Kornimate/medical-research-clean huggingface dataset:
behavioral dynamics between infants with visual loss and healthy controls

Conditions: Behavioral Dynamics; Visual Impairment

Summary: an individual senses the world and reflects feedbacks via independent behaviors. such precise collaboration of the sensory and behavioral systems is fundamental to survival and evolution. when a sensory modality is altered, the behavioral system has the potential to fit in a substitute modality. however, the specific dynamics of human behaviors in response to sensory loss remain largely unknown due to the paucities of representative situations and large-scale samples. here, the investigators focused on thousands of human infants who suffered varying degrees of visual stimuli deficiency in early stages, while their behavioral systems remained sensitive and thus retained high behavioral plasticity. having access to this unique population provides an unprecedented opportunity to investigate the effect of diverse visual conditions on the behavioral system.


Eligibility criteria:
inclusion criteria: * younger than 3 years of age exclusion criteria: * any brain and mental illnesses, or other known illnesses that may affect the behavioral patterns
efficacy and safety of allium ureteral stent for treating refractory ureteral stricture

Conditions: Ureteral Stenosis; Hydronephrosis; Ureteral Stent Occlusion

Summary: to conduct a prospective, multi-center study to observe the long-term efficacy and safety of self expanding ureteral stent for treating participants with refractory ureteral stricture.

the aim of the study is to conduct a prospective, multi-center study to observe the long-term efficacy and safety of self expanding ureteral stent for treating participants with refractory ureteral stricture. about 200 participants with refractory ureteral stricture will be enrolled in four hospitals. after the allium ureteral stents are placed, renal function, renal echo, images and associated complications will be recorded.

Eligibility criteria:
inclusion criteria: * refractory ureteral stricture after at least two times of ureteral dilation exclusion criteria: * poor cardiovascular function for anesthesia unwilling to accept the long-term placement of ureteral stent uncontrolled urinary tract infection

Keywords: ureteral stone ureteral stricture hydronephrosis
chronic anergic-anhedonic depression open trial

Conditions: Depressive Disorder, Treatment-Resistant

Summary: a form of depression called 'dopamine-sensitive anergic-anhedonic syndrome is usually resistant to standard therapies (trad). on the other hand, they respond to dopaminergic approaches for which recommendations have been developed: data ('dopaminergic antidepressant therapy algorithm'). these are two stages starting with non-selective monoamineoxidase inhibitors (maoi) or dopamine d2 receptor agonists (d2rag) in 'monotherapy' (data1) and proposing to combine them in the event of a partial response (data2). the effectiveness of this approach in the management of trad has not yet been evaluated in routine care. the aim of this study is to evaluate the feasibility and effectiveness in routine care of the data recommendations in the management of trad presenting to a specialized consultation for resistant depression (short and long-term results).


Eligibility criteria:
inclusion criteria: * major patient (≥18 years old) * man or woman * patient covered for consultation at the expert resistant depression center of alsace (cedra) (chu-strasbourg branch) for trad between 01 january 2013 and 31 march 2023 * patient not opposing to the reuse of their data for the purposes of this research exclusion criteria: * patient having expressed opposition to participating in the study * patient under judicial protection * patient under guardianship or curatorship

Keywords: depressive disorder treatment-resistant anergic-anhednic trd trad maoi dopamine d2 receptor agonists d2rag dopamine-sensitive
effectiveness of electro-press needle for menopause-associated hot flashes

Conditions: Hot Flashes; Acupuncture Therapy; Perimenopausal Disorder; Postmenopausal Symptoms

Summary: the investigators plan to conduct the randomized controlled trial to evaluate the effectiveness of electro-press needle (epn), a novel acupuncture needle combining shallow and gentle insertion with transdermal electrical stimulation, on menopause-associated hot flash in comparison with waiting-list group among women during menopausal transition and postmenopausal periods.

as the most common type of menopause-associated symptoms, hot flashes affect up to 85% of women aging between 40 and 65 years . in china, women suffer from hot flushes as long as 4 to 5 years on average, some of whom may bear the symptoms for 12 years.hormone replacement therapy (hrt) is generally recommended to relieve menopause-associated hot flashes.however, long-term usage of hrt may increase the incidence of endometrial, breast and ovarian cancer, thrombosis and strokes.results of previous studies indicated that acupuncture might help to relieve the symptoms.there is insufficient evidence supporting its effectiveness for relieving the hot flash symptom.

Eligibility criteria:
inclusion criteria: 1. aged between 40-60 years old; 2. scoring 14 points or more in at least one day during the one-week baseline assessment, or having an average of ≥ 7 moderate or severe heating per 24 hours recorded in hf dairy ; 3. fulfilling either condition mentioned below: 1. the last menstrual period was more than 12 months ago (including 12 months); 2. in the late menopausal transition, and has amenorrhea for more than 60 days; 3. fsh≥25iu, and has vasomotor symptoms of hf, sweating, insomnia, migraine, or restlessness, etc. 4. volunteer to participate in this study and sign the informed consent. exclusion criteria: 1. usage of hrt via transdermal administration in the previous one month, or via oral or intrauterine administration in the previous two months; usage of phytoestrogens therapy, transvaginal estrogen administration, or estrogen or progesterone injections in the previous three months; 2. bilateral salpingo-oophorectomy; 3. amenorrhea secondary to premature ovarian failure, ovarian cyst or tumor, thyroid disease, hyperprolactinemia, or cushing's syndrome, etc.; 4. accepted acupuncture or drugs to treat the symptoms of hf within the previous 3 months; 5. received radiotherapy or chemotherapy before; 6. coagulation dysfunction, or taking warfarin, heparin and other anticoagulant drugs at present; 7. suffering from skin diseases, such as eczema, psoriasis, etc.; 8. severe hepatic and renal insufficiency; 9. uncontrolled hypertension, diabetes or thyroid disease; 10. diabetic neuropathy and mental illness (including depression); 11. being pregnant, breastfeeding or planning to be pregnant during the trial; 12. regular usage of sedatives or anti-anxiety drugs; 13. smoking for more than 5 years (at least twenty cigarettes a day on average) , or with the problem of alcohol abuse; 14. installation of pacemakers; 15. poor compliance.
effect of minocycline on pain caused by nerve damage

Conditions: Neuropathic Pain Caused by Lumbar Radicular Pain

Summary: the purpose of this study is to determine if minocycline is effective in the treatment of neuropathic pain. the effect of minocycline will be compared to the effect of placebo and amitriptyline.

neuropathic pain is pain caused by damage to the central or peripheral nervous system. to date, therapy consists of tricyclic antidepressants (such as amitriptyline) or anticonvulsants. however, results are disappointing. minocycline, a fda-approved second generation tetracycline, was efficacious in various animal models of neuropathic pain. we want to study the effect of minocycline in neuropathic pain in humans. the type of neuropathic pain we want to investigate is lumbar radicular pain since this is the most prevalent condition associated with neuropathic pain in humans. this placebo-controlled randomized double blind trial consists of 3 arms: 1. placebo, once daily by mouth during 14 days. 2. amitriptyline 25mg, once daily by mouth during 14 days. 3. minocycline 100mg, once daily by mouth during 14 days. patients can take rescue medication if necessary: tramadol 50mg by mouths up to 3-times daily. brain-derived neurotrophic factor is implicated in the generation and maintenance of neuropathic pain in different animal models of neuropathic pain. to study the role of brain-derived neurotrophic factor in neuropathic pain in humans, we will determine its concentration in serum and plasma before and after 14 days medication intake.

Eligibility criteria:
inclusion criteria: lumbar radicular pain due to disc herniation, failed back surgery syndrome or spinal canal stenosis causing neuropathic pain exclusion criteria: 1. diabetic, alcoholic or drug induced polyneuropathies 2. depression or psychiatric comorbidity affecting pain sensation. 3. use of antidepressants 4. fibromyalgia and chronic fatigue syndrome 5. pregnancy. 6. previous spinal cord damage 7. malignancies 8. allergy to minocycline or amitriptyline
3d bioprinted models for predicting chemotherapy response in colorectal cancer with/without liver metastases

Conditions: Colorectal Cancer; Colorectal Cancer Liver Metastasis

Summary: the therapeutic regimens of adjuvant and neoadjuvant chemotherapy for colorectal cancer (crc) remain largely relied on clinical experience, and thus preclinical models are needed to guide individualized medicine. the investigators are going to establish 3d bioprinted crc models and organoids from surgically resected tumor tissues of crc patients with or without liver metastases. in vitro 3d models and organoids will be treated with the same chemotherapy drugs with the corresponding patients from whom the models are derived. the sensitivity of chemotherapy drugs will be tested in these two types of in vitro models, and the actual response to chemotherapy in patients will be evaluated. the predictive ability of 3d models for chemotherapy sensitivity in crc patients will be compared with that of the organoids. this observational study will validate the potential value of 3d bioprinted tumor models in predicting the response to chemotherapy in crc.


Eligibility criteria:
inclusion criteria: * more than 18 years old * diagnosed as colorectal cancer with or without liver metastases before * pathologically proven colorectal cancer after surgery exclusion criteria: * medical history with other malignancies or serious diseases * disable to sign the informed consent independently

Keywords: colorectal cancer colorectal cancer liver metastasis three-dimensional bioprinting chemotherapy
evaluation of the safety and efficacy of infantile-onset pompe disease gene therapy drug

Conditions: Pompe Disease Infantile-Onset

Summary: this study is being conducted to evaluate the safety and effectiveness of gc301 adeno-associated virus vector expressing codon-optimized human acid alpha-glucosidase (gaa) as potential gene therapy for pompe disease. patients diagnosed with infantile-onset pompe disease who are younger than 6 months old will be studied.


Eligibility criteria:
inclusion criteria: * age \< 6 months * patient has diagnosis of infantile onset pompe disease * the patient's legal guardian(s) must be able to understand the purpose and risks of the study and voluntarily provide signed and dated informed consent prior to any study-related procedures being performed. exclusion criteria: * left ventricle ejection fraction (lvef) \< 40%; * patient who has aav9 neutralizing antibody titer ≥ 1:100； * patient who has received enzyme replacement therapy (ert) more than twice; * patient who has respiratory dysfunction before enrollment, including the blood oxygen (o2) saturation level \ 55 mmhg, or pco2 in arterial blood \> 40 mmhg; * patient who has laboratory abnormalities of: creatinine \> upper limit of normal (uln), hemoglobin \< 90 g/l; * patient with congenital organ absence; * patient with a history of glucocorticoid allergy; * patient who is positive for human immunodeficiency (hiv) antibody, hepatitis b surface antigen, hepatitis c antibody, or treponema pallidum antibody; * patient who has participated in a previous gene therapy research trial; * patient who has any concurrent clinically significant major disease or any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.
phase i/ii study of azd2281 given in combination with paclitaxel in metastatic triple negative breast cancer

Conditions: Breast Cancer; Triple Negative Breast Cancer; Metastatic Breast Cancer

Summary: this is the first part of a 2-part study assessing the efficacy of azd2281 in combination with paclitaxel in 1st or 2nd line treatment of patients with metastatic triple negative breast cancer. this first part (phase i) is an open-label, intra patient dose finding study to establish the appropriate doses and schedule of paclitaxel and azd2281 in combination, to be used in the randomized phase ii part. the safety and tolerability of azd2281 in combination with paclitaxel will be explored. approximately 10 patients per cohort from 4-5 countries will be enrolled in phase i.


Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically diagnosed metastatic triple negative breast cancer (oestrogen, progesterone and her2 negative adenocarcinoma of the breast) * patients must have normal organ and bone marrow function, ecog performance status of no more than 2 * formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing. exclusion criteria: * any chemotherapy, radiotherapy (except for palliative reasons) or investigational product, within 2 weeks from the last dose prior to study entry (or longer period, depending on the agent used) * major surgery within 4 weeks of starting the study, and must have recovered from any effects of major surgery * patients requiring treatment with the following:certain antibiotic drugs, st.john's wort, carbamazepine, phenobarbitone, phenytoin, and certain protease inhibitors/ non-nucleoside reverse transcriptase inhibitors used as components of hiv/aids treatment, * patients with second primary cancer; except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for at least 5 years.

Keywords: breast cancer triple negative metastatic
expanded access protocol of bhv-0223 for patients with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis; ALS; Lou Gehrig Disease; Lou Gehrig's Disease; Lou-Gehrigs Disease; Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Summary: this is an open label expanded access protocol for the treatment of up to approximately 250 adult patients with amyotrophic lateral sclerosis (als) who have difficulty swallowing oral riluzole tablets and may be able to derive benefit from treatment with an alternative oral formulation of riluzole.

riluzole is indicated in the u.s. for the treatment of patients with amyotrophic lateral sclerosis (als). the commercially available dosage form is a 50mg oral tablet. this expanded access protocol (eap) is designed to provide access to a dissolving tablet formulation of riluzole designed for sublingual (sl) administration, in patients with als who, in the opinion and clinical judgement of the treating physician, would benefit from treatment with bhv-0223.

Eligibility criteria:
inclusion criteria: * patients with diagnosed als of any type or duration * current or previous treatment with oral riluzole tablets, or patients who have never taken riluzole oral tablets, or patients who have successfully completed a clinical trial with bhv-0223 and were not withdrawn prematurely due to adverse events * swallowing difficulties, or patient or caregiver report choking one or more times per week, or investigator deems appropriate to treat with sublingual bhv-0223 because (s)he deems the patient cannot be satisfactorily treated with rilutek® * adequate hepatic function exclusion criteria: * patient with history of severe hypersensitivity reaction to riluzole oral tablets or bhv-0223 * patient is known to have any other acute or chronic liver disease

Keywords: amyotrophic lateral sclerosis als lou gehrig disease lou gehrig's disease lou-gehrigs disease motor neuron disease, amyotrophic lateral sclerosis riluzole rilutek® sublingual oral formulation neuroprotective agents administration, sublingual administration, oral biological availability
cobalamin deficiency - diagnosis and therapy

Conditions: Vitamin B 12 Deficiency

Summary: in a retrospective study with existing values of vitamin b12 and holotranscobalamin 4 strategies are simulated and the results and costs are compared. generally, cobalamin ist substituted by intramuscular administration. however, oral preparations are also available. aims of the focus groups are to investigate the awareness of a (potential) deficiency and to identify a therapy for best adherence.

various diagnostic strategies exist for the identification of a cobalamin deficiency. in a retrospective study with existing serum values of vitamin b12 and holotranscobalamin 4 strategies are simulated and the results and costs are compared. a cobalamin deficiency can have various causes: dietary habits (vegetarian, vegan), advanced age, pernicious anaemia, gastrectomy, drug interactions (metformin, proton pump blocker). therapy is often performed by intramuscular administration of cobalamin. however, oral preparations are also available in very different dosages. investigators want to investigate with focus groups whether different patient groups are aware of a (potential) deficiency, how cobalamin is actually substituted (with registered or otherwise acquired products) and which therapy would lead to best adherence.

Eligibility criteria:
inclusion criteria: * potential cobalamin deficiency exclusion criteria: * refusal to take part in a survey
treatment of pathological gambling with naltrexone pharmacotherapy and brief intervention

Conditions: Pathological Gambling

Summary: the aim of this research is to explore the efficacy of the opiate antagonist, naltrexone as combined with cbt-intervention in the treatment of pathological gambling (pg). the study period is 2011-2014 during which one hundred pathological gamblers will be recruited to participate to this placebo-controlled double-blind trial.

all participants have to be able to read and understand the patient information sheet and sign the informed consent. all participants are free to stop being in the study whenever they wanted. the patients are not paid or reimbursed for participation. the study periods is 21 weeks during which the participant's have 8 appointments with the researchers. during the meetings research data will be collected and the participant is having controlled behavioral therapy (cbt) consulting from a trained therapist. at the study visits, the subjects are given written instructions for the proper use of naltrexone and advised to take 50 mg naltrexone approximately one hour before gambling or feeling urges to gamble (and to refrain from taking naltrexone at other times). in this study the maximal daily dose is 50mg of naltrexone. the medication is free for the subjects.

Eligibility criteria:
inclusion criteria: * pathological gambling (scores 5+ from sogs-r and dsm-iv criteria) exclusion criteria: * acute hepatitis * severe liver or kidney dysfunction * suicide risk or severe depression or other untreated mental health problem * participation to other gambling research at the same time * the use of drugs (especially opiates) * pregnancy * prisoners * retarded and mentally ill patients were also excluded

Keywords: pathological gambling treatment intervention
improving vocational outcomes in arthritis

Conditions: Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Summary: the long-term objectives of this research project are to enhance program participation and improve the employment prospects of people with work disability due to arthritis and related musculoskeletal disorders (armd) who are actively seeking vocational (job-related) rehabilitation (vr) services. this study is designed to compare the employment situations of a group of people receiving a two-part intervention and a group that is not receiving the intervention. the intervention consists of training sessions to help prospective vr clients with armd successfully enter and complete the vr program, and training sessions for a randomly selected group of vr professionals to help them serve vr clients with armd more effectively.

the long-term objectives of this research project are to enhance program participation and improve the vocational outcomes of people with work disability due to arthritis and related musculoskeletal disorders (armd) who are actively seeking vocational rehabilitation services. some researchers think that people with work disability due to armd seeking vocational rehabilitation (vr) services who are exposed to an "agency access intervention" are more likely to gain entrance to the vr system and be determined eligible for services than are similar people not exposed to the intervention. further, they think that people with work disability due to armd who are determined to be eligible for vr services, and who are exposed to an "agency enhancement intervention" while receiving services, are more likely to become and remain employed upon completion of the vr program than are similar people not exposed to the intervention. the research design is a randomized, controlled, field experiment comparing the vocational outcomes of a group receiving a two-part intervention to those not receiving the intervention. the design allows us to evaluate separately each component of the intervention. the intervention consists of training sessions to help prospective vr clients with armd successfully enter and complete the vr program, and training sessions for a randomly selected group of vr professionals to help them serve vr clients with armd more effectively. if this intervention strategy can significantly increase (1) vr utilization rates; (2) post-service employment rates; and (3) length of post-service employment in a previously underserved group with historically poor vr outcomes, it could have a significant role in reducing the immense impact, nationally, of work disability due to armd.

Eligibility criteria:
inclusion criteria: * resident of alabama * previously employed * currently unemployed due to musculoskeletal disability * feel capable of work * want to work exclusion criteria: * not a resident of alabama * unable to work

Keywords: arthritis and related musculoskeletal disorders (armd) vocational rehabilitation (vr) agency enhancement intervention health care service evaluation musculoskeletal disability return to work outcomes research unemployment work disability