Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of parkinson's disease gene therapy drug (bbm-p002)

Conditions: Parkinson's Disease

Summary: safety and efficacy study of bbm-p002 in subjects with primary advanced parkinson's disease

parkinson's disease is a neurodegenerative disorder involving loss of dopaminergic neurons in the substantia nigra. this study is a single-center, single-arm, open-label, treatment clinical study to evaluate the safety, tolerability and efficacy of an adeno-associated virus (aav)-based gene therapy, termed bbm-p002, will be injected into the brain via a neurosurgical procedure.

Eligibility criteria:
inclusion criteria: 1. diagnosed with idiopathic parkinson's disease. 2. males and females, 40 to 70 years of age (inclusive). 3. disease duration from diagnosis of ≥5 years. responsiveness to dopamine. 4. good compliance and regular follow-up. completion of parkinson's disease patient diary accurately during follow-up, and family members, guardians or caregivers can help subjects fill in patient diary. exclusion criteria: 1. atypical or secondary parkinsonism. 2. history of coagulopathy, abnormal bleeding or hemopathy family history. other bleeding risk which increases risk of surgery determined by investigator. 3. any type of prior gene therapy. 4. clinically significant electrocardiogram (ecg) abnormalities. 5. concomitant disease including unstable cardiovascular and cerebrovascular diseases within 3 months, uncontrolled hypertension, sever postural hypotension, poorly controlled diabetes, history of malignancy. 6. acute or chronic: hepatitis b (hbv); hepatitis c (hcv) infection must have completed curative antiviral treatment with hbv/hcv viral load below the limit of quantification or be negative due to prior treatment or natural resolution to be eligible for enrollment. subject with human immunodeficiency virus (hiv) or syphilitic serum positive should be excluded.

Keywords: parkinson's disease gene therapy adeno-associated virus
etiology analysis of chronic cough after covid-19 infection and research on the efficacy of ics or ics/laba

Conditions: Chronic Cough

Summary: this study collected 600 patients, evaluated whether patients had airway hyperreactivity, airway inflammation, specific types and allergic reactions, comprehensively analyzed and classified the causes of chronic cough in patients, and evaluated and compared the improvement of cough symptoms and quality of life after ics or ics/laba treatment.

the subjects of this study were patients with chronic cough who were admitted to the department of respiratory and critical care medicine, xiangya hospital, central south university from september 1, 2023 to december 31, 2024. patients are registered if they meet all of the following criteria: (1) ≥18 years of age; (2) a clear history of covid-19 infection with a positive nucleic acid or antigen test before chronic cough;(3) persistent cough for more than 8 weeks after the acute phase of covid-19 infection has disappeared; (4) chest x-ray and/or chest ct without significant evidence of lung disease; (5) no history of chronic cough (\>8 weeks) prior to covid-19 infection. patients who met any of the following criteria were excluded: (1) patients refused pulmonary function, blood tests; (2) the patient has previously been diagnosed with respiratory diseases with cough as one of the main symptoms, including cough variant asthma, allergic bronchitis, eosinophilic bronchitis, gastroesophageal reflux disease, chronic obstructive pulmonary disease, chronic bronchitis, bronchiectasis, interstitial lung disease, pulmonary/tracheobronchial tuberculosis, etc.; (3) patients who are pregnant or breastfeeding; (4) the patient's medical records are incomplete; (5) patients lost to follow-up.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old; 2. a clear history of covid-19 infection with a positive nucleic acid or antigen test before chronic cough; 3. persistent cough for more than 8 weeks after the acute phase of covid-19 infection has disappeared; 4. chest x-ray and/or chest ct without significant evidence of lung disease; 5. no history of chronic cough (\>8 weeks) prior to covid-19 infection. exclusion criteria: 1. the patient refused pulmonary function and blood tests; 2. the patient has previously been diagnosed with respiratory diseases with cough as one of the main symptoms, including cough variant asthma, allergic bronchitis, eosinophilic bronchitis, gastroesophageal reflux disease, chronic obstructive pulmonary disease, chronic bronchitis, bronchiectasis, interstitial lung disease, pulmonary/tracheobronchial tuberculosis, etc.; 3. patients who are pregnant or breastfeeding; 4. the patient's medical records are incomplete; 5. patients lost to follow-up.

Keywords: covid-19
effect of alveolar bone grafting

Conditions: Alveolar Bone Grafting; Quality of Life

Summary: this study included patients who underwent secondary alveolar bone grafting by harvesting graft from the anterior iliac crest, in oral and maxillofacial department, faculty of dentistry, ankara university, turkey, during the period from january 2012 to march 2016. all patients were operated using the same technique and by the same surgical team. patients will be interviewed to fill short-form health survey (sf-12) and postsurgical patient satisfaction questionnaire (pspsq) 6 months postoperatively. the questionnaires will be used to assess the relationship between health quality and patient satisfaction. also, grafted sites will be evaluated with respect to fistula, the presence of cleft palate, and infection.the descriptive statistics and pearson correlation analyses will be made using pspsq scores and sf-12 pcs and mcs scores.

the postsurgical patient satisfaction questionnaire (pspsq) was designed to assess each patient's overall satisfaction with the procedure(s), functional improvements, and recognized or perceived negative effects of the procedures. one of the most commonly used measures of hrqol is sf-36, which has been reduced to 12 items with the minimal loss of information to form sf-12 . hrqol was assessed using sf-12 physical component summary (pcs) and mental component summary (mcs) scores.

Eligibility criteria:
inclusion criteria: patients who were undergone alveolar cleft surgery before at our hospital at least 6 months after surgery exclusion criteria: patients who don't accept to join questionnaire

Keywords: quality of life cleft lip cleft palate
liposomal bupivacaine for postoperative pain after craniotomy

Conditions: Liposome Bupivacaine

Summary: acute postoperative pain is a common postoperative adverse reaction. it refers to acute pain that occurs immediately after surgery and usually lasts no longer than 3-7. among the craniotomy approaches, patients undergoing supratentorial craniotomy with temporal approach had a higher incidence of moderate to severe pain within 24 hours. in the management of postoperative acute pain, multimodal analgesia is recommended. liposomal bupivacaine was encapsulated by liposomal vesicles and released slowly, lasting up to 72 hours. the long action time also makes the time window of postoperative acute pain completely covered, thus helping patients better control pain. at present, there is an obvious lack of clinical studies on the effectiveness and specific duration of liposome bupivacaine for postoperative acute pain, especially in neurosurgical craniotomy population with transtemporal incision approach, which is a high-risk group for postoperative pain in neurosurgery.


Eligibility criteria:
inclusion criteria: * age 18-65 years old; * patients undergoing craniotomy tumor resection via frontotemporal approach, temporal base approach or temporal occipital approach; * asa grade i \~ iii; * sign informed consent. exclusion criteria: * previous history of combined drug allergy; * patients with a history of severe chronic pain; * long-term history of analgesic drug use; * patients with aphasia and other inability to cooperate with the scale were evaluated; * patients with mental system diseases; * patients with incomplete function of vital organs (heart, lung, liver, kidney); * history of drug and drug abuse; * bmi≥35kg/m2; * pregnant or lactating patients.
platelet-associated inflammation in severe sepsis

Conditions: Severe Sepsis

Summary: sepsis represents a serious public health issue characterized by a complex inflammatory response. in addition to their hemostatic role, platelets display inflammatory functions by secreting a variety of immunomodulatory factors and interacting with circulating immune cells. the investigators postulate that, in severe sepsis, platelets become activated and release amounts of different soluble inflammatory molecules that contribute to sepsis-associated inflammation. first, the investigators propose to assess whether severe sepsis impairs the ability of platelets to release soluble cd40l (scd40l), an powerful platelet-derived immunomodulatory molecule, in icu patients with s. aureus documented infection, icu patients with documented infection involving other bacterial species, compared to icu patients with inflammation of noninfectious origin and healthy blood donors. then, the investigators wish to assess whether the bacterial species affects the release of platelet scd40l and by an extensive screening of platelet soluble factors, the investigators propose to set up profiles of inflammatory molecules associated with the type of infection. finally, the investigators will analyze platelets' activation state and their association with circulating immune, according to the type of infection. therefore, this project is expected to assess to which extent the platelet inflammatory function is super-activated in severe sepsis and to identify new platelet-related biomarkers of sepsis.


Eligibility criteria:
inclusion criteria common inclusion criteria for icu patients : signed informed consent, patient affiliated or entitled to a social security, aged over 18 years, * criteria for blood donor voluntary : to weigh more than 50 kg * criteria for severe sepsis group : sepsis with failure of at least one organ, severe sepsis for less than 72 hours, sepsis with bacteria s. aureus, s. pneumoniae or e. coli. * criteria for uninfectious inflammatory syndrome group : patients operate since less than 24 hours of hip or knee surgery, absence of systemic infection exclusion criteria * failure to participate at the study * patients with a aspirin treatment has continued throughout severe sepsis * patients with an appropriate antibiotic therapy for more than 72 hours * patients with a platelet transfusion in the week before inclusion or 72 hours after a surgical gesture or the occurrence of sepsis * patients with the platelet account is less than 30 000 per cubic millimeter the day of the sampling * patients with a severe sepsis who had a surgical gesture previous week the inclusion * all clinical sequelae or biological at the selection * pregnant woman * patients with a treatment by platelet aggregation has continued throughout severe sepsis

Keywords: platelet severe sepsis inflammation s. aureus biomarkers
effect and complication of two types of nasogastric tube feeding for elderly dysphagia patient after stroke

Conditions: Deglutition Disorders

Summary: dysphagia is a common problem after stroke.patients after stroke with swallow problem will have a nasogastric tube to be feeded. in this study , investigators have including and excluding criteria. continous feeding group and intermittent feeding group had been widely used in enteral nutrition feeding in investigators' institution. investigators will observe participants' nutrition condition and tube-feeding related complications. in continous group patients, participants usually are given prescribed enteral nutrient solution using nutrition pump in 24 hours; while in intermittent feeding group, participants will be given prescribed enteral nutrient solution in 4-5 times by special syringe. during the whole process, investigators will observe all participants' nutrition condition (body mass index, plasma albumin and calf girth) and tube-feeding related complications( regurgitation, aspiration,gastric retention, diarrhea,constipation). with all those data, the investigators will assess which feeding type is better.


Eligibility criteria:
inclusion criteria: * older than 65 years old * clinical diagnosis of stroke( ischemic and hemorrhage) * with moderate and/or sever swallow problem(water swallow test iv-v degree) * with nasogastric feeding tube more than 4 weeks * do rehabilitation in our hospital or designated hospitals exclusion criteria: * without nasogastric feeding tube * patients with fever and other infection * chronic or acute anoxia * poor obedience * quit treatment or go back home to take rehabilitation * critically ill or died
outcome of crisis intervention for subjects with borderline personality disorder or post-traumatic stress disorder

Conditions: Borderline Personality Disorder; Post-Traumatic Stress Disorders

Summary: dr. laddis will test a hypothesis about the nature and the management of behavioral crises in patients with borderline personality disorder (bpd) or post-traumatic stress disorder (ptsd). the term "behavioral crisis" is used strictly for periods of uncontrollable urges to repeat mental or outward activity, e.g., flashbacks, cutting, binging on food, drugs or sex, with no intervals to rethink one's priorities or to consider others' direction. the clinical hypothesis states, in two steps, that: 1. the perception of a life crisis precedes and then underlies every behavioral crisis; 2. the behavioral crisis resolves promptly and all symptoms end if the clinicians engage the patient about his management of the life crisis that underlies the symptoms.

subjects in the experimental group will be treated by dr. laddis after their admission to a crisis stabilization unit (csu) or to an inpatient unit (ipu) for a behavioral crisis. subjects will be included at random, as assigned to dr. laddis according to his routine duties at those units. subjects in the control group will receive treatment for behavioral crisis according to the preference of the clinical staff at other comparable units. that treatment will constitute "treatment as usual". clinicians in the control settings will not be informed about the experimental hypothesis, the clinical intervention and the contingent outcomes. the subjects will be tested for the results of treatment 12-24 hours after composition of a treatment plan. the testing will be done with the brief psychiatric rating scale (bprs), as well as with a set of criteria devised by dr. laddis to measure the outward behavior and the mental events during behavioral crisis. the patients and the attending frontline staff will be interviewed also about their beliefs in regard to what, among the clinicians' interventions, made a difference for the course of the behavioral crisis, for better or for worse. the raters will be trained for interrater reliability and they will not be informed about the hypothesis.

Eligibility criteria:
inclusion criteria: * diagnosed with bpd or ptsd, with a structured interview according to the current diagnostic manual * in behavioral crisis exclusion criteria: * brain damage * currently intoxicated with alcohol or drugs or in withdrawal

Keywords: behavioral crisis perception of social crisis repetition compulsion intrusive mental events uncontrollable urges
studies of the prevention of atrial fibrillation by ala

Conditions: Atrial Fibrillation; Diet Therapy

Summary: an alpha-linolenic acid (ala) rich diet in the lyon heart study reduced sudden cardiac deaths possibly by reducing cardiac arrhythmias and ventricular fibrillation (lancet 1994). since then, there has been a growing interest in ala as a cardioprotective nutrient. much of the interest has focused on the potential antiarrhythmic effect of ω-3 fatty acids, especially the longer chain ω-3 fatty acids, dha and epa, derived from fish. we therefore concluded it important to test whether the shorter chain ω-3 vegetable oil ala also had antiarrhythmic effects, since this might also explain the beneficial effects seen on cardiovascular mortality in the lyon heart study.

objective: we determined the effect of an ala rich diet in reducing recurrence of atrial fibrillation as a further example of a cardiac arrhythmia. design: randomized parallel design efficacy study. setting: three university hospital centers in the bordeaux region, france. patients: 98 successive patients successfully underwent electro cardioversion of whom 75 completed the study without major deviations according to the protocol. intervention: a canola margarine and oil together with a mediterranean diet (ala ω-3, 1.4 g/d) versus a conventional diet (control), with a one year follow-up. main outcome measure: length of time to first recurrence of atrial fibrillation. significance: if ala is antiarrhythmic this action may explain its cardioprotective effect in clinical trials and cohort studies.

Eligibility criteria:
inclusion criteria: * patients hospitalized in one of the three centers in the bordeaux region, and who subsequently underwent successful electrocardioversion for atrial fibrillation. exclusion criteria: * included patients who were unable to receive electrocardioversion or those who were already enrolled in another trial * patients who were unable or unwilling to comply with the diet recommendations (experimental or control) or follow-up requirements * patients with clinically significant cardiac disease, advanced heart failure, cardiac cachexia, thyroid disease, treated or untreated, clinically significant hepatic or renal disease or a history of malignant disease or alcohol abuse were not included * taking ala rich foods or recording intakes of ala \>2g/d on the control diet or reporting using \<1g/d on the ala diet was considered a major deviation from the protocol.
survival, quality of life and resectability in locally advanced pancreatic cancer

Conditions: Pancreas Cancer; Pancreas Neoplasm; Pancreas Disease; Pancreas Adenocarcinoma; Surgery; Chemotherapy Effect; Quality of Life; Locally Advanced Pancreatic Adenocarcinoma; Borderline Resectable Pancreatic Adenocarcinoma

Summary: this study aims to assess overall survival, quality of life and resection rates in locally advanced pancreatic cancer

this is a multicenter pragmatic prospective observational study including nordic hospitals treating patients with borderline resectable and locally advanced pancreatic cancer. eligibility will be assessed at regional multidisciplinary tumor boards. patients with borderline resectable and locally advanced (non-endocrine) pancreatic cancer according to the national comprehensive cancer network (nccn) and the international study group of pancreatic surgery (isgps) are eligible for inclusion. the study is observational. quality of life will be assessed in all study participants. the primary outcomes are exploration rates, resection rates and overall survival.

Eligibility criteria:
inclusion criteria: * confirmed or suspected invasive pancreatic primary tumor * tumor classified as borderline resectable or locally advanced disease according to nccn guidelines exclusion criteria: * suspected endocrine tumor * suspected non-pancreatic periampullary tumor * distant metastasis * age \< 18 years * patient unable to understand verbal or written information interfering with informed consent or treatment * mental or organic disorder interfering with informed consent or treatments
cirmtuzumab consolidation for treatment of patients with detectable cll on venetoclax

Conditions: Chronic Lymphocytic Leukemia

Summary: single center, open-label, phase 2 study to determine the efficacy of cirmtuzumab consolidation in patients with measurable disease on venetoclax.

this is a phase 2 study to test whether cirmtuzumab in combination with venetoclax given as consolidation therapy can decrease the number of cancer cells that may be left in the bone marrow or in the blood in patients who have been treated with venetoclax for at least one year. consolidation therapy is given after initial cancer treatment to further reduce the number of cancer cells that may be left in the body. cirmtuzumab, a monoclonal antibody that inhibits receptor tyrosine kinase like orphan receptor (ror1) signaling and stemness, may be effective in reducing the risk of disease progression in patients with detectable minimal residual disease (mrd) after treatment with venetoclax.

Eligibility criteria:
inclusion criteria: * must have detectable cll/sll (\> 0.01% leukemia cells present) * must have received at least 12 months of venetoclax. * patients may be receiving venetoclax at the time of screening and study entry. * patients who have discontinued venetoclax more than 6 months prior to study entry must still have a disease burden meeting criteria for low risk of tls (i.e. no lymph node greater than 5 cm in diameter; absolute lymphocyte count less than 25 k/ul) exclusion criteria: evidence of other clinically significant uncontrolled condition(s) including, but not limited to: * uncontrolled and/or active systemic infection (viral, bacterial or fungal) * chronic hepatitis b virus (hbv) or hepatitis c (hcv) requiring treatment. note: subjects with serologic evidence of prior vaccination to hbv (i.e. hepatitis b surface (hbs) antigen negative, anti-hbs antibody positive and anti-hepatitis b core (hbc) antibody negative) or positive anti-hbc antibody from intravenous immunoglobulins (ivig) may participate. * child class b or c cirrhosis treatment with any of the following within 7 days prior to the first dose of cirmtuzumab: * steroid therapy for anti-neoplastic intent * biologic agent (monoclonal antibody) within 30 days for anti-neoplastic intent. * chemotherapy (purine analog or alkylating agent) or target small molecule agent within 14 days or 5 half-lives (whichever is shorter), or has not recovered to less than ctcae grade 2 clinically significant adverse effect(s)/toxicity(s) of previous therapy. * cll therapy, aside from venetoclax. * history of other malignancy that could affect compliance with the protocol or interpretation of results (example: patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible.) * women who are pregnant or lactating

Keywords: chronic lymphocytic leukemia cll cirmtuzumab venetoclax