Kornimate/medical-research-clean huggingface dataset:
the impact of arnica montana following the surgical extraction of impacted third molars

Conditions: Edema; Pain; Trismus

Summary: aim: the aim of this study is to evaluate the action of the homeopathic plant arnica montana on postoperative edema, pain and trismus after surgical extraction of impacted wisdom teeth. materials and methods: the study is a double-blinded clinical trial recruiting patients undergoing surgical extraction of symmetrically impacted maxillary or mandibular third molars (right and left side). patients receive alternately and randomly the verum (arnica montana 12 ch) or the placebo, in the form of capsules, to be taken 1 day prior to surgery and for 7 days postoperatively. clinical parameters are collected and include: pain score, maximum mouth opening and facial measurements to assess edema's intensity.


Eligibility criteria:
inclusion criteria: * symmetrically impacted bilateral third molars (mandibular or maxillary). * young patients aged between 16 and 40 years old. * no consumption of tobacco or coffee. * consent to the terms and conditions of the study. * good oral hygiene. * asa 1. exclusion criteria: * not symmetrically impacted third molars * patients with health problems
mesotherapy treatment of irritable bowel syndrome

Conditions: Inflammatory Bowel Diseases

Summary: irritable bowel syndrome (ibs) is a gastrointestinal transit disorder characterized by chronic abdominal pain and impaired transit in the absence of demonstrated organic disease. considered a non-fatal disease, its effects relate more to quality of life, work production and health care systems. given the complexity of this disease, no treatment has been recognized as standard treatment. the treatment is rather focused on treating the symptoms caused (chronic pain or intestinal transit disorder). in general, therapy is considered individualized and includes lifestyle/diet modifications and pharmaceutical therapy. several published case studies evaluating the effect of mesotherapy on improving the severity of the disease have demonstrated an improvement in the symptoms of this syndrome. due to the limited number of case studies and the insufficient level of evidence to conclude, our study will therefore be a before-and-after intervention study, to evaluate the effect of four mesotherapy sessions on the treatment of ibs symptoms.


Eligibility criteria:
inclusion criteria: * patient suffering from irritable bowel syndrome according to the rome iv criteria, whose diagnosis was made by a specialist in hepato-gastro-enterology, * francis score \>75/500, i.e. minimal, moderate or severe severity, * patient who has failed conventional treatment (treatment followed for at least 1 year and not showing an improvement in symptoms) * absence of risk of ongoing pregnancy in women of childbearing age, validated by a urine test during the first consultation and before treatment and each month during treatment and until 1 month after the end of treatment exclusion criteria: * patient with the following medical history or current pathologies: organic gastrointestinal pathology, disabling neurological pathology, disabling psychiatric pathology * recent post traumatic stress syndrome (\<1 year), * fibromyalgia syndrome, * known allergy to medications used in mesotherapy treatment, * pregnant or breastfeeding woman

Keywords: mesotherapy inflammatory bowel disease
augmentation of neuronal network plasticity in schizophrenia

Conditions: Schizophrenia; Healthy

Summary: current pathophysiological models of schizophrenia focus on disconnectivity of distributed neuronal systems to explain the multitude of psychic symptoms. however, therapeutic strategies targeting this specific pathobiology are lacking. our recent work provides strong evidence that complex video-game training interventions facilitate fronto-hippocampal structural and functional connectivity within 2 months in healthy subjects. the planned project transfers this knowledge into a training study in schizophrenic patients to counteract disease-related disconnectivity. underlying mechanisms and behavioral effects are extensively parametrized by resting state functional magnetic resonance imaging (fmri), diffusion tensor imaging (dti), spectroscopy and clinical short- and long-term outcome.


Eligibility criteria:
inclusion criteria: * clinically stabilized * at least one schizophrenic episode in their lives * international classification of diseases 10 (icd-10) f20.x (and f25) exclusion criteria: * clinically relevant anemia * mri contraindication * earlier electroconvulsive shock treatment * significant somatic or neurological disease * significant alcohol or substance abuse in the year before * more than 1h video games per day more than 6 months before study start * simultaneous major psychiatric disease (if symptomatic in the foreground)
safety and efficacy of pilocarpine ophthalmic topical cream for the treatment of dry eye disease

Conditions: Dry Eye Disease; Kerato Conjunctivitis Sicca

Summary: this is a multicenter, randomized, double-masked, placebo-controlled, parallel group phase 2 trial evaluating the safety and efficacy of pilocarpine ophthalmic topical cream for the treatment of signs and symptoms of dry eye disease.


Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or older at the screening visit * willing and able to provide written informed consent on the irb/iec-approved informed consent form * diagnosis of dry eye exclusion criteria: * sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation * history of eczema, dermatitis or skin sensitivity to over-the-counter personal care products such as lotions, creams, makeup, soaps, etc. * history of, or active iritis or uveitis in either eye * pre-existing retinal disease in either eye that may predispose subjects to retinal detachment

Keywords: dry eye syndromes eye diseases corneal diseases keratoconjunctivitis pilocarpine
iron and covid-19 vaccine response

Conditions: Iron Deficiency Anemia; Vaccine Response Impaired; COVID-19 Vaccine; Iron Deficiency Anemia Treatment

Summary: vaccines often underperform in africa compared to high-income countries. why vaccines do not work as well in africa remains uncertain. malnutrition likely plays a role. our study objective is to assess whether iron deficiency anaemia in young women impairs their immune response to the covid-19 vaccine, and whether iron treatment improves their response.

group 1 (immediate iron treatment) will receive iron treatment before vaccination. women in both groups will receive the 1st dose of the covid-19 vaccine. vaccine response will be measured 28 and 56 days after the first vaccine administration in both groups. at 28 days, participants will receive the 2nd dose of the covid-19 vaccine. group 2 (delayed iron treatment) will receive iron treatment at study end.

Eligibility criteria:
inclusion criteria: 18-55 years old zinc protoporphyrin \> or equal 40 mmol/mol heme hemoglobin \< or equal 109 g/l no malaria no known hiv infection no medical condition that precludes study involvement no iron supplementation 1 week prior to study start no recent tuberculosis infection no vaccination of yellow fever or influenza prior to enrolment not pregnant exclusion criteria: -
bonefit: multimodal prehabilitation for people preparing for orthopaedic surgery

Conditions: Orthopedic Disorder

Summary: to conduct a pilot feasibility study to determine the effect of a student-led prehabilitation service in people awaiting total hip or knee replacement surgery.

the aim of bonefit is to provide local people living in the hull region with a needs-based prehabilitation care package to improve their physical and mental health, quality of life \& reduce their length of hospital stay, complications and readmission rates to hospital following orthopaedic surgery (total hip replacement, or total knee replacement. currently, hull university teaching hospitals do not offer a prehabilitation service for local patients. the university of hull will partner with them to provide a student-led multimodal prehabilitation service for referred patients awaiting orthopaedic surgery.

Eligibility criteria:
inclusion criteria: * waiting for unilateral total hip or knee replacement surgery for a minimum of 6 months; * able to provide informed consent; exclusion criteria: * previous hip or knee surgery; * any medical conditions for which moderate to vigorous exercise is contraindicated; * patellar or hip joint instability; * any other disease/condition which severely effects functional performance e.g. stroke or parkinson's disease; * chronic depression or significant psychiatric disorder; * enrolled in a clinical trial (or recently completed one); * cognitive impairment which would affect compliance to bonefit service; * patients unable or unwilling to commit to required study follow-ups * pregnancy;

Keywords: prehabilitation optimisation surgery surgical preparation
hepatitis c virus (hcv) positive liver grafts in hcv negative recipients

Conditions: Liver Failure

Summary: to provide proof-of-concept data on the efficacy/safety of transplanting hcv positive donor grafts in hcv sero-negative liver recipients who are currently listed.


Eligibility criteria:
inclusion criteria: * male or female * age 18 and older * active on the transplant list * donor organ with antibody and nucleic acid test (nat) positive for hcv * graft with f2 fibrosis or less at time of explant * hcv negative recipient; this includes patients who never had hcv and those with hcv previously eradicated with antiviral therapy. the latter is defined as those with undetectable hcv viral load at least 3 months since stopping therapy. * willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject exclusion criteria: * participants co-infected with hiv * donor previously treated with a non-structural protein 5a (ns5a) containing regimen (if treatment history of donor known) * known allergies or hypersensitivity to direct acting antiviral drug (daa) or ribavirin (rbv) * pregnancy and/or actively breastfeeding

Keywords: hcv
adductor canal block versus femoral block on pain and quadriceps strength

Conditions: Anterior Cruciate Ligament Tear; Knee Meniscus Tear

Summary: the purpose of this study is to compare the effects of a femoral nerve block vs. an adductor canal block on pain and quadriceps muscle strength for knee arthroscopy surgery.

patients undergoing arthroscopic knee surgery (acl and non-acl surgery) typically receive an ultrasound-guided femoral nerve block or an adductor canal block in the pre-operative phase for post-operative pain control. while an effective method for post-operative analgesia, the femoral nerve block is associated with profound quadriceps weakness for the duration of the nerve block, which can impair ambulation, rehabilitation, and increase the risk of falls. the more distal adductor canal block, however, contains primarily sensory branches of the femoral nerve and has been been purported by small volunteer studies to provide equally effective analgesia with minimal motor block and quadriceps weakness (as compared to femoral nerve block). the investigators will prospectively randomize patients undergoing knee arthroscopy at the ucsf orthopaedic institute to receive either a single-shot femoral nerve or adductor canal block pre-operatively after taking baseline measurements of quadriceps strength (quantified by maximum voluntary isometric contraction). the quadriceps muscle strength will be checked 20 minutes after the nerve block to assess strength. all patients will subsequently undergo a general anesthetic. the primary outcome variable will be post-block quadriceps strength as a percentage of baseline from pre-block values. secondary outcome variables that will also investigated include: vas pain score in the post anesthesia recovery unit and post-operative day 1, time to onset of sensory block, duration of nerve blockade, block performance time, patient satisfaction score, perioperative opioid use, perioperative analgesic consumption, incidence of paresthesias, number of needle passes, incidence of post-operative nausea, vomiting, constipation, and any other complications.

Eligibility criteria:
inclusion criteria: * american society of anesthesia i-iii classification, * scheduled for arthroscopic knee surgery (meniscal debridement/repair, acl reconstruction) exclusion criteria: * age younger than 18 years * non-english speaking * any contraindication for regional anesthesia, such as allergy to local anesthetics or opioids, -coagulopaty or severe thrombocytopenia * infection at puncture sites * pre-existing neuropathy in operative limb * need for post-operative nerve function monitoring * dementia * patient refusal * high pre-operative opioid requirements

Keywords: knee arthroscopy acl reconstruction femoral block adductor canal block
study and development of application models of "therapeutic education to the patient" (tep) in asthmatic children

Conditions: Asthma

Summary: it is an interventional prospective study. the study will assess the intervention of the "therapeutic education to the patient (tep)" on the quality of life in asthmatic children. the patients will be enrolled from the 1st of may 2016 to the 31st of december 2016 in the outpatient clinic of pediatric allergology \& pulmonology (pap) of respiratory disease research center (rdrc) within the institute of biomedicine and molecular immunology (ibim) of the national research council (cnr) of palermo (rdrc-ibim cnr), italy.

it is an interventional prospective study. the study will assess the intervention of the "therapeutic education to the patient (tep)" on the quality of life in asthmatic children. the patients will be enrolled from the 1st of may 2016 to the 31st of december 2016 in the outpatient clinic of pediatric allergology \& pulmonology (pap) of respiratory disease research center (rdrc) within the institute of biomedicine and molecular immunology (ibim) of the national research council (cnr) of palermo (rdrc-ibim cnr), italy. 25 case patients will follow the therapeutic education to the patient (tep) and 25 control patients will follow the usual care program. the following procedures will be performed: * pediatric asthma quality of life questionnaire (paqlq); * children asthma control test (c-act); * pediatric caregiver asthma quality of life questionnaire (pcaqlq); * familiar empowerment scale (fes); * functional respiratory tests: forced expiratory volume in one second (fev1), forced expiratory flow between 25% and 75% (fef 25-75), forced vital capacity (fvc) and peak expiratory flow (pef); in addition, fev1 and pef will be daily recorded through the smartone device (medical international research s.r.l.), a portable flow peak meter for smartphones; * evaluation of the presence of cotinine and nicotine from hair and urine analysis respectively; * evaluation of levels of exposure to polycyclic aromatic hydrocarbons (pah) through urine analysis. data collection about asthma control, quality of life and spirometry will be managed through dragone, a downloadable app for smartphones.

Eligibility criteria:
inclusion criteria: * diagnosis of asthma exclusion criteria: * acute respiratory infection signs * immunologic and metabolic systemic disease * major malformation of upper respiratory tract * active smokers patients

Keywords: asthma children
zero ischemia laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma with t1a stage

Conditions: Renal Cell Carcinoma; Zero Ischemia

Summary: to evaluate the feasibility and efﬁciency of zero ischemia laparoscopic radio frequency ablation assisted enucleation of t1a renal cell carcinoma in comparison with the conventional laparoscopic partial nephrectomy.

warm ischemic injury is one of the most important factors affecting renal function in partial nephrectomy (pn). zero ischemia partial nephrectomy technique using renal arterial branch microdissection could protect renal function during surgery, but it requires longer operative time and more blood loss than conventional partial nephrectomy. the technique of zero ischemia laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma appears to be an alternative that eliminates warm ischemia, preserves the maximal parenchyma and is oncologically safe. our study was designed to evaluate this technique in comparison with the conventional laparoscopic partial nephrectomy.

Eligibility criteria:
inclusion criteria: * patients with sporadic, unilateral, newly diagnosed t1a presumed renal cell carcinoma * patients with normal contralateral renal function (diﬀerential renal function of \>40% as determined by radionuclide scintigraphy) * patients agreeable to participate in this long-term follow-up study exclusion criteria: * patients' aged \>80 years * patients with other renal diseases * patients not able to tolerate the laparoscopic procedure * patients with previous renal surgery or history of any inﬂammatory conditions of the operative kidney * patients with the renal tumor close to the calyces

Keywords: renal cell carcinoma ischemia radio frequency ablation
influence of superstructure material on crestal bone resorption and esthetic outcome of dental implants

Conditions: Single Tooth Dental Implant

Summary: the aim of this study is to evaluate the influence of superstructure material on crestal bone resorption and esthetic outcome of dental implants in patients with single missing tooth in the aesthetic zone.

the transfer of occlusal forces to the implant bone interface greatly influence the long term prognosis of implants and crestal bone resorption. accordingly this study will investigate the influence of metal ceramic crowns and monolithic zirconia crowns on crestal bone resorption under loading. also these crown materials greatly influence the final aesthetic outcome of the definitive restoration, which will be evaluated using the pink and white aesthetic scoring systems.

Eligibility criteria:
inclusion criteria: 1. patients above 18 years old. 2. patients able to read and sign the informed consent document. 3. medically free patients or with controlled systemic disease. 4. patients with good bone quality and quantity evaluated using c.b.c.t. 5. patients willing to return for follow-up examinations and evaluation. 6. patients having single missing recently extracted premolar tooth. exclusion criteria: 1. young patients in growth stage. 2. patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption) 3. pregnant women to avoid any complication that may occur in dental office. 4. patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient) 5. psychiatric problems or unrealistic expectations. 6. multiple adjacent missing teeth. 7. patients with bad oral hygiene
evaluation of a marine oxygen carrier: hemo2life® for hypothermic kidney graft preservation, before transplantation (oxyop)

Conditions: End Stage Renal Diseases

Summary: kidney transplantation is the treatment of choice for end stage renal diseases, increasing life expectancy and quality of life. improvement in organ preservation is a critical issue in this context. this is a safety study evaluating the use of an oxygen carrier hemo2life® as an additive in organ preservation solution in kidney transplantation.

security of the use of hemo2life® will be analyzed by collecting all events within the first 3 months in terms of : 1. hemo2life® adverse effects 2. graft safety 3. recipient safety (any adverse event) accountability search will be achieved for each of these events.

Eligibility criteria:
inclusion criteria: for kidney : the first ten local kidneys in each participating centers that do not meet the exclusion criteria. * graft retrieved in an adult donor * graft from a deceased donor after brain death (dbd) * graft locally transplanted in one of the 6 kidney transplant centers participating in the study * graft stored in preservation solution containing hemo2life® for patient : patient who signed an inform consent form in case of patient unable to signed an inform consent form for patient under judicial protection (supervision, guardianship) the inform consent form will be obtain from the patient himself and from the supervisor/guardianshiper/parents, they will signed together the patient inform consent form. the probability of the inclusion of a patient unable to signed an inform consent form is low but we can't know the receiver before conditioning the graft. patient \> 18 years old exclusion criteria: * graft from a living donor * graft from a donor after cardiovascular death (dcd) * graft dedicated to a multi-organ transplantation

Keywords: kidney transplantation organ preservation
observational study to assess the efficacy and safety of novorapid™ flexpen™

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems

Summary: this study is conducted in asia. the aim of this observational study is to collect efficacy and safety data in diabetic patients with acute hyperglycemia using novorapid™ flexpen™ as per normal clinical practice.


Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus (according to product labelling) exclusion criteria: * hypoglycaemia * hypersensitivity to insulin aspart or to any of the excipients (according to product labelling)