Kornimate/medical-research-clean huggingface dataset:
allied cleft & craniofacial quality-improvement and research network (accquirenet)

Conditions: Cleft Lip; Cleft Palate; Cleft Lip and Palate

Summary: the allied cleft \& craniofacial quality-improvement and research network (accquirenet) is a group of multidisciplinary cleft teams that have implemented a system for prospective collection of outcomes data, based on the ichom standard set for the comprehensive appraisal of cleft care, cleft-q, and other outcomes instruments. participating cleft teams may analyze clinical and psychosocial outcomes related to care of the child with cleft lip and/or palate (cl/p), compare its performance with those of other cleft centers, and identify opportunities for quality improvement.

the purpose of this project is to implement a system of prospective, standardized data collection for all patients with cleft lip and/or palate (cl/p) treated by the cleft and craniofacial centers that participate in accquirenet. adoption of this prospective data-collection system has two principal goals: 1. to enable on-demand and scheduled review of cleft-care-related safety and outcomes data and team performance for the purpose of internal audits and continuous quality improvement; and 2. to permit participation in multi-site, collaborative quality-improvement projects and/or research networks that require usage of these standardized data-collection methods. (these collaborations are described in corresponding irb protocols and data-transfer agreements. patient privacy and confidentiality is protected at all times.) all patients with cl/p treated at cleft and craniofacial centers participating in accquirenet will be invited to participate in this project. duke university serves as the coordinating center and statistical support center for the study. data are maintained in a local, secured database. the irb protocol details methods of quality assurance, data monitoring, and auditing. data dictionaries employed in accquirenet include the cleftcap redcap project template, cleftkit common data model (an extension of the pcornet common data model), the ichom standard set for the comprehensive appraisal of cleft care, and the cleft-q patient-reported outcome manual, maintained by the international consortium for health outcomes measurement (ichom.org) and mcmaster university, respectively.

Eligibility criteria:
inclusion criteria: * typical orofacial clefts, of which subtypes are: * unilateral or bilateral cleft lip * unilateral or bilateral cleft lip and alveolus * unilateral or bilateral cleft lip and alveolus and palate * unilateral or bilateral cleft lip and palate * overt cleft palate * occult cleft palate exclusion criteria: * atypical (tessier) facial clefts

Keywords: cleft lip cleft palate cleft lip and palate cleft alveolus multidisciplinary team interdisciplinary team
modification of goal-directed and habitual behavior in addiction

Conditions: Tobacco Use Disorder

Summary: this study aims to examine the modification of the hypothesized imbalance between goal-directed and habitual behavior and its neural correlates in smokers. two interventions will be used as add-on trainings to a smoking cessation program.

in this study, the investigators aim to assess the imbalance between goal-directed and habitual behavior, its neural basis and how it can be differentially modified in treatment-seeking smokers, using two training interventions. the first intervention is cognitive remediation treatment (crt), also known as cognitive enhancement therapy, focusing on improving inhibitory control and executive functions. the second intervention, a computer-based habit-modifying training focusing on implicit drug seeking ("implicit computer-based habit-modifying training", icht) uses a conditioning approach through implicit priming and contextual modulation. indicators of the imbalance will be examined with respect to reward devaluation, cue reactivity and a pavlovian instrumental transfer (pit) paradigm. the investigators hypothesize that both interventions change the balance between goal-directed and habitual behavior but by different mechanisms. whereas crt should directly increase cognitive control, in contrast, icht should affect the early processing and the emotional valence of smoking and smoking cues.

Eligibility criteria:
inclusion criteria: * severe tobacco use disorder (tud) according to dsm-5 * sufficient ability to communicate with investigators and answer questions in both written and verbal format * ability to provide fully informed consent and to use self-rating scales exclusion criteria: * severe internal, neurological, and/or psychiatric comorbidities; other axis i mental disorders other than tud according to icd-10 and dsm 5 (except for mild depression, i.e. f32.0, adjustment disorder and specific phobias) in the last 12 months * history of brain injury * severe physical diseases * common exclusion criteria for mri (e.g. metal, claustrophobia) * positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines) * psychotropic medication within the last 14 days * pregnancy

Keywords: addiction nicotine smoking cessation relapse craving habitual behavior cognitive remediation implicit priming pavlovian instrumental transfer
the leeds women's wellbeing (lww) study

Conditions: Weight Loss

Summary: the purpose of this parallel design study is to assess the relative effects of two 12-week healthy eating dietary interventions: general healthy eating (diet a) and general healthy eating combined with advice to increase fibre intake (diet b) to at least 25g/day (with a large proportion of the fibre intake derived from cereal or wheat bran), in overweight low-fibre consuming premenopausal female adults on body weight change (kg). it is hypothesized that adding fibre to a healthy eating diet (diet b) would lead to greater weight loss and/or weight loss maintenance than following a healthy eating diet alone (diet a).

in this randomised, single blind, parallel design study participants were randomly assigned to one of two 12-week healthy eating dietary interventions: diet a: general healthy eating or diet b: general healthy eating combined with advice to increase fibre intake to at least 25g/day (with a large proportion of the fibre intake derived from cereal or wheat bran.

Eligibility criteria:
inclusion criteria: * female * 18-48 years of age (premenopausal) * self reported good health * body mass index (bmi) within overweight/obese range (26-35kg/m2) * willingness to consume study foods and prepared to eat breakfast cereals as part of the intervention * non-smokers or given up more than 6 months ago * exercising no more than 4 times per week at a medium intensity * weight stable in the last 3 months (fluctuation of no more than 3kg) * current fibre intake (≤ 15g/day) according to dine and verified by 7 day food diary (fibre points) * ability to adequately understand verbal and written information in english exclusion criteria: * menopausal or showing menopausal symptoms (e.g. frequent/recurrent hot flushes) at screening or taking any supplements for menopausal symptoms * type 2 diabetes; cardiac pacemaker fitted * taking medication and/or supplements known to affect appetite/body weight in the last 6 months (e.g. asthma, steroids, anti-depressants) * bmi outside range of 26-35 kg/m2 * food allergies or aversions to foods likely to be consumed within the study (e.g. wheat bran, nuts) * non-smokers or given up more than 6 months ago * exercising more than 4 times per week at a medium intensity * shift work (night shifts) * pregnant or planning a pregnancy within the next year; having been pregnant or lactating within the previous 6 months * no history of, or current eating disorders as determined using the eating attitudes test (eat-26;gardner et al., 1982; a score higher than 20) * current fibre intake (\>15g/day according to dine) * insufficient english language skills to complete all study questionnaires

Keywords: dietary intervention dietary fibre weight loss weight maintenance
transcranial static magnetic stimulation (tsms) and potential theranostic biomarkers in amyotrophic lateral sclerosis.

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: the objective of the present study is to assess the efficacy of tsms in als patients. this will be achieved by monitoring: * levels of nf-l and other potential innovative biomarkers, * clinical progression, trough alsfrs-r. after at least three-month follow-up, participants will be recruited to undergo biemispheric tsms for two daily sessions of 120 minutes each, at home, for 12 months. together with clinical status, which will be evalueted each three months, blood and urine samples will be collected before the start of the tsms administration (m0) and during the treatment (m3, m6, m9, m12), to detect potential theranostic biomarkers. in a subgroup of patients, ad additional blood and urine sample will be collected 3 months before m0 (m-3). moreover, cortical excitability will be tested through transcranial magnetic stimulation (tms) before and after the tsms stimulation period.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * diagnosis of possible, probable or definite als according to revised el escorial criteria and awaji-shima criteria * disease duration \< 24 months * alsfrs-r \> 30 at the recruitment * alsfrs-r decline \> 1 in the at least 3-months period before the intervention * normal respiratory functionality at the preliminary evaluation (m-3), assessed in the previous month (fvc ≥ 75% and alsfrs-r items 10,11,12 \> 4) * treatment with riluzole 50 mg x 2/die exclusion criteria: * inclusion in other clinical trials * presence of tracheotomy or/and peg (percutaneous endoscopic gastrostomy) * unable to perform spirometry due to severe bulbar involvement * contraindications to magnetic fields exposure * pregnancy or breastfeeding * history of epilepsy or seizures * use of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines. * cognitive impairment * lack of informed consent

Keywords: amyothrophic lateral sclerosis als tsms transcranial magnetic stimulation nf-l ykl-40 p75ecd biomarkers transcranial static magnetic stimulation tdp43
evaluation of relapse, efficacy and safety of long-term treatment with oracea® vs placebo

Conditions: Rosacea

Summary: the purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea during long-term treatment with either oracea® or placebo, after an initial 12-week regimen of oracea® and metrogel® 1%.

adult subjects with moderate to severe papulopustular rosacea will receive oracea® and metrogel® 1% once daily during phase 1 (baseline to week 12) of the study. subjects will be eligible to enter phase 2 of the study based upon improvements in the investigator's global assessment (iga) score. during phase 2, subjects will receive either oracea® or placebo once daily for up to an additional 40 weeks. subjects who relapse during phase 2 will be discontinued from the study.

Eligibility criteria:
inclusion criteria: * subject is male or female aged 18 to 80 years inclusive. * subject with papulopustular rosacea (11 to 40 papules or pustules) and an iga of moderate or severe. * for subjects using medications to treat a concurrent medical condition, type and dose must have been stable for at least 90 days prior to study entry. exclusion criteria: * female subjects who are pregnant, nursing or planning a pregnancy during the study. * subject has any other active dermatological condition on the face that may interfere with the conduct of the study. * subject uses or has recently used any medication which may interfere with the absorption, distribution, or elimination of study medications, or may interfere with the assessments of efficacy or safety of the study medications. * subject has a known allergy to any of the components of the study products, and/or a known hypersensitivity to tetracyclines or metronidazole.
effect of high-intensity focused electromagnetic (hifem) technology in the treatment of sui in chinese men undergone robotic radical prostatectomy

Conditions: Urinary Incontinence , Stress; Prostatectomy

Summary: this is a prospective, randomized trial to evaluate the efficacy and safety of high-intensity focused electromagnetic (hifem) technology in the treatment of stress urinary incontinence compared with standard of care in chinese men who had undergone robotic radical prostatectomy.

this is a prospective randomised control trial of consecutive patients with prostatectomy to have either standard of care versus hifem assisted pelvic floor exercise. randomization will be performed for patients when the subject has completed the informed consent for study participation. randomization will be performed in 1:1 ratio into 2 arms: hifem assisted (btl emsella) pelvic floor muscle training (arm a) plus standard of care or standard of care (arm b).

Eligibility criteria:
inclusion criteria: * undergone robotic radical prostatectomy * able to carry out 1-hour pad test * voluntary participation and signing of the informed consent form exclusion criteria: * pre-existing stress urinary incontinence * post-void residual urine greater than 200ml * active urinary tract infection * urethral or bladder fistula * history of pelvic irradiation * neurological condition (spinal cord problems, stroke with poor neurological recovery, epilepsy, parkinson disease, multiple sclerosis) * previous surgery for sui * concurrent medication with diuretics, serotonin-norepinephrine reuptake inhibitors or any other medication known to worsen incontinence * condition contraindicated for electromagnetic therapy i.e. arrhythmia, on a pacemaker or implanted metallic device; coagulopathy or on anticoagulant

Keywords: stress urinary incontinence prostatectomy
superdex trial (comparison of two doses of dexamethasone for malignant spinal cord compression treated by radiotherapy).

Conditions: Spinal Cord Compression From Neoplasm Metastasis

Summary: the study aimed to pilot the viability of a full scale randomised comparison of 2 steroid doses in malignant spinal cord compression, to establish safety of high dose dexamethasone in this setting in australia, to test web registration and randomisation and to compare different functional outcome measures.

malignant spinal cord compression (mscc) is an uncommon condition with an estimated annual incidence of 2.5 per 100,000. it is a dreaded complication of malignancy because of the severe impact paralysis and sphincter disturbance has on quality and duration of survival. rat models have demonstrated the effectiveness of high doses of steroids. only three randomised controlled trials (rcts) have been published. the first compared radiotherapy to laminectomy plus radiotherapy in a series of 29 patients and failed to show any significant differences the widespread commonly used dose of dexamethasone in australia at that time was 16 mg/24 hr and the main concern for implementing higher doses was the toxicity profile reported in the few small randomised comparisons available at the time.in view of the conflict between standard australian practice versus published (overseas) guidelines, a randomised comparison was proposed in australia. this study was a pilot study initiated to determine the viability of a large trial, to pilot the use of web technology for trial conduct and to determine clinically useful outcome measures apart from simple ambulation rates. comparisons: patients randomised to receive either 16mg/24hr or 96mg/24hr dexamethasone.

Eligibility criteria:
inclusion criteria: * malignant spinal cord compression with at least one of pain, weakness, sensory disturbance or sphincter disturbance * histology not required if prior biopsy proven malignancy * any stage * age \>16 years * ecog 1-3 prior to cord compression event * minimum power 1 of 5 point scale must not be paraplegic * minimum expected survival 2 months * relevant minimum lab values * patients capable of childbearing using adequate contraception * written informed consent exclusion criteria: * prior radiotherapy to within vertebral±one level affected by cord compression * prior treatment for spinal cord compression at the current level * histology is lymphoma or myeloma * power less than 1 of 5 * more than 12 hours after initiation of dexamethasone\>4mg/24hr * pre-existing co-morbid conditions - peptic ulceration or cardiac failure * allergy to study medications * multilevel cord compression or meningeal carcinomatosis * pregnant or lactating

Keywords: radiotherapy dose fractionation
a study of peripheral blood progenitor cells mobilisation (pbpc) with vtp195183 plus granulocyte-colony stimulating factor (g-csf) compared to mobilisation with g-csf alone

Conditions: Multiple Myeloma; Lymphoma

Summary: hematopoietic stem cells (hsc) are used to support the administration of high dose chemotherapy for a range of human cancers. for a safe hsc transplantation, a minimum of 5 million hsc per kilogram are required. hsc are collected from the bone marrow by using drugs such as g-csf (filgrastim) which 'mobilize' them from the bone marrow into the bloodstream. hsc are collected from the bloodstream using an apheresis machine. between 5 and 60% of patients fail to mobilize the minimum hsc dose required for safe transplantation, and this trial is investigating a way to enhance mobilization to overcome this problem. this trial aims to determine if a new vitamin a derivative is capable of enhancing hsc mobilization when used in conjunction with g-csf. patients will undergo two mobilization procedures. they will be given g-csf alone, or a combination of the study drug plus g-csf, and their stem cells will be collected. a comparison group of patients will be given g-csf alone for both mobilizations. stem cells collected from patients in this trial will be frozen and stored until they are required for transplantation into that patient. at that time, patients will be monitored for how well they recover from their high dose chemotherapy and hsc transplantation.


Eligibility criteria:
inclusion criteria: 1. age 18-70 2. histologically proven multiple myeloma or lymphoma 3. intent of treating physician to proceed to high dose therapy and autologous transplantation 4. not currently receiving thalidomide (within 1 week of commencing vtp195813 or g-csf), cytotoxic agents or high dose prednisolone or dexamethasone (at doses greater than 15 mg prednisolone or equivalent per day) 5. multiple myeloma patients must be taking regular bisphosphonate therapy 6. absolute neutrophil count between 1.5 and 10 x 109/l 7. ecog performance status ? 2 8. life expectancy of at least 2 months 9. written informed consent signed by patient or legally authorized representative exclusion criteria: 1. active infection or a fever \> 38.2 degrees c (fever due to b symptoms in lymphoma patients will not exclude a patient) 2. use within the previous 30 days of other vitamin a preparations within the last 30 days (including oral vitamin supplements, oral retinoids for acne or other skin disorders, bexarotene, or topical vitamin a preparations) 3. pregnancy or breast feeding. women of child-bearing potential, admitted to the trial must take adequate measures to prevent conception (at least two different forms of contraception during the study and for at least one month after completion of study drugs) and are to undergo a pregnancy test 4. significant non-malignant disease including hiv infection, uncontrolled hypertension (diastolic blood pressures \> 115 mmhg), unstable angina 5. known allergy to e.coli-derived products 6. current treatment with tetracycline antibiotics

Keywords: multiple myeloma lymphoma
to predict efficacy by detecting circulating endothelial cell subsets and blood perfusion parameters changes in vivo tumor in study of ql1101 and avastin® in patients with non-squamous non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: to reveal changes of peripheral markers and blood perfusion parameters in vivo tumor in the study of ql1101 and avastin® in patients with non-squamous non-small cell lung cancer

the study is ql1101-002 additional research, by detecting the blood circulating endothelial cells and blood perfusion parameters change within tumors early prediction efficacy and drug resistance.

Eligibility criteria:
inclusion criteria: * aged ≥18 years and ≤75 years; * patients with histologically or cytologically confirmed inoperable locally advanced (stage iiib, not suitable for multidisciplinary treatment), metastatic (stage iv), or relapsed non-squamous cell non-small cell lung cancer. diagnostic result of non-squamous cell non-small cell lung cancer obtained based on sputum cytology should be immunohistochemically confirmed. if a variety of tumor ingredients are mixed, the main cell types should be classified; * ecog score of 0-1 points; * at least one measurable lesion can be evaluated according to recist1.1 criteria; * patients who have not received systemic anti-tumor therapy of locally advanced or metastatic non-squamous non-small cell lung cancer (if the subject received adjuvant therapy after completing the radical treatment of early non-small cell lung cancer, but then the disease relapsed, the subject can be enrolled. in this case, the end time of the adjuvant therapy is required to be more than 6 months from the time of the first administration of this study, and various toxic reactions resulting from the adjuvant therapy should have recovered (≤ grade 1 by ctcae 4.03 criteria, except for alopecia); * expected survival time ≥24 weeks; exclusion criteria: * central squamous cell carcinoma, and mixed gland squamous cell carcinoma with squamous cell as the main ingredient; * alk fusion gene is known to be positive; * medical history or examination shows thrombotic disease within 6 months prior to screening; * imaging shows signs of tumor invasion of large vessels, and the investigator or radiologist must exclude patients whose tumor has been completely close to or surrounded or invaded the lumen of large vessels (e.g., the superior pulmonary artery or superior vena cava); * patients with a past history of symptomatic brain metastases or meningeal metastases, or spinal cord compression; * patients who received palliative radiotherapy for bone lesions outside the chest within 2 weeks prior to the first dose of the study drug; * patients who received major surgical procedures (including thoracotomy), or suffered from major trauma (such as fractures) within 28 days * prior to screening, or need to undergo major surgery during the expected study treatment period; * patients who received a minor surgical procedure within 48 hours prior to the first treatment with anivitis® ql1101 (the investigator judges whether there is bleeding tendency);

Keywords: ql1101 avastin® non small cell lung cancer