Kornimate/medical-research-clean huggingface dataset:
marginal zone lymphoma cohort in korea

Conditions: Lymphoma, B-Cell, Marginal Zone

Summary: marginal zone lymphoma is a rare of subtype of non-hodgkin lymphoma. because of its rarity, prospective clinical trial is difficult to conduct. therefore we want to make prospective mzl patients' cohort for several observation study

marginal zone lymphoma (mzl) is a distinct subgroup of non-hodgkin's lymphoma (nhl), which is typically characterized by an indolent clinical course and long survival duration. mzl is responsible for approximately 7\~8% of all nhl. in korea, mzl accounts for 21% of all b-cell lymphoma and is the second most frequent histologic subtype following diffuse large b-cell lymphoma. annually, an estimated 500 patients are newly diagnosed with mzl. according to the previous large-scale analyses, mzl is usually a quiet indolent malignancy, which generally presents with limited stage of disease. localized disease may be controlled with local treatment, and a high response rate can be achieved. advanced mzl is associated with less favorable survival, and appears to be incurable with the currently available therapy. transformation to large cell aggressive lymphoma may occur in the first recurrence or in subsequent relapses. because of its rarity, prospective clinical trial is difficult to conduct. therefore we want to make prospective mzl patients' cohort for several observation study especially related with rituximab use (ex, hepatitis b virus (hbv) reactivation)

Eligibility criteria:
inclusion criteria: * pathological confirmed marginal zone lymphoma * no history of chemotherapy * enable to routine staging w/u and sampling including hbv serology * informed consent exclusion criteria: * mixed with other type lymphoma * refuse informed consent * co-existing cancer needed treatment * prior organ transplantation * accompany with immunodeficiency

Keywords: marginal zone lymphoma cohort rituximab hbv
safety and efficacy of albuterol in individuals with late-onset pompe disease

Conditions: Pompe Disease

Summary: in this study the study team proposes to investigate the efficacy of albuterol on motor function of individuals with late onset pompe disease (lopd) who are receiving enzyme replacement therapy, given albuterol was well-tolerated in patients with late onset pompe disease.


Eligibility criteria:
inclusion criteria: 1. diagnosis of pompe disease by blood acid alpha-glucosidase assay and acid alpha-glucosidase gene sequencing, 2. age: 18+ years at enrollment. 3. receiving enzyme replacement therapy at standard dose (20 mg/kg every 2 weeks) for at least 52 weeks. 4. subjects are capable of giving written consent. exclusion criteria: 1. continuous invasive ventilation (via tracheostomy or endotracheal tube). 2. clinically relevant illness within two weeks of enrollment including fever \> 38.2 c, vomiting more than once in 24 hours, seizure, or other symptom deemed contraindicative to new therapy. 3. chronic heart disease (myocardial infarction in the past 2 months, arrhythmia, cardiomyopathy). 4. history of seizure disorder. 5. history of diabetes. 6. hypokalemia. 7. history of hyperthyroidism. 8. pregnancy. 9. patients on a non-standard schedule for enzyme replacement therapy; for example, weekly infusions as opposed to infusions every two weeks. 10. anti-rhgaa antibody titer \> 1:100,000 11. history of hypersensitivity to beta 2-agonist drugs such as albuterol, levalbuterol (xopenex), bitolterol (tornalate), pirbuterol (maxair), terbutaline, salmeterol (serevent).. 12. the use of the following medications: * diuretics (water pill); * digoxin (digitalis, lanoxin); * beta-blockers such as atenolol (tenormin), metoprolol (lopressor), and propranolol (inderal); * tricyclic antidepressants such as amitriptyline (elavil, etrafon), doxepin (sinequan), imipramine (janimine, tofranil), and nortriptyline (pamelor); * monoamine oxidase inhibitors such as isocarboxazid (marplan), phenelzine (nardil), rasagiline (azilect), selegiline (eldepryl, emsam), or tranylcypromine (parnate); or * bronchodilators such as albuterol, levalbuterol (xopenex), bitolterol (tornalate), pirbuterol (maxair), terbutaline (brethine, bricanyl), salmeterol (serevent), isoetharine (bronkometer), metaproterenol (alupent, metaprel), or isoproterenol (isuprel mistometer) within 12 weeks prior to enrollment.

Keywords: lopd pompe disease
the effects of attention training on emotion regulation and stress related complaints during covid-19

Conditions: Rumination; Anxiety; Stress; Depressive Symptoms

Summary: attention control for external information and cognitive control for internal information play a causal role in emotion regulation according to different theories and empirical research. former research in the lab of the investigators has shown positive effects of an interactive attention control/interpretation training, in which participants learned to unscramble scrambled sentences ("life is my a party mess") in a positive way ("my life is a party") by getting eye-tracking feedback about attention for positive ("party") vs. negative information ("mess"). after the training, participants could better reinterpret negative photos in a positive way. attention- and cognitive control mechanisms prior to negative stressors (proactive control) and after negative stressors (reactive control) seem to play a role in this. moreover, research has shown that low perceived control and negative expectations about future emotion regulation skills results in lower proactive control and a higher need of reactive control. based on this, the assumption can be made that the effects of attention control training - targeting reactive control - could benefit from adding techniques that affect proactive control (e.g. psycho-education). in the present study this is investigated by testing a new two weeks attention control training to see if this has a positive effect on stress related complaints, depressive symptoms and emotion regulation. given that the current covid-19 pandemic is perceived as very stressful by a lot of people, the training could help here. participants between 18 to 65 years of age are recruited during this corona crisis. the attention control training is a new smartphone based application. participants have to unscramble scrambled sentences into grammatically correct sentences. in the training condition, participants are asked to unscramble the scrambled sentences in a positive way. by swiping, participants can see part of the sentences. this gives the investigators an image about the processing of the sentences. this procedure allows to measure how long participants attend to positive and negative words. in the training condition participants get feedback about the duration they process positive and negative words. in the control group participants unscramble the sentences as fast as possible without feedback on emotional attention. participants only get feedback about the speed at which sentences are unscrambled. before and after the 10 training sessions, attention of the participants is measured to see the effects of the training. questionnaires on depressive and anxiety complaints, emotion regulation strategies, well-being and stress are administered before and after the training. there is also a follow-up measure 2 months after the training. both groups (training and control) watch a psycho-education video before the start of the training.


Eligibility criteria:
inclusion criteria: * android smartphone exclusion criteria: * severe depressive complaints
efficacy and safety of 5 mg sublingual zolpidem vs 10mg oral zolpidem in the induction and maintenance of sleep in patients with primary insomnia

Conditions: Primary Insomnia

Summary: the purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem presentation 5 mg in the induction of sleep in patients with primary insomnia.

* national study, phase iv, single-center, double-blind, randomized, parallel, controlled by zolpidem 10mg oral. * experiment duration: 93 days. * 05 visits (days -3, 0, 15, 45 and 90). * efficacy will be evaluated for: sleep induction and the maintenance of sleep. * adverse events evaluation.

Eligibility criteria:
inclusion criteria: * men or women aged between 20 and 64 years; * diagnosis of primary insomnia according to criteria defined by dsm-iv; * difficulty in maintaining sleep and waking up until 3 am; * not having used any psychoactive drug in the last 30 days prior to their inclusion in the study; * signature of ic. exclusion criteria: * previous history of serious medical illness, neurological or psychiatric disorder; * allergy or hypersensitivity to zolpidem; * obstructive sleep apnea syndrome; * polysomnography with apnea and hypopnea index \>10/hour or plm \>15/h; * other secondary sleep disorders; * history of substance abuse or dependence; * history of daily consumption of alcoholic beverages; * pregnancy, lactation or refusal to use safe contraceptive methods during the study.
a prospective cohort study of advanced colorectal cancer treated with oxaliplatin and irinotecan.

Conditions: Advanced Colorectal Cancer

Summary: the goal of this prospective observational study is to learn about the treatment decisions in advanced colorectal cancer treated with oxaliplatin and irinotecan. the main questions:1. learn about the efficacy and safety of immunotherapy or targeted drugs or other chemotherapy for patients treated with oxaliplatin and irinotecan（non-retreatment/rechallenge group，nr group）. 2. learn about the efficacy and safety of oxaliplatin or irinotecan for patients treated with oxaliplatin and irinotecan (retreatment/rechallenge group, rt/rc group). 3. compare the efficacy and safety of various treatment regimens for patients treated with oxaliplatin and irinotecan. this study will only collect the clinical data of patients, without any intervention, in the treatment services. all participants will be provided written informed consent as per the declaration of helsinki principles.


Eligibility criteria:
inclusion criteria: 1. phologically confirmed colorectal adenocarcinoma 2. treated by oxaliplatin and irinotecan and discontinued due to progression or intolerable drug toxicity 3. ecog 0-2 4. predicted survival more than 3 months 5. estimated by investigators that the main organ function is enough good to tolerate the next treatment plan. 6. sign informed consent. 7. agree to receive survival follow-up exclusion criteria: 1. previously exposed to regorafenib, furoquintinib, tas-102, pd-1 inhibitors, or targeted drugs or immunotherapy for her2 amplification, braf v600e mutation, and ntrk gene fusion. 2. previously rechallenged or retreated by oxaliplatin or irinotecan after progression from chemotherapy regimens including oxaliplatin and irinotecan. 3. participate in another interventional clinical study at the same time, unless in the follow-up stage of intervention study. 4. proposed to use a treatment regimen containing regorafenib, furquintinib, and trifluridine, but has any problems obstacling oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction et al. 5. disagree to take contraceptive measures during the study treatment period or within 6 months after the end of the study treatment period. 6. has other primary malignant tumor history, unless non-melanoma skin cancer or lentigo maligna or carcinoma in situ with sufficient treatment and no disease recurrence. 7. has the history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 8. has concomitant diseases that seriously endanger patient safety or affect patient completion of the study. 9. has other problems that is not suitable for clinical research.
skeletal versus cutaneous traction for treatment of femur fractures

Conditions: Femur Fracture

Summary: the purpose of this study is to determine whether there are any differences in skeletal or cutaneous traction for the treatment of femur fractures.

diaphyseal femur fractures are a common occurrence in busy level one trauma centers and even in the age of damage control orthopaedics most of these fractures are fixed definitively within 24 hours. the historical method of temporizing these fractures has been to place a distal femoral or proximal tibial skeletal traction pin. however, in the pediatric population skeletal traction is not utilized due to concern for physeal injury and cutaneous traction has been the gold standard for decades. reasons for skeletal traction in adults are not well defined and there are no clinical studies showing that skeletal traction provides better outcomes in time of reduction in the operating theater or better pain control than cutaneous traction. with the ever increasing amount of high energy trauma seen by junior residents in the emergency department time constraints have become a large factor in patient care. long delays for sedation and equipment procurement make stabilizing a diaphyseal femur fracture a time consuming experience. the purpose of this study is to determine whether differences exist between skeletal and cutaneous femoral traction in terms of: 1) time in patient consultation and fracture stabilization; 2) cost and risk to the patient due to lack of conscious sedation; 3) pain scores prior to surgery; 4) time of reduction of the diaphyseal femur fraction during surgical fixation; and 5) pain relief after traction application.

Eligibility criteria:
inclusion criteria: * patient willing to consent * 18 years of age or older * sustained a diaphyseal femur fracture, open or closed * english competent * isolated fracture on that extremity exclusion criteria: * pathologic fracture * sedated patient * polytrauma to same extremity * unable or not willing to consent

Keywords: pre-operative traction traction proximal femur fracture femoral fractures femoral fracture skeletal traction cutaneous traction
supra-spinatus rehabilitation program comparison

Conditions: Rotator Cuff Tear

Summary: through a prospective randomized study the aims of this study is to analyze the impact of 3 types of rehabilitation protocols on the optimization of the post-operative clinical and anatomic healing of the rotator cuff. after an arthroscopic repair of a stage 1 or 2 supra-spinatus tendon rupture, patients will be included in 3 groups (98 patients per group): * strict immobilization for 6 weeks then active rehabilitation, * or 3 weeks of immobilization then 3 weeks of passive motion before active rehabilitation, * or immediate passive motion for 6 weeks and then active rehabilitation. patients will be evaluated clinically at 6 weeks, 3 months, 6 months and 1 year and an arthro-ct will be performed at 1 year. the investigators will evaluate: constant score and rate of tendon healing.


Eligibility criteria:
inclusion criteria: * male or female between 40 and 65 years old * non-retracted supra-spinatus tendon tear-pre-operative clinical examination and ct * scan-arthroscopic single-row tendon repair exclusion criteria: * patient with a stiff shoulder * previous surgery of the shoulder * stage 3 or 4 fatty infiltration * insufficient repair of the cuff
caffeine and resistance training in young adults

Conditions: Caffeine and Resistance Training

Summary: introduction: several studies have evaluated and confirmed the ergogenic effect of acute caffeine intake on sports performance, specifically on strength and power performance. however, little is known about the prolonged effect of this supplement on neuromuscular adaptations to strength training. introduction: several studies have evaluated and confirmed the ergogenic effect of acute caffeine intake on sports performance, specifically on strength and power performance. however, little is known about the prolonged effects of this supplement on neuromuscular adaptations to strength training. objectives: the present study aims to analyze the effects of acute and chronic caffeine intake on neuromuscular adaptations to strength training, according to sex (men vs. women) and type of exercise (bench press vs. squat), as well as on fatigue resistance during repeated sprints, fatigue perception, mood state, reaction time, diet, and potential side effects.


Eligibility criteria:
inclusion criteria: * age between ≥ 18 and ≤ 35 years. * body mass index (bmi) \&lt; 25 kg/m². * physically active subjects (\&gt;150 min/week of moderate exercise). * healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from performing physical exercise. * participants capable of performing the tests. exclusion criteria: * history of neuromuscular, cardiac, or diseases that could affect liver or muscle metabolism. * use of drugs or other stimulants that interfere with caffeine intake and intestinal absorption during the tests and study. * body mass index (bmi) \&gt; 25 kg/m². * having undergone prolonged periods of forced physical inactivity during the 6 months prior to the study. * performing strenuous exercise within 48 hours prior to the tests. * failing to replicate the same food intake on the two experimental days. * consuming caffeine after 6 pm on the day prior to training or testing.
effects of strength training on freestyle swimming performance and core muscles strength in swimmers

Conditions: Sports Physical Therapy

Summary: to compare the effectiveness performance and core muscles of strength training . strength in swimmers on freestyle swimming

there is lack of literature on strength training on freestyle swimming performance, core muscles strength in swimmers, kicking, and stroke rate. with the help of this study the swimming performance of individual s will improve.

Eligibility criteria:
inclusion criteria: * competitive swimmers * male gender * experience of more than a year of swimming exclusion criteria: * individuals with associated neuromuscular conditions and any injuries to lower limbs. * spinal injuries have been excluded in the study.

Keywords: stroke rate free style stability ball core strength
positive psychology in suicidal patients

Conditions: Suicidal Thoughts; Suicidal Crisis

Summary: suicide is a major health concern. weeks following psychiatric admission are a highly suicide risk period for those having current suicidal ideation or attempt. recently, a pilot study suggested the feasibility of positive psychology in patients in suicidal crisis. notably, gratitude exercises suggested improvement in optimism and hopelessness, two dimensions associated to suicide. moreover, gratitude has been associated to suicidal ideation and attempt, independently from depression. thus, investigators want to conduct the first randomized controlled study in order to assess effectiveness of gratitude exercises (vs control task) in suicidal inpatients, on 1) psychological pain reduction 2) suicidal ideation, hopelessness, optimism, depressive symptomatology, and anxiety improvement.

study design: monocentric randomized controlled study methods: 206 inpatients (department of emergency psychiatry and post acute care), between 18 and 65 years-old, having attempted suicide before hospitalisation or having current active suicidal ideation at the time of the psychiatric hospitalisation. patients suffering from schizophrenia are excluded. randomization into two groups: positive psychology (i.e., gratitude journal) (n = 103) or control task (i.e., food journal) (n = 103), daily exercises during 7 days (in add-on from usual treatment). clinical assessment: 1) at baseline (the day before the intervention beginning) (v0); 2) short daily self-assessments (immediately before and after the exercise); 3) the day following the last day of the intervention (v1). * v0 : socio-demographic data, treatments, psychopathology, suicidal ideation,depressive and anxious symptomatology, psychological pain, optimism, hopelessness. * daily self-assessments: psychological pain, optimism, hopelessness * v1 : treatments suicidal ideation,depressive and anxious symptomatology, psychological pain, optimism, hopelessness, intervention satisfaction.

Eligibility criteria:
inclusion criteria: * being hospitalized for suicidal thoughts or suicide attempt (from less than a week) * having signed informed consent * be fluent in french * able to understand nature, aims and methodology of the study exclusion criteria: * lifetime history of schizophrenia according to the diagnostic and statistical manual of mental disorders - v (dsm-v) criteria * current eating disorder according to dsm-v criteria * patient on protective measures (guardianship or trusteeship) * deprived of liberty subject (judicial or administrative decision)

Keywords: suicidal inpatients positive psychology gratitude psychological pain
multiple ascending dose study of hm12460a in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this is a phase 1 multiple ascending dose (mad) study, conducted in subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * female subjects must be non-pregnant and non-lactating exclusion criteria: * recurrent severe hypoglycemia or hypoglycemic unawareness or recent severe ketoacidosis, as judged by the investigator * pregnant or lactating women * participation in an investigational study within 30 days prior to dosing
closed vitrification of oocytes

Conditions: Infertility

Summary: this study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.

the cryotop method for oocyte vitrification is classified as "open system", which means that it requires direct contact with liquid nitrogen during the vitrification process. the system has an external straw to protect the samples during storage, but the device is not hermetically sealed. instead closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage. open systems have proven highly effective in achieving similar outcomes with vitrified oocytes compared to those achieved with fresh ones. on the contrary, closed systems have failed to be as effective as open ones when used for oocyte vitrification. although open systems have proven to be highly efficient, where many other methods have failed, they have been related to a theoretical risk of contamination due to direct contact with liquid nitrogen. though to date there have been no reported cases of transmission of disease after cryo-transfers either for slow freezing or vitrification, some european countries prohibit the use of open systems for vitrification. in this study, we will evaluate the results after the donor oocyte vitrification, using a modification of a current device (cryotop®), which makes it capable of being hermetically sealed. the current study is a prospective randomized trial aimed to assess the outcome of ovum donation cycles conducted with vitrified oocytes using the closed device versus oocytes vitrified using the traditional open device.

Eligibility criteria:
inclusion criteria: donors: * \< 35 years old * normal physical and gynecological examinations * no family history of hereditary or chromosomal diseases. * normal karyotype * negative screening for sexually transmitted diseases. oocyte recipients: * oocyte recipients \< 50 years old * body mass index \< 30 * \< 2 previous ivf failures * no severe male factor * no recurrent miscarriage * no hidrosalpinx * no myoma * no adenomyosis * no amh alterations exclusion criteria: donors and recipients not meeting inclusion criteria

Keywords: oocyte vitrification survival rate egg banking ovum donation