Kornimate/medical-research-clean huggingface dataset:
efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in parkinson's disease patients with early wearing-off

Conditions: Parkinson's Disease

Summary: the study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in patients with parkinson's disease and early wearing-off with levodopa


Eligibility criteria:
inclusion criteria: 1. male and female patients ages ≥ 30 and ≤ 80 years old. 2. a clinical diagnosis of idiopathic parkinson's disease. 3. taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at least 1 month prior to study entry. 4. must be using any of the following levodopa/carbidopa standard formulation levodopa/carbidopa 100/25mg dose in any intake of the day. * 1 full tablet, and/or * 1½ tablets the patient can also be using, for a period of at least 1 month prior to study entry, 1 tablet of the controlled release formulation of levodopa/carbidopa 100/25 mg (marketed in spain as sinemet plus retard) or 1 tablet the controlled release formulation of levodopa/carbidopa 200/50 mg (marketed in spain as sinemet retard) in each intake, at different doses. 5. must have early end-of-dose wearing-off defined by \>= 2 or \<=7 positive responses to the quick questionnaire. 6. must have a minimum updrs part ii (adl) score of 9. 7. patients without dyskinesia or with mild dyskinesia. 8. female patients must be either post-menopausal or using one or more acceptable methods of contraception. 9. must be capable of satisfying the requirements of the protocol and must be willing and able to give informed consent according to legal requirements. exclusion criteria: 1. previous or current use of entacapone. 2. history, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism. 3. unstable parkinson's disease patients. 4. patients who experience severe dyskinesia. 5. the following levodopa/carbidopa doses and strengths are not permitted: * patients taking ½ tablet of standard formulation levodopa/carbidopa 100/25 * patients taking standard formulation levodopa/carbidopa 100/10 or 250/25 * patients taking fewer than 3 or more than 6 daily intakes of standard formulation levodopa/carbidopa 100/25 (fewer than 300mg or more than 600mg of levodopa) 6. patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. patients with major depression. 7. female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant. 8. concomitant treatment with mao-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit. 9. patients with a previous history of neuroleptic malignant syndrome (nms) and/or non-traumatic rhabdomyolysis. 10. participated in another trial of an investigational drug/device within the last 30 days prior to study entry. 11. patients who have a history of poor compliance or are in the investigator's judgment unlikely to comply with medical regimens or study requirements.

Keywords: parkinson's disease, adults, levodopa/carbidopa/entacapone, wearing-off, activities of daily living
social support and stress reduction for caregivers of young adults with idd

Conditions: Burden, Caregiver

Summary: the objective of this study is to evaluate the feasibility and stress reduction impacts of a yoga and support group intervention on caregivers of individuals with intellectual and developmental disabilities.

this is a single arm longitudinal trial. we will recruit up to 40 caregivers of young adults with intellectual and developmental disabilities (idd). this is a 12-week social support, resources, and stress reduction intervention delivered in person to a group of caregivers of young adults idd. participants will be asked to attend one 2 hour group session each week. all sessions will have a 1-hour discussion on resources and social support and 1-hour of yoga. all yoga sessions will be taught by 200 registered yoga teacher certified instructors. outcome assessments will be collected at baseline and after the 12-week intervention.

Eligibility criteria:
inclusion criteria: * 1) caregiver of a young adult with idd 2) self-reported ability to participate in a yoga class with no contraindications to participation. exclusion criteria: * 1) actively participating in another health lifestyles interventional research study.

Keywords: caregiver down syndrome intellectual disability parent stress
infectious pathogens in acute respiratory illness in adults and elderly

Conditions: Respiratory Disorders

Summary: the aim of this study is to generate epidemiological data to further explore determinants of chronic obstructive pulmonary disease (copd) and the contribution of bacterial and viral pathogens to acute exacerbation of copd (aecopd) episodes.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes can and will comply with the requirements of the protocol. * written informed consent obtained from the subject. * male or female subjects between, and including, 40 and 85 years of age, at the time of consent. * subjects with confirmed diagnosis of copd with forced expiratory volume of air expired in 1 second (fev1) of \</=80% of predicted normal and fev1/forced expiratory vital capacity (fvc)\<0.7 * subjects have moderate, severe, or very severe copd, according to global initiative for chronic obstructive lung disease (gold) staging. * subjects have a current or prior history of \>/=10 pack-years of cigarette smoking. former smokers are defined as those who have stopped smoking for at least 6 months. number of pack years = (number of cigarettes per day/20) x number of years smoked. * subjects present a documented history of \>/=1 exacerbation requiring antibiotics and/or oral corticosteroids or hospitalization in the previous 12 months. exclusion criteria: * subject also has a confirmed diagnosis of asthma, cystic fibrosis, pneumonia risk factors or other respiratory disorders. * subjects having undergone lung surgery. * subject has a α-1 antitrypsin deficiency as underlying cause of copd. * subject who experienced a moderate or severe copd exacerbation not resolved at least 1 month prior to enrolment visit and at least 30 days following the last dose of oral corticosteroids. * subject using any antibacterial, antiviral or respiratory investigational drug or relevant vaccine up to 30 days prior to the enrolment visit. * subject has other conditions that the principal investigator judges may interfere with the study findings. women who are pregnant or lactating or are planning on becoming pregnant during the study.

Keywords: pathogen chronic obstructive pulmonary disease acute exacerbations of chronic obstructive pulmonary disease copd respiratory aecopd exacerbation
treatment of depression after coronary bypass surgery

Conditions: Depression; Coronary Disease

Summary: this randomized controlled trial will test the efficacy of (1) cognitive behavior therapy and (2) supportive stress management as treatments for depression in people who have recently undergone coronary artery bypass graft surgery.

depression is a very common problem for people who have had cabg surgery, and recent studies have shown that it may increase the risk of additional medical problems and death during the first few years after surgery. cognitive behavior therapy (cbt) has been shown to be efficacious for depression in otherwise healthy individuals, and supportive stress management (ssm) interventions have also been shown to improve depressive symptoms. these therapies have not, however, been tested for depression in individuals who have undergone cabg surgery. participants will be screened for depression within 1 year after cabg surgery. those who have depression will return for additional testing 1 week later. eligible participants will be randomized to receive cbt, ssm, or usual care (uc), with no restrictions on nonstudy antidepressants, for 12 weeks. patients will be monitored for worsening depression referred for additional care if needed. depression, anxiety, and health-related quality of life will be assessed at baseline, 12 weeks after randomization, and 6 months after surgery (2 months after termination of cbt or ssm).

Eligibility criteria:
inclusion criteria: * coronary artery bypass graft (cabg) surgery (alone or combined with valvular or carotid surgery) within past 12 months * meets dsm-iv criteria for major or minor depressive episode exclusion criteria: * severe cognitive impairment * severe psychiatric comorbidity (e.g., alcoholism or schizophrenia) * severely debilitating or life-threatening illness other than coronary disease

Keywords: cognitive therapy relaxation techniques
efficacy and safety study of isuzinaxib in subjects with dkd

Conditions: Diabetic Kidney Disease (DKD)

Summary: this study is a multicenter, double-blinded, randomized, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, pk, and efficacy of isuzinaxib compared with placebo in subjects with dkd.


Eligibility criteria:
inclusion criteria: 1. male/female subject aged ≥19 years inclusive at the time of informed consent. 2. clinical diagnosis of type 2 diabetes and dkd. 3. 18.5 kg/m² \< body mass index \< 35 kg/m². 4. stable uacr values prior to screening visit. 5. uacr between 200 and 3000 mg/g. 6. hemoglobin a1c ≤10% at screening visit. 7. subject who has been taking unchanged dosage of angiotensin-converting enzyme (ace) inhibitor or angiotensin receptor blockers (arb) medication. 8. subject who has been on stable anti-hyperglycemic prior to screening. 9. females of childbearing potential/sexually active males with a partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control. 10. willing to be under dietary management for diabetes. 11. willing to comply with all study procedures and availability for the duration of the study. 12. capable of understanding the content of and able voluntarily to provide a signed and dated written informed consent form (icf) prior to any study procedures. exclusion criteria: 1. history of type 1 diabetes mellitus or gestational diabetes. 2. subject's renal impairment and/or albuminuria is considered to be of origin other than dkd. 3. history of renal transplant and/or plan to undergo a renal transplant during the study. 4. history of acute kidney injury or renal dialysis. 5. subject with uncontrolled blood pressure. 6. subject taking immunosuppressant. 7. subject with known or suspected hypersensitivity to any components of the apx-115 formulation. 8. clinically significant abnormal laboratory findings at screening. 9. history of drug or alcohol abuse within 1 year prior to screening. 10. history of any cardiovascular event or cardiovascular procedure planned during the clinical study. 11. current or history of new york heart association class iii or iv heart failure. 12. clinically significant electrocardiogram (ecg) abnormalities. 13. known significant liver disease. 14. subject with active urinary tract infection or has not fully recovered before randomization. 15. history of malignancy within 5 years prior to screening. 16. administration of any investigational product. 17. major surgery within 28 days or not fully recovered surgery prior to randomization or major surgery planned during the next 6 months. 18. positive hepatitis b surface antigen. 19. female subject who is pregnant or breastfeeding. 20. other medical history which in the opinion of the investigator would make the subject unsuitable for participation in the study. 21. subject who, in the judgment of the investigator, is likely to be non-compliant or uncooperative during the study or unable to cooperate because of a language problem or poor mental status.

Keywords: isuzinaxib apx-115 nox diabetic nephropathy dn diabetic kidney disease dkd
h5n1 milk detection study

Conditions: Influenza

Summary: the purpose of this study is to determine whether drinking pasteurized milk (milk heated to kill harmful germs) that contains inactive particles of a flu virus called a(h5) could lead to the detection of the virus in the nose or throat. inactive particles are not capable of causing disease. the results will help the centers for disease control and prevention (cdc) better understand how milk consumption could affect flu surveillance. investigators also want to see if the body produces antibodies in response to this milk consumption.

since march 2024, avian influenza a (h5n1) viruses have infected u.s. dairy cattle and spread widely. the virus has been identified in high concentrations in raw milk, and research shows that pasteurization - the process of heating milk to a specific temperature for a set time - inactivates the a (h5n1) virus. therefore, the food and drug administration (fda) says that commercial pasteurized milk is safe for consumption. however, trace amounts of inactive influenza particles may still be detected in pasteurized milk. this study aims to determine whether drinking pasteurized milk could be a possible exposure for h5n1 influenza detection. the findings will support the centers for disease control and prevention's (cdc) efforts to evaluate milk consumption as a factor in influenza surveillance and provide context for interpreting surveillance data. healthy adults will drink 250 ml of pasteurized milk containing the inactive h5n1 virus, provided by the cdc, either during a single visit or over three consecutive daily visits. nasal and combined nasal/oral swabs will be collected immediately following milk consumption to assess the presence of influenza. additionally, a subset of participants will provide blood, saliva, and stool samples at the initial visit and again 21-30 days post-consumption.

Eligibility criteria:
inclusion criteria: * individuals aged 18-64 years * bmi ≤ 35 kg/m2 * able to understand and give informed consent (american english) and comply with study visits and procedures. * in good general health based on medical history and the investigator's clinical judgment. exclusion criteria: * symptoms of acute respiratory illness or conjunctivitis within 7 days * febrile illness in the previous 72 hours * recent influenza antiviral use (within 14 days) * immunosuppression due to illness or medications * current pregnancy or breastfeeding * history of allergy or intolerance to milk or milk alternatives * consumption of raw (unpasteurized) milk within the previous 14 days * recent work (within 14 days) on a farm with animals known to be infected with a(h5) virus * previous receipt of a(h5) vaccine at any time

Keywords: pasteurized milk flu virus a (h5) h5n1 avian influenza a
combination bevacizumab and verteporfin (two different sequences of treatment)in neovascular amd

Conditions: Choroidal Neovascularization; Macular Degeneration

Summary: the purpose of this research study is to compare different timing therapies of verteporfin with bevacizumab to treat choroidal neovascularization (cnv) due to age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: 1. patients are men or women of age 55 or older 2. patients have subfoveal cnv due to amd with lesion size less than or equal to 9 mps da 3. patients have not received previous treatment for subfoveal cnv due to amd. 4. patients have a visual acuity between 20/40 and 20/320- exclusion criteria: 1. subjects who have received previous treatment for subfoveal cnv, in their study eye including prior pdt, transpupillary thermotherapy (ttt), submacular surgery, drug therapies such as macugen or other anti-angiogenic compounds, or other local treatment. previous laser photocoagulation therapy is acceptable, provided it was not subfoveal. 2. patients with a known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light. 3. patients who use medications that may induce photosensitivity. 4. patients who have undergone yag capsulotomy within the last month. 5. subjects currently involved in any experimental procedure within the last 12 weeks. 6. female patients who are pregnant, fecund or breast-feeding. -

Keywords: choroidal neovascularization due to age-related macular degeneration
comparison of body weight change during contraception with belara and yasmin

Conditions: Body Weight Changes

Summary: the purpose of this study is to evaluate different side effect in contraceptive use of two oral combined contraceptive pills (ocp)in combination of 30 mcg ethinylestradiol/2 mg chlormadinone acetate (belara®) and 30 mcg ethinylestradiol/3 mg drospirenone (yasmin®), especially body weight change.

oral combined contraceptive pills (ocp) is the most contraceptive use in reproductive women. the various type of progestins in ocp give various effects either benefit (non-contraceptive benefit) and side effect. these effects depend on pharmacological activity of each progestin. many studies showed causes of discontinuation use of ocp, such as increase body weight,androgenic effect and vaginal spotting. ocp in combination of 30 mcg ethinylestradiol/2 mg chlormadinone acetate (belara®) and 30 mcg ethinylestradiol/3 mg drospirenone (yasmin®)are the common used in practice. the each type of progestin (chlormadinone and drospirenone) might effect different outcomes in women especially in body weight change during use. chlormadinone is a c-21 progestin which has glucocorticoid and antiandrogenic effect. drospirenone is a progestin in spironolactone derivative which has antimineralocorticoid and antiandrogenic effect. both progestins might has less effect in body weight change and provide other non-contraceptive benefits. so investigator want to study the different effects from these progestin in two type of ocp. the result from this study could give information to choose the proper ocp for each reproductive woman.

Eligibility criteria:
inclusion criteria: * reproductive woman * woman who has bmi \< 28.5 kg/m2. * woman who has regular menstruation. * woman who don't have pelvic organ disorder. * woman who want contraception with oral contraceptive pills. exclusion criteria: * woman who has abnormal blood pressure * woman who has abnormal vaginal bleeding * pregnant woman * woman who on medication effect contraceptive pills, such as anti-fungal, anti-retroviral, anti-convulsant drug. * woman who has contraindication for ocp. * woman who use steroid in 3 month period before enrollment in this study. * smoking * woman who has eating habit disorder.

Keywords: chlormadinone acetate drospirenone contraceptive pills
short term effects of photodynamic therapy in basal cell carcinoma

Conditions: Basal Cell Carcinoma

Summary: the purpose of this study is to evaluate the efficacy of photodynamic therapy in treatment of basal cell carcinoma (bcc) and factors that affect response rate.

background and aim: basal cell carcinoma (bcc) is the most common skin cancer .photodynamic therapy _as a novel , non-invasive therapeutic approach _may be considered a valuable strategy. this study was designed with the aim of the evaluation of efficacy of pdt in treatment of bcc and factors that may affect response rate. materials and methods: this was a clinical trial which was done on 28 bccs. patients were treated with ala-pdt monthly for 1-6 sessions and evaluated for clinical response,cosmetic results and probable side effects.

Eligibility criteria:
inclusion criteria: * histologically proven bccs exclusion criteria: * rodent ulcer * morphea type * ana + * history of photosensitivity or photodermatosis or ingestion of phototoxic * drugs during last month * pregnancy * breast feeding * age\< 18 * history of another therapeutic intervention for bcc during last 6 months

Keywords: basal cell carcinoma photodynamic therapy photo chemotherapy basal cell epithelioma
role of autologous platelet rich plasma(prp) injection and platelet rich fibrin glue(prfg) interposition for treatment of anal fistula

Conditions: Anal Fistula

Summary: to evaluate the autologous platelet rich plasma and platelet rich fibrin glue effect on the treatment of anal fistula to asses role of platelet rich plasma and platelet rich fibrin glue in decreasing recurrence of perianal fistula

an anal fistula (af) is a tunnel connecting the anal canal or rectum (internal opening) with the skin (external opening) around the anus. patients who have a perianal abscess have symptoms include discomfort, trouble sitting, and pus or blood discharge. simple and complicated anal fistulas are the two types that exist. a complex fistula is difficult to manage, has a higher risk of recurrence rates, and poses a greater threat to continence after surgery. af was associated with significant morbidity which is a devastating condition with profound effects on both the physical and psychological health of the patient. fibrin glue (also called fibrin sealant) is a surgical formulation used to create a fibrin clot for hemostasis, cartilage repair surgeries or wound healing. it contains separately packaged human fibrinogen and human thrombin. new procedures were published in the scientific literature, each with advantages and disadvantages. according to reports, an effective therapy option is the autologous fibrin glue that is rich in platelets. prp began to be used in surgery as a regenerative tissue factor the tract fistula was cleaned with betadine 10% before prp and prfp were applied. then, 2 ml of prp was injected around the fistula into the tissue (the penetration depth in injection was 5-6 mm), and 4 ml prfp was mixed with 1 m thrombin and interpositioned into the tract. 2 ml of prp was injected around the fistula into the tissue (the penetration depth in injection was 5-6 mm), and 4 ml prfp was mixed with 1 m thrombin and interpositioned into the tract. the operation time was about 20-30 minutes, the clot formation usually takes about 8 minutes, but the anesthesia was extended to 20 minutes to make sure a complete clot in the place of fistula

Eligibility criteria:
inclusion criteria: * 60 patients with perianal fistula were in the age group between 20 to 60 years old exclusion criteria: * thrombocytopenia * patient with rectovaginal fistula * fistula with chronic cavities * acute sepsis and patient were not willing undergo this type of treatment
camrelizumab combined with chemotherapy in first-line treatment of her2-positive gastric cancer

Conditions: HER2-positive Gastric Cancer

Summary: according to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety, or affect the patient's completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.);


Eligibility criteria:
inclusion criteria: - rious hepatic and renal impairment, organ function must meet the following requirements: anc ≥ 1.5 × 109/l; plt ≥ 90 × 109/l; hb ≥ 90g/l; tbil ≤ 1.5 × uln; alt and ast ≤1.5 × uln, alp ≤ 2.5 × uln; for patients with liver metastases, alt and ast ≤ 5 × uln bun and cr ≤ 1 × uln and cre exclusion criteria: * rious hepatic and renal impairment, organ function must meet the following requirements: anc ≥ 1.5 × 109/l; plt ≥ 90 × 109/l; hb ≥ 90g/l; tbil ≤ 1.5 × uln; alt and ast ≤1.5 × uln, alp ≤ 2.5 × uln; for patients with liver metastases, alt and ast ≤ 5 × uln bun and cr ≤ 1 × uln and cre