Kornimate/medical-research-clean huggingface dataset:
rehabilitation through the italian version of the teen online problem-solving (tops) program

Conditions: Neurological Diseases or Conditions

Summary: the study aims at evaluating the feasibility and the efficacy of the teen on-line problem solving program (tops) in improving executive functioning and behavior problems in adolescents with neurological condition aged 11-19 years. in order to control for placebo effects, participants are randomized into two intervention conditions. group 1 performs the regular version of the tops, while group 2 performs a modified version containing no activities on executive functions, behavioral strategies and social skills.

adolescents with neurological condition often present with executive dysfunction and behavioral and social problems. ad hoc rehabilitation may significantly ameliorate such difficulties. with this aim, the teen on-line problem-solving program (tops) could represent a suitable opportunity of intervention, as it aims at helping patients to improve executive and behavioral functioning. the program consists of a web-based platform composed of 10 core sessions and eventual supplementary sessions, providing information and activities on executive functioning, behavioral strategies, social skills. injury-related issues and health and wellness. the program is delivered remotely, with patients performing the intervention at home, together with their families. biweekly google meet sessions with a cognitive-behavioral psychotherapist are scheduled along the entire duration of the intervention to monitor the activities related to the program and the real-life problem-solving process that patients are required to perform during the intervention. assessment of executive functions and behavioral problems is conducted before and after the training (immediate post training assessment and follow-up assessment 6 months after the end of the training), in order to investigate the presence of significant changes after the intervention. both questionnaires and performance-based measures are used. participants are randomized into two groups: group 1 performs the regular version of the tops, while group 2 performs a modified version containing no activities on executive functions, behavioral strategies and social skills. based on the average effect of tops program reported by a meta-analysis available in the literature (corti et al., 2019; hedge's g = 0.39) we estimated a small-to-moderate effect size of f =0.2 (f was calculated based on hedge's g value). power analysis was conducted by using gpower3 software. assuming a correlation of 0.50 between repeated measures and setting the alfa level at p \< 0.05, a sample size of 21 subjects per group is required to obtain 80% of power with our 2 groups x 3 time points design.

Eligibility criteria:
inclusion criteria: * diagnosis of neurological condition (non-progressive aquired brain injury, brain tumor, epilepsy etc.) exclusion criteria: * history of abuse * familiarity for psychiatric hospitalization

Keywords: neurological condition
to compare different soft tissue grafts at the time of lateral ridge augmentation procedure.

Conditions: Bone Graft; Complications, Infection or Inflammation; Ridge Deficency; Dental Implant

Summary: this study will compare two commonly used soft tissue grafting techniques (connective tissue graft, ctg vs acellular dermal matrix, adm) to augment the soft tissue at the time of lateral ridge augmentation procedure. following ridge augmentation procedure, most of the times there is a need for soft tissue augmentation to change the quality of the tissue around future implant's site. to our knowledge, the influence of soft tissue augmentation at the time of ridge augmentation procedure has not been tested defects.

research data and daily clinical observations reveal that implants with lack of surrounding keratinized mucosa km (gingiva-like tissue that normally surrounds natural teeth) are more prone to persistent gingival inflammation, faster disease progression and compromised plaque control. ridge augmentation procedure can alter the quality of tissue in the sites where it will receive dental implants. soft tissue grating aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (km) surrounding implants. ctg or adm will be grafted at the same time of lateral ridge augmentation procedure. specific aims for this project include the evaluation of: 1. to evaluate the quality of soft tissue regenerated with the use of the two available soft tissue grafts via histological analysis. 2. to evaluate whether ctg or adm influences the outcomes of guided bone regeneration (gbr) procedures. 3. to quantify the soft tissue augmentation achieved by the two available soft tissue grafts by direct clinical measurements after the healing

Eligibility criteria:
inclusion criteria: 1. be a registered university of alabama at birmingham (uab) dental school patient 2. english speaking 3. healthy enough to undergo the proposed therapy 4. demonstrated willingness to comply with study directions and time-line 5. insufficient alveolar ridge width for endosseous implant placement defined as 5mm or less as determined by bone sounding and cone beam computed tomography (cbct) scan. 6. able to read and understand the informed consent form 7. need for implants to replace missing tooth or teeth in at least one quadrant of the mouth. exclusion criteria: 1. no english speaking 2. smokers/ tobacco users (\>10 cigarettes a day) 3. less than 18 years old 4. know hypersensitivity to titanium 5. patients with significant medical conditions or habbits expected to interfere with bony healing. 6. patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse) 7. bone dehiscence of \>4mm following tooth extraction or vertical loss of bone at edentulous ridge

Keywords: keratinized tissue keratinized mucosa attached mucosa dental implants ridge augmentation guided bone regeneration connective tissue graft acellular demral matrix
effectiveness of personalized breathing exercise device in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease; Inspiratory Muscle Training; Expiratory Muscle Training

Summary: the current "global initiative for chronic obstructive lung diseases" (gold) guideline emphasizes that pulmonary rehabilitation should be recommended to all chronic obstructive pulmonary disease (copd) patients from stage ii onwards. respiratory muscle training applied to individuals with copd is an important part of pulmonary rehabilitation due to its benefits such as improving pulmonary function and respiratory muscle strength, reducing the severity of dyspnea, and increasing exercise capacity and quality of life. although there is sufficient evidence in the literature about the benefits of imt in individuals with copd. there is little evidence showing the effects of emt. studies show that isolated imt and emt are effective in increasing respiratory muscle strength, endurance and exercise capacity. results from a limited number of studies show that combined training of imt and emt is superior compared to isolated imt or isolated emt in improving exercise capacity and dyspnea. incentive spirometers, with their different mechanical properties, are low-cost respiratory exercise devices that are widely used in the early postoperative period, lung diseases, long-term bed rest and in situations where it is necessary to maintain or increase the ventilation ability of the lung, but they do not apply any resistance to the respiratory muscles. in the pulmonary rehabilitation guidelines published by the american thoracic society (ats) and the european respiratory society (ers), the necessity of using devices that apply resistance to the respiratory muscles to strengthen the respiratory muscles is underlined. the personalized respiratory exercise device will be a device that has the clinical features of an incentive spirometer and respiratory muscle training devices (inspiratory and expiratory) and can be personalized according to the desired purpose. with the same device, patients will be able to both improve lung ventilation, such as an incentive spirometer, and strengthen their respiratory muscles.


Eligibility criteria:
inclusion criteria: * diagnosed with copd by a pulmonologist according to gold 2022 diagnostic criteria (gold, 2022) and in classes b, c and d according to gold * followed for at least 6 months * clinically stable patients without exacerbations or infections exclusion criteria: * patients with a history of spontaneous or trauma-related pneumothorax * patients with middle ear-related pathologies (such as tympanic membrane rupture, otitis) * orthopedic and neurological problems that may interfere with exercise training * changes in medical treatment during the study * patients with unstable concomitant cardiac disease * patients who have been involved in another pulmonary rehabilitation program within the last 6 months * insufficient cooperation
ultrasound-guided aspiration of pta vs conventional landmark technique - a rct

Conditions: Peritonsillar Abscess

Summary: the study is a prospective randomized controlled trial conducted at two different centers at the department of orl - head \& neck surgery, odense university hospital and the department of otorhinolaryngology, head and neck surgery \& audiology, rigshospitalet. the research question is: in a group of patients referred to an otolaryngology department with objective findings of peritonsillar abscess, what are the effects of using intraoral ultrasound to diagnose and guide needle aspiration compared to the traditional landmark-based technique, when measured by the number of performed needle aspirations, procedure-related pain and days on sick leave? the secondary outcomes measured are * number of hospitalization days * number of quincy tonsillectomies * number of visits to an outpatient clinic * patient-reported outcome (measured using an 11-point numeric rating scale)


Eligibility criteria:
inclusion criteria: * patients referred to the department of otorhinolaryngology suspected for peritonsillar abscess * clinical findings of peritonsillar abscess by one of the following: 1. trismus 2. unilateral tonsillar/peritonsillar swelling exclusion criteria: * compromised airways or suspected retro / parapharyngeal abscess * needle aspiration of pus already performed (or participated in the study once earlier) * cannot understand the written information
novel exoscope system for 5-ala fluorescence-guided surgery for gliomas

Conditions: Brain Tumor; Glioma

Summary: 5-ala and the orbeye surgical microscope are u.s. food and drug administration (fda) approved products. for this study, the orbeye microscope imaging system is being used with special filters to visualize 5-ala fluorescence. the fda currently permits the use of these filters. the purpose of this study is to collect medical information before, during, and after standard treatment in order to better understand how to make this type of procedure accessible to patients. this study is also being conducted to determine if use of the orbeye equipped with these special filters improves the ability of the surgeon to remove brain tumors.


Eligibility criteria:
inclusion criteria: * must have a suspected or biopsy-proven high-grade glioma (world health organization grade ii or iv), new or recurrent. * indication for craniotomy for removal of a suspected or recurrent brain tumor * karnofsky performance scale \>/- 60% exclusion criteria: * prophyria, hypersensitivity to porphyrins * renal insufficiency as defined per protocol * hepatic insufficiency as defined per protocol * existing pregnancy (to be checked by a pregnancy test if of child-bearing age. * nursing women or women using inadequate contraception

Keywords: orbeye surgical microscope fluorescence-guided surgery 5-ala
efficacy and safety of 100ir, 300ir, 500ir sublingual house dust mite tablets in allergic rhinitis environment exposure chamber model

Conditions: Allergic Rhinitis Due to House Dust Mite

Summary: the purpose of this study is to assess the effect of 3 doses of sublingual house dust mite (hdm) tablets versus placebo in the change from baseline of rhinitis total symptom score during the allergen chamber challenge before and after 6 months of treatment.


Eligibility criteria:
inclusion criteria: * history of hdm rhinitis allergy for \> 1 year * sensitized to d. pteronyssinus and/or d. farinae * rtss \>= 6 at least 2 time points during allergen challenge session exclusion criteria: * co sensitization to other allergen than hdm * fev1 \< 80% * asthma gina \> 1

Keywords: hdm allergic rhinitis
study of nutritional factors in porphyria

Conditions: Porphyria

Summary: objectives: i. determine whether differences in dietary habits are associated with disease activity in patients with acute intermittent porphyria. ii. determine whether premenstrual porphyria attacks are associated with increased luteal phase energy requirements. iii. determine whether energy requirements are higher than intakes in men with unexplained frequent porphyria attacks. iv. assess the nutritional status of women with acute intermittent porphyria using a comprehensive series of laboratory methods, including zinc and pyridoxine status. v. determine whether the frequency of disease exacerbations decreases when dietary and nutritional abnormalities are corrected in these patients. vi. evaluate the safety and efficacy of a parenteral nutrition regimen for patients with acute porphyria attacks.

protocol outline: women record diet intake for at least 1 cycle (28 days), then undergo a comprehensive nutritional assessment at least once during the follicular and luteal phases of the cycle. men also record diet intake for at least 1 month and undergo indirect calorimetry and other studies. all patients receive a comprehensive analysis of diet and energy metabolism. energy expenditure, resting metabolic rates, and basal metabolic rates are determined with indirect calorimetry, including measurements taken during the follicular and luteal phases of the cycle. other testing includes hormone assays, serology for nutritional studies, and a urinary metabolite profile. zinc, lead, and other metals are measured by atomic absorption spectroscopy. the diagnosis of acute intermittent porphyria is confirmed by erythrocyte porphobilinogen deaminase; urinary aminolevulinic acid, porphobilinogen, and porphyrins; and total fecal porphyrins. patients hospitalized for acute attacks of porphyria during the study will receive standard treatment, including intravenous hematin and parenteral support.

Eligibility criteria:
* acute intermittent porphyria * variegate porphyria and hereditary coproporphyria eligible but analyzed separately

Keywords: inborn errors of metabolism porphyria rare disease
support and rehabilitation protocol for non metastatic breast cancer patients in complete remission after chemotherapy

Conditions: Non Metastatic Breast Cancer

Summary: many breast cancer patients (bcp) will gain weight during chemotherapy and about 10% of them are able to find back to their initial weight after all treatments are finished. other studies have shown that overweight at diagnosis was associated to a twice higher risk of relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse. in western countries, 75% of bcp have insufficient physical activity. dietary and activity programs seem to be able to significantly reduce the mortality risk after breast cancer. the investigators performed a prospective randomized trial consisting in dietary counseling, physical training and physiotherapy in hydrothermal centers. intervention were delivered in small group session lasting 12 days. spa cares were offered to patients. patients in the control group also received dietary counseling given by a dietetician inside anticancer hospital, and were asked to perform more physical activities. main endpoints of the trial addressed quality of life (sf36) one year after inclusion, weight reduction, anxiety/depression (had), sleep quality and long term compliance to instructions. an economic study was associated to the protocol, for volunteers only.


Eligibility criteria:
inclusion criteria: * breast cancer * treatment including a chemotherapy * in complete remission * last treatment in the last 9 months before inclusion * signed consent exclusion criteria: * metastatic disease * relapse * women enable to have physical activity * heart disease or any pathology preventing physical activity

Keywords: breast cancer chemotherapy first line treatment treatments include a chemotherapy last treatment not performed more than 9 months earlier
exercise and nutrition in ibd & preconception

Conditions: Inflammatory Bowel Diseases

Summary: the objectives are to: 1) assess the independent and synergistic efficacy of exercise and nutrition interventions to manage major symptomatic concerns of inflammatory bowel diseases (ibd), 2) assess the independent and synergistic efficacy of exercise and nutrition to mitigate inflammation in ibd, and 3) assess the feasibility of such an intervention in preconception women with ibd. the investigators hypothesize that the combination of anti-inflammatory exercise and nutritional interventions will have a synergistic effect on managing major symptomatic concerns associated with ibd, reducing inflammation, and improving fertility status in preconception women with ibd, as compared to either intervention independently.

potential participants will be recruited from the preconception and pregnancy clinic recently established within the saskatchewan multidisciplinary inflammatory bowel disease clinic \[mdibdc\]. eligible participants will be randomized \[stratified\] to one of four groups: 1) exercise and dietary plan, 2) exercise and no dietary plan, 3) stretching \[placebo exercise\] and dietary plan, 4) stretching and no dietary plan. participants will be assessed at baseline, midway \[3 months\], and post-intervention \[6 months\] for indications of disease activity, quality of life, fertility status, and bone health.

Eligibility criteria:
inclusion criteria: * female * confirmed diagnosis of inflammatory bowel disease * child-bearing age exclusion criteria: * currently following a mediterranean diet * currently performing resistance training on a regular basis (within the past 6 months) * failed physical activity readiness questionnaire-plus (par-q+). * past ileal pouch anal anastomosis * unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety
bedside sedation for the prevention of post dural puncture headache

Conditions: Post Dural Puncture Headache

Summary: dural or lumbar puncture (lp), the passing of a needle into the space of the spinal cord, is a common procedure in everyday clinical practice. the most common use for lp is to measure the spinal fluid pressure and sample spinal fluid for laboratory analysis. however, it is also used for therapeutic purposes, such as administering chemotherapy or spinal anesthesia. a notorious side effect of dural puncture is headache that ranges from mild to debilitating and may last for several days following the procedure. among diagnosed patients, 39% experience at least 1 week of impaired ability to perform activities of daily living. the likelihood of developing a headache after dural puncture depends on a number of factors. as fluid leak is assumed to be the culprit mechanism in this headache strategies to minimize the leak seem to offer the best path to lowering the incidence of headache after diagnostic lp, the commonest clinical context of dural puncture in medical practice. lumbar puncture is a highly stressful event for most patients. as both pain and anxiety cause adrenergic stimulation, they also cause an increase in icp. we believe that this mild increase in icp, occurring before the puncture as well as during the puncture itself may exacerbate the pressure difference between the csf space and the epidural space and so worsen the csf leak furthermore, this excess pressure, although mild, might cause the dural puncture hole to widen slightly and so further augment the leak and possibly even prolong it. furthermore, the very anticipation of pain causes a rise in neurotransmitters that may cause a sensitization effect and worsen pain. this increase in adrenergic drive as well as the sensitization to pain can be effectively blunted by the periprocedural use of mild iv sedation. benzodiazepines, with their sedative-hypnotic qualities are well suited for this task. this study aims to test the effect of mild peri-procedural iv sedation using midazolam on the rates of headache after diagnostic lp. patients undergoing a diagnostic lp will be randomized into two groups. group 1 will undergo the procedure as routinely practiced. group 2 will be given midazolam iv 10-5 minutes prior to the procedure and undergo the same diagnostic procedure. all patients in the study will remain under observation in the hospital for at least 6 hours. patients will be evaluated for headache and specifically for headache. clinical follow up will continue for 72 hours by administering a short questionnaire over the telephone.


Eligibility criteria:
inclusion criteria: * 18-50 years old * undergoing diagnostic lp for any indication for the first time exclusion criteria: * copd * any known chronic pulmonary disease * acute febrile illness * persistent headaches * known sensitivity to benzodiazepines * current or prior substance abuse disorder * cognitive decline
studying cognition in spg4

Conditions: Cognitive Impairment; Hereditary Spastic Paraplegia

Summary: comparing the cognitive levels of patients with spg4 mutations to healthy controls.

comparing the cognitive levels of patients with spg4 mutations to healthy controls by using the cantab® and moca.

Eligibility criteria:
inclusion criteria: * patient with spg4 with known spast-mutation (patient group) or healthy control * age 18 to 70 years * written, informed consent exclusion criteria: * lack of ability for a written, informed consent * presence of gait disorder or other neurological condition (for healthy controls)