent. * age 18 - 65, inclusive. * admission to a surgical or neurosurgical intensive care unit following traumatic injury or acute surgical illness * requirement for endotracheal intubation * requirement for mechanical ventilation * patient is currently receiving inspired oxygen concentration (fio2) \>=40% exclusion criteria: * age under 18 or over 65 * isolated or severe head injury (glasgow coma scale = 6 or less) with expected survival less than 24 hours * brain death * anticipated survival less than 48 hours * pregnant female * patient in whom a pulse oximeter cannot detect a reliable signal due to hypotension, hypothermia, or other injury * known carbon monoxide poisoning * uncontrolled diabetic * patient who is unable to maintain spo2 level of 88% at an fio2 of 100% due to their medical condition. (note: being in the trial would impose no additional risk to a patient who presents with this condition however, data from a patient presenting with this pathophysiology would not provide insight into the performance of the controller as it would simply maintain that patient on an fio2 of 100%.) * patient with chronic hypercarbia. * patient where a physician believes that fio2 pclc could be detrimental to the management of the patient. * prisoner * spo2 to sao2 difference \>4% * patient with core temperature \<35 c
faah inhibitor trial for adults with tourette syndrome

Conditions: Tourette Syndrome

Summary: the purpose of this trial is to examine the safety, tolerability and feasibility in the use of a faah inhibitor for the treatment of adults with tourette syndrome.


Eligibility criteria:
inclusion criteria: * adult between 18-60 years of age * meet dsm iv criteria for the diagnosis of tourette's syndrome * significant current tic symptoms: ygtss total tic score greater than or equal to 22 at baseline * on stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning the trial. * accepted method of birth control exclusion criteria: * comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (iq\<70). * current use of medications that have significant effects on the cannabinoid or dopamine systems. subjects will be specifically excluded for recent use (within last 8 weeks) of antipsychotic medications, dopamine agonists or psychostimulants. * recent change (less than 4 weeks) in other medications that have potential effects on tic severity (such as alpha-2 agonists (guanfacine, clonidine or prazosin), ssris, clomipramine, naltrexone, lithium, anxiolytics, topiramate, baclofen etc.). medication change is defined to include dose changes or medication discontinuation. * recent change in behavioral treatment for tourette syndrome or comorbid conditions (i.e. ocd) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks. * positive pregnancy test or drug screening test * history of cannabis dependence * significant medical comorbidity

Keywords: tourette syndrome faah-inhibitor tics tic disorders
mri imaging of chronobiologic abnormalities in depression

Conditions: Depression

Summary: the purpose of the study is to identify and understand patterns of brain activity when people are depressed. the study will use an imaging method called magnetic resonance imaging (mri) which does not involve any exposure to radioactivity or radioactive substances.

the purpose of the study is to identify and understand patterns of brain activity when people are depressed. the study will use an imaging method called magnetic resonance imaging (mri) which does not involve any exposure to radioactivity or radioactive substances.

Eligibility criteria:
inclusion criteria: * weight: less than or at 20% over ideal weight, as specified in the 1983 metropolitan height and weight tables. patients who deviate from these ranges may be reviewed on an individual basis by the investigator. this criterion is necessary because of mechanical limitations in fitting overweight individuals into the scanner, and the risk of excessive claustrophobic responses if tightly constricted. * health: healthy, ambulatory normal or depressed adults exclusion criteria: * presence of aneurysm clips, cardiac pacemakers, cochlear implants, metal in the eyes, and implanted insulin pumps. * evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities. * pregnancy. * patients with a known or suspected history of alcohol or drug misuse and/or a positive urine drug screen. * patients who are unwilling or unable to abide by the requirements of the study or who violate the prohibitions and restrictions of the study. * any condition which would make the patient, in the opinion of the investigator, unsuitable for the study. * patients on antidepressants may not be taking any other medication, except at the discretion of the investigator. untreated depressed or healthy subjects must be free of all medications except as approved by the investigator. * patients with serious medical illness, history or signs/symptoms of lumbar spine/disc disease or significant laboratory findings. * patients who present significant suicide risk, e.g. with a history of highly impulsive suicide attempts.

Keywords: depression mri imaging