Kornimate/medical-research-clean huggingface dataset:
use of platelet rich plasma therapy for acute ankle sprains in the emergency department

Conditions: Sprain of Ankle

Summary: this research study hopes to determine whether or not platelet rich plasma therapy improves healing time of moderate to severe ankle sprain in comparison to standard of care therapy.

the intention of this research project is to study a new treatment for severe ankle sprains.this new treatment is called platelet rich plasma (prp) therapy and involves injecting concentrated platelet's from a patient's own blood into the site of injury to aid healing. platelets, aside from their clotting capabilities also serve a role in re-vascularization of tissue as well as collagen repair. prp therapy has been used in sports medicine for treatment of chronic injuries but has yet to be proven effective in acute injury of a joint. the investigators are comparing treatment and placebo groups based on a subjective patient questionnaire and pain score administered on the day of injury and 2-3 days and 8-10 days follow up.

Eligibility criteria:
inclusion criteria: * severe ankle sprain * x-ray completed exclusion criteria: * pregnancy/breastfeeding * police custody * active infection * metastatic disease/tumors * history of thrombocytopenia * allergy to ester or amine anesthetics * on anticoagulant medication * peripheral vascular disease * known coagulopathy

Keywords: platelet rich plasma ankle sprain injection platelet rich plasma therapy focal, invasive therapy for sprains
prospective pilot study for the evaluation of endoscopic sleeve gastroplasty with endomina® for the treatment of obesity in liver transplant candidates

Conditions: Liver Transplantation; Obesity; Bariatric Surgery

Summary: the goal of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (esg) in allowing obese subjects with the need of liver transplantation to reduce their bmi in order to enter the waiting list (bmi (≥35 kg/m2). the main question\[s\] it aims to answer are: * is the procedure effective in reducing bmi to the target level in 12 months? * which is the effect on weight loss, quality of life and obesity-related comorbidities? participants will undergo esg as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation


Eligibility criteria:
inclusion criteria: * adult patients (i.e., age between 18 and 70 years). * bmi ≥ 35 kg/m²; * subjects with an indication to liver transplantation that are not listed because of a high bmi according to the policy of the transplant centre (cut-off 35 kg/m2); * signed informed consent. exclusion criteria: * clinically significant portal hypertension at upper endoscopy: f3 or f1/f2 with red signs oesophageal varices, gastric varices or severe hypertensive gastropathy; * upper gastro-intestinal bleeding (gastric or esophageal) in the previous six months; * child c class; * clinically or ultrasound-detected ascites in the 15 days before the procedure. only mild ascitic effusion in the pelvis will be accepted; * spontaneous bacterial peritonitis in the previous 6 months; * hepatocellular carcinoma with extra hepatic spread; * previous stomach, oesophagus or duodenum surgery; * technical non-feasibility in the opinion of the endoscopist; * clinical signs of active infection; * unstable cardiac disease or chronic heart failure; * platelet count less than 70.000; * international normalized ratio ≥ 1,5; * concomitant unstoppable anticoagulant or anti platelet therapy, except for low dose aspirin (≤ 100 mg); * acute liver failure; * easy to bleed during diagnostic endoscopy; * active drugs or alcohol abuse; * pregnancy, lactation (desire to become pregnant during study duration); * enrolment in other clinical studies; * contraindication to general anaesthesia; * contraindication to endoscopic procedure; * other conditions to exclude the subject in investigators opinion; * refusal to sign informed consent.
french national registry of children born small for gestational age treated with somatropin

Conditions: Growth Disorder; Small for Gestational Age

Summary: this study is conducted in europe. the aim of the study is to describe the patient population and therapeutic practices (study phase i), assess efficacy on growth and adult height and assess tolerance of somatropin (norditropin® simplexx®) (study phase ii)


Eligibility criteria:
inclusion criteria: * born small for gestational age
safety, tolerability and immunogenicity of meningococcal c conjugate vaccine to children 32 to 40 months of age

Conditions: Meningococcal Infection

Summary: safety, tolerability and immunogenicity of meningococcal c conjugate vaccine to children 32 to 40 months of age


Eligibility criteria:
inclusion criteria: * healthy children exclusion criteria: * known hypersensitivity to any vaccine component * significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 14 days * ascertained or suspected disease caused by n. meningitidis * household contact with or intimate exposure to an individual with a positive culture of n. meningitidis serogroup c within the previous 60 days

Keywords: prevention of meningococcal infection
hepatic small vessel neoplasm

Conditions: Hepatic Small Vessel Neoplasm

Summary: small-vessel hepatic tumor is a new tumor entity of vascular origin, described in 2016 by gill et al, in a series of 17 patients. this rare lesion is difficult to diagnose on imaging because it shares a common radiological semiology with several other differential diagnoses ranging from benign hepatic angioma to more aggressive lesions such as angiosarcoma.

the aim of our study is to enable the imaging diagnosis of a new entity: small vessel hepatic tumor in order to improve diagnostic management.

Eligibility criteria:
inclusion criteria: * histological evidence of a small vessel hepatic tumor either on biopsy or surgical specimen * cross-sectional imaging before the biopsy or pre-operatively (ct, mri) exclusion criteria: * patient under guardianship or curators

Keywords: vascular tumors hepatic imaging neoplasm
study of algorithm for epilepsy alert device

Conditions: Motor Seizures

Summary: an accelerometer with transmitting ability is worn on the wrist. data of movements during seizures will be analyzed to upgrade algorithm that will identify seizures.

patients undergoing video-eeg telemetry will wear movement sensor on their wrist. the sensor will transmit continuous data to a laptop. seizures' data (tonic or clonic) will be analyzed and transformed into an algorithm (up-graded existing preliminary algorithm). in the second phase the algorithm will need to identify seizure events within one minute of the onset. both specificity ("false positive") and sensitivity ("false negative) will be than calculated.

Eligibility criteria:
inclusion criteria: * patients undergoing long term monitoring for motor seizures exclusion criteria: * invasive recording * psychogenic seizures

Keywords: motor seizures accelerometer algorithm detection alert
decision aid for chemotherapy in cisplatin-intolerant patients with locally advanced cervical cancer

Conditions: Locally Advanced Cervical Carcinoma

Summary: the goal of this clinical trial is to investigate the utility and effectiveness of a decision aid in cisplatin-intolerant patients with locally advanced cervical cancer. the main questions it aims to answer are: 1. what is the effectiveness of the decision aid in reducing decisional conflict? 2. what is the utility of the decision aid in preparing for decision-making? participants will be asked to accomplish the decisional conflict scale before and after using the decision aid. researchers will compare patients given routine care and the decision aid with patients given routine care to see if the decision aid reduces decisional conflict.

in locally advanced cervical cancer (lacc), adding chemotherapy (cht) to radiotherapy (rt) improves survival at the cost of increased toxicity. among patients with cisplatin contraindications, compliance to rt may be compromised. shared decision-making (sdm) allows for more patient engagement in the decision-making process and decision implementation planning. in cancer-related decision-making, patient decision aids (ptda) facilitate the sdm process and have increased patient knowledge and satisfaction and decreased decisional conflict and attitudinal barriers improved patient satisfaction and treatment compliance. the cecil study is a two-phase study to develop, validate and test the effectiveness of a ptda for cisplatin-intolerant lacc patients faced with the decision of adding cht to rt. phase 1 is a mixed-methods study to develop a ptda prototype and determine its content validity and user acceptability. phase 2 is a block-randomized clinical trial to determine its effectiveness in reducing decisional conflict and its utility in preparing for decision-making. adult women with biopsy-proven untreated lacc with cisplatin contraindications will be included in this trial.

Eligibility criteria:
inclusion criteria: * squamous, adeno- or adenosquamous histology * international federation of gynaecology and obstetrics (figo) stage i-b3, ii-a2, ii-b to iv-a * contraindication to cht, including but not limited to hydronephrosis, renal or cardiac dysfunction, frailty, or refusal * grade 6 level english literacy * informed consent exclusion criteria: * other histologies * metastatic disease * other active cancers * prior cancer except for a cancer treated curatively, in remission for ≥5 years, with low recurrence risk; adequately treated lentigo maligna or non-melanoma skin cancer without evidence of disease; or adequately treated carcinoma-in-situ without evidence of disease * prior pelvic radiotherapy, brachytherapy, or chemotherapy * pregnancy * cognitive impairment or psychological disturbance limiting study compliance

Keywords: patient decision aid cervical cancer chemotherapy radiotherapy elderly renal failure decisional conflict
endostar and/or cisplatin for treatment of malignant pleural effusion or ascites

Conditions: Malignant Pleural Effusion; Malignant Ascites

Summary: the objective of this study is to compare the efficacy of endostar/cisplatin with cisplatin alone or endostar alone in patients with malignant pleural effusion or ascites.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of thoracic or abdominal tumor * at least medium amount of malignant pleural effusion or ascites * ecog performance status 0-2 * life expectancy ≥ 2 months * adequate hematologic, cardiac, renal, and hepatic function * no major surgery within 4 weeks prior to this study * written informed consent exclusion criteria: * patients with central nervous system (cns) metastases * evidence of bleeding diathesis, serious infection * evidence of myocardial infarction, unstable angina or cardiac insufficiency * presence of serious copd and/or respiratory failure * allergic to study drug * pregnant or lactating women * participation in other clinical trials within 30 days prior to this study
enhanced transcutaneous delivery of betamethasone for the treatment of vitiligo

Conditions: Vitiligo

Summary: vitiligo is the commonest acquired depigmenting disorder characterized by loss of melanocytes from the basal layer of skin causing white patches which leads to great psychological distress in many patients. even though the pathogenic mechanisms of the loss of melanocytes are well researched, a permanent cure for the disease is still elusive. the key principle in the management of vitiligo is to attain stability and to induce active residual melanocytes to repopulate within the depigmented patch thus resulting in repigmentation. in recent years the use of various devices for enhanced transcutaneous delivery of various topical preparations has become more and more common in dermatology. the aim of this study is to see whether using the tixel device to enhance the penetration of topical betamethasone can improve the effectiveness of the treatment of pigment regeneration in vitiligo.

vitiligo is a psychologically devastating disorder. the fact that it typically occurs in exposed areas (the face and hands) has a major impact on self-esteem and perception of self. while lesions are usually asymptomatic, the psychosocial impact on patients can be tremendous. currently available medical therapies for vitiligo are unsatisfactory and there is no fda approved drug for the treatment of vitiligo. the perfect medication for this disease would be a topically applied formulation that can rapidly restore pigmentation without systemic absorption or cutaneous side effects. tixel is a novel non-laser thermo-mechanical system (tixel, novoxel, and israel), that is, a registered medical device in several countries worldwide. the mechanism of action is by evaporation and thermal decomposition of stratum corneum and the dehydration of epidermis. the aim of our study is to evaluate the clinical effectiveness and safety profile of a novel approach using an energy-based device (tixel, novoxel, and israel), followed by the topical application of bethametasone for the treatment of vitiligo.

Eligibility criteria:
inclusion criteria: 1. symmetric vitiligo 2. stable vitiligo for at least six months (\< 10% change in the last 6 months) 3. diagnosis was made clinically by a dermatologist 4. age over 18 -70 years men and women exclusion criteria: 1. non stable vitiligo 2. contraindications for phototherapy 3. pregnancy or lactation 4. lack of willingness to go to phototherapy 3 times a week for at least 6 months 5. segmental vitiligo 6. phototherapy or topical therapy for vitiligo in the last 1 month. exit criteria: 1. intolerable to the the study treatment 2. lack of patient's compliance

Keywords: vitiligo tixel enhanced transcutaneous delivery
the intracept global registry ( tigr ) - pilot study

Conditions: Low Back Pain

Summary: the intracept global registry is a prospective, noninterventional, observational global post market independent data collection of the ongoing effectiveness, safety, and satisfaction outcomes for patients treated with the intracept procedure. this registry will be conducted according to good clinical practice (gcp) guidelines, including participant verbal informed consent and independent review board (irb) / ethics committee (ec) approval and oversight. registry design, conduct, analysis, and reporting are overseen by the principal investigator (pi) and the cross-specialty tigr physician steering committee.

participants in the registry will have seven study visits over a period of five years (one prior to procedure and 6 post their procedure). study visits will be conducted via telephone by a third-party cro and independent clinical research coordinators. participants will be verbally consented and then evaluated via telephonic study visits at baseline (prior to procedure) and at 3, 12, 24, 36, 48, and 60 months post their intracept procedure. primary and secondary objectives are based on patient reported outcomes for functional improvement, pain reduction, and physical and mental health pre and post procedure. the study will also look at utilization of injections and pain interventions/surgery for treatment of low back pain post intracept.

Eligibility criteria:
inclusion criteria: all patients scheduled for the intracept procedure and whose treating physician is referring to the registry exclusion criteria: * no exclusion criteria
tolerability of metoprolol-succinate-er and carvedilol in copd

Conditions: Pulmonary Disease, Chronic Obstructive; Asthma; Adverse Effect of Beta-adrenoreceptor Antagonists

Summary: use of beta-blockers has proven beneficial in patients with hypertension, heart failure, and in people who have suffered a heart attack. the use in patients who have chronic obstructive pulmonary disease (copd) and reactive airway disease, however, has been limited due to possible side effects such as worsening of lung function or increasing airway spasms and asthma attacks. the purpose of this study is to find out if patients with copd can tolerate being on a beta-blocker at doses recommended for the treatment of heart disease conditions. this study also seeks to find out if a selective beta-1 receptor beta-blocker is better than a non-selective beta-blocker in patients with mild to moderate copd.


Eligibility criteria:
inclusion criteria: * 40 years of age or older * mild to moderate copd as defined by the american thoracic society * current treatment with a beta-blocker for either hypertension, myocardial infarction, or congestive heart failure. exclusion criteria: * recent (within 30 days) copd exacerbation or requirement for oral steroid therapy within the last 6 months * any history of ventilator support requirement for copd * patients with asthma or reactive airway disease (rad) defined as obstructive lung disease with a \>15% improvement in fev1 with beta-agonist therapy * relative or absolute contraindication to beta-blocker therapy * exposure to any investigational drugs within the previous 30 days * patients with any concurrent disease or condition, which in the judgment of the investigator would make the patient inappropriate for participation in the study were excluded from this study

Keywords: beta-blocker chronic obstructive pulmonary disease copd cardioselective
diagnostic of rotator cuff calcific tendinosis using mri with zte sequence

Conditions: Cuff Rotator Tendinitis

Summary: conventional radiographs are still considered the reference for identifying rotator cuff calcific tendinosis. mri is widely performed for rotator cuff disorders evaluation but has a moderate accuracy in rotator cuff calcific tendinosis diagnosis and calcific deposits identification (sensitivity and specificity around 60%), even though it helps in determining acuity of the finding by adjacent soft tissue edema depiction and differential diagnosis identification (i.e. adhesive capsulitis, sub-acromial bursitis...). zero echo time (zte) mri provides enhanced bone contrast by enabling the acquisition of signals from tissues exhibiting the shortest t2 values on a single sequence with a spatial resolution of 0.8-1.2 mm isotropic and can therefore provide images similar to those obtained with radiographs. we hypothesize that zte images could also depict rotator cuff calcific tendinosis, but to our knowledge, no study compared this technique to radiographs and/or standard mri.


Eligibility criteria:
inclusion criteria: * patient referred to the imaging department for a mri scan in case of suspicion of rotator cuff tendinosis exclusion criteria: * incomplete data sets
clinical study examining the safety and efficacy of doxorubicin drug eluting microspheres transarterial embolization in the setting of hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma

Summary: the study is designed to determine whether loading doxorubicin (a type of chemotherapy), when loaded onto a drug eluting microsphere will result in increased destruction of a tumor. the study will treat patients with surgically resectable liver cancers with varying doses of doxorubicin loaded into microspheres, with a close review of any side effects and chemotherapy concentrations in the bloodstream. the tumors will be surgically removed after at least 1 month, to determine how much the tumor has shrunk, and the amount of tumor destroyed. it is hoped that the study results will determine if this treatment has a role in controlling tumor growth prior to surgical removal.


Eligibility criteria:
inclusion criteria: * patients diagnosed with surgically resectable hepatocellular carcinoma (hcc)

Keywords: chemoembolization drug eluting microsphere hepato embolotherapy downstage
efficacy study of oral collagen peptide on skin condition improvement

Conditions: Skin Aging

Summary: to assess if oral intake of collagen peptide can improve skin conditions such as skin thickness, density and firmness.

this is an one site, randomized, double-blind controlled clinical trial to assess the oral supplement of lisavei collagen peptide solid beverage on skin ageing improvement. study product with collagen peptide and placebo product without collagen were randomly assigned to 90 eligible participants enrolled according to the inclusion and exclusion criteria. they took the assigned product once daily dissolved in 100 ml warm water for 12 weeks with 4-week regression phase(without intake of the test products), and visit the study site in shanghai for four times(before starting the treatment, after 8 and 12 weeks, and 4 weeks after the last intake). skin measurements including skin firmness, skin density, skin hydration and skin barrier were carried out at each visit with professional equipment and imaging system. data were analyzed to validate if the administration of the test collagen peptide solid beverage will improve skin aging parameters such as firmness, thickness, density, hydration and skin barrier compared to placebo. the lasting effect was also observed by comparing between the two groups after 4-week regression time.

Eligibility criteria:
inclusion criteria: 1. healthy female adults aged between 35-55 years old 2. with fine wrinkles and skin laxity 3. personal informed consents to participate in the study 4. agree to keep their daily skincare routine unchanged for the duration of the study 5. maintain good sun protection habits 5. agree to refrain from wearing make-up on the face on the each study visit exclusion criteria 1. female who is pregnant or nursing or planning to become pregnant during the course of the study 2. individuals who are in the perimenopausal stage. 3. bmi\ 27.9 4. individuals suffering from chronic systemic diseases such as cardiovascular, cerebrovascular, liver, and kidney diseases. 5. individuals who have diabetes. 6. individuals suffering from skin conditions such as psoriasis, eczema, atopic dermatitis, and severe acne. 7. individuals with depression or sleep disorders, those who smoke, and those who abuse alcohol. 8. individuals who are using hormonal drugs, medications for obesity, absorption inhibitors, antidepressants, or appetite suppressants. 9. individuals who have used hormones or anti-inflammatory drugs on their face and upper arms within the past two months. 10. individuals who received facial laser therapy, chemical peeling or uv overexposure in the past 3 months 11. individuals who can not avoid prolonged exposure to sunlight. 12. individuals who are currently participating in other clinical studies or trials.