Kornimate/medical-research-clean huggingface dataset:
arthroscopically assisted versus open surgical reduction of the hip in patients with irreducible ddh before the walking age

Conditions: Developmental Dysplasia of the Hip

Summary: to determine the role of arthroscopy in treatment of the ddh.

* the term developmental dysplasia of the hip (ddh) is composed of a spectrum of pathologies from stable acetabular dysplasia (femoral head centered in acetabulum but acetabulum is shallow) to concentric hips that are unstable (femoral head can be moved in and out of the confines of the acetabulum) and frankly dislocated hips in which there is a complete loss of contact between the femoral head and acetabulum. * open reduction , traditionally through a smith - peterson approach should be considered only if closed reduction cannot be performed. * medial open surgical reduction is a choice for the management of patients younger than 18 months with ddh. the minimal incision and minimal blood loss are advantages of this approach. limited exposure of the hip joint is a disadvantage. * the arthroscopic procedure was reported to represent a meaningful alternative to the open procedure due to a lower complication rate, a safe setting, a lower rate of residual dysplasia, no observed redislocation and low rate occurrence of osteonecrosis. * all the intra-articular structures (hypertrophic ligamentum teres, transverse acetabular ligament, and pulvinar tissue) in the acetabulum that impede the reduction of the femoral head could be eliminated by using the arthroscopic technique.

Eligibility criteria:
* inclusion criteria: * age: - from nine months to 18 months. * irreducible hip dislocation. * exclusion criteria: * patient age: below 9 months or above 18 months. * teratologic hip dislocation
ambulatory surgery for urogenital prolapse : a pilot study

Conditions: Prolapse

Summary: main objective is evaluation of success rate of ambulatory surgery (as) for pelvic organ prolapse (pop). all surgical approaches (laparoscopic, vaginal) are included in the study. secondary objectives are as rate in the overall population and reasons for ineligibility or failure of ambulatory surgery. this pilot study will evaluate the feasibility of as for pop and identify pitfalls in as. a randomized control study will follow pcap study.

the prolapse surgery will be performed in 13% of women. improved surgical and anesthetic techniques available makes this surgery to ambulatory care, while the latter is only slightly conducted in france. main objective is evaluation of success rate of ambulatory surgery (as) for pelvic organ prolapse (pop). all surgical approaches (laparoscopic, vaginal) are included in the study. secondary objectives are as rate in the overall population and reasons for ineligibility or failure of ambulatory surgery. this pilot study will evaluate the feasibility of as for pop and identify pitfalls in as. a randomized control study will follow pcap study.

Eligibility criteria:
inclusion criteria: * age \> 18 years * planned pop surgery * valid social insurance * french spoken and written * informed consent signed * no exclusion criteria exclusion criteria: * refuse participation to study * pregnant or lactating woman * vulnerable people (article l 1121-6 of the french code of public health) * major subject to legal protection or unable to consent (article 1121-8 of the french code of public health ) * participation in another protocol for less than 3 months * patient not presenting all the inclusion criteria.

Keywords: prolapse surgery ambulatory surgery
long-term clinical effectiveness of the delta xtend reverse total shoulder

Conditions: Cuff Tear Arthropathy; Osteoarthritis With Cuff Deficiency; Rheumatoid Arthritis; Post Traumatic Injury to Shoulder; Revision Surgery of a Failed Anatomic Shoulder Prosthesis

Summary: this post-marketing study is designed to collect data relating to the use of the delta xtend™ total shoulder replacement system in shoulder with rotator cuff deficiencies. this allows for continued monitoring of the performance and safety of the prosthesis in a broader range of clinical situations.


Eligibility criteria:
inclusion criteria: * male or female subjects, aged less than 85 years inclusive. * subjects who have cuff tear arthropathy, osteoarthritis with cuff deficiency, rheumatoid arthritis, post traumatic injury, or a need for revision surgery of a failed anatomic prosthesis in the left or right shoulder, which requires (total) shoulder arthroplasty. * subjects with radiographic evidence of sufficient bone stock to seat and support the delta xtendô reverse total shoulder system. * subjects who in the opinion of the clinical investigator are considered suitable for treatment with the delta xtend reverse total shoulder system. * patients with a life expectancy of greater than 12 months. * subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. * subjects who, in the opinion of the clinical investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. exclusion criteria: * male and female subjects aged 86 years or older. * subjects with complete deltoid muscle palsy in the target joint as determined by clinical evaluation. * subjects with active local or systemic infection or with a history of general or local infections in the target joint over the past 12 months. * subjects with severe deformities, or tumours, that would impair fixation or proper positioning of the implant. * subjects with no significant muscle, nerve or vascular disease. * subjects with a pathology that, in the opinion of the clinical investigator, will adversely affect healing. * known allergic reactions to implant materials (e.g. bone cement, metal, polyethylene) implant corrosion or implant wear debris. * subjects with a known history of poor compliance to medical treatment. * subjects who, in the opinion of the clinical investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation. * women who are pregnant. * subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. * subjects who have participated in a clinical investigation with an investigational product in the last month. * subjects who are currently involved in any injury litigation claims.

Keywords: total shoulder replacement rotator cuff osteoarthritis rheumatoid arthritis delta extend
a phase 1 trial of opa-15406 ointment in healthy adult male subjects

Conditions: Atopic Dermatitis

Summary: to assess the safety (especially skin findings) and pharmacokinetics by applying 0.3%, 1%, or 3% formulation of 5g opa-15406 ointment to a 1000 cm2 area as a single-dose and as a multiple-dose twice daily for 2 weeks in japanese healthy adult male subjects.


Eligibility criteria:
inclusion criteria: * bmi = body weight (kg) / \[height (m)\]2: at least 18.5 and less than 25.0 * judged by the investigator or subinvestigator to be healthy based on test results at screening and prior to administration on day 1 of the treatment period exclusion criteria: * findings (sunburn, abrasions, tattoos, etc) on the back that affect the evaluation of the safety of the skin * judged by the investigator or subinvestigator as inappropriate to participate in this trial for any other reasons
the effect of inferior alveolar nerve block in fracture mandibular surgeries

Conditions: Anesthesia

Summary: the aim of the study is to assess the efficacy of adding of pre-emptive inferior alveolar nerve block compared to the conventional systemic intravenous analgesia in controlling perioperative pain in fracture mandibular surgeries.

opioid drug administration is a common technique to reduce pain from surgical trauma. however, the use of large doses of opioid drugs during and after surgery can be associated with an increased incidence of multiple side effects such as; ventilatory depression, sedation, nausea, vomiting, pruritus, difficult voiding and ileus. in maxillofacial surgeries in which patients often receive maxillomandibular fixation these side effects are troublesome to the patient and at worst case scenario can cause a life-threatening complications. ventilatory depression and vomiting are the most serious side effects especially in early postoperative hours. various methods have been proposed to minimize these side effects. nerve block with long-acting local anesthesia is a proposed technique in this regard. in maxillofacial operations, bupivacaine is a highly efficient long-acting local anesthetic and has been used as a safe local anesthetic for neuroanalgesia after cleft lip operation or third molar surgery alone or in combination with low-power laser and diclofenac. inferior alveolar nerve block is considered as gold standard for sensory block of the hemi mandible. it can provide adequate anesthesia and analgesia for one side of the mandibular teeth and gingival mucosa, the body and inferior ramus of the mandible, the anterior two-thirds of the tongue and floor of the mouth cavity. the inferior alveolar nerve (ian) block is a widely used regional anaesthetic nerve block for the mandible. the most commonly used technique for ian block is called the direct approach which include inserting the needle into the pterygomandibular raphae by penetrating the buccinators muscle. once in this space, the aim is to inject the local anaesthetic solution besides the inferior alveolar nerve before it enters the mandibular foramen.

Eligibility criteria:
inclusion criteria: 1. age group: 18 - 65 years old. 2. american society of anesthesiologists (asa) physical status class i to iii 3. scheduled for fracture mandible fixation. exclusion criteria: 1. refusing to participate in the study. 2. history of allergy to the medications used in the study. 3. contraindications to regional anesthesia (including coagulopathy and local infection). 4. psychiatric disorders. 5. pregnancy.
helping empower liver and kidney patients

Conditions: Hepatitis C; Chronic Kidney Diseases; Patient Education

Summary: the overall purpose of this study is to develop and test a web-based decision aid (da) to support patients with hepatitis c and chronic kidney disease during decisions about whether, when, and how to treat each illness. patients will have the opportunity to learn about their hepatitis c and kidney disease, initiate thought about what matters most to them and choose a treatment plan for their liver and kidney disease that works best for them. investigators will evaluate the tool's efficacy, usability, and the likelihood of using it in clinical practice. there are three (3) primary aims of this project: (1) to develop the da; (2) to pilot-test the da to determine efficacy, usability and likelihood of using it in routine practice; (3) to explore stakeholders feedback on the usefulness of the da and likelihood of implementing the tool.

first, for aim 1, investigators along with direction from a diverse expert advisory group of nephrologists, hepatologists, and patient partners developed a decision aid based upon international patient decision aids standards guidelines, literature reviews, and expert advisory reviews. it includes plain language education, interactive learning modules personalized tailored information to help individuals use and consider information appropriate to their values and needs, and guidance on discussions with clinicians about treatment goals. second, for aim 2, investigators will pilot-test the decision aid with 70 individuals in a pre-post within-subjects study design to evaluate the tool's efficacy, usability, and the likelihood of using it in clinical practice. lastly, for aim 3, investigators will conduct 30 semi-structured qualitative interviews with both clinicians and participants after the pilot evaluation of the decision aid to gather feedback about implementing the tool into clinical practice.

Eligibility criteria:
inclusion criteria: * must read and understand english and * must have hepatitis c (any genotype) and chronic kidney disease (any stage) exclusion criteria: * developed jaundice, ascites, variceal hemorrhage, or hepatic encephalopathy also known as decompensated cirrhosis; or * currently has or had liver cancer (hepatocellular carcinoma); or * received a liver transplant

Keywords: patient centered pre-post design decision support health literacy
effect of xp endo finisher versus ultrasonic activated irrigation on post-operative pain in endodontic treatment of symptomatic irreversible pulpitis

Conditions: Symptomatic Irreversible Pulpitis

Summary: recruited patients with symptomatic irreversible pulpitis are assigned to interventional (xp endo finisher file) and control group(ultrasonic activated irrigation) to undergo single visit endodontic treatment and record postoperative pain afterwards.

the investigator will recruit patients from the clinic of endodontics in faculty of oral and dental medicine, cairo university. the patients who are found eligible to the criteria, will be randomly assigned to either the control group (ultrasonic activated irrigation )or to the intervention group( xp endo-finisher file). endodontic treatment will be done in single visit. after the visit, patients will be asked to record post operative pain by nrs (numerical rate scale)in a given sheet.

Eligibility criteria:
inclusion criteria: 1. medically- free of any systemic disease 2. male or female 3. patients with age range 25-45 4. symptomatic irreversible pulpitis in single rooted single canal teeth without apical periodontitis. 5. teeth with mature root 6. restorable teeth 7. teeth without calcified root canals 8. teeth without root caries 9. teeth without internal or external root resorption 10. teeth with no sign of crack formation 11. teeth without anatomic abnormalities exclusion criteria: 1. pregnant females. 2. if analgesics have been administrated during the past two weeks preoperatively. 3. patients having bruxism or clenching. 4. multi rooted or multi canaled teeth. 5. patients with swelling or acute peri-apical abscess. 6. previously endodontically treated teeth 7. periodontally affected teeth .

Keywords: xp endo finisher ultrasonic activated irrigation postoperative pain
evaluation of the impact of the update smm criteria on the natural history of smm to establish new recommendations.

Conditions: Smoldering Multiple Myeloma

Summary: this study is a prospective open label interventional multicenter study evaluating the impact of the update multiple myeloma criteria on the natural history of smoldering myeloma in order to establish new recommendations about follow up and prognostic evaluation of smoldering myeloma.

in 2014, the international myeloma working group (imwg) proposed a revised classification of multiple myeloma (mm) and smoldering myeloma (smm). since the new definition of smm proposed excludes "ultra-high risk smm", the evolution profile of smm will change. therefore, investigators need to update their knowledge of smm to optimize the management of patients. this project is expected to describe more precisely the new landscape of smm. the results will help to establish new recommendations for the standard care of smm and especially for defining accurate follow-up and risk stratifying.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * smm defined by imwg 2014 criteria 1. serum monoclonal protein (igg or iga) ≥30 g/l and/or urinary monoclonal protein ≥500 mg per 24 h and/or clonal bone marrow plasma cells 10-60% 2. absence of myeloma defining events or amyloidosis * diagnosed less than 1 year before the inclusion * able and willing to give valid written informed consent. patients must give written informed consent (ic) in accordance with institutional and local guidelines. exclusion criteria: * previous antimyeloma treatment including bisphosphonates * second primary malignancy and/or auto-immune disease treated by immunosuppressive drugs. * evidence of end organ damage that can be attributed to the underlying smm: 1. hypercalcaemia: serum calcium \>0.25 mmol/l (\>10 mg/l) higher than the upper limit of normal or \>2.75 mmol/l (\>110 mg/l) 2. renal insufficiency: creatinine clearance \ 177 μmol/l (\>20 mg/l) 3. anaemia: haemoglobin value of \>2 g/dl below the lower limit of normal, or a haemoglobin value \<10 g/dl 4. bone lesions: one or more osteolytic lesions on skeletal radiography, ct, or positron emission tomography-computed tomography (pet-ct) * presence of one of the following biomarkers of malignancy: 1. clonal bone marrow plasmocytosis ≥60% 2. involved/uninvolved serum free light chain (flc) ratio ≥ 100 (the involved free light chain must be ≥100 mg/l) 3. presence of one or more focal lesions on mri studies (each focal lesion must be 5 mm or more in size) * history of malignancy other than smm within 3 years before inclusion * amyloidosis * poems syndrome * contraindication to mri * pregnancy * nursing mother * legally protected adults (under judicial protection, guardianship, or supervision)
bioavailability of carotenoids from orange juice in a cross-over study in healthy subjects.

Conditions: Biological Availability; Carotenoids; Lutein; Humans

Summary: commercially available fruit juices are obtained after applying industrial technologies to preserve and extend the shelf-life by inactivation of microorganism and enzymes. these are traditional thermal treatment (eg. pasteurization, sterilization) that causes losses of nutritional and bioactive compounds, changes physicochemical properties (colour, flavor and texture) and can modify their bioavailabilities. thus, the traditional thermal processing is being replaced by less intense thermal technologies (e.g. low-temperature pasteurization / refrigerated storage) and non-thermal treatments such as the high-pressure processing (hpp) and the pulsed electric fields (pef) as an alternative to enhace food safety and shelf-life without compromising organoleptic qualities (retain the flavour, color healthiness of fresh foods) and keeping their health-promoting capacity. the beneficial health effect derived from the orange juice intake is partly related to the bioavailability of their bioactive compounds. the aim of this study was to assess the effect of the intake of freshly squeezed orange juice (citrus sinensis l.) and processed orange juice elaborated with different treatments (low pasteurization / refrigerated storage, high-pressure processing, pulsed electric fields) on the main serum carotenoid concentrations in a cross-over study in apparently healthy subjects using multiple dosis.

methods twelve healthy subjects (6 men), age 20-32 y, were enrolled in a cross-over study, to consume 500 ml of orange juice/day during 14 days periods. all volunteers consumed the lp and hpp, six consumed pef or fs-orange juice. fasted blood was collected at baseline and on days 7 and 14. carotenoid concentrations in serum and orange juice were analyzed by high performance liquid chromatogry (hplc).

Eligibility criteria:
inclusion criteria: * age (20- 32 y) * body mass index (bmi) * serum cholesterol and triglycerides concentrations within the normal range * serum retinol within the range 31 - 70 µg/dl. exclusion criteria: * vitamin / mineral supplements intake * regular medication * pregnancy or lactating * chronic disease * smoking habit.
non-interventional study comparing targiniq and oxycodone/laxatives

Conditions: Pain; Opioid Induced Constipation

Summary: the objective of the non-interventional study is to compare the quality of life, health care resource use and costs between the use of a combination of oxycodone and naloxone (targiniq) versus oxycodone and laxatives for patients with severe pain, and to evaluate the cost-effectiveness of treatment with targiniq.


Eligibility criteria:
inclusion criteria: * male or non-pregnant female ≥18 years of age * malignant or non-malignant opioid sensitive pain * must sign an informed consent form (icf) * must have a stable daily dose of oxycodone prolonged release formulation titrated to analgesic effect (as to be assessed by clinical experts) * use of laxatives for concomitant opioid-induced constipation in an adequate dose and length of time and without sufficient effect * bfi ≥30 and state a discomfort caused by the constipation at screening * ability to answer the patient questionnaires and have an estimated overall life expectancy of at least six (6) months exclusion criteria: * history of, or on-going, abuse of alcohol and/or drugs * inability to read and understand written instructions, icf or questionnaires * constipation not related to opioid use * unsuitable patient for other reason(s) in the opinion of the investigator * inpatients, if admission and/or discharge is expected during study period
study of lumacaftor in combination with ivacaftor in subjects 6 through 11 years of age with cystic fibrosis, homozygous for the f508del-cftr mutation

Conditions: Cystic Fibrosis

Summary: this is a phase 3, 2-part (part a and part b), open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the f508del-mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf defined as: with 2 cf-causing mutations, chronic sinopulmonary disease or gastrointestinal/nutritional abnormalities * subjects who weigh ≥15 kg without shoes at screening visit * subjects who are homozygous for the f508del-cftr mutation * subjects with percent predicted forced expiratory volume in 1 second (fev1) of 70% to 105% (inclusive) (part a) or ≥40% (part b) at screening visit where the predicted values are adjusted for age, sex, and height using the wang equation * subjects with stable cf disease and who are willing to remain on stable cf medication regimen * able to swallow tablets exclusion criteria: * history of any illness or condition that might confound the results of the study or pose an additional risk in administering study drug to the subject * acute respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before day 1 of the study * abnormal liver function as defined in the protocol at screening visit * abnormal renal function as defined in the protocol at screening visit * history of solid organ or hematological transplantation * ongoing participation in an investigational drug study or prior participation in an investigational drug study within 30 days prior of screening visit * history or evidence of lens opacity or cataract at screening visit * colonization with organisms associated with a more rapid decline in pulmonary status at screening visit (part a only) * a standard 12-lead ecg demonstrating qtcf \>450 msec at screening visit