Kornimate/medical-research-clean huggingface dataset:
parkinsonian patients treated with apomorphine pump: observatory of skin lesions

Conditions: Patients With Parkinson's Disease Treated With Apomorphine Pumps

Summary: treatment with subcutaneous apomorphine will be initiated according to the usual procedures at each centre. once the patient is included in the study, he/she will be followed for 24 months according to a schedule of visits corresponding to his/her follow-up care. the procedures outside of the patient's usual care are only more in-depth clinical assessments and examinations (interviews with a nurse, skin lesion assessment scale, quality of life scales, neurological and cognitive assessment scales). at each visit, the patient will be seen in consultation by a state-qualified nurse from the neurology department who will conduct * nursing interviews to assess tolerance and compliance with treatment. she will also look for data concerning the flow rate, the duration of the subcutaneous apomorphine pump and the injection methods (material used, rotation of injection sites, massages). * collection of adverse effects and changes in concomitant treatments. * assessment of skin complications (number, location, characteristics: size, pain, inflammation). for centres that do not have a nurse dedicated to monitoring these patients, the above procedure will be carried out by the neurologist. in all cases, the patient will receive a consultation (in the department or remotely) by the neurologist. the tests and scales performed at inclusion will be repeated at each six-monthly visit.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years, * diagnosis of parkinson's disease according to the mds criteria (2015), * patients with a prescription for subcutaneous apomorphine pump therapy, * patient having read and understood the information letter and having expressed oral non-opposition to the research. exclusion criteria: * patient unable to express opposition or non-opposition, * patient not affiliated to the social security system, * pregnant woman or woman in labour or breastfeeding, * person deprived of liberty by an administrative or judicial decision, * person placed under court protection, guardianship or curatorship.
manually versus digitally fabricated removable partial dentures

Conditions: Partially Edentulous Patients

Summary: in the clinical trial, the computer aided design/computer aided manufacturing (cad/cam) fabricated removable partial dentures (rpd's) are evaluated on casts and clinically compared with a traditional fabricated rpd for 50 consecutive patients. during 5 years the patients are in a follow-up program in order to judge long-term stability, loss of retention, fractures, ... of both groups of dentures.

the classic removable partial denture (rpd) is a denture fabricated in crco using the "lost wax" technique. this hand-made way of working makes the final result vulnerable, not always predictable and not reproducible. computer aided design/computer aided manufacturing (cad/cam) techniques have been introduced in dentistry, particularly to fabricate crowns and bridges (fixed partial dentures). there is little research in the field of removable partial framework fabrication. this may be in part be attributed to the lack of suitable dedicated software. in the technical part of the study, existing software and hardware is adjusted to maximize the automation in the application of computer-aided technologies to surveying of digital casts and pattern design and the subsequent production of sacrificial patterns using removable partial (rp) technologies. in the clinical trial the cad/cam fabricated rpd's are evaluated on casts and clinically and compared with a traditional fabricated rpd for 50 consecutive patients. for every patient, two rpds are made in the same material (crco).the clinical parameters (fit, stability, retention, support, friction) are double blind evaluated by two dentists. at the end of the treatment, the patient can choose one of them. both rpds are fabricated in the same time frame for the fabrication of the "classic" rpd. there are for the patient no extra sessions scheduled. during 5 years the patients are in a follow-up program in order to judge long-term stability, loss of retention, fractures, ... of both groups of dentures. hypothesis1: cad/cam fabricated rpd's can meet the clinical standards for rpd's. hypothesis 2: dentists do not observe a difference between the classic and cad/cam fabricated rpd. hypothesis 3: patients do not see/feel any difference between the classic and cad/cam fabricated rpd.

Eligibility criteria:
inclusion criteria: * patients in need of a classic removable partial denture (rpd)

Keywords: edentulous
a study to investigate the pk and safety of ckd-393

Conditions: Type II Diabetes

Summary: a clinical trial to investigate the pharmacokinetics and safety after oral administration of ckd-393

a randomized, open-label, single-dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety after oral administration of ckd-393 and co-administration of ckd-501, d759 and h053 under fed condition in healthy adults

Eligibility criteria:
\[inclusion criteria\] 1. between 19 aged and 50 aged healthy adult 2. body weight more than 55kg for male, more than 50kg for female 3. body mass index over 18.5kg/m2 and under 27.0kg/m2 4. if female, the subject must satisfy more than one of the following: * subject who have reached menopause (no natural menstruation for at least 2 years.) * subject who is surgically infertile(hysterectomy or bilateral salpingo-oophorectomy, tubal ligation, or in infertile state under other method) \[exclusion criteria\] 1. subject who is currently with or have diagnosed with clinically significant hepatobiliary(severe hepatopathy, etc.), kidney(severe nephropathy, etc.), neurological, immunologic, respiratory, urinary, gastrointestinal endocrinological(diabetic ketoacidosis, diabetic coma, etc.), hematological, oncological, cardiovascular(heart failure, etc.) or metal illness 2. subject with one of the following laboratory test results * ast, alt \> unlx1.5 * egrf \< 60 ml/min/1.73 m2 (mdrd formula) * immuno-serology test results in positive * systolic blood pressure \> 150mmhg or \ 100mmhg or \<50mmhg 3. subject who has history of the following and the history may affect safety of the subject or result of this study * history of any prescription drug or herbal medicine within 14 days before first administration investigational products * history of any non-prescription drug including health food, vitamin within 7 days before first administration investigational products * history of drug-metabolizing induction/inhibition enzyme such as barbital

Keywords: ckd-393 type ii diabetes
phase 1 clinical trial of npi-0052 in patients with advanced malignancies

Conditions: Advanced Cancer

Summary: this is a phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the proteasome inhibitor npi-0052 in patients with advanced malignancies including solid tumors, lymphomas, leukemias and multiple myeloma. by inhibiting proteasomes npi-0052 prevents the breakdown of proteins involved in signal transduction, which blocks growth and survival in cancer cells.

patients were enrolled in 1 of 2 study arms. arm am (weekly doses of npi-0052) consisted of patients with solid and hematological malignancies excluding multiple myeloma (mm), and these patients received npi-0051 once weekly for 3 weeks of every 4 weeks. arm mm (twice-weekly doses of npi-0052) consisted of patients with mm and other hematological malignancies, and these patients received npi-0052 twice weekly for 2 weeks of every 3 weeks. all patients received npi-0052 administered iv over approximately 1 to 120 minutes. patients with mm (arm mm) also received 20 mg dexamethasone per orally or iv on the day before and the day of npi-0052 dosing. patients were initially enrolled in dose-escalating cohorts to determine the maximum tolerated dose (mtd) and/or recommended phase 2 dose (rp2d) of npi-0052. once the rp2d was determined for each arm of the study, the rp2d was evaluated in the dose-expansion stage of the study.

Eligibility criteria:
inclusion criteria: * karnofsky performance status (kps) \> 70%. * histologically-confirmed advanced malignancy for which a standard, approved therapy is not available. * adequate renal, liver, pancreatic and hematologic function * signed informed consent (sample ic form is provided in appendix a). exclusion criteria * administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 28 days * patients that require g-csf and/or platelet support during screening and are likely to require g-csf and/or platelet support for the duration of the clinical trial. * patients with ongoing coagulopathies and/or taking anticoagulants * patients receiving intrathecal therapy. * known brain metastases. * pre-existing adrenal insufficiency; concomitant therapy with replacement corticosteroids. pre-existing acute or chronic pancreatitis. * significant cardiac disease. * pregnant or breast-feeding women. * concurrent, active secondary malignancy for which the patient is receiving therapy. (lymphoma patients with a diagnosis of a potentially hormone-sensitive tumor who are without evidence of disease for this second malignancy may continue to receive hormonal therapy). * patients with proteinuria grade 2 or greater * active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics. * patients who are known to be hiv positive or have active hepatitis a, b, or c infection.

Keywords: multiple myeloma leukemias (inc. cll) lymphomas cutaneous lymphoma marginal zone lymphoma advanced malignancies without standard treatment options
smarter weight loss management

Conditions: Obesity

Summary: the smarter trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive smarter intervention, fixed dpp, and usual care assessment-only (control). the trial will address whether a scalable, stepped-care intervention can stand up to gold-standard dpp by achieving comparable weight loss at a lower cost. alongside evaluation of clinical non-inferiority, a comprehensive economic evaluation will inform relative affordability. cost information is important to inform treatment policy and change standard of care, but is sorely lacking for behavioral interventions. the smarter intervention reduces costs by initially offering minimal intervention to all and stepping up to offer more costly treatment components only to non-responders who fail to attain the target weight loss. a rigorous economic evaluation planned and designed alongside the smarter trial will provide an accurate, robust head-to-head comparison of costs, cost-effectiveness, and projected lifetime health care costs between the three arms.

the proposed study seeks to test the hypothesis that smarter is non-inferior to dpp in its effect on 6-month weight loss. during the 24-week active intervention phase, participants will be randomized to one of three first-line treatments: 1) the adaptive smarter intervention, 2) fixed dpp, or 3) usual care assessment-only (control). participants will be assessed at 3-month, 6-month, 9-month, and 12-month timepoints to evaluate overall weight loss, and to explore whether smarter is cost-effective compared to dpp or standard care.

Eligibility criteria:
inclusion criteria: * over 18 years old * bmi of ≥25, weight \<396 lbs * must own a smartphone, and be willing to install the smarter app * participants must also plan to reside in the chicagoland area for the duration of their participation (i.e., 12 months) * not enrolled in a formal weight loss program exclusion criteria: * cerebrovascular accident or myocardial infarction within six months of enrollment * diabetes treated with insulin * pregnancy, lactation or intended pregnancy * active suicidal ideation * anorexia or bulimia * requiring an assistive device for mobility * taking weight loss medications, such as glp-1 agonists
the safety, tolerability and pharmacokinetic study of yimitasvir in healthy adults subjects

Conditions: Chronic Hepatitis c

Summary: the safety, tolerability and pharmacokinetic study of chronic hepatitis c treatment drug yimitasvir in healthy adults subjects.

this was a randomized，double-blind, placebo-controlled, single ascending dose, single-center study to assess the safety, tolerability and pharmacokinetic of yimitasvir in healthy adults subjects a total of 56 healthy subjects were divided into 7 groups, with each group consisting of 8 subjects. six of the subjects received the investigational drug, and two received placebo. all of the subjects received a single dose.

Eligibility criteria:
inclusion criteria: * male or female, overall healthy subjects; * between 18 and 45 years of age, inclusive, similar ages; * body weight should be≥50 kg; body mass index (bmi) is between 19 and 25 kg/m2, inclusive, similar body weights; * able to comprehend and sign the icf voluntarily prior to initiate the study; * able to communicate well with the investigator and complete the study according to the protocol. exclusion criteria: * pregnant or nursing female, or plan for pregnancy within 6 months; * female with positive urine pregnancy test results; * positive test results for hbsag, anti-hcv ab, anti-hiv ab or syphilis; * have taken any drug inhibiting gastric acid secretion within 1 month prior to study drug administration, such as: h2 receptor antagonists (eg: cimetidine, ranitidine, famotidine, nizatidine and roxatidine); proton pump inhibitors (eg: omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole); cholinoceptor blocking drugs (eg: atropine and pirenzepine); * history of immune system disease (such as thymus disease); * have undergone major surgery within 6 months before enrollment; * history of tumor; * drink frequently within 6 months prior to study drug administration, namely alcohol consumption are more than 20 grams per day; * smokers, who smoke more than 1 cigarettes/day within 3 months before the study; * participated in any clinical trial within 3 months prior to the study; * cannot be tolerant to oral drugs.
influence of cognitive rest on minor traumatic brain injury

Conditions: Minor Head Injury

Summary: background: head injury is a common presentation to family medicine clinics and emergency departments (eds), and the majority will not result in intracranial injury requiring neurosurgical consultation, but will have symptoms of mild traumatic brain injury (mtbi). it is estimated between 15-50% of patients with mtbi develop post-concussive syndrome (pcs). research in the management of mtbi and prevention of pcs has been scarce to date. although expert consensus recommends cognitive rest and graduated return to usual activities, these and other interventions are not based on prospective clinical evidence. objective: the purpose of this study is to determine if providing graduated return to usual activities discharge instructions to mtbi patients in the ed decreases mtbi symptoms post-injury as compared to providing usual ed mtbi discharge instructions. study design: this will be a pragmatic, single-centered, 2-arm parallel-group, superiority randomized trial. patient population: male and female patients presenting to the ed ages greater than 17 and less than 65 with the canadian emergency department information system (cedis) presenting complaint of "head injury". outcomes: the primary outcome of this study is to determine if patients whom receive graduated return to usual activity discharge instructions have more clinically significant decreases in their post-concussion symptom score (pcss) 2 weeks after mtbi versus patients who received usual care mtbi discharge instructions. secondary outcomes include the intervention group's compliance with the intervention, comparison of pcss between groups 4 weeks after initial ed visit, comparison of groups' number of return visit(s) to either an ed or physician's office, and the mean number of days of school or work missed for each group. hypothesis: given cognitive rest and graduated return to usual activities are concepts recommended by expert consensus, it is expected patients who follow the graduated return to usual activities and cognitive rest guidelines will have less mtbi symptoms at two weeks after ed discharge.


Eligibility criteria:
inclusion criteria: * male and female patients presenting to the ed with the canadian emergency department information system (cedis) chief complaint of "head injury". * age greater than 17 years and less than 65 years. * injury occurring within the last 24 hours. exclusion criteria: * acute intracranial injury identified on head ct * glasgow coma scale (gcs) \< 15 at time of discharge * non-english speaking

Keywords: head injury concussion cognitive rest emergency department
is a two-film skull x-ray series as sensitive as a four-film series in the diagnosis of skull fractures in paediatric patients

Conditions: Head Trauma

Summary: minor head injuries are a common presenting complaint in the pediatric emergency department. skull x-rays are a useful tool in the evaluation of paediatric patients with a history of minor head trauma. however, there exists ongoing controversy regarding the ideal number of views that should be obtained in a skull series. this study aims to determine if there is a significant difference in the diagnostic accuracy of skull x-rays in the diagnosis of fracture in paediatric minor head trauma patients when a 2-film series as opposed to a 4-film series is provided to participating pediatric emergency physicians.

minor head injuries are a common presenting complaint in the pediatric emergency department. skull x-rays are a useful tool in the evaluation of paediatric patients with a history of minor head trauma. however, there exists ongoing controversy regarding the ideal number of views that should be obtained in a skull series. this study aims to determine if there is a significant difference in the diagnostic accuracy of skull x-rays in the diagnosis of fracture in paediatric minor head trauma patients when a 2-film series as opposed to a 4-film series is provided to participating pediatric emergency physicians. this will be a prospective, crossover experimental study evaluating the equivalency in sensitivity and specificity of a 2-film series versus a 4-film series in the diagnosis of skull fracture associated with minor head injuries in children. the study will involve 10 pediatric emergency physicians who will evaluate two modules of 100 series of radiography. in order to do so, he or she will be given two work modules. each module will contain the randomized and anonymous x-rays of the same 50 cases and 50 controls mounted on power point slides. among the 50 cases, the evaluation sequence will be randomized such that 25 cases will be evaluated with the 2-film series in the first module and the 4-film series in the second module while the other 25 cases will evaluated in the reverse order. the same procedure will be used for randomizing the evaluation sequence of the 50 controls. the primary outcomes will be the overall sensitivity and specificity of pediatric emergency medicine physicians for the detection of skull fractures using two evaluation methods: one in which they are presented with a skull series that has 2 views and another in which they are presented with a standard 4-view series.

Eligibility criteria:
inclusion criteria: * children who had a radiography for head trauma exclusion criteria: * none

Keywords: head trauma children radiography
allograft reconstruction of massive rotator cuff tears vs partial repair alone

Conditions: Rotator Cuff Syndrome; Rotator Cuff Injury; Disorder of Rotator Cuff; Full Thickness Rotator Cuff Tear; Skin Graft (Allograft) (Autograft) Failure

Summary: the investigators hypothesize that the use of an allograft adjuvant to partial repair will lead to improved shoulder outcome measure scores compared to partial repair alone in massive rotator cuff tears.

a total of 30 patients will be enrolled in the study. subjects will be randomized into two arms, either (1) partial repair/debridement or (2) allograft reconstruction. the patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant, pre-operatively and post-operatively at 6 weeks, 3, 6, 12, 24 months. the examination will consist of range of motion testing by goniometer as well as strength testing by hand dynamometer. the patient will also complete the western ontario rotator cuff index (worc) questionnaire. the main benefit of this procedure is that patients who have currently irreparable massive, chronic rotator cuff tears may acquire a means for their cuff to be repaired. this may aid in improving function of the shoulder, restoring ability to complete activities of daily living, while decreasing pain and sleep disturbances. this would allow the participant to become more functional after rehabilitation. it is our belief that this study could provide new information in helping to understand this relationship, which would in turn lead to future study in this area of orthopaedic surgery.

Eligibility criteria:
inclusion criteria: * large/massive rotator cuff tear \>3cm proven on mri exclusion criteria: * non surgical candidate, unable to consent
a phase 3 study of hrs-8080 versus treatment chosen by physicians in locally advanced and metastatic breast cancer

Conditions: Locally Advanced Breast Cancer; Metastatic Breast Cancer

Summary: this study is a multicenter, open-label, randomized controlled, phase 3 clinical trial.


Eligibility criteria:
inclusion criteria: 1. women aged 18 to 75 years old (including both values). 2. ecog physical strength status (ps) : 0 to 1 point. 3. patients with locally advanced or metastatic breast cancer confirmed by histology. 4. patients previously received 1-2 lines of endocrine therapy. 5. expected survival \> 6 months. 6. the functional level of the organs must meet the requirements. 7. subjects that voluntarily participate in this clinical trial, be willing and able to abide by the procedures related to clinical visits and research, understand the research procedures and have signed the informed consent. exclusion criteria: 1. patients with rapid disease progress and investigators determine that endocrine therapy is not suitable or tolerant. 2. a history of severe clinical cardiovascular diseases. 3. patients with uncontrollable tumor-related pain as judged by investigators. 4. severe infection exists within 4 weeks before the first study administration. 5. patients with clinically significant endometrial abnormalities. 6. untreated active hepatitis. 7. patients known to be allergic to hrs-8080 components. 8. pregnant and lactating women, or those planning to become pregnant during the study period.