Kornimate/medical-research-clean huggingface dataset:
efficacy of pelvic autonomic nerve monitoring system (pams i) in female patients with pelvic tumors

Conditions: Cervical Cancer; Uterine Cancer; Ovarian Cancer

Summary: although nerve-sparing surgery has been introduced for female patients with the pelvic tumors, its success rate depends on operators. to achieve consistency of surgical procedure, it is necessary to adopt pelvic autonomic nerve monitoring technique. the aims of this study is 1. development of pelvic autonomic nerve monitoring system (pams i) by using urodynamic system. 2. evaluation of autonomic nerve sparing by intraoperative monitoring with pams i 3. evaluating the efficacy of pams i by intraoperative neurophysiological monitoring (iom)

after surgery for pelvic tumor, most of patients complain voiding dysfunction, defecation dysfunction and sexual dysfunction which lead to decrease quality of life. recently, nerve-sparing surgery has been introduced. but it is difficult to establish standard surgical procedure for nerve-sparing. and it is the concern that performing nerve sparing surgery may reduce radicality of surgery which influence prognosis. through pelvic autonomic nerve monitoring system (pams i), this trial is expected to raise the possibility of nerve-sparing with maintaining radicality of surgery. pressure sensor of pams i and needle prove of iom are very thin and these instruments have been used clinically. taking this into consideration, additional risk by nerve monitoring is considered to be minimal.

Eligibility criteria:
inclusion criteria: * female, age ≥ 18 years * patients with pelvic malignant tumor who need surgery. * gynecologic cancer; cervical cancer, uterine cancer, ovarian cancer * colorectal cancer * pelvic sarcoma and metastatic pelvic malignant tumor * patients who signed an approved informed consent. exclusion criteria: * female, age \< 18 years * patients with pelvic malignant tumor, but surgery is not indicated. * patients who refused to sign informed consent

Keywords: autonomic nerve monitoring nerve-sparing surgery
effects of pressure garments on hypertrophic hand scar in burn children

Conditions: Burns Laser

Summary: burns are type of injury that affect the skin or other tissues and are typically caused by acute trauma, including thermal sources, electricity, chemicals, friction, or radiation. thermal burns are frequently caused by exposure to high temperature solids or liquids, as well as flames. the epidermis is the only layer of skin affected by superficial burns (sometimes known as "first degree" burns). blistering is a common symptom of partial thickness (second degree) burns, which damage both the epidermis and dermis.

this study will include patients with age 2-10 \& having burns on hands and develop scars will be recruited through randomized controlled trial in which convenience sampling technique will be used. two groups will be formed in which participants will be divided by lottery method. group a which will be treated by low level laser therapy with pressure garment (8-10hrs a day) and group b which will receive low level laser therapy (422-800nm) without pressure garment only for the duration of 6 weeks (3 days in a week with 20-30 minutes per session). vancouver scar scale and psoas tool will be used. the result after statistical analysis will either show both treatments equally effective or not. data will be calculated before and after treatment with the help of outcome measure tools. results will be analyzed on spss.

Eligibility criteria:
inclusion criteria: * age 2-10 years * patient with 2nd degree of burns on hands and develop scar * patients after 3 months of burn on hand * only patients that were diagnosed with hypertrophic scars secondary to burn injuries were included * patients those with second degree burns or more or those with hs from burns * scar type (hypertrophic, flat or atrophic) and scar dyschromia (i.e. erythema) are the main factors that drive laser device selection exclusion criteria: * participants who have certain medical problems that may impair scar healing or response to therapy interventions (such as uncontrolled diabetes, autoimmune disorders, or immunocompromised states). * those who have suffered burns recently (within the past few weeks) or who have had their scars for a long time (five years or more) * wounds that have open area and risk of bleeding occurs. * any spinal cord injuries. * patients with any other skin disease like skin cancer, inflammation,allergic conditions etc * patients with under treatment like radiations etc

Keywords: burn scar, hypertrophy scar pressure garment, low level laser,
telemonitoring study - for chronic myeloid leukemia (cml)

Conditions: Chronic Myeloid Leukemia

Summary: this study is being conducted in a population of patients with chronic phase chronic myeloid leukemia (cml) to learn more about how patients follow prescribed regimens for taking oral cancer drugs.

this is a randomized, controlled pilot study to introduce emedonline telemonitoring technology to cml patients taking gleevec or tasigna. emedonline will be used to automatically collect time-dose specific medication data for individual patients, including dosing times, missed doses, adverse events and e-diary data. all data will be available to research staff for remote review via web interface. adverse events and non-adherence will prompt interventions including supportive care counseling.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older. * pathologically documented diagnosis of chronic phase cml (ph+) in whom treating physician has determined that treatment with imatinib or nilotinib is appropriate * patients currently receiving gleevec (imatinib) 300-600 mg daily or tasigna (nilotinib) 300-400 mg twice daily * ecog performance status 0, 1, or 2 * adequate end organ function, defined as: * total bilirubin \< 1.5 xuln * sgot and sgpt \<2.5 x uln * creatinine \< 1.5 x uln * anc \> 1.5 * platelets \> 100,000 * female patients of child bearing potential must have a negative urine or serum pregnancy test at screening. * patient is able to read and speak english * patient is willing and able to use a cell phone * written, voluntary informed consent exclusion criteria: * patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent

Keywords: chronic myeloid leukemia chronic phase cml
impact of procedure materials on patient anxiety, depression, and pain in prostate biopsy consent

Conditions: Prostate Biopsy

Summary: the gold standard for diagnosing prostate cancer is an ultrasound-guided prostate biopsy. despite its low complication rates, the procedure can cause significant stress, discomfort and anxiety in patients. this study aimed to determine whether visually introducing the materials (ultrasound, probe, biopsy needle) used during the biopsy could reduce patient anxiety and increase comfort.

forty patients suspected of having prostate cancer were included in this prospective study. all patients received detailed information about the procedure, but they were divided into two groups. the first group was shown photographs of the devices alongside the written consent form, while the second group received only the written consent. the study compared the pain, depression and anxiety scores between the two groups

Eligibility criteria:
inclusion criteria: - patient's clinical data indicated the need for a prostate biopsy exclusion criteria: * included having a diagnosis of psychiatric illness * having previously undergone a prostate biopsy under local anesthesia * being a patient under active surveillance for prostate cancer

Keywords: prostate biopsy anxiety pain depression
next generation chest x-ray tomosynthesis for screening of lung cancer

Conditions: Lung Cancer

Summary: the goal of this observational clinical trial is to learn if chest tomosynthesis is a potential alternative to computed tomography for the detection of lung cancer. it will also develop artificial intelligence tools to aid in the diagnosis of lung cancer on chest tomosynthesis images. the main questions it aims to answer are: * what is the accuracy of chest x-ray tomosynthesis in diagnosing lung cancer in a population of individuals undergoing lung cancer screening or evaluation of a suspicious lung nodule? * can artificial intelligence help us detect lung cancer on chest tomosynthesis images? researchers will compare chest tomosynthesis images to computed tomography scans for each participant to see how they compare in diagnosing lung cancer. participants will a chest tomosynthesis scan in addition to their routine clinical computed tomography scan.

lung cancer remains the most common cause of cancer death in the united states for which low-dose ct has proven benefit for early detection and survival from lung cancer. however, adoption remains low. furthermore, \>95% of nodules detected on low-dose ct, especially those smaller than 6 mm, do not represent cancer. we have partnered to develop a novel chest x-ray tomosynthesis (cxrt) device with the hypothesis that this device might be an alternative to ct for detection of lung cancer. we seek to recruit a cohort of patients to undergo cxrt, composed of patients concurrently undergoing lung cancer screening ct and diagnostic ct for new lung cancer. we will determine the effectiveness of cxrt for detecting lung cancer in this population, evaluating its sensitivity and specificity for detecting cancer and lung nodules at multiple size thresholds in a multireader study. we will additionally develop artificial intelligence algorithms and evaluate their efficacy to further enhance cancer detection.

Eligibility criteria:
inclusion criteria: * undergoing lung cancer screening * undergoing evaluation of suspicious pulmonary nodule * newly diagnosed lung cancer exclusion criteria: * prior history of lung cancer treatment
concurrent oct and ffr-guided pci in cad

Conditions: Coronary Artery Disease; Image; Atheroscleroses, Coronary

Summary: the present study is a prospective randomized clinical trial aimed to compare the therapeutic strategy of angiography-guided versus concurrent oct/ffr-guided intervention in patients with coronary artery disease.

most previous clinical trials have assessed various interventional strategies guided by intravascular imaging (intravascular imaging-guided pci), fractional flow reserve (ffr-guided pci), or conventional angiography (angiography-guided pci) to compare differences in treatment outcomes. until now, it remains unclear whether optimizing procedures based on both intravascular imaging and fractional flow reserve indices would lead to improved treatment outcomes compared to pci guided solely by conventional angiography. moreover, there are no studies comparing a treatment strategy that combines optical coherence tomography (oct) and ffr to angiography-guided procedures. hence, this study aims to compare the clinical effectiveness and therapeutic impact of concurrent guidance using ffr and oct in patients undergoing coronary artery stent implantation, as compared to procedures guided solely by conventional angiography.

Eligibility criteria:
inclusion criteria: 1. age greater than 19 years old 2. patients undergoing coronary stent implantation for stable angina or acute coronary syndrome 3. patients provided on informed consent exclusion criteria: 1. individuals with a history of increased bleeding tendencies or hematologic disorders 2. presented with refractory cardiogenic shock 3. individuals with a history of stent thrombosis 4. expected life expectancy of less than 1 year 5. left ventricular ejection fraction (lvef) ≥ 20% 6. women who are breastfeeding, pregnant, or planning to become pregnant 7. deemed unsuitable for participation by the investigator 8. patients unwilling to participate in the clinical trial

Keywords: optical coherence tomography fractional flow reserve angiography coronary artery disease percutaneous coronary intervention drug-eluting stent
a study of the effect of linaclotide on abdominal girth in participants with irritable bowel syndrome with constipation (ibs-c)

Conditions: Irritable Bowel Syndrome Characterized by Constipation

Summary: the objective of this trial is to determine the effect of linaclotide on abdominal girth in ibs-c participants with the baseline symptoms of abdominal bloating and an increased abdominal girth.


Eligibility criteria:
inclusion criteria: • patient meets protocol criteria for diagnosis of ibs-c, abdominal pain, abdominal bloating and abdominal girth exclusion criteria: * patient has history of loose or watery stools * patient has both clinically significant findings and unexplained clinically significant alarm symptoms * patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain * patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
a study of jnj-78278343 in combination with either jnj-63723283 (cetrelimab), taxane chemotherapy, or androgen receptor pathway inhibitors for metastatic prostate cancer

Conditions: Metastatic Castration-resistant Prostate Neoplasms

Summary: the purpose of this study is to identify the recommended phase 2 regimen(s) rp2r(s) of jnj-78278343 and combination agent in part 1 (dose escalation) and to determine safety at the putative rp2r(s) of jnj-78278343 with the combination agent in part 2 (dose expansion).


Eligibility criteria:
inclusion criteria: * part 1 a-g (all combination treatments) and parts 2b-c (cabazitaxel, docetaxel): metastatic castration-resistant prostate cancer (mcrpc) with confirmed adenocarcinoma of the prostate as defined by prostate cancer working group 3 (pcwg3); parts 2d-g (apalutamide, enzalutamide, darolutamide, abiraterone acetate + prednisone \[aap\]): mcrpc: histologically confirmed adenocarcinoma of the prostate as defined by pcwg3, with a minimum psa of 2 nanogram \[ng\]/milliliter (ml); part 2h (apalutamide): (a) metastatic hormone-sensitive prostate cancer(mhspc) with non-castrate levels of testosterone (greater than \[\>\] 150 ng/ deciliter \[dl\]) and a minimum psa of 2 ng/milliliter \[ml\]; (b) metastatic disease documented by greater than equal to (\>=) 1 bone lesion(s) on technetium-99m (99m\^tc) bone scan. no definitive evidence of metastatic visceral disease * measurable or evaluable disease * (a) part 1a (cetrelimab) - prior treatment for mcrpc with at least 1 prior androgen receptor pathway inhibitors (arpi) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (example, docetaxel). (b) part 1c and 2c (docetaxel), part 1d (apalutamide), part 1e and 2e (enzalutamide), part 1f and 2f (darolutamide), and part 1g and 2g (aap)- prior treatment with at least 1 prior arpi (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate). (c) part 1b and 2b (cabazitaxel) - prior treatment with at least 1 prior arpi (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel. (d) part 2d (apalutamide) - prior treatment with at least 1 prior arpi (e) part 2h (apalutamide)- participant must not have received prior cytotoxic chemotherapy * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate organ functions exclusion criteria: * active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications * toxicity related to prior anticancer therapy that has not returned to grade less than or equal to (\<=) 1 or baseline levels (except for alopecia, vitiligo, grade \<=2 peripheral neuropathy) * solid organ or bone marrow transplantation * known allergies, or intolerance to any of the components (example, excipients) of jnj-78278343, cetrelimab (part 1a), cabazitaxel, part 1b and 2b , docetaxel part 1c and 2c , apalutamide (part 1d and 2d and part 2h), enzalutamide (part 1e and 2e), darolutamide (part 1f and 2f), or aap (part 1g and 2g) * significant infections or serious lung, heart or other medical conditions
candesartan cilexetil / hydrochlorothiazide combination tablets special drug use surveillance: long-term use (12 months)

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the safety and efficacy of long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ecard) combination tablets ld\&hd in hypertensive patients in the routine clinical setting

this is a special drug use surveillance on long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ecard combination tablets) to evaluate in hypertensive patients in the routine clinical setting. because the drug contains a diuretic (hydrochlorothiazide) , it is necessary to assess the safety, especially on serum uric acid. (the planned sample size is 3000). the usual adult dosage is 1 tablet (4 mg/6.25 mg or 8 mg/6.25 mg as a candesartan cilexetil/hydrochlorothiazide) administered orally once daily. this drug should not be used as a first-line drug for hypertension treatment.

Eligibility criteria:
inclusion criteria: * hypertensive patients exclusion criteria: (1) patients with a history of hypersensitivity to ingredients of ecard ld\&hd combination tablets, thiazides, or their analogues (e.g. sulphonamide derivatives such as chlortalidone) (2) patients with anuria or patients under hemodialysis (3) patients with acute renal failure (4) patients with noticeably decreased na and k levels in body fluids (5) pregnant women or women planning to become pregnant -

Keywords: drug therapy
correction of hypernatremia by intravenous hypotonic solution compared to enteral water

Conditions: Hypernatremia

Summary: hypernatremia, defined as an elevation of serum sodium \>145 meq/l, is one of the most common electrolyte disturbances in hospitalized patients and intensive care units. in this study, the investigator aims, for the first time, to compare two strategies used for the correction of hypernatremia, using intravenous hypotonic solution compared to naso- or orogastric tube enteral water.

hypernatremia, defined as an elevation of serum sodium \>145 meq/l, is one of the most common electrolyte disturbances in hospitalized patients and intensive care units, increasing mortality. currently, the most effective correction strategy for hypernatremia (intravenous hypotonic solution compared to enteral water) is still a matter of debate due to a lack of evidence and clinical trials. this study aims to determine whether the administration of intravenous hypotonic solution is more effective in the correction of hypernatremia compared to enteral water by naso- or orogastric tube. therefore, the investigator proposes the first randomized clinical trial, which compares two strategies used for the correction of hypernatremia, with this we will determine which of the two is more effective, and we will also compare the speed of correction, renal function during hospitalization with serum creatinine and we will evaluate its safety.

Eligibility criteria:
inclusion criteria: * hospitalized patients with hypernatremia (serum sodium\>145meq/l). exclusion criteria: * age below 18 years * pregnant, on dialysis * unwilling to participate or without informed consent.

Keywords: hypernatremia intravenous hypotonic solution enteral water
ingenio device algorithm study

Conditions: Sinus Node Disease; AV Block; Heart Failure

Summary: the purpose of the ivory study is to gather data to support global submissions/approvals for some models of the ingenio device family.

ivory is a prospective, multi-center, randomized within-patient, single-blinded study to gather data to support right atrial auto threshold and rythmiq

Eligibility criteria:
inclusion criteria: * subjects who are willing and capable of providing informed consent to undergo a device implant and to participate in all testing associated with this clinical study; * subjects whose age is 18 or above, or of legal age to give informed consent specific to national law; * subjects indicated for a dual chamber pacemaker or a crt-p device according to class i or class ii indications of the standard esc or acc / aha implant guidelines; * subjects who are planned to be implanted with all leads intended for a specific device type (dual chamber pacemaker: atrial and right ventricular lead, crt-p: atrial, right and left ventricular lead) or are already implanted with such leads; * subjects who receive or are implanted with a bipolar atrial lead. exclusion criteria: * women of childbearing potential who are or might be pregnant at the time of the study (method of assessment upon physician's discretion); * enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict or affect * schedule of procedures for ivory (i.e. should not cause additional or missed visits); * programming of devices for ivory per cip; * ivory outcome (i.e. involve medications that could affect the heart rate of the subject); * conduct of ivory per gcp / iso 14 155:2011 / local regulations. * subjects who live at such a distance from the clinic that travels for fu visits at a study center would be unusually difficult or burdensome for the subject; * inability or refusal to comply with the fu schedule; * a life expectancy of less than 12 months, per physician discretion; * subjects who are planned to be programmed to a pacing mode other than ddd / dddr during the study period.

Keywords: pacemaker, crt-p, auto threshold
effects of simvastatin in the prevention of pain experienced after tooth extraction

Conditions: Pain

Summary: atraumatic extraction of maxillary premolar teeth (on the right, left side) was done; subsequently, the patients were randomly divided into two equal groups: a group (extraction + filled with a simvastatin solution impregnated gelatin sponge) and b group (extraction + without simvastatin solution impregnated gelatin sponge), were placed in one of the sockets; the pain level is recorded according to the vas scores at the intervals of before treatments, also postoperative analog pain scores were assessed in 30 minutes, 6 hours, 12 hours and 24 hours.

the method of procedure was performed by the same surgeon under local anesthesia (lidocaine 2% with epinephrine 1:100,000, made by darou pakhsh pharmaceutical co; tehran-iran) to avoid bias. all two first premolars were extracted carefully, have used periotome as a means of atraumatic extraction that facilitated the removal of teeth with minimum damage to the surrounding alveolar bone, teeth to be extracted should have minimum periapical changes radiographically; with decreasing soft tissue reflection; the socket was tan gently irrigated with normal saline and hemostasis was achieved. it must be noted that a group (extraction + simvastatin filled with simvastatin (poursina pharmaceutical co. tehran-iran) solution impregnated gelatin sponge (maquira industry dental products s.a. brazil) and b group (extraction + without simvastatin solution impregnated gelatin sponge), was placed in one of the sockets.

Eligibility criteria:
inclusion criteria: healthy patients age group 18-35 years sulcular probing not more than 3 mm and no redness the determination for extraction of teeth (two maxillary first premolars)for orthodontic treatment a tooth requiring an atraumatic extraction technique. exclusion criteria: systemic diseases smoking habits; pregnancy or breastfeeding periodontitis; teeth having radiographically obvious large periapical lesion(abscess/granuloma/cyst) t the history of chemotherapy radiation therapy periodontal and the use of any medicine (antibiotics; steroids; non-steroidal anti-inflammatory drugs allergy to simvastatin.

Keywords: pain measurement;tooth extraction;simvastatin.