Kornimate/medical-research-clean huggingface dataset:
study on the protective effect of a flexible sleeve penis protection device on penis after circumcision

Conditions: Circumcision, Male

Summary: circumcision is a common clinical procedure for both circumcision and phimosis, which are common disorders of the male reproductive system. for post-circumcision patients, a flexible sleeve penile protection device was invented as a modification of the traditional gauze bandage. this study investigated the protective effect of the device by recruiting post-circumcision patients to use the device and collecting indicators related to post-operative recovery and patients' experience of using the device.

circumcision is a common clinical procedure for both circumcision and phimosis, which are common disorders of the male reproductive system. post-circumcision patients remain at risk of gauze detachment, wound pain and post-operative bleeding, leading to serious post-operative adverse effects, including complications such as dehiscence and infection. the investigators have invented a flexible sleeve penile protection device, which consists of two components, a flexible sleeve and a hood, the main function of the flexible sleeve is to stop bleeding with compression and immobilisation, and the main function of the hood is to provide protection to the head of the penis and prevent the wound from rubbing against clothing leading to pain. the aim of this study was to investigate the protective effect of a flexible sleeve penile protection device on post-circumcision patients in terms of gauze loosening and dislodging, post-operative pain and post-operative bleeding. this study was a prospective randomized controlled trial of patients who underwent circumcision at peking university third hospital from february 2023 to may 2023. patients in the experimental group were wrapped with this device postoperatively, while patients in the control group were wrapped with traditional gauze postoperatively. patients were followed up regularly after surgery, and indicators such as complications, pain and recovery time were collected to investigate the protective effect of this device.

Eligibility criteria:
inclusion criteria: 1. diagnosed redundant prepuce and circumcised at peking university third hospital. 2. male patients aged between 12 and 60 years (inclusive). 3. the person or guardian fully understands and signs the informed consent form. exclusion criteria: 1. acute urinary and genital infections, such as acute urethritis, acute prostatitis, acute epididymitis, etc., or trauma. 2. abnormal blood clotting function. 3. those who are allergic to the materials used in the manufacture of the product. 4. patients who are mentally incapable or unable to understand the requirements for participation in the study and have difficulty in cooperating. 5. subjects who, in the opinion of the investigator, are unable to comply with follow-up, compromising the scientific validity and integrity of the study.

Keywords: circumcision postoperative complications protection devices
central aspects of pain in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study seeks to measure the psychometric properties of a newly developed central aspects of pain in rheumatoid arthritis (cap-ra) questionnaire, and investigate the ability of this questionnaire to measure central mechanisms of pain and also to predict worse pain and fatigue outcomes in people with rheumatoid arthritis (ra).

persistent pain and fatigue are prevalent and disabling symptoms in people with rheumatoid arthritis, even in the absence of active inflammation. the investigators believe that these symptoms may be a result of abnormal pain processing by the central nervous system (cns), in a process called central sensitization. the investigators have developed a short, self-report questionnaire to measure central pain mechanisms in people with ra. it is called central aspects of pain in rheumatoid arthritis (cap-ra), and was adapted from a pre-existing questionnaire called cap-knee (which measures central sensitization in people with chronic knee pain). this study aims to measure the psychometric properties of cap-ra, and the ability of the questionnaire to predict worse pain in the ra population. secondary objectives of the study include predicting worse fatigue in people with ra, deriving cap-ra scoring recommendations, investigating other factors associated with persistent ra pain, the association between central sensitization and pain, and investigating the course of pain and fatigue in ra. participants will be recruited from a rheumatology clinic. at baseline and 12 weeks these participants will undergo quantitative sensory testing (qst, pain tests), ultrasound for synovitis, clinical assessments, laboratory tests for systemic inflammation and, complete a questionnaire booklet, including the cap-ra questionnaire. some participants will complete the cap-ra questionnaire 1 week after the baseline visit to assess the test-retest reliability of the questionnaire. in addition, participants will provide weekly pain and fatigue self-report via text message (sms) for 12 weeks.

Eligibility criteria:
inclusion criteria: * adult (age≥18y) of any sex and ethnicity. * satisfy eular criteria for ra. * active ra, as defined as das28 ≥3.2 at baseline visit exclusion criteria: * unable to give informed consent. * insufficient understanding of spoken or written english to comply with the requirements of the study protocol * unable or unlikely to complete the proposed 12-week study follow up (eg. moving house, terminal diagnosis, current or planned pregnancy). * active comorbidity (e.g. uncontrolled diabetes mellitus, cancer, infection) requiring changes in medical treatment at baseline * major active psychiatric condition (e.g. major depression) * inability to meet the requirements of clinical assessments

Keywords: pain fatigue central sensitization
fecal microbiota transplantation for steroid resistant and steroid dependent gut acute graft versus host disease

Conditions: Stem Cell Transplant Complications; Graft Versus Host Disease, Acute; Fecal Microbiota Transplantation

Summary: the investigators hypothesize that perturbations in the intestinal microbiota following allogeneic hematopoietic stem cell transplantation (hsct) are essential for the development and propagation of acute graft-versus-host disease. therefore, modification of hsct recipients' gut microbiota using fecal transplantation from a healthy donor could be used to treat gut acute gvhd. the study evaluates safety and feasibility of fecal microbiota transplantation with frozen capsules from healthy donors for the treatment of steroid resistant or steroid dependent acute graft-versus-host disease of the gut.


Eligibility criteria:
inclusion criteria: * adults (ages 18 to 75 years) who underwent allogeneic hematopoietic stem cell transplantation (hsct) and developed gut acute graft-versus-host disease (agvhd). * participants have steroid-resistant or steroid-dependent gut agvhd. * steroid resistant gut agvhd is defined as cases in which gastrointestinal symptoms do not improve within 7 days after initial steroid therapy (≥1 mg/kg of methylprednisolone) or clear progression after 5 days.) * steroid-dependent gut agvhd is defined as cases in which reduction of steroid dose was not possible due to exacerbation of gastrointestinal symptoms. * participants may have undergone allogeneic hsct for any diagnosis at any time prior to developing agvhd, and are not restricted to any specific conditioning regimen or by the subsequent administration of donor lymphocyte infusion. * participants should be able to give informed consent. exclusion criteria: * participants may not have gut agvhd which permits the tapering of steroid dose. * participants may not have ongoing, uncontrolled infection (i.e. unresolved bacteremia, uncontrolled cmv infection). * participants may not have ongoing enteritis primarily caused by enteropathy other than gut gvhd, excluding resistant clostridium difficile infection. * participants may not have acute neutrophil count \< 500 cells/µl. * participants may not have toxic megacolon * participants may not have active gastrointestinal bleeding. * participants may not be pregnant or lactating. * participants may not be unable to swallow pills.

Keywords: fecal microbiota transplantation intestinal acute graft versus host disease hematopoietic stem cell transplantation
study of the inflammatory reaction in standard vs single port cholecystectomy for uncomplicated cholelithiasis

Conditions: Cholelithiasis; Inflammatory Response

Summary: this is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy vs single port laparoscopic (sil) cholecystectomy. it is assumed that the reduced trauma in sil cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic cholecystectomy.

two groups of 20 patients each are included in this study. pre operatively, 6 and 24 hours postoperatively, blood is taken from these patients, it is centrifuged and the plasma is taken. il-6, a-defensins and crp are measured for each sample.

Eligibility criteria:
inclusion criteria: * uncomplicated cholelithiasis * american society of anesthesiologists (asa) i or ii * no previous operations in upper abdomen * body mass index (bmi) \<30 exclusion criteria: * cholecystitis * asa \> ii * bmi\>30 * previous operations in upper abdomen * previous operations in intestine

Keywords: sils inflammatory reaction a-defensins sils vs standard laparoscopic cholecystectomy
home telehealth follow-up after hospital discharge for chronic obstructive pulmonary disease (copd) patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to assess the effects of a complex telemedicine intervention as a part of an integrated care program for patients with chronic obstructive pulmonary disease (copd) discharged from the hospital after disease exacerbation. will be evaluated whether the intervention produces benefits in terms of mortality, reduction in hospital readmissions and health-related quality of life. in addition, the trial evaluates the economical and organizational impact of the new service and examines its acceptability by patients and health professionals.


Eligibility criteria:
inclusion criteria: * exacerbation of copd * age \> 40 years * capability to use the devices provided * willing to participate exclusion criteria: • participation in a previous copd home telehealth study
strategies for defibrillation during out-of-hospital cardiac arrest

Conditions: Cardiac Arrest (CA)

Summary: the "strategies for defibrillation during out-of-hospital cardiac arrest" (strat-defi) trial is an investigator-initiated, individually randomized, 3-group clinical trial comparing standard anterior-lateral pad positioning with anterior-posterior positioning and double sequential defibrillation during adult out-of-hospital cardiac arrest.


Eligibility criteria:
inclusion criteria: 1. out-of-hospital cardiac arrest 2. age ≥ 18 years 3. ≥ 1 manual defibrillation attempt by emergency medical services 4. shockable rhythm as the last known rhythm 5. two manual defibrillators present on-site exclusion criteria: 1. blunt trauma, penetrating trauma, or burn injury suspected to be the cause of the cardiac arrest 2. prior enrollment in the trial 3. posterior pad placement not deemed possible by on-site clinician

Keywords: out-of-hospital cardiac arrest defibrillation double-sequential defibrillation
the validity of modern mobile applications in management of covid-19 home isolation patients: a survey for health care professionals

Conditions: the Use of Modern Technology Applications in Home Isolation

Summary: in late 2019, a novel coronavirus, sars-cov-2, was identified as the causative agent of a cluster of pneumonia cases (covid-19) in wuhan, china. clinical symptoms of covid-19 may be mild or severe. the location where a person will self-isolate will be determined by their healthcare provider and their health authority. when determining the location, several factors to determine the suitability of the home setting are described as the case should stay in a room of their own so that they can be isolated from other household members. the rapid increase and evolution of modern mobile applications for communication and messaging for personal purposes have proved great benefit in healthcare management


Eligibility criteria:
inclusion criteria: * healthcare professionals in ain shams university, cairo, egypt. exclusion criteria: * junior staff
profile of chronic musculoskeletal pain patients related to treatment adherence and virtual reality

Conditions: Chronic Musculoskeletal Pain

Summary: lack of adherence is one of the main problems of chronic musculoskeletal pain treatment. to improve adherence it is essential to take into account the characteristics of the patients and their thoughts and beliefs about pain. virtual reality can present some advantages in the face of these problems too. the objective of this study is to evaluate the profile of chronic musculoskeletal pain patients, the barriers associated with lack of adherence to treatment, and the interest of virtual reality in rehabilitation.

* background: lack of adherence is one of the main problems of chronic musculoskeletal pain treatment. to improve adherence it is essential to take into account the characteristics of the patients and their thoughts and beliefs about pain. virtual reality can present some advantages in the face of these problems too. * objectives: evaluate the profile of chronic musculoskeletal pain patients, the barriers associated with lack of adherence to treatment, and the interest of virtual reality in rehabilitation. * methodology: observational study. the profile of chronic musculoskeletal pain patients will be described. patients will be recruited using the snowball method. the evaluation will be carried out via telematics through the use of videoconference and surveys. we will evaluate chronic pain and characteristics, kinesiophobia, functionality, quality of life, psychosocial aspects and other related outcomes. we will identify barriers associated to treatment adherence and we will evaluate patients' perception of rehabilitation with virtual reality.

Eligibility criteria:
inclusion criteria: * chronic musculoskeletal pain (≥ 3 months) * adults (≥ 18 years) * have a computer or mobile device/basic knowledge and access to the internet * wish to participate in the study and sign the informed consent exclusion criteria: all those participants who present any physical pathology or of any kind that imply an inability to understand the necessary instructions to carry out the study will be excluded.
leber congenital amaurosis inherited blindness of gene therapy trial(light)

Conditions: Leber Congenital Amaurosis

Summary: the purpose of the study is to determine whether hg004 as gene therapy is safe and effective for the treatment of leber congenital amaurosis caused by mutationsin rpe65 gene.


Eligibility criteria:
inclusion criteria: * male or females between 8 and 50 years of age at the time of signing theinformed consent form. * willing to adhere to protocol as evidenced by written informed consent orparental permission and subject assent. * clinical confirmed diagnosis of leber congenital amaurosis (lca) andmolecular diagnosis of lca due to rpe65 mutations. * ability to perform tests of visual and retinal function. * visual acuity of ≤ 20/160 or visual field less than 20 degrees in the eye to beinjected. * acceptable hematology, clinical chemistry, and urine laboratory parameters. exclusion criteria: * oct examination determined that the outer nuclear layer was not visible inthe planned injection area (bleb) in the study eye. * presence of epiretinal membrane by oct. * complicating systemic diseases or clinically significant abnormal baselinelaboratory values. * complicating systemic diseases would include those in which the diseaseitself, or the treatment for the disease, can alter ocular function. * prior ocular surgery within six months. * prior gene therapy or oligonucleotide therapy treatments. * any other condition that would not allow the potential subject to completefollow-up examinations during the study and would, in the opinion of theinvestigator, make the potential subject unsuitable for the study.
an n-of-1 study of homeopathic treatment of fatigue in patients receiving chemotherapy

Conditions: Fatigue; Effects of Chemotherapy

Summary: fatigue is frequently identified as one of the most troublesome symptoms in cancer patients and there are very few conventional therapies which can address the symptom of fatigue in patients who are undergoing cancer treatment. this study will be testing whether the administration of a complementary therapy (individualized homeopathy) to a patient undergoing chemotherapy treatment is feasible and whether this treatment can lessen the fatigue symptoms of adults. the study will also test whether the n-of-1 study design is feasible in this population.

this is an n-of-1 pilot trial of individualized homeopathic treatment of fatigue in a single adult who is undergoing any type of chemotherapy administered intermittently (i.e. not continuously). the participant will have a homeopathic consultation within 3 days of a round of chemotherapy ("treatment period") and will be administered either verum or placebo according to a binary randomization allocation sequence unknown to both the clinician and participant. during the subsequent treatment period the participant will be given the other allocation (verum or placebo). the following pairs of allocations will also be randomized with treatment continuing for as long as the participant is undergoing chemotherapy treatment.

Eligibility criteria:
inclusion criteria: * diagnosed with any type of cancer. patient may have newly diagnosed, relapsed or a second malignant disease. * receiving any type of cytotoxic chemotherapy with 6 or more cycles post study enrollment administered intermittently every two or three weeks with no planned radiation treatment. * is experiencing fatigue due to the chemotherapy treatments. (or has a score of 2 or higher on the fatigue item of the symptom distress scale) * above 18 years of age. * able to ingest medications in lactose/sucrose globule or liquid form. exclusion criteria: * previous history of allergy to the homeopathic products. * pregnant or lactating

Keywords: homeopathy fatigue chemotherapy cancer
addressing disability effectively with psychosocial telemedicine

Conditions: Crohn Disease

Summary: this multi-site study will be implemented at 5 gastroenterology practices to recruit 420 adults with ibd to complete a baseline survey and enroll those with higher scores on a validated ibd-disability scale into a randomized controlled trial of telehealth-delivered cognitive behavioral therapy with a licensed psychologist versus usual care. the investigators aim to lay the foundations that will shift the paradigm of ibd clinical practice towards a new horizon of holistic and equitable high-value care.


Eligibility criteria:
inclusion criteria: 1. adults ≥18 years old with a diagnosis of crohn's disease (cd) or ulcerative colitis (uc) 2. willingness to complete the baseline survey online. participants in aim 1 with moderate-to-severe disability based on the ibd disability index (ibd-di) will be invited to the aim 2 clinical trial 3. able to consent and complete surveys in english. exclusion criteria: 1. no/low disability (ibd-di \<35) on the baseline survey 2. inability or unwillingness to participate in telemedicine with a therapist 3. have an existing relationship with a mental health specialist within the past 3 months 4. lack of access to a computer, working internet connection, and a private environment to complete teletherapy sessions if they are randomized to this intervention
protocol for camus nurse delphi study

Conditions: Perioperative/Postoperative Complications; Urologic Diseases

Summary: multi-staged, international nurse delphi study that aims to validate the newly proposed camus system and camus cci in an experienced nursing staff population.

background: comprehensive and reproducible assessment of post-operative complications are essential for reliable evaluation of quality of care and subsequent reformation of hospital safety infrastructure. at present, significant discrepancies exist in complication reporting and grading, and current complication systems lack holistic assessment of patient care by failing to consider and incorporate nursing insight and perception of patient burden. objective: to gain experienced nursing perspective on current and future complication reporting and grading in urology, validate the camus-cci, and quality control the use of the cdc in nurses. design, setting, and participants: the 12 part redcap-based delphi survey was developed in conjunction with methodologist review, experienced nursing and urologist opinion. certified local and international inpatient and outpatient nurses specialised in urology, perioperative nurses, and urology-specific advanced practice nurses/nurse practitioners will be included. a minimum sample size of 250 participants is targeted. outcome measurements and statistical analysis: the survey assesses participant demographics, nursing experience and opinion on complication reporting and the proposed camus reporting recommendations, grading of intervention events using the existing clavien-dindo classification and the proposed camus classification, and rating various clinical scenarios. consensus will be defined as ≥75% agreement. if consensus is not reached, subsequent delphi rounds will be performed under steering committee guidance.

Eligibility criteria:
inclusion criteria: * certified nurses * local or international nurses * inpatient or outpatient nurses * peri-operative nurses * urology-specific advanced practice nurses/nurse practitioners exclusion criteria: * under 18 years of age
a clinical study to evaluate the safety and efficacy of etx101 in infants and children with scn1a-positive dravet syndrome

Conditions: Dravet Syndrome

Summary: endeavor is a phase 1/2, 2-part, multicenter study to evaluate the safety and efficacy of etx101 in participants with scn1a-positive dravet syndrome aged ≥6 to \<36 months (part 1) and aged ≥6 to \<48 months (part 2). part 1 follows an open-label, dose-escalation design, and part 2 is a randomized, double-blind, sham delayed-treatment control, dose-selection study.


Eligibility criteria:
inclusion criteria: * participant must be aged between ≥6 months and \<36 months in part 1 and \<48 months in part 2. * participant must have a predicted loss of function pathogenic or likely pathogenic scn1a variant. * participant must have experienced their first seizure between the ages of 3 and 15 months. * participant must have a clinical diagnosis of dravet syndrome or the treating clinician must have a high clinical suspicion of a diagnosis of dravet syndrome. * participant is receiving at least one prophylactic antiseizure medication. exclusion criteria: * participant has another genetic mutation or clinical comorbidity which could potentially confound the typical dravet phenotype. * participant has a known central nervous system structural and/or vascular abnormality (indicated by an mri or ct scan of the brain). * participant has an abnormality that may interfere with csf distribution and/or has an existing ventriculoperitoneal shunt. * participant is currently taking or has taken antiseizure medications (asms) at a therapeutic dose that are contraindicated in dravet syndrome, including sodium channel blockers. * participant has experienced seizure freedom for a period of 4 consecutive weeks within the 90-day period prior to informed consent. * participant has previously received gene or cell therapy. * participant is currently enrolled in a clinical trial or receiving an investigational therapy, including under an expanded access and/or compassionate use program. * participant has clinically significant underlying liver disease.

Keywords: dravet scn1a dee developmental and epileptic encephalopathy dravet syndrome scn1a-positive scn1a+