Kornimate/medical-research-clean huggingface dataset:
ambulatory physical exercise program in hematopoietic stem cell transplantation recipients

Conditions: Hematopoietic Stem Cell Transplantation

Summary: the proposed study in an inception cohort of patients with hematological malignancies treated with pbsct is designed to evaluate the effects of a physical exercise intervention on muscular-skeletal, physical activity and quality of life outcomes.

peripheral stem cell transplantation is a frequently used therapy option to increase survival in hematological and lymphatic malignancies. these malignancies and their treatment are associated with numerous physical and psychological symptoms and severe side effects. physical exercise has been proposed as a promising strategy for the treatment of some of these physical and psychological complaints, and various exercise interventions are currently available after cancer treatment. to date, promising preliminary results concerning exercise programs in pbsct recipients were published with limited sample size populations. results of musculoskeletal outcomes in pbsct recipients after cancer treatment are lacking.

Eligibility criteria:
inclusion criteria: * status after high-dose chemotherapy following hematopoietic stem cell transplantation * willing to enter a physical exercise program * good understanding of the german language * written informed consent exclusion criteria: * uncontrolled cardiovascular disease and myocardial infarction in the previous six months * uncontrolled hypertension * uncontrolled thyroid disease * uncontrolled diabetes * diagnosis of depression before entering the study.

Keywords: cancer, exercise, health related quality of life, pbsct
the effect of training given by whatsapp application on mamography health beliefs and behaviors

Conditions: Breast Cancer

Summary: it is known that the healing process of breast cancer is accelerated thanks to the early diagnosis and effective treatment. mammography screening is an important diagnostic method in the early diagnosis of breast cancer. it is thought that the education to be given according to the health belief model will make important contributions to developing a positive attitude in breast cancer screenings and regular mammography.

the research will consist of women who have previously applied to erzurum cancer early diagnosis, screening and education center, had mammography taken, and whose phone records are available, whose appointment has been made since december 2022, and who meet the screening selection criteria. women who have had a mammography appointment from ketem and have not taken it yet, request their phone information. after the women were searched one by one to identify those who fit their characteristics and volunteers, they would leave the simple random experiment control elements. during the searches, all women will be invited to ketem to have a mammogram again. the experimental group will send educational content through the whatsapp application once a week, and will also answer questions and provide individual counseling. a total of 8 weeks of intervention will be implemented, the first 6 weeks of training will be provided with training presentations and the last 2 weeks of training video will be sent. feedback will be received after the training presentations are followed through the whatsapp application where they are read. the control group will not take any action and will be invited to ketem for mammography. pre-test and post-analysis phone access will be collected. at the end of the training, he will have the final examinations applied after 3 months. the number of women who participated in the study will be determined by examining the ketem records of mammography.

Eligibility criteria:
inclusion criteria: * be between the ages of 40-69, * be woman, * not having been diagnosed with breast cancer, * not to be pregnant, lactating or puerperal, * absence of a mental illness * at least 2 years have passed since the last mammogram, * being able to use the whatsapp application exclusion criteria: * having had problems with breast cancer before, * having a mammogram at regular intervals, * having had breast-conserving surgery for any purpose.

Keywords: breast cancer health belief model mammography
systematic symptom assessment in cancer patients treated with immune checkpoint inhibitors

Conditions: Melanoma; Lung Cancer

Summary: immune-related adverse events (iraes) can be different in their onset, kinetics and presentation but unlike chemotherapy are seldom predictable. toxicity can affect nearly any organ system and multiple presentations of rare but severe iraes have been reported, highlighting the relevance of vigilant monitoring. although early detection and timely management of high grade or special interest iraes (such as cardiac and neurological) is obvious, it is unclear whether early identification of less serious events can lead to clinical benefit. furthermore, it is of the utmost importance to develop new tools which can increase identification of side effects. the current study investigates systematic symptom assessment through an electronic patient reported outcome tool and aims to define whether this can reduce the rate of serious iraes.

systematic collection of symptom information during immunotherapy treatment will be compared to usual care in locally advanced or metastatic lung cancer (nsclc or sclc) and surgically resected or advanced melanoma. electronic survey will be administered every other day to report 14 common symptoms selected from the nci-pro-ctcae tm library developed by the national cancer institute (national institutes of health, bethesda, maryland) italian version (nci-pro-ctcaetm items-italian-item library version 1.0).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old at time of signing informed consent form * histologically documented diagnosis of locally advanced or metastatic lung cancer (nsclc or sclc), surgically resected or advanced melanoma * patients eligible for immunotherapy in any line of treatment, either alone or in combination with other immunotherapy drugs or with chemotherapy * signed informed consent form * life expectancy ≥3 months * ecog performance status of ≤2 * adequate hematologic and end-organ function, defined by laboratory test result by investigator's judgment * viral hepatitis screening: 1. negative hepatitis b surface antigen (hbsag) test 2. for patients with positive total hbcab test, hepatitis b virus (hbv) dna test is required 3. for patients with positive hcv antibody test, hepatitis c virus (hcv) rna test is required exclusion criteria: * patients receiving immunotherapy at time of enrollment * \> 1 grade adverse events from previous treatments * any uncontrolled symptom * clinically unstable brain metastases (i.e., symptomatic, not treated with rt and rapidly evolving)
evaluation of nasal elevator versus grayson's nasal stent with d-nam appliance on nasolabial esthetics in bilateral cleft lip and palate infants

Conditions: Cleft Lip and Cleft Palate

Summary: newborns with bilateral cleft lip/ palate will be treated pre-surgically by either nasal elevator or grayson nasal stent in conjunction with digital nasoalveolar molding (d-nam) appliance in order to evaluate their effect on the nasolabial esthetics.

the aim of this trial is to evaluate and compare the short-term effect of nasal elevator with grayson nasal stent in conjunction with digital nasoalveolar molding appliances at 2 stages t1 (before nam therapy), and t2 (after nam therapy) as regards nasolabial esthetics and maxillary arch changes. newborns with bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive nasal elevator with digital nasoalveolar molding appliance while the second group will receive grayson nasal stent with digital nasoalveolar molding appliance. the follow-up period will be 4-6 months till surgical lip closure. the nasolabial esthetics will be assessed using facial scans and 2d photographs, while changes in the maxillary arch will be assessed by digital maxillary models.

Eligibility criteria:
inclusion criteria: * non-syndromic infants with complete bclp infants * infants less than 1 month of age. * males and females. * infants with displaced premaxilla * patients whose parents provided written consent for the study. exclusion criteria: * patients above 1 month of age. * syndromic and systemically ill infants. * patients with unilateral cleft lip and palate. * incomplete cleft lip or simonart band (soft tissue bridge at the cleft side). * medically compromised patients * patien parents/guardians who will be unwilling to go through the naso-alveolar molding (nam) therapy.

Keywords: cleft lip and palate
implementation of indication criteria for total knee replacement in osteoarthritis (value-based tkr)

Conditions: Knee Osteoarthritis; Arthroplasty, Replacement, Knee

Summary: the aim of this trial is to investigate the effect of a medical decision aid (ekit-tool) on decision quality for knee arthroplasty.

the tool will guide the sdm process and support the consultation, providing a systematic presentation of individual patient and disease-specific information and the fulfilment of indication criteria. furthermore, it will present health information about knee replacement to empower the patient. to investigate the effect of the tool on decision quality, we choose a prospective multi-center, stepped wedge, cluster randomized controlled trial (sw-rct) design.

Eligibility criteria:
inclusion criteria: * patient with knee osteoarthritis who are candidates for knee replacement * capacity to consent * understanding of the german language (written and oral) * age of 18 years or older * informed consent exclusion criteria: * meeting not all inclusion criteria
accelerated transcranial magnetic stimulation (tms) for smoking cessation in people living with hiv/aids (plwha)

Conditions: Hiv; Tobacco Smoking

Summary: to demonstrate whether four sessions of tbs improves attentional bias and craving in plwha smokers compared to four sessions of sham stimulation. we hypothesize 4 sessions of tbs to the left dlpfc will significantly improve attentional bias and craving for smoking cues compared to neutral cues in a population of subjects who are smokers with hiv/aids compared to sham stimulation.

the proposed pilot study seeks to explore modulation of attentional bias and tobacco craving in plwha with one session of adequately dosed theta burst stimulation (tbs). results of this trial will spur clinical research to further investigate the use of tbs as an adjunctive smoking cessation aid for plwha and could have broad implications for smoking cessation programs. data obtained from this pilot study will also facilitate resubmission of a grant application examining adjunctive theta burst stimulation (tbs) combined with varenicline for smoking cessation in plwha. people living with hiv/aids (plwha) smoke at nearly three times the rate of the general population. these extraordinary smoking rates are associated with greater aids-related morbidity, non-aids related morbidity including non-aids-defining cancer, cardiovascular disease, pulmonary disease, and mortality. smoking significantly impacts the progression and outcome of hiv disease and has been identified as the leading contributor to premature mortality in plwha. one study estimated plwha lose more years from smoking than from hiv infection. in our view, shared by others in the field, the single greatest health behavior change that could improve mortality is to assist smokers living with hiv/aids to quit smoking.

Eligibility criteria:
inclusion criteria: potential participants will be * patients enrolled in the bluegrass clinic * 18-60 years of age * male or female gender * able to read, understand and communicate in english * willing to adhere to the general rules of the bluegrass clinic/smartclinic/beyond birth clinic * willing and able to abstain from drug use other than suboxone * exhaled breath on day of study carbon monoxide (co) \< 5 ppm * stabilized on maintenance buprenorphine if having comorbid opioid use disorder. exclusion criteria: * positive pregnancy test for females, traumatic brain injury, history of seizure disorder, history of or current diagnosis of schizophrenia, intracranial metal shrapnel. * previous adverse effect with tms. * sub-threshold consistency while performing behavioral tasks. * failure to show baseline attentional bias to smoking versus neutral cues.
inspiratory support improves preoxygenation in healthy subjects

Conditions: Healthy

Summary: preoxygenation optimizes oxygen content in the functional residual capacity (frc). adequate preoxygenation is defined by an expiratory oxygen fraction (feo2) \> 90%. inspiratory support and positive end expiratory pressure (peep) can create a better reservoir, improve gas exchange and shorten the time needed for adequate preoxygenation. the goal of the study is to evaluate the efficacy and tolerability of different levels of inspiratory support and positive end expiratory pressure during preoxygenation in healthy subjects.

we conducted a double blind prospective randomized trial on 20 healthy volunteers. each subject went through three modes of preoxygenation in random order: normal breathing (sp), breathing under inspiratory support 4 cmh2o/peep 4 cmh2o (psm-4) and inspiratory support 6 cmh2o /peep 4 cmh2o (psm-6). each mode lasted for 3 min and parameters were recorded every 10 s. we evaluated subject's tolerance, leaks and easiness of each mode of preoxygenation according to a simplified (1 to 4) scale. two-way anova was used to compare feo2 while simple anova was used for time to reach feo2=90%.

Eligibility criteria:
inclusion criteria: * healthy volunteers * aged between 20 to 40 years exclusion criteria: * body mass index \> 30 * mustache, beard * claustrophobia

Keywords: preoxygenation inspiratory support healthy endtidalo2
f-18-psma-1007 versus f-18-fluorocholine pet in patients with biochemical recurrence

Conditions: Prostate Cancer; Prostate Cancer Recurrent

Summary: this study evaluates the diagnostic performance and safety of f-18-psma-1007 and f-18-fluorocholine pet/ct imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.


Eligibility criteria:
inclusion criteria: * male with original diagnosis of prostate carcinoma with prior definitive therapy * suspicion of recurrence (3 consecutive psa rises and/or psa rise by 2.0 ng/ml or more above nadir after radiotherapy or cryotherapy and/or psa rise by greater than 0.2 ng/ml after prostatectomy) * life expectancy of 6 months or more as judged by the investigator * willing and able to undergo all study procedures * informed consent in writing (dated and signed) exclusion criteria: * age: less than18 years * contraindications for f-18-fluorocholine * contraindications for any of the ingredients of f-18-psma-1007 * close affiliation with the investigational site; e.g. first-degree relative of the investigator * at the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial * having been previously enrolled in this clinical trial * mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial * being clinically unstable or requiring emergency treatment * being considered a vulnerable person
inflammatory bowel disease : could a regular physical activity reduce patients fatigue ?

Conditions: Inflammatory Bowel Disease

Summary: the chronic fatigue is observed in approximately 40 % of the patients with a chronic quiet inflammatory bowel disease (ibd) and impacts the quality of life of the patients. the beneficial role of a regular physical activity on the quality of life of patients having an ibd was demonstrated in 5 studies including only 1 controlled one \[bilski, on 2013\]. the mechanism by which the physical activity could improve the quality of life of the patients remains unknown (stress decreased, reduction of the inflammatory process) \[bilski, on 2014\]. several studies concerning other chronic pathologies such as fibromyalgia, have demonstrated the beneficial effect of a regular physical exercise to reduce the fatigue of patients. it was recently demonstrated that the chronic fatigue observed in patients with ibd came along with a physical reduction in the performances during the exercise test and a reduction in the physical activity of the patients \[vogelaar, 2015\]. our hypothesis is that a regular moderate physical activity could improve physical performance during an effort et could reduce the chronic fatigue and improve their quality of life.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old * patients suffering from ibd * patients with a facit score \< 30 * patients with bd in remission with a c-reactiv protein dose \< 5 * patients with hemoglobin dosage \> 10g/dl * patients with 18\<bmi\<30 kg/m2 * informed consent given by the patients * patients affiliated to the social security * patients living not far from the centre where the rehabilitation program will be performed * women with no risk of pregnancy (menopausal women or with contraceptive drugs). exclusion criteria: * patients ≥ 45 years old * inability to walk or to ride a bike * contraindication to practice physical exercise * contraindication to exercise test * participation to another research study within the week preceding the beginning of the protocol * patients unstable smokers * patients unable to keep their medical treatment stable along the study * patients with a regular intensive physical practice * patients with depression (had\>11/21) * patients with bad sleep quality (psqi score \>5) * pregnant or breast-feeding patients * patients under legal protection
intracerebral gene therapy in children with sanfilippo type b syndrome

Conditions: Sanfilippo Syndrome B

Summary: this is an open-label, phase i/ii study of intra-cerebral administration of adenovirus-associated viral vector containing the human naglu cdna to children suffering from sanfilippo type b syndrome.

this is an open-label, phase i/ii study of intra-cerebral administration of adenovirus-associated viral vector containing the human naglu cdna to children suffering from sanfilippo type b syndrome. four patients, 18 months up to the 5th birthday, have been included. the inclusion period will be 8 to 12 months. the duration of follow-up for each patient is 1 year post-surgery. the duration of the first extension phase is 18 months. the duration of the second extension phase is 36 months. therefore, the maximum time of the follow-up will be 66 months

Eligibility criteria:
inclusion criteria: * age: 18 months up to 60 months (5th birthday); * onset of clinical manifestations related to mucopolysaccharidosis type iiib (mpsiiib); * naglu activity in peripheral blood cell and/or cultured fibroblast extracts of less than 10% of controls; * patient affiliated to, or covered by a french social security regimen, or european patients with european health insurance card; * family understanding the procedure and the informed consent; * signed informed consent by both parents or legal representative; * vital laboratory parameters within normal range. exclusion criteria: * presence of brain atrophy on baseline mri judged on a cortico-dural distance of more than 0.6 cm; * any condition that would contraindicate general anesthesia; * any other permanent medical condition not related to mpsiiib that could contraindicate the study participation; * no independent walking (ability to walk without help); * any medication aiming at modifying the natural course of mpsiiib given during the 6 months before vector injection (sleep and mood regulators are accepted); * any condition that would contraindicate treatment with modigraf®, cellcept® and prednisolone (solupred® and solumedrol®).
the travel trial: transcatheter right atrial-ventricular valve replacement with lux-valve

Conditions: Tricuspid Valve Insufficiency

Summary: the trial aims to evaluate the safety and effectiveness of lux-valve transcatheter tricuspid valve and delivery system which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.

the travel study is a prospective multi-center single-arm trial for transcatheter tricuspid valve replacement with lux-valve. a series of physical, imaging and laboratory exams will be performed to determine whether a subject has severe tricuspid regurgitation with high surgical risk. subjects who meet the criteria will then receive lux-valve implantation if an informed consent is obtained.

Eligibility criteria:
inclusion criteria: 1. age ≥ 50 years at time of consent. 2. subjects or subject's legal representative has been informed of the nature of the study and provided written informed consent. 3. the site heart team confirmed the subject is at high risk for tricuspid valve surgery (euroscore ii ≥ 7.0%) and the subject will get benefit from the intervention. 4. subjects must guarantee they won't participate in any other clinical trial for a period of one year after the intervention. 5. subjects are with new york heart association (nyha) functional class iii or iv. 6. subjects are with normal left heart function (ef ≥ 50%). 7. no indications for left-sided or pulmonary valve intervention. 8. subjects must have severe or greater tricuspid regurgitation ( the vena contracta (vc) width ≥ 7 mm or the effective regurgitant orifice area (eroa) ≥ 40 mm2), which confirmed by the echocardiography core lab (ecl) via transthoracic echocardiogram (tte). exclusion criteria: 1. subjects with pulmonary hypertension (systolic pressure ≥ 55mmhg determined by right heart catheterization). 2. subjects with previous transcatheter or surgical tricuspid valve procedure. 3. subjects with tricuspid stenosis or other anatomy disorders that unsuitable for the procedure. 4. subjects with depressed right heart function (tricuspid annular plane systolic excursion (tapse) \< 10mm or right ventricle fractional area change (fac) \< 20%). 5. subjects with aortic stenosis (mean δp≥ 40mmhg or aortic valve area ≤ 1 cm2), aortic regurgitation (≥ 3+), mitral stenosis (mitral valve area ≤1.5 cm2) or mitral regurgitation (≥ 3+). 6. subjects with active endocarditis or other infectious diseases. 7. subjects with untreated severe coronary artery disease. 8. subjects with percutaneous coronary intervention, cerebrovascular accident or surgical intervention within 3 months of the date of the procedure. 9. subjects with coagulation disorders. 10. subjects with known allergy, hypersensitivity or contraindication to the material or drugs used in the procedure. 11. subjects with cognitive disorders that can not cooperate the study or follow-up. 12. subjects with less than 12 months life expectancy because of non-cardiac conditions.

Keywords: tricuspid regurgitation lux-valve transcatheter valve replacement