Kornimate/medical-research-clean huggingface dataset:
development and evaluation of a methadone protocol for severe chronic pain management

Conditions: Pain, Chronic

Summary: methadone is a synthetic mu opioid agonist that has been proved as clinically effective in pain management. however, methadone usage for pain control in thailand has been limited because physicians are not familiar with its dosing and concern about the risk of drug accumulation and cardiac arrhythmia. therefore, this prospective study was conducted to evaluate the efficacy and safety of a methadone protocol in thai patients with severe chronic noncancer and cancer pain.

chronic pain is defined as pain that persists beyond normal tissue healing time, which is assumed for 3 months by the iasp. the symptoms include either continuous or intermittent pain, that could be caused by tumor or other multiple etiologies. the consequence of uncontrolled chronic pain presents not only physiologic symptoms but also psychiatric disorders leading to severely impact daily living. in thailand, the use of methadone for pain management has been limited because physicians are not familiar with its dosing and concern about the risk of drug accumulation and cardiac arrhythmia. therefore, the aim of this study is to evaluate the efficacy and safety of a protocol of methadone dosing in outpatients with severe chronic pain. thirty four chronic pain patients will be included to initiate methadone use following the protocol. pain scores, pain interferences scores, neuropathic pain score, severity of adverse effects, and qtc intervals will be assessed at baseline, and two, four, eight, and twelve weeks after starting methadone. the approved protocol of methadone therapy obtained from this study could be clinically utilized by physicians for severe chronic pain management.

Eligibility criteria:
inclusion criteria: * outpatients aged 18 or over who suffered from severe chronic cancer or noncancer pain to be firstly treated with methadone as analgesics exclusion criteria: * qtc interval that was more than 500 msec * history of opioid addiction * having structural heart diseases * during pregnancy or lactation period * patients who have hypersensitivity to methadone

Keywords: methadone chronic pain noncancer pain cancer pain qtc prolongation
evaluation of optical system in the treatment of - dry eye disease

Conditions: Dry Eye Syndromes

Summary: single-center, prospective, open label, with before-after study design, to evaluate the safety and efficacy of the optical system in the treatment of dry eye disease.

single-center, prospective, open label, with before-after study design. up to 15 subjects will be enrolled in the study to provide at least 10 evaluable subjects. all subjects will undergo 3 treatments two weeks apart (2 weeks (+/-3 days) from the previous treatment). follow-up visits after the last treatment visit: 4 weeks (±7 days), 12 weeks (±7 days).

Eligibility criteria:
inclusion criteria: * age 18 years and older of any gender or race. * provide written informed consent before study participation. * willingness and ability to return for all study visits. * ocular surface disease index (osdi) questionnaire and a score of ≥ 23 at the baseline visit. * tear break-up time (tbut) \<10 seconds in both eyes. * agreement/ability to abstain from dry eye/mgd medications for the time between the treatment visit/s and the final study visit. ocular lubricants are allowed if no changes are made during the study. exclusion: * history of ocular surgery including intraocular, oculoplastic, corneal or refractive surgery within 1 year. * patients with giant papillary conjunctivitis. * patients with punctal plugs or who have had punctal cautery. * ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination. * active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months. * aphakic patients. * cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc. * active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye). * active ocular inflammation or history of chronic, recurrent ocular inflammation within 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis). criteria: -
post-trial access for guselkumab in participants with familial adenomatous polyposis

Conditions: Adenomatous Polyposis Coli

Summary: the purpose of this post-trial access (pta) program is to provide guselkumab to participants with familial adenomatous polyposis (fap) who are experiencing clinical benefit after completing 48 weeks of treatment in study cnto1959cor1001.


Eligibility criteria:
vitamin/mineral supplement for children and adults with autism

Conditions: Autism

Summary: the investigators hypothesis is that a new, revised formulation of a vitamin/mineral supplement will result in: 1. improvement of nutritional status in some children/adults with autism, and 2. reduction of some of the symptoms of autism in some children

the major goal of this study is to determine the effect of this vitamin/mineral supplement on levels of vitamins, minerals, neurotransmitters, and biomarkers for nutritional deficiencies. the study design is a randomized, double-blind, placebo-controlled. blood and urine measurements will be measured at the beginning of the study in children with autism and typical children. then, the children with autism will be given the supplement or placebo for 12 weeks, and then their blood and urine will be re-measured.

Eligibility criteria:
inclusion criteria: 1. age 3-60 years old; 2. autism group: diagnosis of autism, pervasive developmental disorder/not otherwise specified (pdd/nos), or asperger's by a psychiatrist or similar professional 3. control group: in good mental and physical health, and no siblings with autism spectrum disorders, and no evidence of attention deficit disorder by parent report exclusion criteria: 1. usage of a vitamin/mineral supplement in the last 2 months 2. current use of any chelation treatment

Keywords: vitamins minerals
a study to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous infusions of abbv-951 in subjects with parkinson's disease

Conditions: Parkinson's Disease (PD)

Summary: the purpose of the study is to assess the safety, tolerability, and pharmacokinetics of single, ascending doses of abbv-951 administered as a subcutaneous bolus infusion followed by a continuous subcutaneous infusion in subjects with parkinson's disease.


Eligibility criteria:
inclusion criteria: * subject has a diagnosis of definite idiopathic pd, which is ld responsive, according to the united kingdom parkinson's disease society brain bank criteria. * subject must be taking an optimized and stable regimen of oral medications for pd, which has remained stable and unchanged for at least 30 days before dosing in this study. this regimen must include oral carbidopa/levodopa (cd/ld) tablets (e.g., sinemet). * females must have negative results for pregnancy tests at screening and prior to confinement. * if male, subject must be surgically sterile or practicing an adequate method of birth control from initial study drug administration until 30 days after last dose of study drug. * body mass index (bmi) is 18.0 to 38.0, inclusive. * a condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ecg). exclusion criteria: * receipt of any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration. * history of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations that in the investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments. * use of any medication from the prohibited concomitant therapies. * subjects with glomerular filtration rate (gfr) less than 45 ml/min/1.73 m2 as determined by the chronic kidney disease epidemiology collaboration (ckd-epi) creatinine equation. * donation or loss of 550 ml or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to initial study drug administration. * consideration by the investigator for any reason that the subject is an unsuitable candidate to receive abbv-951.
effect of a preparation video on preoperative anxiety in children undergoing dental treatment under ga

Conditions: Preoperative Anxiety

Summary: the present study investigated the effect of an animated preoperative preparation video in mitigating preoperative anxiety among children receiving comprehensive dental treatment under general anesthesia (ga).

this randomised controlled trial, conducted at king abdullah university hospital (kauh) over an eight-month period from february to october 2023, focused on children aged four to seven years undergoing comprehensive dental treatment under ga. participants were randomly assigned to either the control group or the study group. participants in the control group received the standard care provided upon arrival at the day case unit (dcu) at kauh, involving only a verbal explanation of the anaesthesia induction process. in contrast, on the night before the surgery, participants in the study group were presented with an animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home. additionally, all parents watched the video alongside their children and provided positive comments on its content. the primary outcome assessed was the children's preoperative anxiety measured by modified yale preoperative anxiety scale (m-ypas) and visual facial anxiety scale (vfas), allowing for an evaluation of the intervention's impact.

Eligibility criteria:
inclusion criteria: * children who are healthy, with american society of anesthesiologists (asa) grade 1 and 2 status. * age 4-7 years. * children undergoing ga for the first time who require comprehensive dental rehabilitation. exclusion criteria: * presence of a systemic disease, as well as mental, cognitive, and intellectual disabilities. * presence of visual or auditory disability. * participants who refuse to answer subjective scales due to heightened anxiety levels. * participants with no access to internet services. * presence of active severe dental pain and/or facial abscess as it could affect the participant's state anxiety.
imaging possible appendicitis with ct

Conditions: Abdominal Pain

Summary: pain in the right lower abdomen is one of the commonest reasons patients present to general surgeons as an emergency. whether or not such patients have appendicitis is crucial to their assessment. in uk practice, when the diagnosis is unclear, ultrasound scanning (us) is commonly used to investigate the problem. us is very safe but it will only visualise the appendix in the minority of cases. as a result, the sensitivity for diagnosing appendicitis in this setting is probably only 5-30%. alternatively, computed tomography (ct) is an accurate way of diagnosing appendicitis in over 90% of cases. ct scans are readily available and with modern scanners, high quality images can be achieved with lower radiation doses. unenhanced scanning avoids the use of contrast media and permits further reductions in ionising radiation exposure.

pain in the right lower abdomen is one of the commonest reasons patients present to general surgeons as an emergency. whether or not such patients have appendicitis is crucial to their assessment. in uk practice, when the diagnosis is unclear, ultrasound scanning (us) is commonly used to investigate the problem. us is very safe but it will only visualise the appendix in the minority of cases. as a result, the sensitivity for diagnosing appendicitis in this setting is probably only 5-30%. alternatively, computed tomography (ct) is an accurate way of diagnosing appendicitis in over 90% of cases. ct scans are readily available and with modern scanners, high quality images can be achieved with lower radiation doses. unenhanced scanning avoids the use of contrast media and permits further reductions in ionising radiation exposure.

Eligibility criteria:
inclusion criteria: • acute presentation with abdominal pain and/or tenderness which is most marked in the right lower abdomen exclusion criteria: * age\<18 * age\>60 * pregnancy * patients with a firm clinical diagnosis of appendicitis where surgical management is indicated at presentation * patients who have undergone ct scanning within the past two months * patients with cognitive impairment who would lack capacity to give consent * inability to understand written or spoken english * patients who have previously undergone appendicectomy
prophylactic norepinephrine and phenylephrine infusion for hemodynamic effects in patients with preeclampsia

Conditions: Hemodynamic Instability

Summary: the purpose of this study is to investigate the maternal cardiac output response to prophylactic norepinephrine and phenylephrine infusion for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. in preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. as a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. however, hemodynamic effects of the prophylactic norepinephrine infusion is still unknown. the purpose of this study is to investigate the maternal cardiac output response to prophylactic norepinephrine and phenylephrine infusion for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

Eligibility criteria:
inclusion criteria: * 18-45 years * primipara or multipara * singleton pregnancy ≥32 weeks * american society of anesthesiologists physical status classification ii to iii * scheduled for cesarean section under spinal anesthesia exclusion criteria: * baseline blood pressure ≥180 mmhg * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension * hemoglobin \< 7g/dl * fetal distress, or known fetal developmental anomaly

Keywords: norepinephrine phenylephrine hemodynamic effects preeclampsia cesarean section
topical/oral melatonin for preventing concurrent radiochemotherapy induced oral mucositis/xerostomia cancer patients

Conditions: Head and Neck Cancer

Summary: the study evaluates the effect of melatonin for preventing concurrent radiochemotherapy induced oral mucositis and xerostomia and improving quality of life in head and neck cancer patients. this is a randomized, double-blind, placebo controlled trial conducted in head and neck cancer patients. mixed-block randomization is used to divide eligible patients into two groups: melatonin 40 mg or matched placebo. the patients are required to take the studied drugs 20 mg suspensions before radiation and 20 mg capsules at night (after 21.00 pm) on the first night of radiation and continue for 7 weeks. standard treatment is radiation 2 gy 5 fraction/week not more than 7 weeks with cisplatin chemotherapy base regimen according to standard hospital protocol. study endpoints are level of mucositis (ctcae scale, who scale and mts scores), level of xerostomia (ctcae scale, vas), qol (fact-h\&n), pain (vas 0-10) and adverse event frequency.


Eligibility criteria:
inclusion criteria: * new diagnostic of head and neck cancer patient who need treatment with radiation involved with the oral cavity area. * never received radiotherapy or chemotherapy * karnofsky performance status \> 70% * stopped smoking * able to eat and swallow medications * written informed consent exclusion criteria: * melatonin allergy * active oral cavity inflammation scar * pregnancy * creatinine clearance \< 30 ml/min * active periodontal disease * steroids or pain killer drugs used for oral cavity pain except nsaids for thromboembolism prevention * currently use benzydamine mouthwash
intraoral measurement of pressure in preterm infants

Conditions: Preterm Infants

Summary: the aim of the study is to show pressure curves in the nasopharynx in non-invasively ventilated and spontaneously breathing premature and newborn babies

the aim of the investigation is to show the pressure curves in the nasopharynx in non-invasively ventilated and spontaneously breathing premature and newborn babies, with a number large enough for an analysis. for this purpose, the pressure in the nasopharynx of these children is to be measured using a suction catheter, as is usually used to suction off mucus and saliva, and the measured values are to be evaluated with software. this method is a tried and tested method in adults for measuring the pressure conditions in the nasopharynx, which was developed and used by mr. olthoff. a possible later clinical application in premature and newborn infants ranges from the measurement of breathing and ventilation to manual control of respiratory support depending on the measured value to automatic triggering and control of a ventilator in the sense of nsippv ventilation (non-invasive synchronized intermittent positive pressure ventilation )

Eligibility criteria:
inclusion criteria: newborns, non-invasive ventilation exclusion criteria: * bad clinical condition of the patient (e.g. sepsis) * bleeding tendency * anatomical peculiarities that make it difficult to insert the suction catheter through the nose (e.g. choanal atresia) * lack of acceptance of the probe by the child * proven infection / colonization of the child by a multi-resistant germ (mrgn 2-4, mrsa) or with noro- / adenoviruses * missing / withdrawn consent by the legal guardians
a study to evaluate the efficacy and safety of simtuzumab combined with gemcitabine for metastatic pancreatic adenocarcinoma

Conditions: Pancreatic Cancer

Summary: this study will compare the efficacy of simtuzumab (gs-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. the treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.


Eligibility criteria:
inclusion criteria: * initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior to the completion of screening. * the presence of measurable metastatic pancreatic cancer documented by contrast enhanced ct (or mri) scan in addition to 1 of the following: 1. histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist or 2. pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreatic origin in conjunction with either: 1. the presence of a mass in the pancreas or 2. a history of resected pancreatic carcinoma * measurable disease per recist (ver. 1.1) * ecog performance status of 0 or 1. * adequate hepatic, hematologic and renal functions. exclusion criteria: * a history or evidence of clinically significant disorder other than metastatic cancer of the pancreas. * a diagnosis of pancreatic islet neoplasms. * subject has undergone major surgery other than diagnosis surgery within 4 weeks of randomization * presence of biliary obstruction requiring external drainage * brain metastases. * unstable cardiovascular function within the last 6 months of screening * clinically active liver disease, including active viral hepatitis (hbv or hcv) or cirrhosis * known hiv infection. * uncontrolled hypertension at screening * history or presence of any form of cancer, other than pancreatic cancer, within the 3 years prior to enrollment * prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced pancreatic cancer are allowed. * uncontrolled systemic fungal, bacterial or viral infection * participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study

Keywords: gsi gilead gilead sciences pancreatic cancer pc gemcitabine phase 2 phase ii gs-6624 oncology monoclonal antibody