Kornimate/medical-research-clean huggingface dataset:
development of chronic ankle instability after acute ankle sprain

Conditions: Ankle Sprains

Summary: the goal of this observational prospective cohort study is to determine key clinical predictors for chronic ankle instability and return to sports in patients who suffered an acute ankle sprain. the researchers will evaluate clinical outcome measures and patient reported outcome measures on 3 test moments and at 12 months of follow-up.

in this prospective cohort study, 4 different measurement time points will be used: 7-14 days, 6 weeks, 12 weeks and 12 months after the initial ankle sprain event. the researchers will include physically active people that engage in sports regularly, who recently suffered an acute ankle sprain. recruitment will be done via hospital emergency departments, casualty departments and sports injury clinics, gp's, sports federations and social media. the researchers will only use outcome measurements that are applicable in clinical practice, and patient reported outcome measures to evaluate the participants. the main outcome of this study is the development of chronic ankle instability, based on published criteria. the researchers aim to determine which clinically applicable outcome measures are key determinants for the development of chronic ankle instability. a secondary outcome is successful return to sports, with the objective to determine key clinically applicable determinants for successful recovery and return to sports.

Eligibility criteria:
inclusion criteria: * 18-55 years old * acute ankle sprain: \<7 days * athletes (recreational or professional) * previous ankle sprain \>12 months exclusion criteria: * recurrent ankle sprain * ankle fracture * chronic ankle instability * high ankle sprain (syndesmosis) * a history of ankle or foot operations * other lower limb injuries and/or complaints * severe ocular impairments * any neurological, cardiac, vascular or metabolic disease

Keywords: ankle sprain rehabilitation sports injury chronic ankle instability
hypnosis, self-hypnosis and weight loss in obese patients

Conditions: Obesity

Summary: high food impulsiveness, impaired food reward and stress response are involved in the phenomena of weight gain and resistance at weight loss. henceforth, hypnosis is a complementary medicine which is recognized as effective for defined indications. complexity and diversity of methodological studies with hypnosis does not allow to conclude on its efficacy in treating this disease. in obese subjects with high food impulsiveness, it is expected that erickson's hypnosis and self-hypnosis practice would improve food disinhibition assessed by an adapted questionary (tfeq 51).

obese failing patients are recruited in an university hospital. half of the subjects will be randomised to practice hypnosis and will learn to practice self-hypnosis to reduce food impulsivity and specially disinhibition. in the same time, all the included patients will follow therapeutic workshops based on current recommendations of the high health authority of france (has) for physical activity and the dietetic. in the hypnosis group, eight workshops are planned during six months. furthermore, patients have to practice daily self-hypnosis. in the same time, all the patients included will participate in eight dietetic workshops. it is expected an improvement in patient involvement in personalized care plan, that eating behavior is more suited and consequently a significant decrease in weight.

Eligibility criteria:
inclusion criteria : * subjects adult volunteers under 70 years old * high score of disinhibition (d\> 8) * obesity grade 1 and 2 (bmi between 30 and 40 kg m ²) * no previous practice of hypnosis exclusion criteria : * weight change of more than 3 kg peak to peak in the last 6 months * psychiatric illness known * craniopharyngioma * treatment with a significant influence on the weight and / or eating behavior: steroids, hyperthyroidism, uncontrolled hypothyroidism, * bariatric surgery * major tca according to dsm iv * sensory impairments (hearing, visual skills) and cognitive impairing its award of rating scales * planned or ongoing pregnancy * refusal of hypnosis.

Keywords: hypnosis self-hypnosis obesity high food impulsiveness
chatgpt & surgeon synergy: redefining breast reconstruction consultations for enhanced patient engagement and satisfaction

Conditions: Breast Cancer; Cancer of the Breast

Summary: in this study, patients who are scheduled for breast reconstruction consultation will be randomized into the intervention group (chatgpt-generated patient education regarding possible reconstruction options) or the control group (usual patient education). all patients will complete a survey following their in-person consultation to assess their experience and overall satisfaction with the consultation process. additionally, participating surgeons will complete a separate survey to evaluate their consultation experience, satisfaction, and to assess the accuracy and clinical utility of the chatgpt-generated patient education materials. the surveys are designed to gather information on patient characteristics, organizational health literacy according to brega et al. other survey questions have been designed to meet the outcomes of this study and have not been based on previously published surveys.


Eligibility criteria:
patient eligibility criteria: * scheduled for initial preoperative breast reconstruction consultation following therapeutic or prophylactic mastectomy with a surgeon at washington university school of medicine. * at least 18 years of age. * can speak and understand english. surgeon eligibility criteria: * routinely performs breast reconstruction surgery at washington university school of medicine. * at least 18 years of age. * can speak and understand english. * surgeon must not be a resident or fellow at time of enrollment.

Keywords: patient education chatgpt breast reconstruction
to assess the safety, tolerability and efficacy of itacitinib immediate release tablets in participants with primary or secondary myelofibrosis who have received prior ruxolitinib and/or fedratinib monotherapy (limber-213)

Conditions: Myelofibrosis; Polycythemia Vera; Thrombocythemia

Summary: this is a 2-part study. in part 1, participants will be dosed at 2 different dose levels in order to select the rp2d for part 2 of the study.


Eligibility criteria:
inclusion criteria: * diagnosis of primary mf meeting the 2016 who criteria for overt pmf or secondary mf (ppv-mf or pet-mf) meeting the 2008 iwg-mrt criteria. * at least intermediate 1 risk mf according to the dipss. * prior treatment with ruxolitinib and/or fedratinib monotherapy * currently receiving ruxolitinib or fedratinib monotherapy for pmf or secondary mf. * splenomegaly defined as palpable spleen at least 5 cm below the left costal margin or volume ≥ 450 cm3 on imaging assessed during screening. * allogeneic stem cell transplant not planned. * platelet is greater than or equal to 50 × 109/l at screening. * ability to comprehend and willingness to sign a written icf for the study. * willingness to avoid pregnancy or fathering children. exclusion criteria: * prior treatment with a jak inhibitor other than ruxolitinib or fedratinib * record of ≥ 10% myeloid blasts in the peripheral blood (on peripheral blood smear) or bone marrow prior to or at the time of screening * for participants on ruxolitinib or fedratinib, unable to be tapered from that treatment over the course of 14 days without corticosteroids, hydroxyurea, or other agents * treatment with ruxolitinib, fedratinib or other mf-directed therapy (approved or investigational) within 2 weeks of day 1 * prior splenectomy or splenic irradiation within 6 months before receiving the first dose of itacitinib * unable or unwilling to undergo serial mri or ct scans for spleen volume measurement * unable or unwilling to complete mfsaf v4.0 diary on a daily basis during the study * ecog performance status ≥ 3 * life expectancy less than 24 weeks * not willing to receive rbc or platelet transfusions * participants with laboratory values at screening outside of protocol defined ranges * significant concurrent, uncontrolled medical condition * participants with impaired cardiac function or clinically significant cardiac disease unless approved by medical monitor/sponsor * history or presence of an abnormal ecg that, in the investigator's opinion, is clinically meaningful * chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment. * evidence of hbv or hcv infection or risk of reactivation * known hiv infection.

Keywords: myelofibrosis post-pv myelofibrosis post-et myelofibrosis limber limber-213 mf myeloproliferative neoplasms
dysphagia in head and neck cancer with radiation

Conditions: Swallowing Function

Summary: this study focuses on swallowing dysfunction, a common issue affecting 60-75% of head and neck cancer patients due to tumor damage, treatment complications, and chemoradiotherapy side effects, which can lead to malnutrition and reduced quality of life. with limited research on the effects of radiation doses on swallowing muscles and nutrition, this study aims to evaluate these impacts in non-surgical patients undergoing radiotherapy, conducting assessments before treatment, three months after, and within one year post-treatment.

swallowing dysfunction is a common and debilitating symptom in head and neck cancer patients, affecting approximately 60-75% during the disease course, primarily due to tumor destruction, postoperative complications, and side effects of radiotherapy and chemotherapy. combined chemoradiotherapy exacerbates adverse effects, such as mucositis, odynophagia, taste alterations, xerostomia, nausea, vomiting, and fatigue, which can result in dehydration, significant weight loss, and detrimental impacts on nutritional status, functionality, and quality of life. limited research exists on the effects of radiation and chemoradiation doses on swallowing muscles, quality of life, and nutritional changes in these patients. this study aims to evaluate the impact of radiation doses on swallowing muscles and quality of life in head and neck cancer patients undergoing chemoradiotherapy while identifying malnutrition risk in this population. non-surgical patients receiving radiotherapy as the primary treatment will be recruited, with swallowing, muscle, and nutritional assessments conducted before treatment, three months after treatment, and within one year post-treatment.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo radiotherapy or concurrent chemoradiotherapy ; * aged between 18 and 80 years; * able to perform self-care independently (ecog ≤ 2); * all patients provide written informed consent. exclusion criteria: * patients scheduled to undergo surgical treatment; * patients with neuromuscular diseases, such as stroke or parkinson's disease; * patients with other diseases or complications, including heart disease classified as nyha functional class ≥ 2 with thrombotic conditions, or lung disease classified as hugh-jones grade ≥ 4; * patients with psychological disorders that may affect their ability to provide informed consent or comply with the study protocol; * patients who do not consent to undergo high-resolution impedance manometry.

Keywords: dysphagia head and neck cancer radiation therapy
trial of one versus two doses of dexamethasone for pediatric asthma exacerbation

Conditions: Asthma

Summary: comparing one versus two doses of oral dexamethasone for the treatment of asthma in the pediatric emergency department.

a randomized double blinded placebo controlled trial comparing one dose of dexamethasone administered in the emergency department with two doses, the first given in the emergency department and the second 24 hours after the index ed visit.

Eligibility criteria:
inclusion criteria: * history of asthma defined as at least two (2) prior episodes of respiratory illness characterized by wheezing treated with inhaled beta agonists exclusion criteria: * pregnancy * severe chronic cardiac, respiratory, neurological or neuromuscular disease * complete resolution of symptoms after one treatment of beta agonists * severe asthma symptoms as defined by a pulmonary index score of 12 or greater

Keywords: asthma pediatric emergency department dexamethasone steroid
pioglitazone tablets special drug use surveillance "combined use of insulin products / long-term treatment"

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to investigate the safety and efficacy of long-term treatment with pioglitazone (actos tablets) in the routine clinical setting in combination with an insulin product in patients with type 2 diabetes mellitus who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy.

this is a special drug use surveillance on long-term use of newly co-administered pioglitazone tablets (actos tablets) as part of routine medical care in patients with type 2 diabetes mellitus who have poorly controlled blood glucose when using an insulin product in addition to diet therapy and exercise therapy; this survey is designed to determine the safety and efficacy of long-term use of pioglitazone tablets (actos tablets) in the routine clinical setting in combination with an insulin product (the planned sample size, 1000.) the usual adult dosage is 15 mg of pioglitazone administered orally once daily before or after breakfast. dose adjustment will be made according to gender, age, and symptoms with an upper limit of 30 mg.

Eligibility criteria:
inclusion criteria: participants with type 2 diabetes mellitus assumed to have insulin resistance who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy who meet the following criteria at enrollment. 1. participants treated with an insulin product for at least 4 weeks 2. participants who started actos tablets for the first time after the start of an insulin product 3. participants likely to be available for a 52-week observation and evaluation after the start of co-administration of actos tablets exclusion criteria: participants with contraindications to actos tables and insulin products treatment

Keywords: drug therapy
cimt and bimt affect functional outcome in cp

Conditions: Cerebral Palsy, Congenital

Summary: the aim of this randomized controlled trial is to determine the effects of constraint induced movement therapy cimt and bim bimanual activities on functional outcome in hemiplegic cp. two randomized groups of patients with cp are treated with constrained arm for three hours on affected side and bimanual activities on bim group respectively. both, male and female patients meeting the inclusion criteria will be included. patients having concurrent malignancy, infection, trauma or any bony deformity will be excluded.

it is a randomized control trial. cerebral palsy children of age groups of 5 yrs to 12 years were included in the study with total sample size of thirty eight (38) with confidence interval of 95%. simple random sampling was done by lottery method and data was collected from alfarabi special school of education islamabad. two groups were formed and named as group a; cimt with nineteen participants and group b, bim bimanual training with nineteen participants respectively. the rct compared the functional outcome of 3 hours constraining for 3 times a week for 6 weeks duration for cimt group and five bimanual activities performed for three hours a day for bimanual group b and were assessed on the pretest and post test score evaluation of quest and jthf test. all the participants were hemiplegic cp from both gender, fall on mac system level ii. treatment for three hours was done on alternate days for 3 days a week. five bimanual activites of holding a tray, cutting a fruit with knife, buttoning, cutting paper with scissor, and carry heavy objects with both hands are applied. whereas the activities performed in cimt are brushing teeth, holding spoon, fork combing hair and writing. forty five children were screened before the evaluation and as a result 38 were enrolled in both groups having 19 in each group.

Eligibility criteria:
inclusion criteria: * patients with age group of 5-12 years. patients with hemiplegic cerebral palsy of both genders. patients who have active wrist extension, active pip -mcp joint extension and active thumb extension. patients who have mild spasticity on spasticity rating scale of quest test patients who fall on level ii on mac system are included patients who has cognitive dysfunction ( screening by wisc wechsler intelligence test for children) all have score above 80. exclusion criteria: * patients who can develop any sort of behavior problems patients who does not co-operate with therapist in cimt procedure any structural deformity. any surgical intervention that requires patient to be immobile.

Keywords: cerebral palsy neurorehabilitation spasticity
microbiota and pancreatic cancer cachexia

Conditions: Pancreatic Cancer; Microbiota; Cachexia

Summary: this monocentric study aims at evaluating the effects of fecal microbiota transplantation from newly diagnosed cachectic and non-cachectic pancreatic cancer patients, and healthy volunteers on several cachexia-related parameters of germ-free mice.

aim: evaluating the effects of fecal microbiota transplantation (fmt) from 6 newly diagnosed cachectic and 6 non-cachectic pancreatic cancer patients, and 12 healthy age-and sex-matched volunteers on several cachexia-related parameters of 96 germ-free mice (4 per donor) over a 30-day period. the fecal material of all 12 pancreatic cancer patients will be collected at diagnosis before any cancer treatment onset. hypothesis: fmt of cachectic patients with pancreas cancer, naïve of any anti-cancer treatment and artificial nutrition, into germ-free mice impairs weight gain, in contrast to fmt of non-cachectic patients and healthy controls.

Eligibility criteria:
inclusion criteria: patients with pancreatic cancer (n=12) * ≥18 years and * newly diagnosed of pancreatic adenocarcinoma (local or metastatic) and * tube feeding or parenteral nutrition ≤ 14 days cachectic pancreatic cancer patients (n=6) * cachexia according to the fearon criteria 1: involuntary weight loss \>5% over the last 6 months, or any level of weight loss \>2% and a bmi \<20 kg/m2 or sarcopenia. sarcopenia will be diagnosed by bia (fat-free mass index is \<17 kg/m2 in men and \<15 kg/m2 in women) 81, and not by ct, as it is faster and can be performed at the bedside of the patient. non-cachectic pancreatic cancer patients (n=6) * normal nutritional state: weight stability (± 2% of habitual weight) over the last 6 months, no anorexia before the diagnosis (appetite rating on a visual analogue scale of 100mm), no known impaired glucose tolerance. healthy matched subjects (n=12) * ≥18 years and * bmi between 18.5 and 30 kg/m2 and * absence of chronic or acute disease and * matching for gender and age (± 5 years) with an included pancreatic cancer patient exclusion criteria: * \< 18 years or * inability to give consent or * insufficient knowledge of project language (french, german) or * pancreatic adenocarcinoma already treated by chemo- or radiotherapy, or major surgery as duodenopancreatectomy or biliary diversion * known rheumatologic or immunologic diseases * therapeutic antibiotics or immunosuppressive drugs (for instance glucocorticoids, cytostatics, antibodies) in the 30 days preceding the inclusion
effectiveness of shock wave therapy versus low level lazer therapy in diabetic frozen shoulder patients.

Conditions: Diabetes Complications

Summary: patients will be divided randomly into 3 groups.

patients will be allocated from out patient clinics of qena university hospitals then they will be randomly assigned to three groups, every one will contain 30 patients of both gender, with age range between 45 and 60 years old

Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus. * patients with frozen shoulder due to diabetes mellitus. * patients age ranged between 45 and 60 years old. * cooperative patients. exclusion criteria: * patients with un-controlled hypertension. * patients sensetive to shock wave or lazer irradiation. * patients with infectious skin diseases. * un-cooperative patients.

Keywords: diabetes frozen shoulder
observational cohort study of tachosil (tc-018-in)

Conditions: Blood Loss, Surgical

Summary: the purpose of this study is to collect information, after exposure to tachosil ®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding. in addition, pharmacoeconomic data will be collected.


Eligibility criteria:
inclusion criteria: * all subjects, treated with tachosil ® by the participating physicians, will be registered with a set of basic data from their already existing data (i.e. no additional diagnostic procedures will be performed). * subjects who will provide their written informed consent to use existing data, allow direct access to data and data processing.

Keywords: collection of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding after exposure to tachosil®.
anti-inflammatory diet effect in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: the current study pretends to clarify, whether or not a healthy anti inflammatory diet improves different health-related outcomes in participants with rheumatoid arthritis.

the current study pretends to clarify, whether or not a healthy anti-inflammatory diet improves different health-related outcomes: clinical, analytical, anthropometric and psychological outcomes in participants with rheumatoid arthritis. due to the intervention has been based in a dietary advise, one of the goals of this study is also to evaluate the role of dietary advice in changing effectively the dietary patterns of the patients.

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis patients exclusion criteria: any additional pathology or situation that could be considered, according to clinical criteria, of risk for the patient or for the study. for example: * chronic renal failure * liver failure * heart failure * pregnancy

Keywords: rheumatoid arthritis diet antiinflammatory diet nutrition
a single arm, open-label clinical trial to evaluate the efficacy and safety of maintenance treatment with capecitabine plus cetuximab in metastatic colorectal cancer

Conditions: Colorectal Neoplasms

Summary: this is a single arm, open-label, multi-center clinical trial to evaluate the efficacy and safety of maintenance treatment with capecitabine plus cetuximab after first-line 5-fluorouracil-based chemotherapy plus cetuximab for patients with ras wild-type metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: 1. subjects has been fully understand this research and volunteered to sign the consent form; 2. histologically and/or cytologically diagnosed with ras wild-type metastatic metastatic colorectal cancer(phase iiic/iv), any other histological type is excluded; 3. subjects with stable disease or better after induction treatment with eight to twelve 2-weekly cycles of 5fu-based standard chemotherapy; 4. ecog performance status (ecog ps) ≤1(0-1); 5. evident measurable lesion(s) that meets the response evaluation criteria in solid tumors (recist 1.1); 6. expected survival\>16 weeks. exclusion criteria: 1. subjects with presence of clinically detectable second primary malignant tumors at the enrollment, or other malignant tumors within the last 5 years (excluding adequately treated skin basal cell carcinoma or carcinoma in situ of cervix); 2. clinical refractory diseases(including uncontrolled epilepsy),and affect survivor; 3. central nervous system (cns) metastatic disease or prior cerebral metastasis; 4. researchers think that the subjects exist any clinical or laboratory abnormalities or compliance issues and not suitable to participate in this clinical study.

Keywords: metastatic colorectal cancer maintenance treatment cetuximab