Kornimate/medical-research-clean huggingface dataset:
effects of intraarticular botulinum toxin a in ankle osteoarthritis

Conditions: Ankle Osteoarthritis

Summary: the purpose of this study is to compare the effects of intraarticular botulinum toxin a versus intraarticular hyaluronate plus rehabilitation exercise in patients with ankle osteoarthritis.

recent pilot studies report that intraarticular injection of botulinum toxin a into painful joints of patients with various types of arthritis leads to significant and durable improvement in pain and function and is safe to use. to date, there is no published literature that evaluate the effects of intraarticular botulinum toxin a in the treatment of ankle oa. sun el al reported that 3 or 5 weekly injection of hyaluronate may improve pain and physical function in patients with ankle oa and the treatment effects may last for 6 months. the effect of one injection of hyaluronate plus exercise had never been studied. the purpose of this study is to compare the effects of intraarticular botulinum toxin a versus intraarticular hyaluronate plus rehabilitation exercise for patients with ankle oa.

Eligibility criteria:
inclusion criteria: * an age of 20-85 years with diagnosis of ankle osteoarthritis * unilateral ankle pain that had lasted for at least 6 months, with no significant benefit from conservative treatment or with an inability to tolerate the side effects of medications * ankle radiographs taken within 6 months equivalent to grade 2 on the kellgren-lawrence grading system * a current total ankle osteoarthritis scale (aos) score of \>3 and \< 9 (possible range, 0-10) * a normal activity level-i.e., not bedridden or confined to a wheelchair, and are able to walk 30 meters without the aid of a walker, crutches or cane * no changes in shoes or orthotic devices during the study period. exclusion criteria: * pregnancy or lactation in women * lower leg trauma other than ankle trauma * previous surgery involving the spine, hip or knee * the presence of an active joint infections of foot or ankle * previous surgery or arthroscopy on the ankle within 12 months * history of chicken or egg allergy * intraarticular steroid or hyaluronate injection in the treated ankle within the previous 6 months * treatment with anticoagulants or immunosuppressives * a history of rheumatoid arthritis, gout, or any other inflammatory arthropathy * the presence of other comorbidity (such as neoplasms, diabetes mellitus, paresis or recent trauma) or poor health status that would interfere with the clinical assessments during the study.

Keywords: osteoarthritis, botulinum toxin, hyaluronate
computer-aided design/computer-aided manufacturing for mild to moderate molar incisor hypomineralization treatment

Conditions: Molar Incisor Hypomineralization

Summary: molar incisor hypomineralization (mih) is a disease causing a structural defect in the enamel of permanent teeth. the treatment of these teeth consists of the removal of the affected part of the tooth and its reconstitution. classically, the restoration is done with a resin in direct method. with the development of computer-aided design (cad) and computer-aided manufacturing (cam), it is possible to make a custom-made part to replace the affected part of the tooth. the main objective is to describe the effect of the 6-month management of cad/cam type restorations compared to direct restorations, performed in children aged 7 to 12 years with mild to moderate mih on permanent molar teeth.

molar incisor hypomineralization (mih) is a structural defect of the enamel affecting at least one of the first four permanent molars. the prevalence is high, ranging from 20% to 40% of children. the consequences of mih are multiple, including pain during food intake or an increased risk for the development of carious disease. the current standard protocol for mild to moderate mih is the use of direct restorations (glass cement ionomer type). however, this therapy is not suitable due to frequent failures. in terms of longevity, indirect restorations are superior to direct restorations. cad/cam in dentistry offers the possibility of making these inlay/onlay type perennial coronary restorations. it is faster to implement and does not require a conventional impression.

Eligibility criteria:
* inclusion criteria: 1. child from 7 to 12 years old presenting a mild to moderate hin on at least one permanent first molar requiring reconstitution. 2. child presenting a state of anxiety compatible with the provision of oral care (score on the venham scale modified by veerkamp below 2). 3. child affiliated to or benefiting from a social security scheme. 4. free, informed and signed consent by the parent(s)/holder(s) of parental authority and the investigator (at the latest on the day of inclusion and before any examination required by the research). 5. oral consent of the child. * non-inclusion criteria: 1. child presenting an allergy or a history of allergy to one of the constituents of biomaterials 2. child with fluorosis 3. child with amelogenesis imperfecta 4. child with pacemaker (contraindication to cad/cam) -

Keywords: molar incisor hypomineralization direct restauration computer-aided design (cad) computer-aided manufacturing (cam)
meopa breathing analgesia for oocyte retrieval(kaloval)

Conditions: Infertility; Pain

Summary: the purpose of this study is to assess pain, at or after oocyte retrieval, the effectiveness of self-controlled inhalation analgesia by nitrous oxide (n2o of 50% and 50% o2) by the patient compared to a local anesthesia combined with a tablet of 0.5 mg of alprazolam.

oocyte retrieval is a major event during in vitro-fertilization, with or without sperm micro-injection. initially done by laparoscopy with general anesthesia, the oocyte collection is now carried out by trans-vaginal controlled ultrasound puncture. this potential painful event, related to trans-vaginal puncture or mechanical movements of the stimulated ovary, requires analgesia or anesthesia. general anesthesia is certainly effective in terms of collected oocytes. it remains, however, a heavy time consumer, with personal risks and distributor of anesthetic agents in blood or follicular fluid. these products could have a deleterious effect on early embryonic development or implantation. few data are available concerning these risks in the literature. general anesthesia is still essential for pusillanimous patients or for patients with a heavy surgical past. nitrous oxide is an inhaled gas with properties widely used in obstetric during parturition. it is regularly used during general anesthesia performed for oocyte retrieval. with a gas composed of 50% n2o and 50% o2, its main interest is to provide analgesia in a state of conscious sedation. the effects of nitrous oxide in this form had never been assessed on the clinical or biological oocyte collection. we conducted a preliminary study to assess pain in patients receiving local anesthesia, according the current protocol. thus, 44% of patients had severe pain (vas\> 40/100) during or just after transvaginal oocyte retrieval. in our preliminary experience, immediate or distance post-operative pain was high and we plan to evaluate the benefit of analgesia with nitrous oxide in terms of immediate post-operative pain with a prospective, randomized and controlled study as compared with local anesthesia associated to alprazolam.

Eligibility criteria:
inclusion criteria: * patient requiring a first or second oocyte retrieval procedure for ivr or icsi after ovarian stimulation by gonadotrophin * agreement to participate to this study exclusion criteria: * absolute indication for oocyte retrieval with general anesthesia * no agreement to participate to this study, * painfully known patient-not easy ovarian vaginal accessibility for monitoring or puncture * respiratory pathology-chronic liver, kidney pathology, immunodeficiency, -contraindication to the medications used during the protocol

Keywords: oocyte retrieval pain surgery anaesthesiology assisted reproductive technologies
neoadjuvant immunotherapy for t4 dmmr colon cancer

Conditions: Colon Cancer; Mismatch Repair Deficiency; Immunotherapy

Summary: due to dmmr colon cancer patients respond poorly to conventional chemotherapy, but immunotherapy can significantly improve the pcr in this group of patients, this study intends to explore whether neoadjuvant immunotherapy can improve the r0 resection rate with preservation of adjacent organs in t4 colon cancer patients with dmmr.


Eligibility criteria:
inclusion criteria: 1. aged 18-75 years; 2. ecog score 0-2; 3. adenocarcinoma confirmed by pathology and dmmr confirmed by ihc or pcr; 4. tumor located in cecum, ascending colon, transverse colon and sigmoid colon; 5. patients with clinical stage ct4: (1) loss of space between tumor and adjacent organs or invasion of adjacent organs as assessed by enhanced ct; (2) r0 resection cannot achieve according to intraoperative exploration; 6. no evidence of distant metastasis; 7. newly treated patients who have not received treatment including chemotherapy and surgery; 8. liver, kidney and other organs have good function and can tolerate chemotherapy and surgery; 9. patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent. exclusion criteria: 1. a history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years; 2. complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery; pregnant or lactating women; 3. patients with a history of severe mental illness, immune disease, hormone medication; 4. patients contraindicated by immunotherapy or surgery; 5. participated in other clinical researchers in the past 3 months; 6. any other circumstances that the investigator considers inappropriate for inclusion.
treatment with xeomin versus botox in children with spastic equine and equinovarus foot deformation in pediatric cerebral palsy

Conditions: Cerebral Palsy; Spastic Paraplegia and Hemiparesis; Equine and Equinovarus Foot Deformation

Summary: 1. to assess the clinical and neurophysiological efficacy of xeomin® vs. botox® in children with spastic equine and equinovarus foot deformation in pediatric cerebral palsy 2. to assess the safety of xeomin® use as compared to botox® in this patient population


Eligibility criteria:
inclusion criteria: * children from 2 through 12 years of age, of both sexes, suffering from spastic paraplegia or hemiparesis in pediatric cerebral palsy. * equine and equinovarus foot posture. * gastrocnemius spasticity of 2 points and greater, by modified ashworth scale. * patient can walk unassisted or with a support. * mental development of patients is normal or mildly retarded. * previous course of spasticity treatment with bta products was completed earlier than at 6 months before this trial or never administered before. * patient's parents have signed an informed consent, are able and wishing to adhere to procedures described in the trial protocol and to the schedule of visits throughout the entire period of treatment. exclusion criteria: * fixed ankle joint contracture. * previous denervation of spastic muscles by surgery, phenol or alcohol; * athetosis and dystonia in the area of injected muscles. * inflammation at the planned injection site. * elevated body temperature and acute (infectious and non-infectious) diseases at the time of injection. * neuromuscular transmission disorders (myasthenia gravis, lambert-eaton syndrome, etc.). * decompensated physical diseases potentially affecting the trial findings. * acute fever, infection or surgery within 1 month before the trial. * use of aminoglycosides or spectinomycin within 1 month before starting the trial. * hypersensitivity to any of product ingredients. * positive history for allergies (especially with regard to protein-containing products). * patient's parents are unable or unwilling to adhere to the trial protocol requirements including signing the informed consent and conforming to the schedule of visits. * participation in other clinical trials in the last 4 weeks before inclusion.
efficacy and safety study of polidocanol injectable foam for the treatment of saphenofemoral junction (sfj) incompetence

Conditions: Varicose Veins

Summary: varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. in this study, patients with varicose veins in the legs will be participating. the purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, polidocanol injectable foam compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.


Eligibility criteria:
inclusion criteria: * incompetence of sfj associated with incompetence of the gsv or other major accessory vein * ability to comprehend and sign an informed consent document and complete study questionnaires in english * ability to record symptoms in accordance with the protocol * symptomatic varicose veins * visible varicose veins exclusion criteria: * patients who only have telangiectatic or reticular veins (clinical finding c1, as assessed by ceap (clinical, etiologic, anatomic, and pathophysiologic) classification of venous disorders). * leg obesity impairing the ability to access the vein to be treated and/or to apply postprocedure compression bandaging and stockings * ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion * deep vein reflux unless clinically insignificant in comparison to superficial reflux * peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings * reduced mobility * major surgery, prolonged hospitalization or pregnancy within 3 months of screening * major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.) * known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions * current alcohol or drug abuse * pregnant or lactating women * women of childbearing potential not using effective contraception * history of dvt, pulmonary embolism or stroke

Keywords: varicose veins
validation and assessment of patient adherence to opioids for cancer pain using mmas 8 pain clinic

Conditions: Chronic Cancer Pain

Summary: this study aims at finding degree of adherence of patients to their chronic pain medication prescriptions containing opioid e.g. morphine, using morisky medication adherence scale 8, self- reported questionnaire. also relationship of various demographic, disease related and opioid related factors to medication adherence.

after institutional review board approval, a pilot study including 30 patients will be conducted to validate morisky medication adherence scale 8 to validate the questionnaire for cross cultural variation. the data collected will be analyzed and result will be submitted to institutional review board for approval to conduct the parent study. following the above approval, all adult patients , more than 18 yrs. of age, who are on a strong opioid for their chronic cancer pain, taken prescription from pain clinic at least once in past, who are able to understand and communicate hindi will be invited to participate in the study. each patient will be verbally asked about their medication and same will be confirmed by their previous medical records. an informed written consent will be obtained. data will be collected by pi or co-investigator after obtaining written consent at pain clinic(general and private) of tata memorial hospital. fund for purchasing the copyright to use the hindi translation of morisky medication adherence scale 8, was provided by the department of anesthesia account, tata memorial hospital, after due permission obtained from, director tata memorial center and head of the department of anesthesiology, critical care and pain, tata memorial center. the precise scoring and permission to use the hindi translation of the scale has been obtained from the developer. for income we will be considering private and general category of the patients respectively.data will be analyzed using international business machines software package for statistical analysis version 20.0.pilot study data will be analyzed applying tests as internal consistency (cronbach's alfa), test retest variability and factor analysis.for parent study in the uni-variate analysis all variables listed above will consecutively tested for significant associations with ''good adherence'' as the outcome variable. chi-square tests and student's t-tests will used for categorical and continuous variables, respectively. all variables will be unconditionally entered into a binary logistic multi variate analysis. all p values #0.05 will regarded as statistically significant.

Eligibility criteria:
inclusion criteria: 1. all adult patients \> 18 yrs. of age 2. patients suffering from chronic pain of any type and severity 3. on opioid i.e. morphine, taken prescription at least once 4. who can understand and communicate hindi exclusion criteria: 1. refusal of consent 2. paediatric patients 3. patients who cannot understand or communicate hindi

Keywords: adherence opioid mmas 8, morisky medication adherence scale validation
a study to assess long-term safety, tolerability, and efficacy of rocatinlimab in adult and adolescent participants with moderate-to-severe atopic dermatitis (ad)

Conditions: Atopic Dermatitis

Summary: the primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe ad.


Eligibility criteria:
inclusion criteria: * completion of an end of treatment duration visit (week 24 or week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (rocket-ignite, rocket-horizon, rocket-shuttle, rocket-astro, rocket-orbit, or rocket-voyager) within the past 28 days. * participants from the parent study rocket-orbit must achieve an improvement in easi score at week 52 of at least 60% compared to parent study baseline (easi 60). exclusion criteria: * permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (rocket-ignite, rocket-horizon, rocket-shuttle, rocket-astro, rocket-orbit, or rocket-voyager), or at the time of screening or day 1.

Keywords: atopic dermatitis rocatinlimab amg 451 eczema
a study to examine the efficacy and safety of zanubrutinib given to adults with primary membranous nephropathy

Conditions: Primary Membranous Nephropathy

Summary: the primary objectives of this study are: in part 1 to evaluate the efficacy of zanubrutinib as measured by proteinuria reduction, and in part 2 to evaluate the efficacy of zanubrutinib compared with tacrolimus as measured by complete remission rate, in participants with primary membranous nephropathy (pmn) who are on optimal supportive care.


Eligibility criteria:
inclusion criteria: * biopsy-confirmed pmn within 5 years before the initial screening (ie, the day the informed consent is signed) * upcr (based on 24-hour urine collection) \> 3.5 at initial screening and at confirmation assessment * treatment with a maximally tolerated or allowed dose of an angiotensin-converting enzyme inhibitor (acei) or angiotensin ii receptor blocker (arb) for ≥ 24 weeks before randomization (12 weeks before initiation of study drug for part 1) and with adequate blood pressure control (blood pressure \< 130/80 mmhg, measured on ≥ 2 occasions \[not on the same day\] within 4 weeks before the assignment of study treatment) * anti-pla2r antibody \> 50 ru/ml at confirmation assessment (part 1 only) exclusion criteria: * participants with a secondary cause of membranous nephropathy * type 1 or 2 diabetes mellitus with hemoglobin a1c (hba1c) ≥ 7% at screening * severe renal disease as determined by rapid decline in egfr (defined as \> 15 ml/min/1.73m\^2 within 24 weeks prior to randomization, not otherwise explained) * a known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus (hiv) infection or splenectomy that predisposes the participant to infections * patients at risk for tuberculosis at screening * known infection with serologic status reflecting active or chronic hepatitis b virus infection, or presence of hepatitis c virus antibody * severe hepatic insufficiency (child-pugh c) * clinically significant cardio-cerebrovascular diseases note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: bgb-3111 zanubrutinib btki
fast track for wrist and scaphoid fractures

Conditions: Wrist Fracture; Scaphoid Fracture

Summary: this is a mono centric, prospective, randomised trial on the implementation and assessment of a shortened pathway for mono-trauma of the wrist and suspected fracture of distal radius and/or ulna and/or scaphoid bone.

patients will be randomised into two groups: fast track and normal pathway. at the arrival in the emergency department a triage will be performed. in case of met inclusion criteria the patient will sign the informed consent and will be randomised in one of the two study groups. the fast track group will be straightforwardly evaluated for absence of exclusion criteria (in case of exclusion criteria present the investigators will follow the normal pathway and the patient will not be included in the study). then, patients will be assessed with an ad hoc checklist and then sent for x-ray performance, if necessary. after the x-ray the patients will be examined by an emergency physician that will have the opportunity to request new x-ray views if necessary. the normal pathway group will go straight to medical examination as soon as possible, depending on waiting times in the emergency department. investigators will collect anagraphical data, waiting times, time to x-ray, overall length of stay in the emergency department, patients' and staff's satisfaction for the two groups.

Eligibility criteria:
inclusion criteria: * adults patients presenting at the emergency dept with suspected scaphoid or wrist fracture * monotrauma * written informed consent exclusion criteria: * patients younger than 18 yr * pregnant women * either vascular or neural impairment * signs of open fracture * multiple trauma patient