Kornimate/medical-research-clean huggingface dataset:
peritubal infiltration of bupivacaine in pcnl

Conditions: Pain

Summary: patients may feel significant pain at the surgery site after they wake up from the surgery. usually pain is managed in the ward by giving strong pain medication that may slow down your mobilization and recovery process. some recent work in other countries has shown that if investigator give patients an injection at the end of the operation, patients have less need for pain medication when they wake up. if investigator find that is also true in our population, then we can use this method as routine step after this operation to improve pain management and early mobilization of our patients


Eligibility criteria:
inclusion criteria: * age 18-60 years of age * single pcnl track exclusion criteria: * spinal disc prolapse * any previous renal surgery * complication secondary to pcnl * hydrothorax that requires intervention * pneumothorax * massive hemorrhage that requires more than 1 u transfusion * conversion to open procedure.

Keywords: percutaneous nephrolithotomy postoperative analgesia peritubal block pain visual analog pain scale
immunogenicity and reactogenicity of gsk bio dtpa-hbv-ipv and hib vaccines when coadministered to healthy infants

Conditions: Diphtheria; Poliomyelitis; Hepatitis B; Tetanus; Acellular Pertussis

Summary: the purpose of this study is to evaluate the immune response and reactogenicity of gsk biologicals' dtpa-hbv-ipv combined pentavalent vaccine and hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.


Eligibility criteria:
inclusion criteria: * a male or female infant between 6 and 8 weeks of age at the time of the first vaccination. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * written informed consent obtained from the parents or guardians of the subject. * born after a normal gestation period (between 36 and 42 weeks). exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine. * administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after. * previous vaccination against diphtheria, tetanus, pertussis, polio or haemophilus influenzae type b. * history of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis b, polio and/or haemophilus influenzae type b. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. * major congenital defects * serious chronic illness * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * acute disease at the time of enrollment.
effect of counseling on psychological stress amongst women felt to be at high risk for breast cancer development

Conditions: Breast Cancer

Summary: to evaluate 1) the extent of patient overestimation of breast cancer development risk in subjects referred to a physician-based high-risk breast clinic; 2) the ability of physician counseling to improve patient risk perception and reduce psychological distress; 3) to identify factors relevant in clinical practice associated with increased distress and risk perception.

patients referred to the baystate comprehensive breast center high-risk clinic wil, after giving consent, complete an intake evaluation of breast cancer risk, the patient's perceptions of breast cancer development risk, and the brief symptom inventory-18. physician history, physical and counseling then takes place, with sharing of risk estimates based on modified gail model and myriad tables regarding breast cancer risk and probability of brca1/2 mutation. after counseling, patients complete another assessment of risk perception and bsi-18, and again 2 months and 1 year post counseling. recommendations for hormonal management and referral for formal genetic evaluation and testing will be tracked.

Eligibility criteria:
inclusion criteria: * attendance at high-risk clinic * ability to complete bsi-18 and risk perception questionnaire exclusion criteria: * diagnosis of invasive breast cancer * diagnosis of ductal carcinoma in situ.

Keywords: breast cancer risk counseling prevention anxiety brca1 mutation brca2 mutation tamoxifen
reveal in-office implants

Conditions: Arrhythmias, Cardiac

Summary: the purpose of this study is to gather evidence about the safety and feasibility of performing the implant procedure for the reveal insertable cardiac monitor (icm) in an office or clinic setting rather than the traditional hospital operating room, cardiac catheterization or electrophysiology (ep) laboratory setting.


Eligibility criteria:
inclusion criteria: * patient is indicated for continuous arrhythmia monitoring with an insertable cardiac monitor (icm) * patient is willing to undergo implant in clinic setting with only local anesthetic and/or oral anti-anxiety medications for sedation * patient is 18 years of age or older * patient is willing and able to provide consent and authorize the use and disclosure of health information * patient is willing and able to comply with the protocol including the required follow-up exclusion criteria: * patient has reduced immune function or is otherwise at high risk for infection * patient has had a recent (within 30 days) or otherwise unresolved infection * patient is implanted or indicated for implant with a pacemaker, implantable cardioverter-defibrillator (icd), cardiac resynchronization therapy (crt), or hemodynamic monitoring system * patient is participating in another clinical study that may have an impact on the study endpoints * patient's life expectancy is less than 1 year * patient is pregnant * patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure
the effect of inadvertent perioperative hypothermia on surgical site infection in laparoscopic choleistectomy.

Conditions: Surgical Site Infection; Perioperative Complication

Summary: there are conflicting results in the literature explaining the relationship between surgical site infection (ssi) and inadvertent perioperative hypothermia (iph). although it is thought that the risk of iph is lower in laparoscopic surgery types due to the short duration of the surgical procedure, these conflicting results raise doubts as to whether there is a relationship between iph and ssi in laparoscopic surgery patients. a randomized controlled study will be planned in the future to examine the effect of iph on ssi in patients who will undergo laparoscopic cholecystectomies. the study will be conducted in the general surgery clinic and operating room of a university hospital. it will be completed with a total of 100 patients, 50 of whom will be in the case group, and 50 will be in the control group.

objective: this study was conducted to examine the effect of inadvertent perioperative hypothermia (iph) on surgical site infection (ssi) in patients undergoing laparoscopic cholecystectomy. summary of background data: there are conflicting results in the literature explaining the relationship between ssi and iph. although the risk of iph is thought to be lower in laparoscopic surgery types due to the short duration of the surgical procedure, these conflicting results raise doubts about the existence of a relationship between iph and ssi in laparoscopic surgery patients. methods: this study will be a quasi-experimental and randomized controlled study in the future. the study will be conducted with patients who will have undergone laparoscopic cholecystectomy in the general surgery clinic and operating room of a university hospital. the study will be completed with a total of 100 patients, 50 in the case group, and 50 in the control group. during the study, preoperative, intraoperative, and postoperative body temperatures, as well as biomarkers of the patients, will be monitored using a form developed by the researchers. additionally, patients will be followed up postoperatively to evaluate the potential impact of iph on ssi.

Eligibility criteria:
inclusion criteria: * being aged 18-65 years old, * having an asa score of i-ii, * remaining in the hospital for at least 24 hours in the postoperative period, * undergoing laparoscopic cholecystectomy exclusion criteria: * being under 18 or over 65, * having an asa score above iii, * requiring emergency surgery * having a neurological, psychiatric, or neuromuscular disease, * being addicted to alcohol and/or other toxic substances, * being pregnant or having a suspected pregnancy, * undergoing open surgery, or being converted to an open procedure during surgery, * having symptoms of fever * having an active infection excluding cholecystitis.

Keywords: inadvertent perioperative hypothermia surgical site infection laparoscopic cholecystectomies perioperative nursing
effect of adipokines in hemodialysis patients

Conditions: End Stage Renal Disease

Summary: this is a double blinded randomized clinical trial of pioglitazone vs. placebo in overweight or obese, diabetic and non-diabetic hemodialysis patients. this study will examine whether pioglitazone modulates adipokine production by adipose tissue in hemodialysis patients and whether these changes result in reduction of inflammation, insulin resistance and oxidative stress and increase in muscle mass. in addition, this study will also examine the associations of adiposity with adipokines and the metabolic milieu in hemodialysis patients to better understand the biology of adipocytes in uremic milieu.

randomization: 100 overweight or obese patients will be randomly allocated to oral pioglitazone 15 mg/d or placebo for two weeks by blocks of five using a random number generator and monitored for adverse events including hypoglycemia. if they tolerate the 15 mg pioglitazone or matching placebo for two weeks, participants will be assigned to 30 mg of pioglitazone or matching placebo for 24 more weeks. those who received 15 mg of pioglitazone will receive 30 mg of pioglitazone for the next 24 weeks. those who received placebo for initial 2 weeks will receive another placebo that matches the 30 mg pioglitazone pill for 24 weeks. baseline: participants will have fasting blood drawn for adipokines: tumor necrosis factor-alpha (tnf-alpha), interleukin-6 (il-6), high sensitivity c-reactive protein (hscrp), high molecular weight adiponectin (hmw-a), and leptin. all patients will undergo mri scans on the mid-week non-dialysis day. twenty each of overweight/obese patients randomized to pioglitazone or placebo will also undergo subcutaneous fat biopsy on the mid-week non-dialysis day. study period: participants will return to the dialysis unit at weeks 2, 4, 6, 10, 14, 18, 22, and 26. during these visits, clinical assessments will be conducted including review of blood sugars, jaundice, weight gain, and visual symptoms. study treatment compliance will be assessed and details of adverse events experienced, particularly hospitalizations and emergency department visits will be collected. fasting blood draws for primary and secondary outcomes will be collected on visit weeks 10 and 26.

Eligibility criteria:
inclusion criteria: * overweight (body mass index ≥ 25 kilograms per meter squared (kg/m2)) * adult (18 years or older) * chronic hemodialysis patient * diabetic (type 2) or insulin resistant exclusion criteria: * \<18 years old * no insulin resistance * active liver disease * class iii or iv new york heart association heart failure * macular edema or hard exudates near macula on fundoscopy * current active malignancy (excluding squamous and basal cell skin cancers) * active aids * chronic lung disease requiring supplemental oxygen therapy * enrolled in interventional trials using drugs or devices * bone break of long bones, vertebrae, or hips in the past three years

Keywords: end stage renal disease hemodialysis pioglitazone adipokines
incidence of recurrent caries next to tooth restorations

Conditions: Recurrent Caries

Summary: the aim of this study is to determine the incidence of recurrent caries around the different types of restorative materials (composites, amalgam, ceramics, crowns, etc.) and to better characterize recurrent caries lesions in terms of location and size of the lesions and type, material and age of the restoration.

the data will be collected from patients who are visiting the dental clinic for a check-up. these data will be retrieved in the patient records. in particular the clinical (mouth) exam and the radiographic images ('rx-bite-wings'), which are routinely taken during these check-up consultations, will be used for the evaluation of recurrent caries. information regarding medical background, oral hygiene, sugar eating habits and possible parafunctional activities will also be gathered from the patient files. in addition, caries risk of the patients will be assessed using commercial kits for analysis of their saliva (saliva-check buffer, gc, tokyo, japan) and dental plaque (tri plaque id gel, gc, tokyo, japan), which are a part of the routine care of the patients at the clinic.

Eligibility criteria:
inclusion criteria: * patients visiting the university dental clinic (department of oral health care) for a dental check-up exclusion criteria: * patients for who not all necessary data could be registered (incomplete mouth exam records, missing rx-bite wings, etc)

Keywords: recurrent caries secondary caries dental composite dental amalgam
comparison of three different pain and anxiety reducing methods in adult patients undergoing bone marrow puncture

Conditions: Patients Undergoing Puncture of the Bone Marrow

Summary: the purpose of this study is to investigate and compare the effects of three different methods for reducing pain and anxiety in adult patients undergoing puncture of the bone marrow. the investigated methods are: cognitive behavioural technique, administration of a sedative drug(midazolam) and administration of an analgetic drug (piritramid)prior to the procedure. additionally, there are two comparison groups in which the patients receive either placebo treatment or no treatment at all.

the puncture of the bone marrow is a routine medical procedure which is often performed in the field of hematology/oncology. when carefully and appropriately performed, the puncture of the bone marrow has a very low rate of complications and is generally safe for the patient. however, it is an invasive and painful procedure associated with anxiety, especially in patients undergoing repeated punctures. therefore an appropriate preparation of the patient for the puncture is essential in order to minimize the stress experienced during the procedure. in this regard, there are numbers of both pharmacological and non-pharmacological interventions in pedriatric patients aimed at reducing the punction related pain and anxiety in this patients. nevertheless an evidence based approach for the pretreatment of the patients is yet to be established. the aim of this study is to investigate three different methods for reducing the pain and anxiety associated with the puncture of the bone marrow in adult patients. two of the of the investigated methods involve pretreatment of the patients with pharmacological agents (sedative drug or analgetic drug), whereas the third method involves cognitive behavioural pretreatment in form of an audio material. the patients in the control group receive placebo injections.

Eligibility criteria:
inclusion criteria: * patients scheduled for both first or repeated punction of the bone marrow * age between 18 and 85 years * written informed consent exclusion criteria: * contraindication for a punction of the bone marrow * administration of benzodiazepines or analgetic drugs prior to the bone marrow punction * known hypersensitivity to benzodiazepines or piritramid * known contraindication to benzodiazepines (myasthenia gravis in particular) or piritramid (pheochromocytoma or conditions affecting the consciousness) * poor general condition (ecog performance status 3,4; karnofsky index \< 50%) * addictive disorders * administration of antidepressive drugs * administration of drugs that potentially depress the respiratory function * severe cardio-circulatory or respiratory insufficiency, sleep apnea syndrome * known bradycardia * history of syncope(s) of unclear etiology * pregnancy or lactation

Keywords: bone marrow puncture pain
investigation of the effects of stabilization exercises and pelvic floor muscle training on pain and urinary parameters in individuals with chronic low back pain with urinary incontinence

Conditions: Low Back Pain; Urinary Incontinence

Summary: the research will be done with people with urinary incontinence and low back pain. 3 groups of volunteer participants will be formed. the groups were planned as study group, classical application group and control group. classical pelvic floor muscle training will be applied to the classical application group. pelvic floor muscle training combined with stabilization exercises will be applied to the study group. in this study, the effect of pelvic floor muscle training combined with stabilization exercises on pain and urinary parameters compared to classical pelvic floor muscle training will be investigated in people with urinary incontinence and low back pain at the same time.

the rehabilitation period in the study was determined as 2 months. participants will receive treatment with a supervisor 1 or 2 days a week. on other days, they will continue as a home program.

Eligibility criteria:
inclusion criteria: * those with low back pain for at least 3 months (at least once a week with low back pain) * those with urinary incontinence * 4 and above according to numerical pains rating scale * at least 20% according to the oswestry disability index * body mass index 30 and below exclusion criteria: * those who have undergone lumbar or pelvic surgery in the last 6 months * those who received pelvic floor muscle training in the last 3 months * systemic, inflammatory, rheumatic, malignant, osseous pathologies etc. that may cause low back pain. those with diseases * those who are pregnant * stage 3-4 of pelvic organ prolapse * those who are pregnant

Keywords: low back pain urinary incontinence pelvic floor muscle training stabilization exercises
gynecological follow-up of patients with dystrophic epidermolysis bullosa (ebd)

Conditions: Dystrophic Epidermolysis Bullosa

Summary: dystrophic epidermolysis bullosa is a rare genetic pathology resulting in fragility of the skin and mucous membranes, causing bubbles and wounds following trauma. scarring is pathological with a tendency to retraction. the gynecological and in particular the vulvovaginal mucous membranes can be affected but no description of any series is available in the literature. likewise, some of these patients have a sexual and obstetrical life, despite sometimes-severe damage, but again no specific data is available. the investitigator thus wish to carry out a non-interventional multicenter prospective descriptive study. better knowledge of gynecological semiology in patients with ebd will allow better adaptation of gynecological follow-up, screening for stds and gynecological cancers, as well as possible specific complications. this study would eventually allow the draw up of recommendations for our gynecologist / obstetrician colleagues.


Eligibility criteria:
inclusion criteria: * 18 years old or older * with hereditary dystrophic epidermolysis bullosa (dominant or recessive) * followed at the nice university hospital or at the st louis hospital of the aphp. * not opposed to participation after being informed of the study exclusion criteria: * men * age \< 18years old
predicting effective therapy in pancreatic cancer

Conditions: Pancreatic Cancer; Pancreatic Adenocarcinoma

Summary: the purpose of this phase ii study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at mskcc, ajcc stage iv disease at time of enrollment. * patient planning to receive treatment with folfirinox or gem/nab-p chemotherapy, with or without investigational agents. * prior surgery, chemotherapy and/or radiation therapy for ajcc stage i-iii pancreatic adenocarcinoma is permitted. * ecog performance status 0-2. * a minimum age of 18 years old. exclusion criteria: * prior chemotherapy for ajcc stage iv pancreatic adenocarcinoma * known to be hiv positive on antiretroviral therapy * prior organ allograft * any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures

Keywords: stage iv pancreatic cancer folfirinox gem/nab-p chemotherapy 17-042
the role of f-18 florbetapir in the early detection of cardiac amyloidosis

Conditions: Cardiac Amyloidosis

Summary: the investigators postulate that f-18 florbetapir will show improved detection of cardiac amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.

f-18 florbetapir is currently used for the early detection of brain amyloid (alzheimer's disease). the hypothesis is that f-18 florbetapir will detect amyloid deposition in myocardium prior to current non-invasive diagnostic measures, particular electrocardiography with strain and technetium pyrophosphate scintigraphy. the investigators intend to use f-18 florbetapir and assess its correlation between standard non-invasive diagnostic modalities.

Eligibility criteria:
inclusion criteria: 1. patients with extra-cardiac biopsy-proven al or attr amyloidosis 2. patients with a ratio of affected to unaffected free light chains \>5 or free light chain difference of \>50 exclusion criteria: 1. echocardiographic evidence of cardiac amyloidosis with septal and posterior wall thickness ≥ 13mm 2. contraindication to florbetapir or its components 3. refusal to participate in the study

Keywords: f-18 florbetapir amyvid pet scan early detection
effect of dexmedetomidine as adjuvant to ropivacaine for brachial plexus block

Conditions: Local Anesthesia Adjuvants; Upper Extremity Fracture; Brachial Plexus Block

Summary: brachial plexus block is used for upper limb surgery. local anesthesia alone for brachial plexus block provides good operative conditions, but have short duration of postoperative analgesia. hence, various adjuvants to local anaesthetic agents to prolong the duration of peripheral nerve, analgesia. however, results are either inconclusive or associated with side effects. the purpose of this study is to determine whether dexmedetomidine as an adjuvant to ropivacaine in brachial plexus block improve quality of block in terms of duration of post operative analgesia.


Eligibility criteria:
inclusion criteria: * asa physical status i and ii patients, weight 45 to 74 kg * elective upper limb surgery under brachial plexus block exclusion criteria: * known hypersensitivity or contraindication to ropivacaine, lidocaine and dexmedetomidine * pregnant or lactating mothers * hepatic, renal or cardiopulmonary abnormalities * long term analgesic therapy