Kornimate/medical-research-clean huggingface dataset:
translation of parkinson's disease questionnaire -8 in urdu language

Conditions: Parkinson Disease

Summary: cross cultural analytical study to translate parkinson's disease questionnaire-8 in urdu language. along with the translated version by evaluating its validity and reliability among the patients of parkinson's disease. no such study has been previously conducted in pakistan which translate this questionnaire in urdu and follows the proper cross- culture adaptation. condition or disease: parkinson's disease. convenient sampling technique would be used

parkinson's disease questionnaire-8 (pdq-8) is the brief version of pdq-39 formulated to reduce the respondent burden and for convenient use in clinical settings in patients of parkinson's disease. (pdq-8) is the patient reported outcome measure constructed by taking one question from each of the eight domains of pdq-39 (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. pdq-8 will be translated into urdu language by beaton et al guidelines for cross cultural adaptation of tool. the validity and reliability of urdu version of pdq-8 will be evaluated by calculating cronbach's alpha, intra-class correlation coefficient and pearson/spearman rank correlation co-efficient. continuous variables will be shown by mean and standard deviation and the categories will be demonstrated in frequency and percentage. factor structure of the pdq-8 will be extracted using exploratory factor analysis (efa), utilizing principal component analysis with varimax rotation.

Eligibility criteria:
inclusion criteria: * age 40-65 years * both genders * patients with diagnosed idiopathic parkinson's disease (ipd) by neurophysician * patient able to read urdu language. patients who can participate in community, patients with cognitive issue, patients with mmse more than 24 will be included exclusion criteria: * patients with any other neurological issue * patients who undergo brain surgery

Keywords: pdq-8, parkinson's disease, validate .
when closing midline incisions, do small stitches reduce the risk for incisional hernia, wound infection or dehiscence?

Conditions: Wound Infection; Incisional Hernia; Wound Dehiscence

Summary: the purpose of this study is to determine whether a technique using very small stitches when closing a midline incision can reduce the risk for wound complications such as incisional hernia, infection or dehiscence.

most abdominal surgical operations are made through a midline incision and 10% of the patients may get a wound infection. infection is a risk factor for incisional hernia, which 12 months after the operation can be seen in 10-20% of the patients. wound dehiscence is seen in approximately 1% of the patients. surgery because of incisional hernias are common and in sweden approximately 2000 patients per year needs an operation creating big costs. we know that a midline incision should be closed using a continuous technique, with a suture length to wound length ratio over 4. an earlier interventional study at the surgical department in sundsvall showed that using that technique reduced the risk for hernia with 50%. subsequent experimental studies indicates that the suture length to wound length ratio should be obtained by small stitches, placed close to each other only incorporating the aponeurosis, and not by large stitches incorporating the complete abdominal wall (mass closure). the hypothesis that midline incisions should be closed with small stitches only incorporating the aponeurosis has to be tested in a clinical trial.

Eligibility criteria:
inclusion criteria: * male or female patient with an acute or planned operation trough a midline incision at the surgical department in sundsvall, sweden exclusion criteria: * age under 18 * previous surgery through a midline incision * scars from previous surgery crossing the midline * preexisting hernia in the midline (umbilical, epigastric)

Keywords: wound infection incisional hernia wound dehiscence wound healing postoperative complications surgical techniques
treatment and survival continuation study of atamestane plus toremifene vs letrozole in advanced breast cancer

Conditions: Breast Neoplasms; Neoplasms, Hormone-Dependent

Summary: protocol 777-clp-32 is the treatment and survival continuation protocol of biomed 777-clp-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (ai) atamestane combined with the fda-approved anti-estrogen toremifene (fareston®), to the single agent fda-approved aromatase inhibitor letrozole (femara®) for the treatment of advanced breast cancer. the purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of atamestane, plus toremifene (fareston®), is more effective than letrozole (femara®) in delaying the growth of breast cancer.

aromatase is an enzyme expressed in tissues such as muscle and fat in postmenopausal women. these non-ovarian tissues become the dominant sources of estrogen in postmenopausal women. breast cancer cells are often very dependent on estrogens to continue to grow. atamestane blocks the formation of estrogens from androgenic precursors in the body via the aromatase enzyme. toremifene blocks circulating and intracellular estrogens from stimulating estrogen receptors in breast cancer cells. the goal of therapy with atamestane, an aromatase inhibitor, in combination with the estrogen receptor antagonist, toremifene, is to achieve complete suppression of estrogen stimulation of breast cancer cells. this study is designed to determine whether combined hormonal therapy will lengthen the time to disease progression and the survival time for subjects with advanced breast cancer.

Eligibility criteria:
inclusion criteria: * to be eligible to receive continued treatment, subjects must remain eligible to receive study drug at the time of their last biomed 777-clp-29 visit * to continue on survival follow-up, subjects must be in survival follow-up in study biomed 777-clp-29 * written informed consent obtained for subjects who continue study drug treatment exclusion criteria: * subjects who have withdrawn consent to participate in biomed 777-clp-29 for any reason * subjects for whom the investigator considers study participation is no longer in the best interest of those subjects.

Keywords: atamestane breast neoplasms combined hormonal therapy complete estrogen blockade ductal breast carcinoma estrogen blocker fareston® femara® first line therapy letrozole lobular breast carcinoma locally advanced breast cancer locally recurrent breast cancer maximal estrogen inhibition metastatic breast cancer neoplasms, hormone-dependent receptor-positive stage iiia breast cancer stage iiib breast cancer stage iv breast cancer toremifene
a study to investigate the safety and efficacy of k-321 eye drops after simultaneous cataract surgery and descemetorhexis in participants with fuchs endothelial corneal dystrophy (fecd)

Conditions: Fuchs Endothelial Corneal Dystrophy

Summary: a study to assess the safety and efficacy of k-321 in participants with fecd after simultaneous cataract surgery and descemetorhexis.


Eligibility criteria:
inclusion criteria: * is at least 18 years old at the screening visit (visit 1) * has a diagnosis of fecd at visit 1 * meet all other inclusion criteria outlined in the clinical study protocol. exclusion criteria: * is a female subject of childbearing potential and any of the following is true: 1. is pregnant or lactating/breastfeeding, or 2. is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy) * meet any other exclusion criteria outlined in the clinical study protocol.
dual specificity cd19 and cd22 car-t cell immunotherapy for cd19+cd22+ relapsed and refractory lymphoma

Conditions: Lymphoma

Summary: patients with relapsed or refractory lymphoma often develop resistance to chemotherapy. chimeric antigen receptor-modified t cell (cart) therapy showed promising effect in b-cell malignancies these years. cd19 and cd22 are proteins expressed on the surface of the lymphoma cells in patients with cd19+cd22+ lymphoma. the car enables the t-cells to recognize and kill the tumor cell through recognition of cd19 and cd22. this is a phase 2 trial to study the safety and efficacy of dual specificity cd19 and cd22 car-t cell immunotherapy for cd19+cd22+ relapsed and refractory lymphoma.


Eligibility criteria:
inclusion criteria: * histological detection confirmed cd19/cd22 postive lymphoma; * recieved more than 2 lines of chemotherapy; * not eligible for hematopoietic stem cell transplantation or relapsed after hematopoietic stem cell transplantation; * life expectation for more than 3 months; * ecog ≥ 2; * adequate organ function: ef≥50%; normal ecg; ccr≥40ml/min; alt and ast ≤ 3 × upper limitation of normal, t-bil ≤ 2.0mg/dl; pt and aptt \ 92%; * cbc results: hb ≥ 80g/l, anc \> 1 × 10e9/l, plt ≥ 50 × 10e9/l; * results of pregnant test should be negative, and agree to conception control during treatment and 1 year after car-t infusion; * with measurable disease; * written informed consent could be acquired; exclusion criteria: * immunosuppressive agents or steroids in recent 1 week before recruitment; * uncontrolled infection; * hiv positive ; * active hbv or hcv infection; * women in pregnancy and lactation; * refuse to conception control during treatment and 1 year after car-t infusion; * uncured malignancies other than non-hodgkin lymphoma; * have participated similar trial for treating relapse/refractory non-hodgkin lymphoma; * inheritated immune deficiancy; * severe heart disease.
the effectiveness rmgi and giomer, individually and combined anterior cervical caries

Conditions: Dental Caries; Cervical Caries

Summary: this study compares the effectiveness of three dental materials for restoring anterior cervical caries in high-risk patients: resin-modified glass ionomer (rmgi), giomer, and a combination technique where rmgi is veneered with giomer. the 18-month randomized clinical trial will assess 75 patients (25 per group), primarily evaluating secondary caries formation, with additional measurements of restoration integrity, appearance, and sensitivity at baseline, 6, 12, and 18 months.

this study aims to evaluate the clinical performance of three different restorative materials for treating anterior cervical caries in high-risk patients over 18 months. the research will compare resin-modified glass ionomer (rmgi), giomer, and a combination technique where rmgi is veneered with giomer (lamination technique). the randomized controlled clinical trial will involve 75 patients, with 25 patients in each treatment group. the primary outcome is secondary caries assessment, while secondary outcomes include fracture, retention, marginal integrity, marginal discoloration, anatomic form, surface texture, and postoperative sensitivity. assessments will occur at baseline, 6, 12, and 18 months using modified usphs criteria. the rationale behind this study is that high-risk caries patients need restorative materials that provide both protection against recurrent decay and aesthetic outcomes. the bioactive properties of these materials, including fluoride release and remineralization capabilities, make them potentially suitable for these patients. the research protocol includes detailed methods for patient selection, randomization, blinding, treatment procedures, follow-up assessments, and statistical analysis. the study is self-funded and will be conducted at the conservative dentistry department, faculty of dentistry, cairo university, with appropriate ethical approvals and informed consent.

Eligibility criteria:
inclusion criteria: * patient age range from 18-55 years * presence of anterior cervical caries on the labial surface (icdas 4 \& 5) * high caries risk * good general health exclusion criteria: * severe or chronic periodontal disease * bruxism * non-vital teeth * fractured or cracked teeth * defective restorations * pregnancy and/or lactation * allergy to the main components of the products to be used in the study

Keywords: risk factor patient outcome assessment
a study of v110 a pneumococcal vaccine in healthy adults (v110-013)

Conditions: Healthy; Pneumococcal Infections

Summary: the purpose of this trial is to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adults.


Eligibility criteria:
inclusion criteria: * males and females in good health, ages 20-40, with no history of pneumococcal vaccination exclusion criteria: * subjects with a recent febrile illness * known or suspected immune dysfunction, conditions associated with immunosuppression, and receipt of immunosuppressive chemotherapy, including long-term corticosteroid therapy
balancing of patients treated by vitamin k antagonists (vkas) in general medicine

Conditions: Thromboembolism

Summary: despite the rise in prescriptions for direct oral anticoagulants,vitamin k antagonists(vka) remains the most prescribed treatment for treating and preventing long-term thromboembolic events. they remain the most important drugs of iatrogenic accidents despite the means deployed by the health authorities. the balance of the patients under vka can be appreciated thanks to the time spent in the therapeutic zone or ttr which is correlated with the risk of occurrence of haemorrhagic or thrombotic events.

despite the rise in prescriptions for direct oral anticoagulants, vitamin k antagonists (vka) remains the most prescribed treatment for treating and preventing long-term thromboembolic events. they remain the most important drugs of iatrogenic accidents despite the means deployed by the health authorities. the balance of the patients under vka can be appreciated thanks to the time spent in the therapeutic zone or ttr which is correlated with the risk of occurrence of haemorrhagic or thrombotic events. the management of vka in france seems hardly comparable to that of the neighboring countries in front of: * a ttr estimated at 60%. * majority management of anticoagulant treatments by general practitioners. * the weak development of clinics anticoagulants. * the takeoff of direct oral anticoagulant prescriptions. * preponderance of fluindione prescriptions among the various oral anticoagulants. it therefore seems interesting to study a cohort of french patients under vka. through the calculation of the ttr, the investigators will be able to draw a picture of the balance of the anticoagulant treatment and try to identify factors that can influence it.

Eligibility criteria:
inclusion criteria: * patient treated with vka. * realization of inr in one of the labs of the territory of labosud oc biology between 1 september 2015 and 13 january 2016. exclusion criteria: * less than 3 inr during the data collection period (ttr calculation not possible). * time greater than 56 days between two inrs (calculation of the invalid ttr). * interrupted treatment (calculation of invalid ttr). * lack of information about the patient
hr021618 in moderate to severe pain after abdominal surgery

Conditions: Pain After Abdominal Surgery

Summary: the study is being conducted to evaluate the efficacy and safety of hr021618 in the treatment of moderate to severe pain after abdominal surgery.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. subjects requiring elective general anesthesia abdominal surgery 3. male or female 4. meet bmi standard 5. conform to the asa physical status classification exclusion criteria: 1. subjects with a history of abdominal surgery 2. subjects had hemorrhagic disorders 3. subjects had cardiac, serious hepatic or renal, cardiovascular or cerebrovascular, metabolic, psychiatric disorders, chronic pain, or malignant tumors 4. subjects with poor blood pressure control after medication 5. abnormal qtc 6. abnormal random blood glucose 7. abnormal values in the laboratory 8. allergic to meloxicam or any excipient of hr021618, aspirin, other non-steroidal anti-inflammatory drugs (nsaids) or to any peri- or postoperative medications used in this study 9. use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives 10. pregnant or nursing women 11. no birth control during the specified period of time 12. participated in clinical trials of other drugs (received experimental drugs) 13. the inestigators determined that other conditions were inappropriate for participation in this clinical trial
insulin glargine versus twice-daily nph

Conditions: Type 2 Diabetes Mellitus

Summary: to compare the efficacy and safety of once-nightly insulin glargine versus twice-daily nph insulin in ethnic minority type 2 diabetic patients inadequately treated with once-nightly nph insulin alone.

insulin glargine has a longer action than compared to nph insulin, but whether this results in improved control when compared to twice-daily nph insulin is not known when used in low-income ethnic minority patients. this study investigates whether insulin glargine may be more or less effective and safe than twice-daily nph insulin in this population.

Eligibility criteria:
inclusion criteria: * male or female, age 18-75 * type 2 diabetes diagnosed for at least 1 year * inadequate glycemic control (hemoglobin a1c ≥ 7.5%) on stable and maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione, plus a single bedtime injection of nph insulin * except for the subject's current bedtime nph insulin, no other past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration) * average fasting plasma glucose level \<130 mg/dl without fasting hypoglycemia * hemoglobin a1c between 7.5% and 12% * body mass index (bmi) between 20 and 40 kg/m2 exclusion criteria: * history of confirmed (or clinical suspicion of ) type 1 diabetes * female subjects of childbearing potential who are sexually active and not using a reliable form of contraception. * current pregnancy or lactation. * subjects for whom intensive insulin therapy is contraindicated * subjects with advanced proliferative diabetic retinopathy * subjects who are unable to stay on a consistent daily meal schedule * history of any clinically significant renal, hepatic, cardiovascular, neurological, endocrinological or other major systemic disease that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the data difficult. * subjects who will likely require or initiate therapy with drugs which may interfere with glucose metabolism during the course of the study * subjects who are in another investigational study or have received another investigational medication within 30 days of study entry * subjects who are unable or unwilling to comply with all components of the study protocol, including contacting the investigators at specified times and attending all scheduled follow-up visits.

Keywords: glargine type 2 diabetes basal insulin
efficacy of perioperative duloxetine as a part of multimodal analgesia in laparoscopic colorectal cancer surgery

Conditions: Colorectal Cancer

Summary: our aim will be to evaluate the efficacy of perioperative duloxetine in decreasing acute postoperative pain after laparoscopic colorectal cancer surgery and its role in reducing postoperative morphine requirements

abdominal surgery is usually associated with severe; wide spread post-operative pain. the greater propensity for pain and opioid-related side effects are likely contributing factors for poor postsurgical recovery, and it often results in significant pain and slow recovery. although opioids are considered the analgesics of choice to treat moderate to severe pain, their use carries the risk of side effects and hyperalgesia. multimodal analgesia is advocated for perioperative pain management to reduce opioid use and its associated adverse effects. multimodal analgesia can be achieved by combining different analgesics and different methods of administration, to provide better analgesia synergistically compared with conventional analgesia.therefore, lower doses for each drug can be provided with fewer overall side-effects obtained from individual compounds.serotonin and norepinephrine are involved in the modulation of endogenous analgesic mechanisms via descending inhibitory pain pathways in the brain and spinal cord. an increase in serotonin and norepinephrine may increase inhibition of nociceptive input and improve pain relief. duloxetine is a serotonin-norepinephrine reuptake inhibitor commonly prescribed for the treatment of major depression and anxiety. duloxetine also has been used in the treatment of chronic pain conditions. there several reasons why duloxetine might improve postsurgical quality of recovery. first, systemic duloxetine seems to have perioperative analgesic effects. in addition, as a serotonin-norepinephrine reuptake inhibitor, it is possible that the drug may prevent transient emotional problems that are common during the perioperative period. lastly, the combination of less pain and better emotional status can result in better physical independence scores after surgery. the main objective of the current study is to examine the effect of perioperative duloxetine on postoperative pain after laparoscopic colorectal surgery.

Eligibility criteria:
inclusion criteria: * asa i-iii * aged 18-65 years and scheduled for laparoscopic colorectal surgery for cancer colon exclusion criteria: * unable to express their pain or patient refusal. * allergy to the study drug * an abnormal liver or renal function tests * a chronic opioid abuser(\> 3 mo), being on chronic gabapentin or pregabalin(\> 3 mo) * antidepressant drugs, patients with psychiatric disorders * pregnant females