Kornimate/medical-research-clean huggingface dataset:
double-blind, placebo controlled, phase 3 trial of zgn-440 (beloranib) in obese subjects with prader-willi syndrome

Conditions: Prader-Willi Syndrome; Obesity

Summary: the purpose of this study is to evaluate efficacy and safety of zgn-440 (beloranib) in obese adolescent and adult subjects with prader-willi syndrome.

phase 3, randomized, double-blind, placebo controlled, phase 3 trial of zgn-440 (subcutaneous beloranib in suspension) in obese subjects with prader-willi syndrome to evaluate total body weight, food-related behavior, and safety over 6 months

Eligibility criteria:
inclusion criteria: * confirmed genetic diagnosis of prader-willi syndrome * age 12-65 * obesity * age 12-17: bmi ≥ 95th percentile for age and gender * age 18-65: bmi ≥27 to ≤60 kg/m2 exclusion criteria: * subjects living in a group home ≥ 50% of the time * recent use (within 3 months) of weight loss agents including herbal medication * poorly controlled severe psychiatric disorders

Keywords: prader-willi syndrome obesity hyperphagia
glycemic control and iron status in diabetic pregnancies - a study of new markers

Conditions: Diabetes Mellitus Pregnancy

Summary: this is an observational study at the obstetrical outpatient clinic at stavanger university hospital. the main goal is to compare the current marker of glycemic control (glycated hemoglobin a1c, hba1c) with glycated albumin in pregnancies with pregestational diabetes mellitus. women with diabetes are at increased risk for adverse pregnancy outcomes. with improved glycemic control, the risk decreases. glycated albumin is suggested to be a better marker for monitoring glycemic control in pregnancies because it reflects blood glucose for a shorter period than hba1c (3 versus 8-12 weeks). other studies have shown that hba1c increases in pregnancy because of iron deficiency. the investigators want to investigate hba1c, glycated albumin and iron status in diabetic pregnancies. the investigators will compare hba1c and glycated albumin throughout pregnancy with the patient's own blood glucose measurements or data from cgm (continuous blood glucose monitoring). blood samples for hba1c and glycated albumin will be taken 6 times during pregnancy (week 12, 20, 24, 28, 32, 36).


Eligibility criteria:
inclusion criteria: * pregestational diabetes mellitus * singleton pregnancy * follow-up at stavanger university hospital in pregnancy exclusion criteria: * gestational diabetes * twin pregnancies

Keywords: hba1c glycated albumin
prevalence of hiatus hernia in gastro-esophageal reflux disease patients underwent upper endoscopy

Conditions: Hiatus Hernia

Summary: to study the prevalence of hiatus hernia in gerd patients underwent upper endoscopy to study the effect of hiatus hernia on the severity of gerd symptoms.

gastro-esophageal reflux disease (gerd) is a common problem for which patients seek care from a broad array of primary care providers, medical sub-specialists, and surgeons. it is estimated that 10 to 20 percent of people in western countries have gerd, when defined as heartburn or regurgitation at least once a week. (chapelle, et al. 2021) the practice guidelines for gerd recommend diagnostic testing in the presence of alarm symptoms, which include dysphagia, odynophagia, weight loss, gastrointestinal bleeding, and anemia. a detailed history of the pattern, severity, and duration of alarm symptoms is essential. (katz, et al., 2022) hiatus hernia refers to condition in which elements of the abdominal cavity, most commonly the stomach, herniate through the esophageal hiatus into the mediastinum. hiatus hernia is a frequent finding during upper gastrointestinal endoscopy. type i hiatal hernia is the sliding hiatal hernia, which accounts for more than 95% of all hiatal hernias with the remaining 5% being para-esophageal hiatus hernias (kotekar, et al 2021) endoscopy is a common diagnostic tool in the evaluation of patients with upper gastrointestinal pathology, specifically gastroesophageal reflux disease (gerd) and hiatal hernia. the relationship between these two disease processes are relatively intertwined and have clinical significance given the fact patients with hiatal hernia may be more likely to have acid reflux and there is a close relationship with hiatal hernia size and incidence of reflux disease. (gomaa, et al 2022) worldwide, it is believed that the relation between hiatus hernia and gastro-esophageal reflux disease (gerd) have varied considerably. in our locality the prevalence of hiatal hernia in gerd patients and the effect of hiatal hernia on the severity of gerd symptoms is unknown.

Eligibility criteria:
inclusion criteria: * aged 18 years or older, patients with gerd symptoms who don't respond to ppi therapy (8 weeks ) or cases with alarm symptoms (dysphagia, anemia ,vomiting , weight loss , gi bleeding , onset of symptoms in old age ,..etc) exclusion criteria: * complete ppi responder. patient with any contraindication for endoscopy . refusal of participation
promis evaluation study

Conditions: Hip Arthropathy; Osteoarthritis, Hip; Perthes Disease; Osteonecrosis; Femoral Neck Fractures

Summary: a total of 250 total hip arthroplasties (tha) are performed at the bezirkskrankenhaus st. johann. in a majority of those, implants from the company falcon medical (austria) are used. those implants are undergoing constant development and improvement. to guarantee their clinical performance, this clinical study is evaluating safety and efficacy of all implants produced by falcon medical. the purpose of this study is to evaluate the effcacy and safety of implants produced and distributed by falcon medical. all patients with primary tha and usage of a falcon medical implant are included. the outcome measures include intra-operative complications, early post-operative complications, revision for any cause and patient reported outcome (womac questionnaire). all data is prospectively collected in a standardized fashion.


Eligibility criteria:
inclusion criteria: * primary total hip arthroplasty with the promis stem exclusion criteria: * n/a
validity and reliability of the modified delirium diagnostic tool - provisional (ddt-pro) (thai version) in peri-operative fragility hip fracture patient

Conditions: Old Age; Hip Fractures; Delirium

Summary: nowadays, the number of hip fracture patients is increasing. as thailand enters into an aging society, hip fractures are becoming more common. they are typically treated with surgery. complications, such as urinary tract infections, pressure sores, and acute confusion, are often observed. these various complications contribute to an increased rate of illness and death. delirium is a common problem among hip fracture patients. currently, diagnosis is typically made using the diagnostic and statistical manual of mental disorders (dsm-v), which is a standard tool. however, utilizing it effectively requires expertise. additionally, other tools such as the confusion assessment method (cam) and the memorial delirium assessment scale (mdas) are available. nonetheless, training is necessary for their proper use, and they may be more suitable for specific patient groups. the delirium diagnostic tool-provisional (ddt-pro) is another tool created to aid in diagnosing delirium. unlike other tools, it does not require specialized training. it can assess the main symptoms of delirium, including cognitive ability, higher-level thinking skills, and the sleep-wake cycle. this tool has been utilized in foreign countries such as spain. the tool was found to have good accuracy and reliability and is useful in aiding the diagnosis of delirium. however, it has never been translated and tested for use in elderly thai patients with fragility hip fractures.

inclusion criteria * patients older than 65 years * had a hip fracture within 7 days before receiving treatment at siriraj hospital * received surgical treatment for a hip fracture exclusion criteria * unable to communicate in thai * was diagnosed with cancer before or during treatment for a hip fracture * have a history of schizophrenia * patients infected with covid-19 primary outcomes include: validity: conducting concurrent validity to examine the relationship between the thai version of ddt-pro and the thai version of dsm-v using the 95% confidence interval (ci) for the auc statistic. reliability: determining the internal consistency of the tool through cronbach's alpha with a 95% confidence level, and assessing inter-rater reliability using the 95% ci for kappa statistic. secondary outcomes include: prevalence of delirium in patients undergoing surgery for fragility hip fractures

Eligibility criteria:
inclusion criteria: * patients older than 65 years * hip fracture within a period of 7 days * receiving treatment at siriraj hospital and who have undergone surgical treatment for the hip fracture. exclusion criteria: * unable to communicate in thai * was diagnosed with cancer before or during treatment for a hip fracture * have a history of schizophrenia * patients infected with covid-19
figure-of-eight hand, volumetric measurements and reliability in clinic with hand injured patients

Conditions: Hand Injuries; Edema Arm

Summary: this study determined the intra-rater and inter-rater reliability of the figure-of-eight method on healthy hands, and compared the figure-of-eight measurements to the gold standard volumetric measurements. part b of the study conducted in a clinic, assessed the intra-rater reliability and inter-rater reliability on both hands of patients with hand injuries.

edema is the retention of fluid in the intracellular spaces, which is common in inflammatory condition such as traumatic injury and post surgical conditions. edema in the hand and wrist can result in detrimental physiological changes which decrease the range of motion of joint and limit the overall functional capacity and dexterity of the hand. the gold standard volumetric measurements are reliable for measuring edema changes in upper extremity. using volumeters can be cumbersome in a busy clinic. figure-of-eight measurements using a tape measure on the wrist and hand is an easy way to measure edema and can capture the accumulation in the dorsal hand that circumferential tape measurements do not capture. this study was performed in two parts. part a determined the intra-rater and inter-rater reliability of the figure-of-eight method on healthy hands, and compared the figure-of-eight measurements to the gold standard volumetric measurements. no study other study has compared right and left hands. part b of the study was conducted in a clinic to assess the intra-rater reliability and inter-rater reliability on both hands of patients with hand injuries.

Eligibility criteria:
inclusion criteria * healthy-part a * recent history of hand or wrist injury with swelling -part b exclusion criteria * open wounds-part a * current swelling-part a * history of injury in either upper extremity-part a * diabetes mellitus-part a * raynaud's syndrome-part a * pregnant women-part a \& b * could not speak english-part a \& b * could not consent for oneself-part a \& b

Keywords: reliability edema physical therapy occupational therapy figure-of-eight
a comparative study of ly900014 to insulin lispro (humalog) in healthy participants

Conditions: Diabetes Mellitus, Type 2

Summary: this study compares ly900014, a drug that lowers blood sugar, with insulin lispro (humalog). both drugs are given by injection under the skin of the abdomen. the study will be conducted in healthy people to investigate how quickly and how much ly900014 is absorbed and the effect of different doses of ly900014 on blood sugar levels in comparison with insulin lispro. the study will last about 7 to 12 weeks for each participant, including screening and follow up. screening is required within 28 days prior to entering the study.


Eligibility criteria:
inclusion criteria: * healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion) * have a body mass index (bmi) of 18 to 30 kilogram per square meter (kg/m²) * have normal blood pressure, pulse rate, electrocardiogram (ecg), blood and urine laboratory test results * are nonsmokers, have not smoked for at least 6 months prior to entering the study exclusion criteria: * are currently participating in or completed a clinical trial within the last 30 days * have previously participated or withdrawn from this study * have donated blood or have blood loss of more than 500 ml within the past 3 months
effect of high intensity interval exercise training in patients with allergic rhinitis

Conditions: Allergic Rhinitis

Summary: the objective of this study was to compare the effects of training between high-intensity interval training and moderate continuous exercise training on the pulmonary function, respiratory muscle strength, symptoms of patients with allergic rhinitis, cytokines, and oxidative stress in patients with allergic rhinitis.

36 patients with allergic rhinitis were divided into 3 groups, 12 people per group: the control group (con), the group with high-intensity interval training at a ratio of 1:2 (hiit) and the group with moderate continuous training (mct), 3 days per week, over a total period of 12 weeks. before and after the experiment, lung function, respiratory muscle strength, allergic rhinitis symptoms, nasal blood flow rate, peak nasal inspiratory flow, nitric oxide levels, cytokines and quality of life were measured and used for statistical analysis.

Eligibility criteria:
inclusion criteria: * a patient with allergic rhinitis who underwent a skin prick test and received a positive result. * patients with persistent allergic rhinitis, male and female, with symptoms of nasal congestion, sneezing, nasal itching, and runny nose for more than 4 days per week, and an average score of 7 or more in the past week using the allergic rhinitis symptom assessment questionnaire. * stopped taking all medicine before the study such as antihistamine for 3 days, oral steroid and nasal steroid for at least 2 weeks and leukotriene receptor antagonist for at least a week prior to the study * had no exercise program, non-smoking and without any food supplementation for at least 6 months prior to the start of the study * must not have other respiratory diseases such as bronchitis, pertussis, pneumonia, pneumonitis, aspergilloma, tuberculosis, asthma, lung cancer, emphysema, etc. * have a body mass index (bmi) between 18.5 and 24.9 kg/m². * complete the physical activity readiness questionnaire (par-q+) by answering "no" to all questions. exclusion criteria: * there is an unforeseen circumstance, such as an illness, that prevents participation in the research. * less than 80% of the research was completed.

Keywords: allergic rhinitis aerobic exercise high intensity interval training pulmonary function cytokines
a pilot study on animal-assisted intervention in correctional settings

Conditions: Psychological Wellbeing; Animal-assisted Intervention

Summary: mental health concerns such as depression, anxiety, and post-traumatic stress are particularly prevalent among incarcerated individuals and are considered risk factors for recidivism. leveraging the natural human-animal bond, animal-assisted intervention (aai) offers a less threatening alternative to engage incarcerated individuals and address their mental health needs. as an initial effort to help promote rehabilitative security in hong kong, the current study examines the acceptability and effectiveness of a brief animal-assisted program among offenders in local secured facilities.


Eligibility criteria:
inclusion criteria: * persons-in-custody * aged 18 or older * understand cantonese exclusion criteria: * an allergy, a fear, or a dislike toward dogs * a history of aggression toward animals * a criminal history involving animals * a history of neurodevelopmental disorders * active psychosis or mania * active suicidality
argonaut: stool and blood sample bank for cancer patients

Conditions: Non-small Cell Lung Cancer; Colorectal Cancer; Triple Negative Breast Cancer; Pancreas Cancer

Summary: argonaut is a longitudinal, prospective, observational study that will enroll up to 5,000 advanced-stage cancer patients of diverse racial backgrounds to collect data used to develop precision microbiome medicines and for the identification of clinically actionable cancer-specific biomarkers to guide therapeutic decisions. four types of solid tumor cancers will be profiled including non-small cell lung cancer (nsclc), triple negative breast cancer (tnbc), colorectal cancer (crc) and pancreatic cancer. healthy control subjects without a cancer diagnosis will also be studied, comprised of individuals at high risk for crc and healthy individuals at low risk for crc. risk assessment will be based on family history or past neoplastic findings during crc screening. data collected from this study will be used to develop the most effective new therapies, via microbiome optimization, all to the benefit of patients and the physicians treating them. stool and blood samples will be collected longitudinally and analyzed to determine the impact of gut microbiome composition and function on the immune system and efficacy of the treatment. currently enrolling the crc, high risk, and low risk cohorts. subjects who meet the entry criteria will provide up to 5 samples each of blood and stool over a 2-year period. approximately 10%-20% of the subjects will provide colon tissue samples, either from research biopsies during standard of care (soc) screening colonoscopy or retained surgical tissue from colectomy. electronic health records will be obtained at various times for up to 8 years, to collect tumor imaging results and any other updated medical data, with no additional samples collected. in select cases, stool and blood samples will be collected beyond 2 years.


Eligibility criteria:
inclusion criteria: * men or women who are ≥ 18 years old with stage iii or stage iv non-small cell lung cancer (nsclc), colorectal cancer, triple-negative breast cancer, or pancreatic cancer treated by a particular cancer treatment for the first time, or healthy subjects undergoing a standard of care colonoscopy * subjects able to provide written informed consent exclusion criteria: * subjects with known hiv, hepatitis a, hepatitis b, hepatitis c, or sars-cov2 * subjects without the mental capacity to complete either a written or online questionnaire, alone or with assistance, or make sound decisions * women who are pregnant or who plan on becoming pregnant * women who are nursing

Keywords: microbiome immunotherapy checkpoint inhibitor cancer colonoscopy
the efficacy of celext07 in the treatment of toenail onychomycosis

Conditions: Onychomycosis

Summary: this will be an interventional safety and efficacy study of celent07 when used as a topical treatment of onychomycosis in the toenails (tinea unguium) of adults 18 years and older. this is randomized, double-blind, parallel design, placebo and active controlled study in patients with mild to moderate toenail distal lateral subungual onychomycosis (dlso) (n=120). subjects will be randomized (1:1:1) to receive celenxt07, placebo of celenxt07 or penlac®, daily for 52 weeks. efficacy assessments will include complete cure, mycologic cure and clinical efficacy and safety and tolerability.


Eligibility criteria:
inclusion criteria: subjects are eligible to be included in the study only if they meet all of the following criteria: 1. age \> 18. 2. clinically diagnosed onychomycosis of the target nail. 3. presence of mild to moderate onychomycosis, defined as 20-50% of the area of the target nail being clinically affected. 4. has a positive koh examination from the target nail. 5. has a positive dermatophyte culture from the target nail. 6. written informed consent obtained. 7. subject agreed to follow the protocol. exclusion criteria subjects will be excluded from the study if they meet any of the following criteria: 1. presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug. 2. use of any systemic antifungal therapy within 4 weeks prior to the screening visit or non-responsive to systemic antifungal therapy for onychomycosis. 3. use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the screening visit. 4. woman who is pregnant, nursing an infant, or planning a pregnancy during the study period. 5. inability to understand and comply with the instructions of the study 6. patients less than age 18 7. individuals with known allergy/hypersensitivity to thuja occidentalis, chelidonium majus, eucalyptus citriodora, tea tree or thymus vulgaris.
gastric residual volume measurement in the intensive care unit

Conditions: Preventing Malnutrition

Summary: nutritional support is considered a key component of the treatment strategy for intensive care patients. malnutrition, energy protein, and inadequate or excessive intake of other nutrients have measurable effects on tissues, body structure, body function, and clinical outcomes of patients receiving treatment. it increases hospital-acquired infections, hospitalizations, and intensive care prolongs and leads to complications. this study aimed to observe the time to reach target calories, nutritional failures, and complications during feeding in measured and unmeasured gastric residual volume patients receiving enteral nutrition under ventilation in the intensive care unite.


Eligibility criteria:
inclusion criteria: * mechanical ventilatory support * open enteral route (nasogastric/peg) exclusion criteria: * history of gastrointestinal bleeding, * parenteral nutrition support, * hospital stay of fewer than two days, * under 18 years of age

Keywords: gastric residual volume malnutrition target calorie intensive care unit enteral nutrition