Kornimate/medical-research-clean huggingface dataset:
impact of apalutamide in metastatic hormone sensitive prostate cancer patients

Conditions: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Summary: the adapt study is an observational study of apalutamide, which can be given to patients with hormone sensitive metastatic prostate cancer as standard of care. the clinical decision for patients to have apalutamide as part of their management plan will be decided by the clinician. the patient will only be approached about the adapt study if they decide they want to have apalutamide as part of their management. the aims of the adapt study include documenting the biochemical effectiveness, as determined by the prostate-specific antigen (psa) and impact of apaluatmide on health related quality of life. the blood test for psa is regularly monitored as standard of care. additionally, the impact of apalutamide on fatigue, cognitive function, patients reported outcomes, health related quality of life will be evaluated using patient questionnaires answered at defined timepoints. the questionnaires will be sent either electronically or via post at week 12, 24, 36, 48, 72 and 104 weeks after commencement of apalutamide. currently, the majority of data regarding tolerability and biochemical response to apalutamide has been from large phase iii trials, where there are strict eligibility criteria. real-world data as from the adapt study can provide valuable complementary data to randomised controlled trials, which can be used to address the 'generalizability' limitations of randomised control trials and can provide evidence on the external validity of their findings. this information can advance knowledge of patterns of care, treatment effectiveness and side-effects and inform clinical practice to improve outcomes.


Eligibility criteria:
inclusion criteria: * male 18 years of age or older * histologically confirmed diagnosis of adenocarcinoma of the prostate with both: * metastatic hormone sensitive prostate cancer * treatment decision for apalutamide by clinician exclusion criteria: * non-metastatic prostate cancer * prior chemotherapy / abiraterone / apalutamide / darolutamide / enzalutamide for prostate cancer * unable to complete patient reported outcome questionnaires
patient and operator centered outcomes concerning connective tissue graft should be considered to choose adequately which protocol to use

Conditions: Gingival Recession

Summary: the goal of this clinical trial is to evaluate patient and operator centered outcomes after connective tissue graft harvesting with a fully digital workflow and compare this approach with a conventional one. the main questions it aims to answer are: * does it differ in patient- and operator-centered outcomes between the conventional and digital workflow? * what is the difference in time efficiency between conventional and digital protocols? researchers will compare digital guided versus conventional technique to choose adequately which protocol to use. participants will: * receive periodontal surgery to treat gingival recession site * visit the clinic after 2 weeks for suture removal \& filling the survey * the time will be recorded during the surgery

50 sites will be included. all investigations will be carried out in accordance with the 1975 helsinki declaration, as revised in 2013 for ethical approval. all participants will provide written informed consent after receiving explanations on study objectives and procedures. primary outcomes will be patient- and operator-centered outcomes. patient- and operator-centered outcomes will be assessed through visual analogue scale (vas), questionnaires containing self-developed questions about each phase of the treatment which will be administered at the end of each phase. the questionnaires will be administered as part of a survey which aimed to obtain information about the dental practices. secondary outcomes will be time-efficiency by assessing workflow duration and number of appointments needed to complete the procedure. the treatment phases will include digital analysis of landmarks and design, of the guide and surgical phase (free gingival graft harvesting ). time will be recorded in minutes. all the parameters will be recorded in the clinical chart by the same two operators not involved in the treatment after each phase was completed. the planned duration for the research will be 6 months.

Eligibility criteria:
inclusion criteria: * area need soft tissue augmentation around teeth either coronal or apical to recession * must have a general health showing no contraindications for oral surgery must be at least 20 years old. * patients also had to have good oral hygiene before the treatment exclusion criteria: * signs or symptoms of bruxism or clenching * if they were suffering from uncontrolled systemic conditions
safety and efficacy study of human t lymphoid progenitor (htlp) injection after partially hla compatible allogeneic hematopoietic stem cell transplantation in scid patients

Conditions: Pediatric Patients; Any Type of Severe Combined Immunodeficiency (SCID); Partial HLA Incompatible Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Summary: the purpose of this study is to evaluate the safety and the efficacy of human t lymphoid progenitor (htlp) injection to accelerate immune reconstitution after partially hla compatible allogeneic hematopoietic stem cell transplantation in scid patients.

not provided

Eligibility criteria:
inclusion criteria: * pediatric patients affected by any type of scid confirmed by clinical, immunological and/or molecular diagnosis and eligible for an allogeneic hsct * absence of a matched sibling donor or a matched unrelated donor (mud) 10/10 * clinical conditions incompatible with the search of a mud * written, informed consent of parents/ legal representative (child) * age ≤ 2 years at the time of screening * no prior therapy with allogeneic stem cell transplantation * no treatment with another investigational drug within one month before inclusion * patient affiliated to social security exclusion criteria: * presence of an hla genoidentical donor * absence of written parental consent * treatment with another investigational drug within one month before inclusion * positive for hiv infection by genome pcr * contra-indication to allogeneic transplantation or conditioning therapy (except scid patients with dna repair deficiency)

Keywords: scid hematopoietic stem cell transplantation human t lymphoid progenitor
oral vs rectal admin of naproxen for post-vag perineal pain control

Conditions: Post-Vaginal Delivery Perineal Pain

Summary: the primary objective of this study is to determine whether the route of administration of naproxen (either by mouth or rectally) influences post-vaginal delivery perineal pain control.

postpartum perineal pain is common after vaginal delivery. naproxen suppositories have been shown to be effective at reducing postpartum perineal pain. to date, no studies have investigated the efficacy of oral naproxen for perineal pain control. currently, rectal naproxen is used postpartum because of an assumption that there is a "local effect" compared to oral administration. however, this effect has never been documented in the literature. principles of pharmacology dictate that the least invasive route of drug administration should be used when two or more routes are equally effective. if oral and rectal naproxen are equally efficacious at controlling post-vaginal delivery perineal pain, then current practice would be challenged. the primary objective of this study is to determine whether the route of administration of naproxen influences post-vaginal delivery perineal pain control. pain scores will be measured using a visual analog scale. the secondary outcome measures are three-fold: patient preference of route of administration, medication adverse effects, and additional requests for analgesia. the working hypothesis is that there is no difference in pain control between oral and rectal administration and that patients will prefer the oral route.

Eligibility criteria:
inclusion criteria: * potential volunteers who meet all of the following criteria are eligible for this study: 1. active labor, whether spontaneous or induced 2. age between 18 and 40 years old 3. nulliparous 4. bmi \< 40 5. single live intrauterine fetus in cephalic presentation 6. term gestation (370 weeks to 416 weeks inclusive) as defined by ultrasound or last menstrual period dating 7. intrapartum epidural labour analgesia 8. written informed consent exclusion criteria: * potential volunteers meeting one of more of the following criteria may not be enrolled: 1. medical conditions including: 1. naproxen, aspirin or other non-steroidal anti-inflammatory drug hypersensitivity 2. asthma 3. peptic ulcer disease or other inflammatory gastrointestinal disease 4. renal, hepatic or cardiac disease 5. coagulopathy 6. rectal or anal pathology including recent (within 1 month) rectal bleeding 7. prescribed medications including lithium, furosemide, antihypertensives, anticoagulants, aminoglycosides, hydantoins, or sulfonamides 2. obstetrical conditions including: 1. multiple pregnancy 2. extensive perineal trauma (third or fourth degree laceration) 3. forceps delivery 4. cesarean section delivery 5. paracervical or pudendal nerve blocks 6. vulval or vaginal hematomas 3. nulliparous women not requiring intrapartum epidural labour analgesia
optimizing the management of staphylococcus aureus bacteremia (optimus-sab)

Conditions: Staph Aureus Bacteremia

Summary: staphylococcus aureus bacteremia (sab) is associated with high morbidity and mortality rates with an incidence disproportionately higher in vulnerable populations. management according to evidence-based care parameters, in particular infectious diseases (id) consultation, is associated with improved mortality. sab management is suboptimal in alberta compared to other jurisdictions. an alberta-based pilot study confirmed that timely recommendations to optimize sab care, including id consultation, was associated with improved adherence to all evidence-based quality-of-care indicators. leveraging this pilot work, the investigators aim to implement optimus-sab, an enhanced model of the pilot, to optimize and standardize sab management across alberta. the implementation study will be a zone-based acute care site stepped wedge design. optimus-sab will consist of a centralized sab care team whom will receive automated notification of all blood cultures positive for s. aureus allowing them to review the patient's medical chart and make preliminary management recommendations according to an evidence-based care bundle. the investigators will evaluate adherence to evidence-based sab quality-of-care indicators before and after optimus-sab implementation and expect this to improve with a resultant reduction in duration of bacteremia, length of stay, readmission rates, and mortality. in turn, this will translate into cost savings for the health care system.


Eligibility criteria:
inclusion criteria: * age greater than 18 years at the time of hospital admission * confirmed s. aureus bacteremia by blood culture performed at a laboratory in alberta, canada * admitted to a designated acute care site in alberta, canada exclusion criteria: * the treating team believes death is imminent or inevitable . * gcd are c-level within 48 hours of admission. * the patient is transferred in from an out-of-province acute care center with a pre-existing sab diagnosis.

Keywords: care pathway infectious disease consultation
sms reminder to assess adherence

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: 6 months open label non-interventional observational study acc to § 4, section 23 and § 67, section 6 german medicines act with two parallel groups 1. the sms group receiving a daily sms - a reminder to inhale spiriva® 18 microgram 2. the control group not receiving a daily sms reminder

purpose: study design: observational

Eligibility criteria:
inclusion criteria: * chronic obstructive pulmonary disease (copd) patients requiring long-acting bronchodilators according to approved summary of product characteristics (spc) and guidelines * user of mobile phone exclusion criteria: - patients presenting with the general and specific contraindications listed in the patient information leaflet and the spc
a prospective, randomized trial to compare saroglitazar with pioglitazone in nonalcoholic fatty liver disease

Conditions: Fatty Liver

Summary: non alcoholic fatty liver disease (nafld) is considered as the component of metabolic syndrome. the prevalence of the same has been increasing rapidly in india, along with an increase in the prevalence of diabetes and obesity. insulin resistance is the key underlying pathogenetic mechanism of nafld. nafld accounts for significant morbidity and mortality and the therapeutic options are limited. insulin sensitizing drugs are used in the management of nafld.

the therapeutic options for the management of nonalcoholic fatty liver disease (nafld) include lifestyle modifications, insulin sensitizers, vitamin e, antioxidants and cytoprotective agents. glitazones are insulin sensitizing drugs and act by stimulating the ppar gamma receptors. the drugs like pioglitazone and rosiglitazone have shown conflicting results in the nafld trials. dual ppar stimulators (ppar gamma and ppar alfa) are known as the "glitazars" and are useful in simultaneously controlling the hyperglycemia, dyslipidemia and insulin resistance. saroglitazar is the first drug approved in the investigators country for the management of diabetic dyslipidemia. the investigators plan to study the efficacy of this drug in comparison to pioglitazone in patients of nafld over a period of 24 weeks.

Eligibility criteria:
inclusion criteria: * drug naive patients with nafld diagnosed on ultrasonography, bmi \> 23 kg/m2 and alt \> 1.5 times the upper limit of normal exclusion criteria: * use of any drugs other than lifestyle modification for nafld, hba1c \> 8% fbs\>200, bilirubin \> 1.5 mg/dl * any illness likely to cause transaminitis and positive viral markers

Keywords: nafld, diabetes, glitazone
clinical proposal for the comparison of intraperitoneal anesthetic to injected local anesthetic

Conditions: Pain, Postoperative; Morbid Obesity

Summary: the purpose of this study is to determine if pre-incisional lidocaine injection, instilled liquid bupivacaine, intra-abdominal aerosolized bupivacaine, or post-operative bupivacaine injection is superior in post-operative pain control in laparoscopic bariatric surgical patients.

the research objective is to compare our standard post-operative port site injection of 0.5% bupivacaine against pre-incisional port site injection of 1% lidocaine against the instillation of streamed bupivacaine 0.5% against the instillation of aerosolized 0.5% bupivacaine as it relates to post-operative analgesia usage and pain scale scores. the null hypothesis will be that there is no difference between the four arms of the study in regards to pain score and analgesia usage.

Eligibility criteria:
inclusion criteria: 1. male and female patients between 18 and 65 years of age. 2. patients undergoing elective bariatric surgery. exclusion criteria: 1. patients allergic to bupivacaine or any other local anesthetics (amides \& esters). 2. patients who have used opiates or opiods within 15 days prior to surgery. 3. patients converted to open gastric bypass.

Keywords: bupivacaine marcaine lidocaine normal saline narcotics analog pain scale postoperative pain preemptive aerosolization streamed
epiretinal proliferation in eyes with full thickness macular hole

Conditions: Macular Disease

Summary: we evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (ftmh) whether the epiretinal proliferation (ep) was detected and detection of ep was correlated to the visual improvement.

we evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (ftmh) whether the epiretinal proliferation (ep) was detected and detection of ep was correlated to the visual improvement.

Eligibility criteria:
inclusion criteria: * eyes with macular hole exclusion criteria: * eyes with retinal detachment, retinal vascular disease, glaucoma, proliferative diabetic retinopathy

Keywords: idiopathic macular hole
effect of a fermented soy product on cognition, immune status and vaccine

Conditions: Cognitive Change; Inflammation; Immune Response

Summary: the research study will test the effects of q can plus powder on the immune, inflammatory and cognitive functions.

the purpose of this study is to determine the effects of a fermented soy product (q-can), compared to placebo, on the immune, inflammatory and cognitive functions of elderly individuals. the study intervention will be four months in length. sixty two participants , 65 years or older will be randomized to participate in the study.

Eligibility criteria:
inclusion criteria: * elderly men and women, 65 years of age or older * ambulatory * able to accommodate the intervention food products * live in or around loma linda to be able to commute to the nutrition research center exclusion criteria: * intolerance to soy products * immune system insufficiency or disease * insulin dependent diabetes mellitus * alzheimer's disease * dialysis * current cancer radiation or chemotherapy * prednisone or prednisolone therapy greater than 10mg/d

Keywords: fermented soy cognition inflammation immunity
comparison of the classical healing concept with the complete remission concept after treatment with pantoprazole in adult patients with erosive gerd (gastroesophageal reflux disease) (by1023/m3-342)

Conditions: Gastroesophageal Reflux Disease

Summary: the aim of this study is to evaluate the complete remission rates, endoscopic relapses, study discontinuation rates, and quality of life parameters in patients with erosive gerd. the study duration consists of a treatment period up to 16 weeks according to the classical healing concept or the complete remission concept. during this period, the patients will receive pantoprazole (tablet) at one dose level once daily. the following observational phase lasts up to 6 months. the study will provide further data on efficacy, safety, and tolerability of pantoprazole.


Eligibility criteria:
main inclusion criteria: * written informed consent * endoscopically confirmed gerd (los angeles classification a-d) * patients whose compliance is expected to be high with respect to the completion of the questionnaires main exclusion criteria: * other gastrointestinal diseases * severe concomitant diseases * proton pump inhibitors (ppis) during last 14 days before start * h2 receptor antagonists, prokinetics during last 7 days before study start * helicobacter pylori (h. pylori) eradication during last 28 days before study start

Keywords: gerd pantoprazole complete remission
neuromuscular electrical stimulation (nmes) and muscle protein accretion (es-pro)

Conditions: Sarcopenia

Summary: in the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged nmes will be studied.


Eligibility criteria:
inclusion criteria: * male * age 65 - 85 years * 18.5 \< bmi \< 30 kg∙m2 exclusion criteria: * type ii diabetes * all co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders, paralysis, hip/knee surgery). * use of anticoagulants, blood diseases, allergy for lidocaine * use of nsaids and acetylsalicylic acid * patients suffering from pku (phenylketonuria) * presence of implantable cardioverter defibrillator and/or pacemaker * performed regular resistance type exercise in the past 6 months

Keywords: neuromuscular electrical stimulation ageing protein ingestion
a study to assess the safety and pharmacokinetics of gdc-8264 in combination with standard of care in participants with acute graft-versus-host disease (agvhd)

Conditions: Acute Graft-versus-host Disease

Summary: the primary purpose of the study is to assess the safety and pharmacokinetics (pk) of gdc-8264 in participants with acute graft-versus-host disease (agvhd).


Eligibility criteria:
inclusion criteria: * diagnosis of post-allogeneic hematopoietic stem cell transplantation (hsct) agvhd at screening * evidence of engraftment post-transplant * diagnosis of high-risk agvhd, per refined minnesota high-risk agvhd criteria during screening * initiation of treatment with systemic corticosteroids for agvhd at a dose of prednisone ≥2 milligrams per kilograms per day (mg/kg/day) by orally (po) or methylprednisolone ≥2 mg/kg/day intravenously (or equivalent) in divided doses at diagnosis and up to 3 days prior to or on the same day as initiation of gdc-8264 (day 1), with no taper planned prior to day 3 exclusion criteria: * evidence of relapsed, progressing, or persistent malignancy, or treatment for relapse after transplant, or requirement for rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse * prior receipt of more than one allogeneic hsct * prior receipt of solid organ transplantation that are target organs for agvhd (e.g., liver transplant) * prior systemic treatment for agvhd, except for the standard of care corticosteroid treatment initiated as part of this trial * diagnosis of chronic gvhd or overlap syndrome * uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment, or persistently positive blood cultures despite treatment, or any other evidence of severe sepsis) * severe organ dysfunction (e.g., acute liver failure, renal failure requiring dialysis, ventilator support, or vasopressor therapy) * initiation or planned use of a marketed small molecule (excluding corticosteroids) or biologic therapy as treatment for agvhd from the start of screening through the treatment period