Kornimate/medical-research-clean huggingface dataset:
psychosocial treatment of depression in parkinson's disease

Conditions: Major Depressive Disorder; Parkinson's Disease

Summary: the purpose of the study is to examine the effects of a form of talk therapy called cognitive behavior therapy (cbt) in the treatment of major depression in individuals with parkinson's disease (pd).

cbt is a specific type of treatment that has been shown to be as helpful in treating depression as medications for depression. cbt focuses on thoughts, feelings, and behaviors. it focuses on the here and now, rather than the past. cbt offers concrete strategies and skills for coping with depression, pd, and other life problems. previous research leads us to believe that this type of therapy may help people with pd cope with their depression.

Eligibility criteria:
inclusion criteria: in addition to the dsm-iv diagnostic criteria for major depressive disorder, the following conditions must be met for patient eligibility: * written informed consent. * subjects with a primary diagnosis of pd who also currently meet dsm-iv criteria for mdd * subjects must be stable on their anti-parkinson treatment, as defined by no medication changes over the past 6 weeks * subjects may be taking an antidepressant as long as they have had a stable dose for up to 6 weeks and do not alter the dosage during the course of the study * men or women 40-80 years of age * hamd-17 scores \> 14 at screen visit * score of 25 or greater on the mini-mental status examination * willing to come to mgh for screening and study participation exclusion criteria: patients meeting any of the following criteria are to be excluded from the study: * subjects who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk * patients who would not be appropriate for a delayed cbt control due to the severity of their depression based on clinical judgment as well as hamd-17 scores \> 28 * the following dsm-iv diagnoses: 1) substance use disorders, including alcohol dependence, active within the last 3 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not elsewhere classified; 5) bipolar disorder; 6) mdd with psychotic features * subjects who meet dsm-iv criteria for dementia * severe, unstable concurrent medical conditions (determined by his/her physician) that are likely to require hospitalization within six months from study entry (e.g., a patient with severe congestive heart failure who has a history of recent hospital admissions) * subjects may not be receiving a psychosocial intervention that is specific for depression; psychosocial interventions not specific for depression (e.g., couples counseling) and established for three or more months before screen visit are allowed

Keywords: depression parkinson's disease major depression cognitive behavioral therapy
study to evaluate the immunogenicity and safety of lbvd(hexavalent vaccine), given to healthy infants at primary series

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Haemophilus Influenzae Type B Infection

Summary: the purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine in comparison to co-administration of pentavalent vaccine and poliomyelitis vaccine (inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine(stage 1) and to demonstrate lot-to-lot consistency of three lots of lbvd (stage 2)

stage 1 (dose-level finding;phase 2) 1. to compare the immunogenicity and safety of three lbvd vaccine candidates, varying at different dose levels, to the control vaccines at 4 weeks after a three-dose primary series of vaccination and thereby, select an optimal vaccine dose level for stage 2 stage 2 (evaluation of safety, immunogenicity, and lot-to-lot consistency;phase 3) 1. to demonstrate the non-inferiority and lot-to-lot consistency in the immunogenicity of three separate lots of lbvd to the control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age 2. to demonstrate the safety and immunogenicity of lbvd at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age

Eligibility criteria:
inclusion criteria: * infants in stable health * male or female 6 to 8 weeks of age * signed informed consent by the infant's parent(s) or legally acceptable representative(s) exclusion criteria: * known or suspected hib, hepb, diphtheria, tetanus, pertussis, or poliomyelitis * fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration * known or suspected immunodeficiency * previous use of blood or blood-derived products * previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), hib conjugate, poliovirus, or combination * household contact or intimate exposure with a confirmed case of hib, hepb, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration * any history of allergy (hypersensitivity) to any of the vaccine components * participation in another interventional clinical trial simultaneously
methylphenidate (ritalin®) effect during exposure to exercise and heat stress in add/adhd treated patients

Conditions: Methylphenidate

Summary: the purpose of this study is to explore the possible effects of mph use on physiological functions among adhd\\add patients, by performing a set of physical trials to assess aerobic and anaerobic capacity, to characterize the tendency for muscle break down while performing monitored moderate physical effort and to assess the physiological strain while performing moderate exercise in heat load conditions by using the heat tolerance test.

20 male, non-combat soldiers with a pre-existing childhood diagnosis of adhd\\add, who are chronically treated with mph will participate in the study. if necessary, civilian volunteers with a childhood diagnosis of adhd\\add may also be recruited to complete the study population (up to 50%, i.e. 10 participants). 1. st encounter: the subjects will receive an explanation of the study and sign an informed consent form, complete a medical questionnaire and undergo physical examination by a physician, including ecg. 2. nd-9th encounter: the subjects will be requested to undergo 10 tests on 8 examination days, which will include the: maximal oxygen consumption test, wingate test, heat tolerance test and step test. each subject will perform each test twice: once while taking mph and once with placebo.

Eligibility criteria:
inclusion criteria: * civilian volunteers aged 18-25 years. * bmi range of 17-25. * diagnosed with attention deficit disorder (add or adhd) since childhood. * routine use of methylphenidate (at least 5 days a week). * without known medical illness or medication use. * report of performing physical exercise (twice or more a week). * without history of heat injury. exclusion criteria: * the existence or suspicion of existing cardiac or respiratory disease. * infectious disease 3 days prior to the experiment.
study of fish oil to reduce alt levels in adolescents

Conditions: Non-alcoholic Fatty Liver Disease; Fatty Liver

Summary: this trial will provide preliminary data to test the hypothesis that a six-month treatment period with fish oil for overweight adolescent with mild to moderate persistent elevation of alt levels and presence of hepatic steatosis on ct-scan is safe and will result in decreased alt.

over the past two decades, pre-adult nonalcoholic fatty liver disease (nafld) has emerged from the relative obscurity to become the most common cause of liver disease in pediatric patients. currently, over 17% of us children and adolescents have a bmi at or greater than the 95th percentile for age and gender and 20% of children in weight management programs are estimated to have nafld. untreated nafld can lead to fibrosis and to established cirrhosis in children as young as 10. fish oils are a rich source of omega-3-acid ethyl esters or n-3 long-chain polyunsaturated fatty acids, and increasing evidence suggest they may safely improve hepatic steatosis. given the prevalence of obesity, of nafld, and the severe, progressive nature of this condition, effective treatment strategies are urgently needed. we plan to gather preliminary data on the efficacy and safety of fish oil supplements in reducing persistent elevation of alt levels and hepatic steatosis on abdominal ct-scan among urban youth (bmi\>=95th percentile). this preliminary data will provide the necessary information to calculate the sample size for a phase 2 trial.

Eligibility criteria:
inclusion criteria: * bmi (kg/m2) at or above the 95th percentile for age and gender * weight below 400 pounds (less than 182 kilograms) * persistent elevation of alt (41-90 ui/l at study screening) * presence of hepatic steatosis on abdominal ct-scan * able to give informed consent/assent exclusion criteria: * type 2 diabetes mellitus * prior drug treatment for diabetes, insulin insensitivity, or weight loss medications six months before screening * use of prescription strength glucocorticoids within three months before screening * history of syndrome or medical disorder associated with significant obesity * participation in a weight loss program within six months of screening resulting in 5% or more weight loss * history of weight loss surgery * alcohol use more than twice weekly or more than 3 alcohol containing beverages within a 24-hour period in the past six months * known or suspected bleeding condition * history of liver disease including prior liver biopsy with nash type 2 or cirrhosis * former or present positive blood tests for infectious hepatitis b or c, autoimmune hepatitis, wilson disease, alpha-1 anti-trypsin deficiency, iron storage disease, or high tsh * history of past or current pregnancy * use of illegal/illicit drugs * other conditions contraindicated or cause for caution in the use of fish oil * unable to comply with the protocol * any other serious disease determined by the study gastroenterologists and physician nutrition specialist as potential study risk for the patient

Keywords: alt non-alcoholic fatty liver disease adolescents overweight treatment
postoperative headache in elective surgery patients

Conditions: Drug Withdrawal Headache

Summary: to evaluate the association of anaesthesia and surgery with postoperative headache in elective surgery patients by multiple logistic regression analysis of data collected during a six-month period from 446 patients undergoing elective surgery, a prospective single centre cohort study in a university hospital. participants were interviewed preoperatively and for five days postoperatively regarding the appearance of headache; while demographics, life style, type of anaesthesia and surgery, the anaesthetic drugs administered and intraoperative adverse effects in elective surgery patients are recorded.

a dedicated team interviewed patients preoperatively and during the first five postoperative days and collected data regarding medical history, surgery, anaesthesia and the presence of postoperative headache by manual record review. the frequency of preoperative headache was assessed by asking the subjects on the appearance or not of headache within the last year. additional information were obtained to distinguish migraine which was deemed present only when the participants reported two or more of the following specific symptoms supporting this diagnosis as proposed by the international headache society; episodic headache (4-72 hours) with the following features: moderate or severe throbbing pain, worsened by movement, associated with nausea/vomiting, photophobia or phonophobia, with or without visual aura. specifically, preoperative data included patients' demographics, marital status, life-style and habits, as caffeine consumption (\>200 mg/day or \>2 cups of coffee/day), alcohol (drink equivalent \> 15ml absolute alcohol) and tobacco consumption, previous experience or/and family history of headache. intraoperative data included the type of anaesthesia (general, regional anaesthesia or their combination); anaesthetic drugs used; type and duration of surgery; intraoperative patients' position; and intraoperative adverse events including hypotension (decrease \>20% from baseline), hypertension (increase \>20% from baseline), hypercarbia (paco2 \>6 kpa) and hypoxia (spo2 \<90%). noticeably, the choice of anaesthetic technique and postoperative management were determined by the engaged anaesthesiologist. postoperative headache was defined as a dichotomous variable (i.e. present or not present) by asking the participants twice daily for the first five days (or less if discharged earlier) after anaesthesia and surgery.

Eligibility criteria:
inclusion criteria: * all adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ent(ear nose and throat) and vascular procedures exclusion criteria: * patient refusal * age under 18 years * cognitive dysfunction * head trauma or neurological disorders * difficulty with language comprehension or any other inability to communicate verbally with the interviewer.
colorectal cancer screnning colonoscopy under hypnosis

Conditions: Colorectal (Colon or Rectal) Cancer

Summary: through this study, the effectiveness of hypnosis in the realization of a colonoscopy for the detection of colorectal cancer will be evaluated

colorectal cancer is the 3rd most common cancer. colonoscopy, a screening examination, has led to an increase in patient survival. in more than 90% of cases, this examination is performed under general anesthesia (ga) because it is considered painful, even though several studies have shown its feasibility without ga with a good tolerance in 75% of cases. however, only 28% of patients accept the examination without ga because of great apprehension. ga entails an increased risk of complications but also additional costs. thus, performing colonoscopies without ga would reduce risks and costs by 15 to 30%. in order to make the examination more acceptable and less anxiety-provoking, methods such as hypnosis have been tested with the result that pain and anxiety are reduced and the hemodynamic state of the patients is stabilized, thus reducing the examination time. to date, the majority of studies on hypnosis, of varying indications, are small, mono-centric and non-randomized. the use of hypnosis for colorectal cancer screening colonoscopies would reduce patient anxiety, avoid complications related to ga and reduce the organizational constraints and costs related to ga.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * undergoing a screening colonoscopy (mass screening fecal immunochemical test positive or as an individual (family history of colon cancer or adenoma, personal history of adenoma, cancer, chronic inflammatory bowel disease) or in the context of a transit disorder, hemorrhage or anemia * affiliated with a french social security system * having signed a written consent exclusion criteria: * patient requiring emergency colonoscopy * history of colonic resection * carriers of behavioral disorders and/or psychiatric illness * limited cognitive abilities making it impossible to read or fill out a discrete choice questionnaire (language problems, comprehension problems) * contraindication to hypnosis, preventing quality interaction (comprehension and/or language problems, hearing impairment) * contraindication to general anesthesia * under a legal protection regime * pregnant or breastfeeding woman
antimicrobial photodynamic therapy in chronic periodontitis and diabetes mellitus

Conditions: Type 2 Diabetes Mellitus; Prediabetic State; Chronic Periodontitis

Summary: with this design, this study hypothesizes that; (i) icg-pdt would produce superior clinical, microbiological, and immune-inflammatory outcomes as compared to rsd and (ii) icg-pdt would produce equal efficacy among different forms of diabetes as produced in non-diabetic subjects and that diabetes mellitus would not produce negative impact on the therapeutic outcomes of icg-pdt. therefore, the aim of this randomized controlled clinical trial was to evaluate the efficacy of icg-mediated apdt in the treatment of stage iii grade c periodontitis among patients with prediabetes, t2dm and non-diabetic subjects.


Eligibility criteria:
inclusion criteria: 1. aged ≥30 years 2. clinically diagnosed with mild to moderate periodontitis 3. self-reported type-2 dm for ≥2 years confirmed by a physician with hba1c levels ≥6.5% 4. patients who complied with the treatment protocol. exclusion criteria: (i) pregnancy and lactation (ii) who had taken antibiotics in the previous 3 months (iii) who had undergone periodontal therapy or any decontamination treatment in their oral cavity in the previous 6 months (iv) former/current smokers (v) failure to provide a signed informed consent.
a study of the safety and tolerability of hki-272 administered orally to japanese subjects with advanced solid tumors

Conditions: Tumors

Summary: the purpose of this study is to assess the tolerability and safety of hki-272, and to determine the maximum dose that can safety be given. the secondary purpose of this study is to determine how the body uses and gets rid of hki-272 and to assess whether hki-272 is effective for the treatment of advanced solid tumors.

this is a phase 1 open-label sequential-group study of ascending single and multiple oral doses administered to subjects with advanced solid tumors. each subject will participate in only 1 dose group and will receive a single dose of test article, followed by a 1-week observation period, and then will receive the test article administered once-daily by mouth in cycles consisting of 28 days. subjects will be enrolled in groups of 3 to 6. adverse events and dose-limiting toxicities will be assessed from the first single dose.

Eligibility criteria:
inclusion criteria 1. diagnosis of metastatic or advanced cancer that has failed standard effective therapy 2. life expectancy of at least 12 weeks and adequate performance status 3. adequate bone marrow, kidney and liver function 4. willingness of male and female subjects who are not surgically sterile or post-menopausal to use adequate methods of birth control exclusion criteria 1. any anticancer chemotherapy, radiotherapy immunotherapy or investigational agents within 4 weeks of first dose of hki-272 2. inadequate cardiac function 3. surgery within 2 weeks of first dose of hki-272 4. active central nervous system metastases (i.e., symptomatic, required use of corticosteroids and/or progressive growth) 5. significant gastrointestinal disorder with diarrhea as a major symptom 6. pregnant or breast feeding women

Keywords: advanced malignant solid tumors hki-272 neratinib nerlynx
feasibility of implementing a cohort of people living with hepatitis c in vietnam

Conditions: Hepatitis C Infection

Summary: the purpose of this study is to evaluate the feasibility of implementing a cohort of patients with hepatitis c in order to generate a larger cohort for future studies


Eligibility criteria:
inclusion criteria: * the patient must have given their free and informed consent and signed the consent form * the patient is at least 18 years old * the patient is hcv rna positive exclusion criteria: -
efficient postoperative pain management with multimodal iv

Conditions: Post Operative Pain

Summary: postoperative pain remains a prevalent concern despite ongoing improvements in surgical methods and pain management strategies. opioids, while commonly prescribed, frequently lead to undesirable side effects. epidural analgesia, though a viable option, carries its risks and complications. recent research indicates that combining intravenous lidocaine and ketamine can significantly alleviate postoperative pain and decrease the reliance on opioids within the initial 24 hours following surgery. this approach offers a promising alternative with minimal additional adverse effects, suggesting a potential shift in pain management practices.


Eligibility criteria:
inclusion criteria: * patients were assigned for surgical intervention; * patients of asa grade i-iii; * patients were free of exclusion criteria; exclusion criteria: * patients who are not in asa grade i-iii; * patients who had uncontrolled hypertension and/or diabetes mellitus; * patients who had uncompensated cardiac, renal, or hepatic diseases; * patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs; * patients who refused to sign the informed consent were excluded from the study.
a study about nutritional support of enhanced protein in critical patients

Conditions: Critical Illness

Summary: this is a prospective randomized controlled trial. 180 patients with critical illness will be included and randomly divided into two groups. in the control group, patients will be fed with basic energy; and in the experiment group, the patients will be given extra protein intake except the basic energy intake. the intervention duration will last 6 days. the primary outcomes of this study are urea nitrogen of 24h and prealbumin(pa). and other outcomes include nutritional status, safety indicators and clinical indicators.

critical illness patients are commonly in the risk of malnutrition, because of various factors. and nutritional supplement, particularly the supplement of protein, can decrease the nitrogen balance, improve the nutritional status, accelerate the speed of healing and decrease the mortality rate. this is a multi center prospective randomized controlled trial. 180 patients with critical illness will be included and randomly divided into two groups. in the control group, patients will be fed with basic energy; and in the experiment group, the patients will be given extra protein intake except the basic energy intake. the intervention duration will last 6 days. the primary outcomes of this study are urea nitrogen of 24h and prealbumin(pa). and other outcomes include nutritional status(total protein, albumin, grip and calf circumference), safety indicators(liver function, kidney function, tolerance, etc.) and clinical indicators(overall complication rate, length of hospital stay and cost).

Eligibility criteria:
inclusion criteria: 1. diagnosed as critical illness, stayed in icu; 2. score of m-nutric ≥ 5; 3. score of 3. apache ⅱ \>12; 4. anticipation of length of hospital stay \> 6 days; 5. 18 ≤ age ≤ 45; 6. pattens volunteer to attend this study and sigh the inform consent form; exclusion criteria: 1. liver function(ast/alt) of blood test ≥ 2.5 uln(upper limit of normal); renal function of blood test \> 1.6 uln; 2. the patients are used or are planned to use the human albumin solution within 3 days before receiving enteral nutrition; 3. consume any natural food or something made by natural food; 4. patients are used or are planned to use all-in-one solution or amino acid solution within 3 days before receiving enteral nutrition; 5. anticipation of survival time is less than 5 days; 6. have the contraindications of enteral nutrition; 7. patients are allergic to material of the production; 8. patients who are considered not suitable for this study by investigators;

Keywords: national support protein critical illness