Kornimate/medical-research-clean huggingface dataset:
investigation of efficacy of improved acetaminophen labeling

Conditions: Acetaminophen Overdose; Pain

Summary: the purpose of this study is to evaluate, through brief, one-on-one cognitive interviews, the efficacy of 'enhanced' acetaminophen messages and icons in improving consumer understanding and use of prescription (rx) and non-prescription (over-the-counter, otc) acetaminophen containing products compared to the current standard.

acetaminophen is a pain reliever and fever reducer found in many over-the-counter (otc) analgesics as well as prescription (rx) products commonly prescribed at discharge from the emergency department. 1 an estimated 36% of americans ingest acetaminophen at least once a month.1, 2 while acetaminophen is generally safe and effective when used at recommended doses, acetaminophen overdose has surpassed viral hepatitis as the leading cause of acute liver failure (alf) in the united states.2-4 moreover, one half to two-thirds of overdoses leading to acute liver failure are unintentional, suggesting the root cause may be poor understanding of medication labeling or failure to recognize the consequences of exceeding the recommended maximum daily dosage.2-4 on-going studies by this research group have shown patient misunderstanding of dosing instructions and warnings associated with otc medicines to be prevalent. it has also been suggested that patients receiving prescription medications containing acetaminophen may not be informed or aware of the potential risk of acetaminophen overuse when taking prescription products in combination with over-the-counter pain relievers.1 this is supported by the finding that a third of narcotic users were simultaneously using an otc acetaminophen containing product in a multicenter study of alf cases.2 to address the growing concern of acetaminophen misuse, in june 2009 the us food and drug administration (fda) convened a panel to discuss the maximum dose recommendations of acetaminophen found in otc medications. the panel concluded that there was a notable lack of available evidence on consumer understanding and use of over-the-counter acetaminophen products. studies are needed to explore patients' 1) knowledge of potential acetaminophen overdose when using prescription analgesics simultaneously with non-prescription acetaminophen and 2) avenues available to increase awareness of potential acetaminophen overdose from misuse of both otc and rx acetaminophen containing medicines.

Eligibility criteria:
inclusion criteria: * 18-80 years old * english speaking exclusion criteria: * visual or hearing impairments * moderate to severe cognitive impairments

Keywords: acetaminophen patient safety health literacy
study of aripiprazole in patients with a history of bipolar disorder

Conditions: Bipolar Disorder

Summary: the purpose of this study is to learn if aripiprazole is effective in the treatment of patients with a history of bipolar disorder.


Eligibility criteria:
patients with a history of bipolar i disorder

Keywords: bipolar i disorder
ptc299 for treatment of neurofibromatosis type 2

Conditions: Neurofibromatosis 2

Summary: formation of new blood vessels (angiogenesis) is important for tumor growth in neurofibromatosis type 2 (nf2). it is known that tumors make a protein called vascular endothelial growth factor (vegf) and there are higher levels of vegf in the tumors and blood of many patients with nf2. vegf stimulates the formation of blood vessels that supply the tumor with nutrients and oxygen. ptc299 is an oral drug that has been shown to decrease production of vegf in animal models of human cancer. in these animal models, oral ptc299 administration decreases vegf levels in the tumor and in the bloodstream, decreases blood vessel numbers in the tumor, and significantly slows or halts tumor growth. safety studies in research animals indicate good tolerability at doses and drug levels that are higher than those planned for the clinical studies. results from phase 1a studies in healthy volunteers indicate that ptc299 achieves levels of ptc299 in the bloodstream that are known to be active in animal models of human tumor. this phase 2 study is designed to test the hypothesis that ptc299 will be tolerable and will show evidence of vegf reduction, antitumor activity, and hearing improvement when administered orally to patients with nf2.

the study will be conducted in 2 stages. in stage 1 of the study, 11 patients will receive daily treatment with ptc299 administered at 100 mg/dose twice per day for up to 1 year or until tumor progression. if no subject responds with tumor shrinkage or an improvement in hearing, then the study will be stopped. if ≥1 out of 11 subjects respond, then the study will proceed to stage 2 to enroll an additional 14 subjects for a total of 25 subjects.

Eligibility criteria:
inclusion criteria: * age ≥18 years * diagnosis of nf2 * presence of vestibular schwannomas * evidence of progressive increase in vestibular schwannoma size or worsening hearing loss due to vestibular schwannoma * adequate functional status (karnofsky performance score ≥60) * adequate bone marrow, liver, kidney function * if sexually active, willingness to use effective barrier or medical contraception * for women of childbearing potential, no pregnancy or breast-feeding * discontinuation of other therapies (except corticosteroids) for the treatment of nf2 and resolution of any acute toxic effects of prior therapies * willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions * willingness to provide informed consent exclusion criteria: * uncontrolled hypertension, major bleeding, hiv infection, or recent acute cardiovascular event * prior exposure to another anti-angiogenic therapy (eg, bevacizumab, sunitinib)

Keywords: angiogenesis neurofibromatosis post-transcriptional control ptc299 vegf
dynamics of 18-fdg uptake in stage iii/iv non small cell lung cancer during first line pembrolizumab treatment

Conditions: Non Small Cell Lung Cancer

Summary: the aim of this study is to describe the early dynamics of 18-fdg uptake in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response at 3 months.

immunotherapy with anti-pd1 antibody, such as pembrolizumab, is widely used in the treatment of stage iii/iv non small cell lung cancer. in order to refine treatments and patients' prognosis, early assessment of tumour response is needed. the aim of this study is to describe the early tumour metabolic changes in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response. eligible patients with stage iii/iv, pdl1\>50% nsclc will receive pembrolizumab treatment as per standard of care. tumour metabolism will be assessed by 18-fdg petscan before each of the 3 first pembrolizumab infusions. treatment response will be determined by recist, irrc and mchoi criteria at 3 months. prognostic and predictive value of baseline and dynamic metabolic parameters will be assessed.

Eligibility criteria:
inclusion criteria: * non operable non small cell lung cancer * indication of treatment by pembrolizumab * pd-l1 status superior to 50 % * age more than 18 years * at least one measurable target * written inform consent exclusion criteria: * no treatment by pembrolizumab * immunosuppressive treatment * uncontrolled diabete * pregnancy or breast-feeding * curatorship or guardianship * not possibility to follow-up the procedures of the study due to geographic, social or psychic reasons

Keywords: pet scan imaging pembrolizumab response parametric imaging
clinical efficacy of darqeen capsule for the management of hypothyroidism associated with female reproductive hormonal imbalance

Conditions: Hypothyroidism

Summary: study objectives 1. to assess the safety of darqeen capsule for the management of hypothyroidism 2. evaluate the efficacy of darqeen capsule for the management of hypothyroidism 3. to provide an alternative cost-effective treatment for the management of females suffering from hypothyroidism. null hypothesis (ho) the unani medicine darqeen capsule is not effective for the management of hypothyroidism. alternate hypothesis (h1) unani medicine darqeen capsule is effective for the management of hypothyroidism.

hypothyroidism is a common endocrine disorder characterized by deficiency in the thyroid hormones, thyroxine (t4) and triiodothyronine (t3) which are crucial for regulating metabolism and maintaining overall bodily functions. there are several etiologies and manifestations of hypothyroidism. the most common clinical signs are weight gain, hair loss, sensitivity to cold, tiredness, constipation, dry skin, and voice changes. the prevalence in pakistan has been a growing concern, necessitating extensive research to address the underlying causes, risk factors, and optimal management strategies. it is estimated that hypothyroidism impacts approximately 5% of the population and 15% in females, with up to 5% possibly having undiagnosed thyroid failure. in pakistan, the prevalence of hypothyroidism is reported to be 4.1%. the description of qillat-e-ifraz-e-darqiyya (hypothyroidism) in unani system of medicine resembles the clinical manifestation associated with su-e-mizaj barid maddi (derangement in cold temperament). the management of hypothyroidism involves thyroid hormone replacement therapy with levothyroxine, regular monitoring of hormone levels, and lifestyle modifications like a balanced diet, exercise, and stress management. iodine supplementation is recommended in iodine-deficient regions, while underlying causes and pregnancy considerations should be managed. educating patients about their condition and treatment plan is essential for active involvement in their health management. darqeen capsule is an unani polyherbal formulation that primarily consists of natural ingredients, it is time tested pharmacopoeia formulation that is further modified by hamdard research center. it is being used clinically for more than two years at hamdard matabs all around pakistan and found effective for managing hypothyroidism and its associated symptoms.

Eligibility criteria:
inclusion criteria: * subjects diagnosed with hypothyroidism * having raised tsh * t3 \& t4 hormones level below normal limits * females between the age group of 15-45 years exclusion criteria: * subjects below the age group of 15 and above 45 * suffering from chronic liver diseases and kidney failure, cancer or any other comorbid condition * currently taking any medication for hypothyroidism or having history of adverse drug reaction * pregnant and lactating mothers.

Keywords: hypothyroidism female infertility hormonal imbalance qillat e afraz e darqiyya
clinical trial on alpha lipoic acid in diabetic macular edema

Conditions: Diabetes Mellitus; Macular Edema

Summary: to evaluate the effect of alpha lipoic acid (ala) on the occurrence of diabetic macular edema.

randomised, double-blind, placebo controlled multicentre study. patients were randomised to the treatment group with 600 mg ala per day or the placebo group. at each examination we took stereo fundus photographs, hba1c levels, and performed an ophthalmological examination. primary endpoint of the study was the occurrence of clinically significant macular edema (csme) within a follow-up period of 2 years.

Eligibility criteria:
inclusion criteria: * diabetes type ii, mild non proliferative diabetic retinopathy, * microalbuminuria \> 30 mg/l exclusion criteria: ophthalmic exclusion criteria * severe non-proliferative or proliferative diabetic retinopathy * macular edema * eye diseases interfering with the examinations of the fundus such as preretinal haemorrhage, cataract, vitreous haemorrhage * amblyopia * best corrected visual acuity (va) over 0.5 * glaucoma * patients with cataract surgery within a period of three months * other relevant retinal diseases * non-authorized interventional therapy of diabetic retinopathy (e.g. laser, kryo-coagulation, vitrectomy) * general exclusion criteria * chronic administration of alpha lipoic acid or of more than five successive days during the last twelve months * known intolerance/hypersensitivity to alpha lipoic acid * type i diabetes mellitus * poor metabolic control with hba1c \>10.5 %/dl * late sequelae of diabetes with organic manifestation (e.g. dialysis in cases of renal insufficiency, history of kidney transplantation, creatinine \> 1.6 mg/dl) * poorly controlled arterial hypertension (systolic blood pressure \> 160 mmhg and/or diastolic blood pressure \> 95 mmhg) * severe disturbances in lipid metabolism (triglycerides \> 500 mg/dl or total cholesterol \> 320 mg/dl) * unpermitted concomitant medication defined as any medicine with a potential interaction with alpha lipoic acid or with the effect of alpha lipoic acid were excluded as concomitant medication. these included aldose reductase inhibitors, substances promoting blood flow, anticoagulants apart from acetylsalicylic acid 500 mg/day and short-term treatment of diseases with the normal dose of acetylsalicylic acid, chronically and systemically administered corticosteroids, hormonal contraceptives * malignancies or life threatening diseases * drug or alcohol abuse * blood donation or blood loss greater than 500 ml) within the last 3 months * pregnancy or breast feeding * participation in a clinical trial within the last 30 days

Keywords: macular edema diabetes mellitus prevention alpha lipoic acid
investigating bioequivalence between single-dose liraglutide administered subcutaneously with two different pen-injectors

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: this trial is conducted in europe. the aim of this trial is to investigate bioequivalence between single-dose liraglutide administered subcutaneously with two different pen-injectors.


Eligibility criteria:
inclusion criteria: * male or female, age 18-60 years (both inclusive) at the time of signing informed consent * body mass index (bmi) greater than or equal to 27.0 and less than 35.0 kg/m\^2 * bodyweight up to 130.0 kg (inclusive) * hba1c (glycosylated haemoglobin) below 6.5% exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner * history or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the trial, as judged by the investigator * use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (but including mega-dose vitamin therapy, as judged by the investigator) within 2 weeks before the trial defined as screening * significant history of alcoholism or drug/chemical abuse within 1 year from screening, or a positive result of the urine drug screen or alcohol breath test, or consuming more than 21 units of alcohol per week (one unit of alcohol equals about 250 ml of beer or lager, one glass of wine (120 ml), or 20 ml spirits) * smoking more than 5 cigarettes, or the equivalent, per day and unable to refrain from smoking during the in-house periods
walnut consumption and gut microbiota

Conditions: Obesity; Inflammation

Summary: obesity is a growing health issue that effects the majority of adults in the united states. prevalence of other metabolic diseases are increased in obese adults, including systemic inflammation. there is emerging evidence that the gut microbiota have a mediating role in controlling inflammation by producing butyrate when ingested fiber is fermented. since these microbes are modifiable by diet, the investigators plan to introduce walnuts to the diets of participants with obesity because they are rich in fiber and unsaturated fatty acids. the purpose of this study is to understand the impacts of walnut consumption on the gut microbiota and the effect they have on bile acid profiles and systemic inflammation. the investigators intention is to identify how these walnut-derived molecules influence faecalibacterium spp., a butyrate producing microbe. increased levels of butyrate have shown to decrease secondary bile acids and decrease inflammation.


Eligibility criteria:
inclusion criteria: participants will include adults ages 25-75 years bmi of \> 30 kg/m2 ability to drop-off fecal sample within 15 minutes of defecation exclusion criteria: * walnut allergy or intolerance * food allergies or intolerances * prior diagnosis of metabolic or gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, hiv, cancer, etc.) * women that are pregnant, had a baby within the last 12 months, or lactating * individuals that smoke, use tobacco, abuse drugs, or consume \> 2 alcoholic beverages per day. * \> 5% weight change in the past month or \> 10% change in the past year * oral antibiotics during the previous 6 weeks * fasting blood glucose \>126 mg/dl, blood pressure \>160/100 mm hg, elevation in serum transaminases (i.e. \>3 times the upper limit of normal) or with evidence of liver disease, including primary biliary cirrhosis or gallbladder disease, constipation, are currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin, or certain medications (laxatives, bile acid sequestrants, and opiates) * history of malabsorptive or restrictive bariatric surgeries (e.g., gastric bypass, sleeve gastrectomy, adjustable gastric band) or gall bladder removal surgery. * are unable to consume the experimental meals/snacks. * participants who have donated blood within the last 8 weeks * recent diagnosis of anemia * concurrent enrollment in another dietary, exercise, or medication study

Keywords: walnuts gastrointestinal microbiota bile acid profiles inflammation glycemia insulinemia
effect of raw milk on the immune response upon cholera vaccination

Conditions: Infection

Summary: rationale: infections are an important worldwide cause of death, both in elderly and young children. therefore, support of immunity could help to reduce the incidence of infections. to screen the potential of specific foods or food ingredients to support immunity, oral vaccination can serve as a model. in this study, oral cholera vaccination will be applied in human adult volunteers, and used as a model to study the support of the immune response by raw milk. objective: to investigate whether raw milk is able to enhance the immune response as induced by oral cholera vaccination. study design: the study is designed as a single-blind randomized controlled trial of 4 weeks. study population: healthy subjects of 18-50 years of age. intervention: raw milk, obtained from farms that comply to the high quality requirements for production of raw milk, and that has been screened according to the safety criteria for raw milk.


Eligibility criteria:
inclusion criteria: * age 18-50 yr * signed informed consent * availability of internet connection * male or female * willing to stop blood donation at the blood bank during the study period exclusion criteria: * currently participating in another clinical trial * previous cholera, salmonella, or e. coli vaccination * tonsillectomy * acute gastroenteritis in the past 2 months * use of antibiotics in the past 2 months * hypersensitivity to the vaccine, to formaldehyde or to any of the excipients (sodium salts) * pregnancy or lactating (pregnancy test will be performed on the vaccination days) * not willing to drink raw milk * allergic to milk or lactose-intolerant * disease of gi tract, liver, gall bladder, kidneys, thyroid gland * immune-compromised * use of immunosuppressive drugs * drug abuse, and not willing/able to stop this during the study * excessive alcohol usage (men: \>4 consumptions/day or \>20 consumptions/week; women: \>3 consumptions/day or \>15 consumptions/week)

Keywords: immunity vaccination milk
a controlled study on regulation of systemic inflammation by fecal bacteria transplantation in patients with covid-19.

Conditions: Fecal Microbiota Transplantation; COVID-19 Infection

Summary: a total of 30 hospitalized patients with covid-19 over 60 years old were enrolled in this study and were divided into the experimental group (n=15) and the control group (n=15) at a ratio of 1:1. both groups were treated according to the 2022 shanghai guidelines for diagnosis and treatment of covid-19 infection and the hierarchical diagnosis and treatment process. the experimental group was treated with fecal microbiota transplantation (fmt) capsules for 1 week, and the control group was treated with empty capsules. patients in both groups were followed up for 1 month after discharge. to observe the effect of combined fmt capsule treatment on the regulation of inflammatory factors in peripheral blood and the remodeling of intestinal flora, and to verify its safety.


Eligibility criteria:
inclusion criteria: * 1. over 60 years old, male or female; 2. meet the diagnostic criteria of covid-19; 3. the patient signed the informed consent, agreed to receive fmt capsule treatment, agreed to cooperate with the whole process of the clinical trial, and agreed to collect clinical data and blood, saliva, urine, stool and other samples; 4. the patient was able to swallow 3# capsules by herself. exclusion criteria: * 1. confirmed diagnosis of non-covid19 pneumonia; 2. critically ill patients requiring mechanical ventilation, or patients who are unable to eat by mouth and swallow 3# capsules; 3. patients who had undergone gastrointestinal surgery; 4. presence of intestinal organic lesions such as congenital megacolon, intestinal obstruction, intussusception, etc. 5. pathological intestinal inflammatory changes, such as inflammatory bowel disease; 6. planned use of antacids, probiotics, antibiotics, fmt and other treatments affecting intestinal flora within the past 3 months or the following 2 months; 7. patients and their families did not agree to receive fmt treatment; 8. patients unable to cooperate with follow-up visits.
time-dependent improvement of functional outcome following lcs rotating platform tkr

Conditions: Osteoarthritis; Total Knee Replacement

Summary: the objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the knee injury and osteoarthritis outcome score (koos) and (2) the time course of range of motion (rom) the first four years following tkr using the lcs rotating platform prosthesis. improvement of patient self-reported pain and daily function during the study period, are of particular interest.


Eligibility criteria:
inclusion criteria: * patients with knee osteoarthritis * admitted for total knee replacement * no rheumatoid arthritis * no previous knee infection * age 40-85 years exclusion criteria: -