Kornimate/medical-research-clean huggingface dataset:
a study of khk4827 in subjects with palmoplantar pustulosis

Conditions: Palmoplantar Pustulosis

Summary: evaluation of efficacy and safety of khk4827 in subjects with palmoplantar pustulosis


Eligibility criteria:
inclusion criteria: * subject has had a diagnosis of palmoplantar pustulosis for at least 24 weeks as of the time of informed consent. * subject has a pppasi total score ≥12 and a pppasi severity score of pustules/vesicles on the palms or soles ≥2 both at the pre-examination and enrollment examination; * subject inadequately responded to any one or combination of the following therapies before informed consent: topical corticosteroids, topical vitamin d3, phototherapy, etretinate exclusion criteria: * subject has a diagnosis of plaque psoriasis, pustular psoriasis, drug-induced palmoplantar pustulosis, or pompholyx; * subject has an improvement in pppasi total score of ≥4 points during the screening period; * subject has a history or evidence of psychiatric disorder or alcohol/drug abuse that, in the opinion of the investigator or subinvestigator, may compromise the safety of the subject because of participation in the study or may interfere with assessments and procedures in the study or study completion; * subject has a past or current history of suicidal ideation (severity of 4 or 5) or any suicidal behavior at enrollment, as assessed by the columbia-suicide severity rating scale (c-ssrs); * subject has severe depression with a phq-8 total score of ≥15 at enrollment

Keywords: palmoplantar pustulosis brodalumab khk4827
validation of radio-induced damage biomarkers

Conditions: Bone Metastasis; Malignant Hemopathy

Summary: the aim of this study is to confirm in humans the relevance and the kinetics of radio-induced bio-markers in plasma and urines, previously described at the preclinical stage.

the nuclear and radiologic risks monitoring is a major preoccupation for our society. during an accident, it is primordial to define the biologic dosimetry. the dose and distribution knowledge is crucial for the medical care. indeed, total body irradiation (tbi) and partial body irradiation (pbi) do not have the same clinical outcome. a total body irradiation induces an acute radiation syndrome with a medullary aplasia. a quick diagnostic would allow the optimization of the medical care. nowadays, the analyse of the chromosome with two centromeres is the current norm to estimate the radiation dose, but this technique is time consuming, and not adapted to an emergency situation, and to a large population. the new genetic techniques could permit the quick radiation dosimetry diagnosis. the research of early exposition bio-markers seems to be of a major interest. these bio-markers would allow to rapidly define the radiations perceived by an exposed subject, before the apparition of the symptoms, and by the way, to conduct to a therapeutic strategy more adapted to the patient. in this purpose, the present study will need blood and urines samples of patients totally or partially exposed to radiations, according to their usual medical care.

Eligibility criteria:
inclusion criteria: * more than 18 years old * for the group a: patient suffering from a malignant blood disease requiring a whole-body radiation, without (or prior to) a concomitant chemotherapy, according to the following protocol: 2x2 gray per day, during 3 days. * or for the group b: patient with one (or more) pelvis metastasis requiring radiation therapy without concomitant chemotherapy, according to the following protocol: 4 gray per day for 5 days. exclusion criteria: * more than 70 years old, * subject presenting abnormal blood count (grade 3), * person with a not controlled chronic illness, * subject presenting an abnormal hepatic assessment (grade 3), * subject having already received ionizing treatments, * subject reached hiv, hepatitis c or any other progressive infectious diseases, * pregnant women or nursing mothers, * person under protection of justice or unable to give consent.

Keywords: bio-markers radiation appropriate therapeutic strategy total body irradiation partial body irradiation
is oxidative stress in semen reduced by lifestyle intervention

Conditions: Oligospermia

Summary: in this study we aim to investigate whether a 3-month life-style intervention would reduce oxidative stress (os) in semen in men of infertile couples attending ivf-treatment. men with a dfi above 15% (scsa method) are recruited for intervention with a 3-month follow-up. it is hypothesized that men who also have a os above 1.34 using a novel os diagnostic method (mioxsys) respond better to antioxidant treatment with a change in os and dfi. the primary outcome is the change in os following the intervention. secondary outcomes are morphological semen parameters and dna fragmentation index.


Eligibility criteria:
inclusion criteria: * dfi\>15 * attending ivf treatment for unknown or male factor infertility. exclusion criteria: * genetic diseases * azospermia
effect of growth hormone (gh) on cardiac echos in gh deficient patients after acromegaly treatment

Conditions: Acromegaly

Summary: the purpose of this research study is to study the effects of growth hormone (gh) replacement on the heart. the investigators will study these effects in people who have been cured of acromegaly and then have developed growth hormone deficiency (ghd, not enough growth hormone).


Eligibility criteria:
inclusion criteria: * age 18-75 * history of acromegaly with biochemical cure * growth hormone deficiency exclusion criteria: * untreated thyroid disease within the past 3 months * untreated adrenal insufficiency within the past 3 months * uncontrolled hypertension * congestive heart failure * gonadal steroid therapy within the past 3 months * pregnancy or nursing

Keywords: acromegaly growth hormone growth hormone deficiency
digital symptom tracking, patient engagement and quality of life in gi oncology clinic patients

Conditions: Cancer

Summary: a pilot study of an epro system in cancer patients receiving systemic therapies.

the primary purpose of this pilot study is to determine the feasibility of the noona healthcare mobile pro application to describe oncology patient engagement using a web-based symptom self-monitoring instrument. additionally, the studyy will dentify side effects as well as long term or chronic adverse events during and following cancer therapy based on the united states (us) national cancer institute (nci) patient reported outcomes common terminology criteria for adverse events (pro-ctcae), and identify patients to participate in future long-term quality of life studies following cancer therapy. the study is not intended to compare outcomes between groups receiving different therapies.

Eligibility criteria:
inclusion criteria: 1. individuals (men and women) aged 18 years or older 2. history cancer with no limitation on prior lines of therapy in the metastatic setting 3. ecog performance status of 0-2 4. estimated life expectancy of at least 12 months 5. access to smartphone, tablet or computer with capability to utilize symptom-tracking application 6. willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures 7. willing and able to comply with all study procedures exclusion criteria: 1. concurrent disease or condition that interferes with participation or safety 2. non-english speaking, as the application is developed in the english language 3. children will not be included in the study. the pattern of disease and symptoms are different in children than in an adult population. the web-based tool was designed based on the symptom experience of adults with cancer.

Keywords: cancer patient reported outcomes symptom management
comparison of coagulation factors during laparoscopic cholecystectomy

Conditions: Gall Stone Disease; Polyp

Summary: pneumoperitoneum is formed with co2 during laparoscopic abdominal operations. effect of pneumoperitoneum on coagulation factors is not well known. in our study the investigators aimed to compare the general anesthesia(ga) and combined spinal-epidural anesthesia (ca) during laparoscopic cholecystectomy(lc) with effect on coagulation factors. fifty patients will be randomly assigned to either the laparoscopic cholecystectomy under combined anaesthesia (25 patients) or laparoscopic cholecystectomy under general anaesthesia (25 patients). all patients has symptomatic gall stone disease or polyp of gall bladder.

objective of study : the aim of this study was to compare general anesthesia (ga) and combined (epidural and spinal) anesthesia (ca) for laparoscopic cholecystectomy(lc).laparoscopic cholecystectomies are usually performed under general anesthesia. studies involving cholecystectomies with regional anesthesia recently published. during regional anesthesia pneumoperitoneum is performed with lower pressure(10mmhg co2). patients can not tolerate higher intraabdominally pressure. thera are very few studies involving the effect of pneumoperitoneum on coagulation factors. in our study the investigators separate the patients into 2 groups. group1:10 mmhg pressure, laparoscopic cholecystectomy under general anesthesia ; group2 : 10 mmhg pressure, laparoscopic cholecystectomy under combined spinal-epidural anesthesia the investigators performed standard conventional laparoscopic cholecystectomy procedure with 10mmhg pressure in both groups. the investigators aimed to investigate prothrombin time(pt), activated partial thromboplastin time(aptt), thrombin time(tt), d-dimer and fibrinogen levels preoperative, postoperative 1st hour and 24th hour respectively.

Eligibility criteria:
inclusion criteria: * gall bladder stone * gall bladder polyp exclusion criteria: * pregnancy * malignancy * children * acute cholecystitis * vertebral deformities

Keywords: d-dimer fibrinogen laparoscopic cholecystectomy
cheetah - sterile glove and clean instrument change at the time of wound closure to reduce surgical site infection

Conditions: Surgical Site Infection

Summary: to assess whether the practice of using separate sterile gloves and instruments to close wounds at the end of surgery compared to current routine hospital practice can reduce surgical site infection

internal pilot the aim of the 12-month internal pilot is to assess: 1. whether hospitals adhere to their allocation 2. what proportion of patients who are eligible for cheetah can be followed up successfully at 30 days after their surgery main study to assess whether the practice of using separate sterile gloves and instruments to close wounds at the end of surgery compared to current routine hospital practice can reduce surgical site infection at 30-days post-surgery for patients undergoing clean-contaminated, contaminated or dirty abdominal surgery

Eligibility criteria:
inclusion criteria * countries: lmics defined by the development assistance committee (dac) official development assistance (oda) list where there are at least 4 eligible hospitals per country in hic-cheetah protocol (hics are those that do not appear on the organisation for economic co-operation and development's official development assistance (oda) list * hospitals (clusters): in lmics where glove and instrument change is not currently routine hospital practice * participants: patients undergoing abdominal surgery who satisfy the following criteria are eligible: * emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) * intraoperative finding of clean-contaminated, contaminated or dirty surgery * with at least one abdominal incision that is ≥5cm * aged 16 years and over on the day of surgery (applicable to hic-cheetah protocol only) participant exclusion criteria: • patients undergoing caesarean section
safety and feasibility of laparoscopic intracorporeal anastomosis for colorectal surgery- a multiple center real world study

Conditions: Colorectal Cancer

Summary: the goal of this observational study is to explore the safety and feasibility of laparoscopic intracorporeal anastomosis in colorectal cancer surgery. the main questions it aims to answer are: 1. if intracorporeal anastomosis is safe in terms of short-term outcome? 2. if intracorporeal anastomosis can achieve the same oncological outcome as conventional extracorporeal anastomosis?

this study is a retrospective real-world research initiated by the chinese academy of medical sciences cancer hospital, including cancer hospital of the chinese academy of medical sciences, shenzhen hospital and peking university first hospital. the study aims to retrospectively analyze the clinical data of approximately 2,000 patients who underwent laparoscopic surgery with preoperative imaging staging of ct1-4ananym0 and pathological diagnosis of adenocarcinoma or high-grade intraepithelial neoplasia from april 2016 to april 2020. the patients will be divided into the intracorporeal anastomosis group (ia) and extracorporeal anastomosis group (ea) based on the surgical records. the primary endpoints of the study are 3-year disease-free survival (dfs) and 3-year overall survival (os). the secondary endpoints include overall complication rate within 30 days, postoperative pain score, time to first flatus after surgery, time to first bowel movement after surgery, time to first oral intake after surgery, length of hospital stay, and postoperative quality of life.

Eligibility criteria:
inclusion criteria: 1. patients voluntarily enrolled in this study and signed an informed consent form; 2. age: 18-75 years; 3. completion of colonoscopy and biopsy, with pathological confirmation of adenocarcinoma or high-grade intraepithelial neoplasia; 4. preoperative enhanced ct or mri examination showing no evidence of distant metastasis; 5. preoperative staging as ct1-3nanym0; 6. underwent laparoscopic surgery. exclusion criteria: 1. contraindications to laparoscopic surgery; 2. cases requiring emergency surgery due to acute bowel obstruction, perforation, or bleeding; 3. patients with distant metastasis; 4. patients with multiple primary colorectal cancers; 5. patients with a history of malignancy; 6. patients unwilling to sign the informed consent or unwilling to follow the study protocol for follow-up.

Keywords: colorectal cancer minimally invasive surgery laparoscopic surgery intracorporeal anastomosis
prophylactic versus therapeutic dose anticoagulation in covid-19 infection at the time of admission to critical care units

Conditions: Covid19

Summary: this is a multi-center, retrospective, study to determine if therapeutic dose anticoagulation (high dose group) improves inpatient mortality in severely ill patients with covid-19 compared to prophylactic dose anticoagulation (low dose group). the study involved 704 individuals who were admitted to beaumont health system (bhs) from march 10th to april 15th, 2020.


Eligibility criteria:
inclusion criteria: * age \>18 years old * positive reverse transcription-polymerase chain reaction (rrt-pcr) test for the qualitative detection of nucleic acid from sars-cov-2 in upper and lower respiratory specimens. * intensive care unit (icu) patient or step-down unit (sdu) patient on invasive mechanical ventilation, bipap, 100% non-rebreather mask, or high flow oxygen or supplemental oxygen of at least 4 liters per minute nasal cannula. * peak d-dimer levels exceeding 1,000 mcg/ml at any time during admission. exclusion criteria: * hospital length of stay less than 5 days. * hemorrhage before icu/sdu admission. * treatment with an anticoagulant other than low molecular weight heparin or unfractionated heparin. * constant treatment with the same dose of anticoagulant for less than 5 days.

Keywords: anticoagulation covid19 thrombosis heparin coagulopathy
continuation study of entinostat in combination with pembrolizumab in patients with advanced solid tumors

Conditions: Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Carcinoma, Non-Small-Cell Lung; Lung Diseases; Breast Diseases; Renal Neoplasm; Solid Tumors

Summary: the objectives of this study are to explore different dosing levels and schedules of entinostat in combination with pembrolizumab in patients with advanced solid tumors, in terms of safety, tolerability, pharmacokinetics (pk), impact on immune correlatives, and efficacy

this is a phase 1, open-label, single center, randomized study to assess the safety and tolerability of 3 different dose regimens of entinostat in combination with pembrolizumab in patients with advanced solid tumors who previously completed study sndx-275-0140 (nct02897778). up to 30 patients will be randomized in a 1:1:1 fashion to one of three arms. in the event that greater than or equal to 2 out of the first 6 patients randomized experience a dose-limiting toxicity, the next patient randomized to that arm will receive treatment at a reduced starting dose as outlined in the protocol.

Eligibility criteria:
inclusion criteria: 1. completed study sndx-275-0140 (nct02897778) 2. any ae or toxicity experienced in study sndx-275-0140 (nct02897778) is resolved to less than or equal to grade 1 3. continues to meet inclusion criteria for study sndx-275-0140 (nct02897778) at the time of entry into this study exclusion criteria: 1. completed study sndx-275-0140 (nct02897778) more than 30 days prior to cycle 1 day 1 of this study 2. continues to meet exclusion criteria for study sndx-275-0140 (nct02897778) at the time of entry into this study

Keywords: entinostat pembrolizumab solid tumor histone deacetylase inhibitor
prucalopride for postoperative ileus in patients undergoing gastrointestinal surgery

Conditions: Postoperative Ileus

Summary: the purpose of this study is to evaluate the effect and safety of prucalopride on recovery of gastrointestinal function in patient undergoing major gastrointestinal surgery. the investigators hypothesize that patients who take prucalopride after major gastrointestinal surgery will have shorter duration of postoperative ileus.

postoperative ileus (poi), an interruption of bowel motility function, virtually occurs in all patients undergoing major gastrointestinal(gi) surgery. this functional impairment persists for a variable duration, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. therefore, time of return of colonic function is the the major determinant of duration of poi. attempts to reduce the duration of poi have prompted the implementation of fast track surgery including early removal of the nasogastric tube, early feeding, alvimopan, gum chewing, and prompt ambulation. however, it is still reported to be more than 4-5 days in most of the randomized trial. therefore, methods specifically aiming at promoting postoperative colon motility may further enhance the gi function recovery, and prucalopride may be one of the options. prucalopride, a substituted benzamide with selective 5-ht4 agonist activity, has been shown previously to significant improve colon motility and transit, but it only has mild effect on gastric or small bowel transit. the drug is well tolerated with no significant adverse effects. recently, prucalopride has been approved in europe and america for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. however, its usage in the postoperative period has not been tested. this study will test the ability and safety of prucalopride given 24hrs after gi surgery to hasten the recovery of gi function.

Eligibility criteria:
inclusion criteria: 1. consecutive patients undergoing elective gastric, small bowel, or partial colonic resection via laparotomy or laparoscopy. 2. patients with american society of anaesthesiologists grading i-iii 3. informed consent available. exclusion criteria: 1. patients with stoma creation, extensive adhesiolysis, total or subtotal colectomy , or patients who had a history of total or subtotal colectomy. 2. patients who developed intraoperative problems or complications, or had peritoneal carcinomatosis. 3. patients who developed serious complications within 24 hours after surgery. 4. those who received epidural anesthesia or analgesia. 5. patients who received other prokinetic drugs. 6. patients who were allergic to prucalopride. 7. patients with severe comorbidity and/or organ(kidney, liver, and heart) dysfunction 8. patients had complete bowel obstruction 9. patients who have participated other clinical trials. 10. patients who have short bowel(\<200cm small bowel) or history of constipation.

Keywords: prucalopride gastrointestinal diseases postoperative ileus randomised trial
safety and efficacy study of rx-10045 on the signs and symptoms of dry eye

Conditions: Dry Eye Syndrome

Summary: the purpose of this study is to compare the safety and efficacy of rx-10045 to placebo for the treatment of the signs and symptoms of dry eye.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * have provided written informed consent; * have a history of dry eye for at least 6 months prior to enrollment; * have a history of use or desire to use eye drops for dry eye symptoms within the past 6 months; * demonstrate a response when exposed to the cae. exclusion criteria: * have an on-going ocular infection, or active ocular inflammation * have worn contact lenses within 72 hours of visit 1 or have anticipated use of contact lenses during the study; * have contact lens-induced dry eye; * have previously had laser in situ keratomileusis (lasik) surgery; * be using or have anticipated use of temporary punctual plugs during the study; * have best corrected visual acuity \> +0.7 in both eyes; * be a woman who is pregnant, nursing or planning a pregnancy; * have a known allergy and/or sensitivity to the test article or its components; * be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen for at least 30 days

Keywords: keratoconjunctivitis sicca dry eye resolvin