Kornimate/medical-research-clean huggingface dataset:
talampanel for amyotrophic lateral sclerosis (als)

Conditions: ALS

Summary: the purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with als.


Eligibility criteria:
subjects with sporadic or familial als classified as definite, probable, or laboratory-supported probable als according to the revised el escorial criteria. inclusion criteria: 1. diagnosis of definite or probable als in accordance with the el-escorial criteria. 2. subject has experienced his/her first als symptoms within 3 years prior to the screening visit. 3. slow vc test equal to or greater than 70% of the predicted value. 4. the sum of the 3 respiratory items on the alsfrs-r must total at least 10 points. 5. subjects taking riluzole must be on a stable dose for at least 8 weeks prior to screening visit. 6. ages 18-80 (inclusive) exclusion criteria: 1. the use of invasive or non-invasive ventilation. 2. subject having undergone gastrostomy. 3. subject with any clinically significant or unstable medical condition. 4. subject participating in any other investigational drug trial or using investigational drug (within 12 weeks prior to screening and thereafter). 5. females who are pregnant or nursing.

Keywords: als
prevalence and risk factors of uterine niche following different caesarean section techniques:a hospital based study

Conditions: Appropriate Diagnostic Criteria of Uterine Niche With Detection of Prevalence , Risk Factors and Associated Symptomes

Summary: the primary objective of this study is to institute clically relevant and objective sonographic criteria for the diagnosis of ceasearan section scar defect(cssd) once the appropriate diagnostic criteria are established the natural history of cssd could be elucidated through exploration of the prevelance ,risk factors, and associated symptomes of the disease


Eligibility criteria:
inclusion criteria: * all women underwent c-section exclusion criteria: * known uterine anomaly * prior uterine surgery -prior uterine rupture * chronic medical disease like diabetes -use of steroid over last year regularly * obstetrical complications like multifetal pregnancy

Keywords: niche , caesearan section scar defect , isthmocele
study of the long-term effects of exercise on heath indicators in older people

Conditions: Hypertension With Complications and Secondary Hypertension; Overweight and Obesity; Lipid Metabolism Disorders; Sarcopenia; Osteoporosis; Personal Satisfaction

Summary: cardiovascular diseases (cvd) represent the most frequent cause of death among the elderly population. hypertension, unfavorable lipid profile, obesity and physical inactivity are among the main risk factors for cvd. in contrast, mortality from cvd is inversely related to levels of physical activity, and is lower in individuals who exercise and have higher functional fitness levels. thus, the centers for disease control and prevention, the american college of sports medicine, and the american heart association have recommended 20-30 min of moderate-to-vigorous aerobic training for the elderly, preferably every day or at least 3 days a week in the case of vigorous exercise.the same organizations also suggest the inclusion of resistance training in order to improve functional fitness. therefore, the purpose of this study was to compare different exercise modalities in long-term changes of cvd risk factors and physical fitness among older adults.


Eligibility criteria:
inclusion criteria: * older adults living independently; * medical approval. exclusion criteria: * non-smokers; * non-morbidly obese; * no history of severe hypertension; * no history of falls; * no orthopaedic, neurological, pulmonary, or cardiac problems.

Keywords: exercise blood pressure lipids body composition fitness bone density quality of life
study of hl-085 and vemurafinib in metastatic colorectal cancer (mcrc)

Conditions: CRC

Summary: the study consists of the two parts, phase iia and phase iib.

the study consists of the two parts, phase iia and phase iib. phase iia study is to assess the safety and the antitumor activity in patients with mcrc and to recommend reasonable dosage regimen of hl-085 for phase iib study. phase iib is a pivotal study to evaluate hl-085 plus vemurafenib in patients with brafv600e mcrc whose disease has progressed after 1 or 2 prior regimens in the metastatic setting.

Eligibility criteria:
inclusion criteria: * signed written informed consent prior to enrollment； * adults 18 years of age or older, male or female; * histologically- or cytologically-confirmed crc that is metastatic disease, and a) progression of disease or intolerance after line 1 or line 2 therapy，or inappropriate for line 1 therapy (for phase ⅱa); b) progression of disease or intolerance after line 1 or line 2 therapy (for phase ⅱb); * patient must have measurable disease according to response evaluation criteria in solid tumors version 1.1 (recist version 1.1); * eastern cooperative oncology group (ecog) performance status of 0-1; * life expectancy ≥ 3 months; * able to take the medicine orally; * adequate bone marrow and organ function. exclusion criteria: * prior treatment with any ras inhibitors, raf inhibitors, or mek inhibitors; * history or screening evidence of retinal diseases; * impaired cardiovascular function or clinically significant cardiovascular and cerebrovascular diseases; * previous or current neuromuscular diseases that is associated with ck elevation (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, rhabdomyolysis syndrome); * impaired liver function, defined as child-pugh class b or c; * toxicity has not recovered to grade 0 or 1 from prior anticancer therapy (except for alopecia, pigmentation, and grade 2 chemotherapy-related neurotoxicity); * use of any medications or foods that are strong inhibitors or inducers of cytochrome p450 (cyp) 3a4/5 within 7 days prior to the start of study treatment or during the study period, , drugs with a narrow therapeutic window for cyp1a2 metabolism.

Keywords: metastatic colorectal cancer (mcrc) hl-085 vemurafenib
an hpv vaccine provider intervention in safety net clinics

Conditions: Human Papillomavirus; Uterine Cervical Neoplasms

Summary: the purpose of this study is to develop, deliver and evaluate a provider intervention for mothers and their children to encourage receipt of the human papillomavirus (hpv) vaccine in the children and appropriate cervical cancer screening in the mothers.

in this study the investigators utilized community based participatory research approaches in combination with our previous and ongoing research, patient and provider education materials available from professional organizations, and qualitative information obtained from provider in-depth interviews and parent/daughter focus groups to develop a provider intervention to encourage receipt of the hpv vaccine, and appropriate cancer screening in african americans and hispanics. a focus of the study was the formation of a community advisory board (cab) which provided input into the development and modification of the provider intervention. safety net clinics in nashville and memphis served as intervention sites, and in chattanooga and nashville (meharry) served as control sites. mothers and children at the intervention sites viewed a 5-minute video in the exam room during any visit type before seeing the provider, and received an information sheet with a list of suggested questions to ask the provider. mothers and children at the control sites received usual care. the selected study sites identified cervical cancer screening as a priority area based on the needs assessments conducted as part of the meharry medical college community health center-community network program (chc-cnp). the investigators conducted pre- and post-intervention quantitative surveys with mothers and their children to evaluate whether the provider intervention was effective in improving hpv vaccination coverage, and cervical cancer screening rates. the investigators abstracted medical records and have indicated this in the hipaa privacy form. after conducting pre- and post-intervention surveys and abstracting medical records, the investigators found that increasing hpv vaccine uptake requires more intensive, multicomponent interventions.

Eligibility criteria:
inclusion criteria: * being seen as a pediatric patient at a study clinic on the day of enrollment * self-identified african american or hispanic * aged 9-18 years (mother accompanying child to clinic visit had no age limit) * had received no doses of hpv vaccine or received one shot and was overdue for the second dose (three or more months after the first dose was given) prior to the clinic visit exclusion criteria: * already having received two or more doses of hpv vaccine * mother or female guardian (referred to as "mother" henceforth) not accompanying the child * plans to move away from the clinic catchment area within the next 12 months * not completing the baseline assessment prior to entering the exam room * mother not providing or unable to give consent * child not giving assent.

Keywords: human papillomavirus (hpv) vaccine cervical cancer screening provider intervention
the improvement of intraoperative neuromonitoring of recurrent laryngeal nerve

Conditions: Thyroid Intra-Operative Injury

Summary: objectives: the use of neuromuscular blocking agent may interfere with the function of intraoperative neuromonitoring (ionm) in thyroid surgery.

an enhanced neuromuscular-blockade (nmb) recovery protocol was investigated in a clinically applied during thyroid neural monitoring surgery. in as subsequent clinical application study, 60 patients who underwent thyroidectomy with ionm followed an enhanced nmb recovery protocol- rocuronium 0.6 mg/kg at anesthesia induction and sugammadex 2 mg/kg at operation start. train-of-four (tof) ratio was used for continuous quantitative monitoring of neuromuscular transmission.

Eligibility criteria:
inclusion criteria: * patients undergoing intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy exclusion criteria: * patients with a history of significant cardiac, pulmonary, hepatic, or renal disease, body mass index \ 35, chronic drug or alcohol abuse

Keywords: intraoperative neural monitoring
endometrial safety of a low dose of vagifem® in postmenopausal women with atrophic vaginitis

Conditions: Menopause; Postmenopausal Vaginal Atrophy

Summary: this trial is conducted in europe. the purpose of this study is to evaluate endometrial safety of intravaginal estradiol (vagifem®) in healthy postmenopausal women having atropic vaginitis.


Eligibility criteria:
inclusion criteria: * postmenopausal women whose last menstruation was at least two years prior to the time of screening * at least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity * generally healthy exclusion criteria: * exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months
physiological and environmental data in a remote setting to predict exacerbation events in patients with chronic obstructive pulmonary disease

Conditions: COPD Exacerbation

Summary: the study plans to monitor around 300 people from different hospitals with copd for a period of 3 months after they are discharged from the hospital using a smartphone app and a fitbit device. this device can passively track certain health metrics; this way the research team can research whether it is possible to identify the early warning signs of a decline in health by using these ongoing measurements of vital signs and symptoms. this could allow doctors to intervene early and potentially prevent further deterioration in health decline and hospital admission altogether. the study seeks to investigate how similar these physiological measurements are when collected in the real world rather than just in the hospital setting, and what influence environmental factors have on a patient's health and experience of their condition.


Eligibility criteria:
inclusion criteria: * aged 18 or over. * diagnosis of copd, currently admitted to hospital and clinically stable with a confirmed acute exacerbation of copd. * ownership of a smartphone (ios version 13 or above, android version 8 or above). * able to provide informed consent to participate in study. exclusion criteria: * patients who require less than 24 hours in hospital at initial visit. * patients deemed unlikely to cooperate with study requirements. * patients with implantable devices. * patient not felt to be suitable for research enrolment by admitting clinical team. * patients requiring non-invasive ventilation or deemed to have a life-expectancy of less than 90 days following discharge.
tenting screws in combination with platelet concentrate for vertical alveolar ridge augmentation

Conditions: Bone Loss, Alveolar

Summary: alveolar bone resorption often occurs after tooth extraction. at present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. tenting screw technology, basic on the classical gbr, implants screws into the surgical area to prevent the barrier membrane from collapsing. moreover, advanced platelet rich fibrin and injectable platelet-rich fibrin are used to provide the osteogenic function. the investigators intend to increase vertical alveolar bone augmentation by combining tenting screws and a-prf, i-prf.

alveolar bone resorption often occurs after tooth extraction. at present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. tenting screw technology, basic on the classical gbr, implants screws into the surgical area to prevent the barrier membrane from collapsing. moreover, advanced platelet rich fibrin and injectable platelet-rich fibrin are used to provide the osteogenic function. the investigators intend to increase vertical alveolar bone augmentation by combining tenting screws and a-prf, i-prf.

Eligibility criteria:
inclusion criteria: 1. 18-80 years old; 2. single tooth in the maxillary posterior area cannot be retained (third degree loosening / alveolar bone resorption to the periapical area), implantation is needed after extraction, and cbct shows vertical bone defect ≥ 3mm; 3. 4 weeks after extraction or missing teeth within 3-5 weeks; 4. adjacent teeth exist and loosening is less than ⅰ degree; 5. periodontal disease in inactive stage, whole mouth bleeding index (fmbs) is less than 20%; 6. thick gingival biological type. 7. cbct shows that the bone of the edentulous site meets the requirements of tent screw implantation (bone height ≥ 3mm and bone mineral density is sufficient); 8. the patients and their families have informed consent and signed the informed consent form. exclusion criteria: 1. pregnant and lactating women; 2. smoking (\> 10 cigarettes per day) and alcoholism; 3. taking anticoagulants within 3 months before operation; 4. suffering from autoimmune diseases, diabetes, liver disease, blood system diseases and infectious diseases; 5. patients taking any drugs that affect platelet function or whose platelet count is less than 200000/mm3 3 months before blood collection; 6. patients who have been treated with bisphosphate / steroids for a long time; 7. have received alveolar ridge bone augmentation surgery; 8. previous history of radiotherapy in the head and neck; 9. acute inflammation in edentulous sites; 10. inability to maintain good oral hygiene or follow-up visits as required.

Keywords: tenting screws advanced platelet rich fibrin injectable platelet rich fibrin guided bone regeneration
efficacy study of the product "chf 1535" versus beclomethasone (bdp) and free combo in asthmatic children

Conditions: Asthma

Summary: the purpose of this study is to demonstrate that chf 1535 in pressurized metered dose inhaler (pmdi) is non-inferior to the corresponding dose of free combination of beclomethasone (bdp) and formoterol fumarate (ff) and superior to the corresponding dose of bdp in terms of lung functions in asthmatic children patients.


Eligibility criteria:
inclusion criteria: * male and female children (aged ≥ 5 and \< 12 years) * partly controlled asthma children according to global initiative for asthma guidelines (gina) * symptomatic asthmatic patients treated with bdp up to 400 micrograms or equivalent * fev1 ≥ 60% and ≤ 95% of predicted normal values exclusion criteria: * patients with two or more admissions to hospital for asthma exacerbation in the past 12 months or any admission to intensive care ever. * occurrence of acute asthma exacerbations or lower respiratory tract infections in the 4 weeks before study entry * history of near fatal asthma * history of cystic fibrosis, bronchiectasis or primary ciliary dyskinesia * diagnosis of restrictive lung disease. * patients treated with systemic corticosteroids * significant medical history and/or treatments

Keywords: asthma children chronic treatment
evaluating an in-home multicomponent program to manage concerns about falling in frail community dwelling older people

Conditions: Concerns About Falling; Aged

Summary: the main objectives of this study are: 1. an effect evaluation of an in-home multicomponent cognitive behavioural program on concerns about falling and related avoidance of activity (primary outcomes), as well as disability, fall incidents (secondary outcomes) and several additional outcomes in frail community-dwelling older people, 2. a process evaluation of the feasibility of the program, with the following main outcomes: population reached, performance according to protocol, exposure and engagement, opinion on the program of participants and facilitators, perceived benefit or achievement, and experienced barriers and potential solutions, and 3. an economical evaluation on the impact of the program on healthcare utilization and related costs.


Eligibility criteria:
inclusion criteria: * aged 70 years or over * at least some concerns about falling * at least some associated avoidance of activity * fair or poor perceived general health * living independently in the community * written informed consent exclusion criteria: * cognitive impairment (a score of less than 4 on the abbreviated mental test 4) * language or hearing problems that impede completing an interview by telephone * sight problems that impede completing the intervention * confinement to bed * waiting for nursing home admission * permanent use of a wheelchair

Keywords: fear of falling cognitive behavioral therapy randomized controlled trial frailty accidental falls
educational brochure in preparing patients with gastric cancer and their caregivers for recovery after surgery

Conditions: Anxiety; Gastric Carcinoma; Stress

Summary: this pilot clinical trial studies an educational brochure in preparing patients with gastric cancer and their caregivers for recovery after surgery. giving an educational brochure may help prepare patients and their caregivers by improving knowledge about symptoms after surgery. it may also improve quality of life and reduce worry after surgery.

primary objectives: i. to pilot test an educational intervention in the form of a teaching brochure to prepare patients and informal caregivers for recovery following partial or total gastrectomy. secondary objectives: i. to describe preliminary effect of the intervention on patient-reported outcomes (pros), informal caregiver-reported outcomes, and clinical/system outcomes. outline: participants are enrolled sequentially to 1 of 2 cohorts. cohort i: participants receive standard post-operative care. cohort ii: participants receive a 2-page educational brochure after surgery and prior to discharge home. after completion of study, participants are followed up for approximately 2 months.

Eligibility criteria:
inclusion criteria: * patients will be accrued using the following inclusion criteria: * scheduled to undergo partial or total gastrectomy for treatment of gastric cancer * able to read and understand english * informal caregivers will be accrued using the following inclusion criteria: * the primary informal caregiver as identified by patients participating in the study; this refers to either a family member or friend who will be providing the majority of care following surgery * able to read and understand english * all participants must have the ability to understand the willingness to provide informed consent exclusion criteria: * subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Keywords: caregiver
totally implantable catheters in pediatric hematology-oncology: a study on infectious complications

Conditions: Infections

Summary: this is a retrospective analysis of infection on catheters of pediatric oncology patients.


Eligibility criteria:
inclusion criteria: * patients admitted between jan/2008 and dec/2009
is pnf application effective on temporomandibular dysfunction

Conditions: TMD; TMJ Disorder; Pain

Summary: the goal of this clinical trial is to compare effects of rocabado exercises which is conventional physiotherapy treatment alone vs. combine it with proprioceptive neuromuscular facilitation (pnf) in people with temporomandibular dysfunction (tmd) with forward head posture. the main question aims to answer: - does adding neck and jaw pnf techniques to the treatment affect the pain and functional status of the jaw compared to rocabado exercises alone? participants will be randomized into two groups (group 1: only rocabado exercises, group 2: rocabado + pnf) and perform 8 weeks long exercises. they will be assessed in the beginning of the study and at the end of the 8th week.

infrared heat will be applied to the neck and face areas for 15 minutes for individuals with tmd with forward head posture in both groups. then group 1 will perform rocabado exercises only, and group 2 will perform pnf exercises in addition to rocabado exercises. exercises will be demonstrated and applied by a physiotherapist at the university clinic. pain intensity, pain threshold, tmj functions, joint range of motion and mandibular function are among the parameters to be evaluated. all evaluations will be made by a blinded evaluator at baseline (baseline t=0), before exercise and after exercise (post-exercise, t=8.week).

Eligibility criteria:
inclusion criteria: * diagnosis of tmd according to the diagnostic criteria for temporomandibular disorders (rdc/tmd), * presence of trigger points in the relevant muscles, * presence of pain exclusion criteria: * intra-articular or degenerative joint disorders and subluxation requiring urgent treatment; * history of temporomandibular joint (tmj) or cervical region surgery in the last 3 months; * treatment history from relevant areas; * presence of rheumatic diseases, including tmj diseases; * tmj instability or fracture; * presence of perception-cognition disorder; * presence of chronic pain such as trigeminal neuralgia * orthopedic, neurological or rheumatological cervical disorders affecting jaw movements * history of surgery in the jaw, head and neck area * presence of vertigo that prevents head movements during exercise