Kornimate/medical-research-clean huggingface dataset:
effectiveness of sacral neuromodulation in low anterior resection syndrome

Conditions: Low Anterior Resection Syndrome; Sacral Neuromodulation - Interstim Therapy; Rectal Cancer

Summary: low anterior resection syndrome (lars) is a complex disorder suffered by patients who undergo rectal resection mainly due to rectal cancer. it is characterized by fecal incontinence, fragmented defecation, constipation, defecatory urgency among others, which induce an impairment in quality of life. lars treatment armamentarium is scarce and with no long-term relief, being a difficult challenge for surgeons. there is evidence showing that sacral neuromodulation (snm) improves patients' symptoms and quality of life. however, no prospective randomized studies have supported this improvement. this is a prospective randomized cross-over study which evaluates the effectiveness of snm in lars, specifically analyzing intestinal, urinary, sexual symptoms as well as quality of life.


Eligibility criteria:
inclusion criteria: * patients who have had an anterior rectal resection with sphincter preservation by any approach, with or without preoperative radiotherapy. * patients with symptomatology of major anterior resection syndrome (\>29 points on lars score) including fecal incontinence, defecatory urgency, fecal fragmentation. * period greater than one year since the last definitive surgery (rectal resection or ileostomy closure). * period longer than one year in cases in which any other type of therapy has been performed for the anterior resection syndrome (for example: biofeedback, posterior tibial stimulation, physiotherapy, etc). exclusion criteria: * patients who refuse to sign informed consent or are unable to understand the study. * patients with progression of the oncological disease. * patients in initial stage iv (metastatic). * patients with inflammatory bowel disease. * patients with known irritable bowel prior to rectal surgery. * patients who have undergone resection of other intestinal segments. * patients with systemic neurological diseases with involvement of long pathways or spinal cord injury.
safety and efficacy study of transumbilical laparoendoscopic single site cholecystectomy

Conditions: Gallstone; Gallbladder Polyps

Summary: the purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy.

as the natural orifice during embryonic, the transumbilical surgery not only can mask the abdominal scar and avoid infection produced by puncturing stomach, vagina or rectum in notes,but also can be played by the conventional laparoscopic instruments. tu-less (transumbilical laparoendoscopic single site surgery), is considered to be the most feasible notes(natural orifice transluminal endoscopic surgery)technology at present. researches about tu-less mostly are case reports and small samples or the control experiments up to now,there are not persuasive randomized controlled trail between tu-less and conventional laparoscopic cholecystectomy. so the investigators design this prospective randomized controlled trail to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy .

Eligibility criteria:
inclusion criteria: * 18 years to 5 years * benign gallbladder diseases * kps ≥ 70 * informed consent exclusion criteria: * obstructive jaundice * broadening of the common bile duct * gallstone pancreatitis * serious heart,brain,lung, metabolic diseases history * history of upper abdominal surgery * pregnancy or breast-feeding women * refuse tu-lessc * bmi(body mass index)≥ 30

Keywords: laparoscopic cholecystectomy single site randomized controlled trail
an observational study of patients with endometriosis to evaluate the usefulness of the medl score, a new method for evaluating endometriosis using mri

Conditions: Endometriosis

Summary: the purpose of this study is to confirm the reproducibility that the medl score can be evaluated by magnetic resonance imaging (mri) in the similar way as laparoscopy, the gold standard for the evaluation of the disease state of endometriosis, in order to establish the medl score, a new evaluation index for endometriosis using mri. approximately 70-90 patients with endometriosis diagnosed by imaging and who are candidates for fertility-preserving surgery will be recruited retrospectively or prospectively, and the disease status of endometriosis will be evaluated using preoperative mr images, laparoscopic surgery videos, etc. the relationship between the condition and clinical symptoms, such as pain, is also considered.


Eligibility criteria:
inclusion criteria: * patients who consent to use their data in this study * patients with endometriosis diagnosed by transvaginal ultrasound (tvus) and/or mri * patients undergoing fertility-preserving surgery * patients with pain due to endometriosis * patients with endometriotic lesions other than ovarian cysts confirmed by mri (concomitant ovarian cysts can be recruited) * patients with the following patient clinical information (tvus is not mandatory when archived data is used) patient clinical information: preoperative mr images, videos of laparoscopic surgery, pathological evaluation of endometriosis, videos of preoperative tvus, pain information related to endometriosis, information about infertility before surgery, information on qol, information on postoperative recurrence, information on surgical difficulty, operating time, length of hospital stay for surgical operation, age, history of treatment (drugs, surgery), anamnesis and complication, history of endometriosis, age at menarche, menstrual cycle, date of surgery, date of mr image acquisition, operative procedure and history of pregnancy and childbirth. exclusion criteria: * patients who had surgery for endometriosis prior to the surgery included in this study * patients deemed inappropriate by the principal investigator * patients who obtained their voluntary consent but later withdrew their consent
ultrasound in evaluating muscle-glycogen content in cancer patients

Conditions: Cachexia; Malignant Solid Neoplasm

Summary: this trial studies how well an ultrasound procedure (non-invasive musclesound technology) can be used to learn about levels of glycogen (a type of sugar) in cancer patients during inpatient rehabilitation. the ultrasound information will be processed to represent the energy storage in the muscle. the energy storage in the muscle may help future research to look for dietary plans that can help to increase energy storage, patient exercise tolerance, and functional improvement.

primary objectives: i. determine feasibility of using non-invasive musclesound technology to determine glycogen stores in cancer patients. exploratory objectives: i. determine the baseline glycogen storage in two different groups of cancer patients, who are undergoing inpatient rehabilitation: (1) those with cachexia; (2) those without cachexia. ii. determine the rate of depletion of muscle-glycogen stores by calculating the "fuel rating" score (frs) at baseline, after 10-min of exercise and then again after 20-min of exercise. iii. determine if there is any correlation between muscle-glycogen (at baseline and its depletion rate over time) and other factors including cancer type, cancer stage, patient age, patient sex, current body mass index (bmi), presence or absence of cachexia, functional measures and patient reported outcomes. outline: patients undergo ultrasound via musclesound technology over 3 minutes at baseline and immediately after each of 2 physical therapy sessions comprising cycling or walking over 10 minutes.

Eligibility criteria:
inclusion criteria: * participants are willing and able to give written informed consent and to comply with study procedures. * patients with a biopsy-confirmed solid malignant neoplasm with at least one neurologically-intact lower extremity, who fit into one of the following groups: * group 1: patients with cachexia, defined by loss of \> 5% of body weight over the preceding 6-months (in absence of simple starvation defined as intentional weight loss) or weight loss \> 2% with bmi \< 20. * group 2: patients without cachexia, as defined above. * patients who have a record of weight or bmi over preceding 6-months. * patients must be receiving rehabilitation that includes exercise under the direction of a physical therapist. exclusion criteria: * non-english speaking patients. * patient with neurological compromise of both lower extremities causing muscle atrophy. * underlying unstable medical condition (i.e: cardiac, pulmonary, or hematological) or musculoskeletal injury, which in the opinion of the investigator, limits participation in exercise of the measured lower extremity. * patients who are unable to understand or follow through with study instructions.
pain control in hip arthroscopy: comparing lumbar plexus versus peri-capsular injection

Conditions: Nerve Block; Hip Arthroscopy

Summary: comparison of lumbar plexus nerve block versus pericapsular injection for pain control during hip arthroscopy

the purpose of this study is to compare two different methods of pain control during and after hip arthroscopy surgery. it is not clear which of many different pain control methods are ideal to reduce pain for patients; consequently, the investigators are performing this study to compare the two main choices for pain control commonly used in order to identify if either is superior to the other.

Eligibility criteria:
inclusion criteria: 1. patient scheduled to undergo hip arthroscopy with dr. wolff 2. patient age between 25 and 60 years of age. exclusion criteria: 1. patient has known allergy to ropivicaine or morphine. 2. patient unable to speak/read english (no translators available in clinic site). 3. pregnant female. 4. patient has a pre-operative narcotic use for hip pain 5. patient has pre-existing chronic pain disorder (i.e. fibromyalgia)
platelet tissue factor as biomarker of thrombotic risk in coronary artery disease patients (trit-one)

Conditions: Cardiovascular Diseases

Summary: enhancing thrombotic risk stratification in patients with coronary artery disease (cad) is crucial for the prevention and management of cardiovascular disease. existing risk scores, which predict mortality risk and/or the likelihood of adverse cardiovascular events, are based on clinical and laboratory parameters. however, none of these scores incorporates the elevated platelet activation observed in cad, a critical factor influencing disease progression. over the past two decades, research has consistently shown that activated platelets play a pivotal role in plaque formation. these platelets, together with fibrin, form the primary components of thrombi that obstruct coronary arteries, making them central to the pathogenesis of coronary syndromes. published studies have highlighted how platelet activation triggers the expression of tissue factor (tf), a key glycoprotein involved in blood coagulation and thrombotic complications in atherosclerosis. notably, in patients with coronary syndrome, platelet tf expression is significantly higher than in healthy individuals. the functional ability of platelet tf to generate thrombin further enhances the pro-thrombotic potential of these platelets, underscoring their critical role in thrombus formation. the objective of this study is to validate the predictive value of platelet tissue factor (tf) for cardiovascular events in a cohort of secondary prevention patients treated with antiplatelet drugs, including clopidogrel, ticagrelor, prasugrel, and/or aspirin. the primary endpoint is the assessment of all-cause mortality and cardiovascular death, over a 5-year follow-up period from admission.


Eligibility criteria:
inclusion criteria: patients of either sex, aged 18 years or older, with a diagnosis of acute or stable coronary syndrome, treated with anti-platelet drugs (aspirin and/or clopidogrel, prasugrel and ticagrelor) as per guidelines exclusion criteria: pregnant subjects (self-declared); subjects who have received blood transfusions in the last 30 days; subjects over 89 years of age; subjects with hereditary platelet disorders

Keywords: platelet tissue factor biomarker coronary artery diseases
evaluation of the synergistic impact of needle and forceps biopsy with electromagnetic navigation bronchoscopy

Conditions: Lung Cancer; Lung Cancer (Diagnosis)

Summary: this randomized crossover study aimed to evaluate whether a multimodal biopsy strategy using both needle and forceps can provide additive benefits compared with a single device for diagnosing peripheral pulmonary lesions with electromagnetic navigation bronchoscopy under moderate sedation and assess the comparative yield and discordance between the two devices.

this randomized crossover study aimed to evaluate whether combining electromagnetic navigation bronchoscopy (enb)-guided needle aspiration and forceps biopsy provides synergistic benefits, and compare the diagnostic performance of needle aspiration biopsy and forceps biopsy for diagnosis of pulmonary lesions. the investigators designed this study to prospectively enroll patients with lung lesions that warrant histologic diagnosis and are feasible for undergoing electromagnetic bronchoscopy under moderate sedation. participants will be randomized to two groups. one group will receive an enb-guided biopsy with lung lesion with needle aspiration followed by forceps biopsy (needle-first group), while the other groups will receive the same procedure with forceps biopsy followed by needle aspiration biopsy (forceps-first group). all participants will undergo enb under moderate sedation without the concurrent use of other guiding techniques such as fluoroscopy and radial endobronchial sonography. all participants will be followed up for up to 12 months to confirm the final diagnosis. the primary endpoint is the diagnostic accuracy of combined needle aspiration and forceps biopsy for diagnosing pulmonary lesions compared with forceps biopsy alone. diagnostic accuracy was defined as the proportion of participants in whom the biopsy yielded a definitive diagnosis, consistent with the strict definition; a biopsy procedure was considered diagnostic if the specimen established a definitive malignancy (true positive) or a specific benign diagnosis that sufficiently represented the lesion and informed further management (true negative) without the change in diagnosis through 12 months of follow-up. secondary endpoints include diagnostic accuracy of the combination compared with needle aspiration alone, sensitivity for malignancy, and the strictly defined diagnostic yield determined solely based on the enb procedural encounter, successful lesion approach, sampling duration, number of attempts for needle and forceps biopsy, and adverse events related to the enb procedure.

Eligibility criteria:
inclusion criteria: * patients with lung lesions with a possibility of malignancy and need tissue confirmation, which is eligible for enb procedure under moderate sedation exclusion criteria: * patients who disagree to participate

Keywords: electromagnetic navigation bronchoscopy bronchoscopy diagnosis
pregnancy and neonatal outcomes following antenatal exposure to raltegravir: a pooled analysis from the european pregnancy and paediatric infections cohort collaboration (eppicc)

Conditions: HIV Infections

Summary: raltegravir is the preferred insti for for treatment of antiretroviral-naïve pregnant women in the us perinatal guidelines, alongside dolutegravir, and for late pregnancy. there are relatively limited information available on its use during early pregnancy, particularly the peri-conception period. the aim of the study is to assess "real-world" maternal, fetal and newborn outcomes following ral use during pregnancy through pooled analysis of individual patient data from observational studies participating in the european pregnancy and paediatric infections cohort collaboration.


Eligibility criteria:
inclusion criteria: * pregnant women living with hiv, exposed to raltegravir at any time during the pregnancy participating in eppicc and their infants. exclusion criteria: * see inclusion
safety and efficacy of ibi322 in chinese subjects with advanced malignant tumors

Conditions: Advanced Malignancies

Summary: this is a phase i study evaluating the safety, tolerability and preliminary efficacy of ibi322 in cancer subjects who failed standard treatment.

phase 1a/ib study will be conducted to evaluate the tolerability, safety, pk, pd, immunogenicity and preliminary antitumor activity of ibi322 in china. phase 1a is dose escalation and plans to enroll approximately 38-60 subjects with advanced malignant solid tumors who failed the standard treatment. phase ib is dose expansion, and plans to enroll approximately 180 subjects with advanced malignant tumors.

Eligibility criteria:
inclusion criteria: 1. histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors. 2. at least one evaluable lesion. 3. male or female subject above 18 years old, no more than 75 years old. 4. eastern cooperative oncology group performance status (ecog ps) performance status 0 or 1. 5. must have adequate organ function exclusion criteria: 1. previous exposure to any anti-cd47 monoclonal antibody, sirpα antibody, or cd47/sirpα recombinant protein. 2. previous exposure to any anti-programmed death receptor 1 (pd-1) or anti-programmed death ligand 1 (pd-l1) /anti-programmed death ligand 2 (pd-l2) antibodies 3. subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies. 4. patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroids anti-inflammatory medications. patients with a history of a bleeding diathesis (von willebrand disease, end stage liver disease, hemophilia, etc.) 5. subjects who have a history of blood transfusion within 2 weeks prior to the study.

Keywords: oncology
cutaneous leishmaniasis diagnostic study

Conditions: Cutaneous Leishmaniases

Summary: the performance of the cl detect rapid test will be tested in individuals with suspected cutaneous leishmaniasis in ethiopia using both skin slit and dental broach samples against a combined reference of microscopy and pcr. alternative sampling methods will also be evaluated.

cutaneous leishmaniasis is common in ethiopia and mainly affects the poor living in rural areas. diagnosis of cl routinely uses invasive skin slits which are examined with microscopy, requiring trained staff and an equipped lab. a new rapid diagnostic test for cl which may be used in the field has been developed and validated in several countries where other leishmania species are present. less invasive tape sampling has also become available. whether this new rdt and alternative sampling methods can be used in ethiopia is unclear. the performance of the cl detect rapid test against a combined reference (microscopy and pcr) and alternative sample collection methods will be tested in cl suspected individuals in north-west ethiopia in a cross-sectional study.

Eligibility criteria:
inclusion criteria: - clinical suspicion of cl exclusion criteria: * ≤ 2 years of age * not willing or able to provide consent/assent * cl presentation with only lesions for which skin slit samples cannot be obtained (e.g. eyelids) * co-morbidity with visceral leishmaniasis * on cl treatment at time of enrollment

Keywords: cutaneous leishmaniasis ethiopia rdt
effect of taurolidin on prevention of bloodstream infection

Conditions: Sepsis

Summary: home parenteral nutrition (hpn) is a validated technique for patients with various intestinal disease leading to chronic malabsorption or obstruction, whatever the aetiology. intravascular catheter-related bloodstream infections (crbsi) is the more frequent complication of patients with hpn and an important cause of morbidity and mortality in these patients. moreover, crbsi often recur after a first treatment of the catheter with a combination of an antibiotic lock on the catheter and systemic intravenous antibiotics. in more than 50 % of the cases, another crbsi will occur in a median delay of 5 months. the aim of the study is to evaluate the efficacy of a taurolidine lock secondary prophylaxis on crbsi recurrence in hpn patients. study population is separated in 2 groups, the first one receiving the taurolock and the second one receiving a placebo. this is a randomized double-blind six-month study.


Eligibility criteria:
inclusion criteria: * age superior to 18 years * home parenteral nutrition on tunnelized central venous catheters * bloodstream infection confirmed by differential hemocultures * informed consent form signed * negative b-hcg test exclusion criteria: * subject unable to give his informed consent * pregnancy * subject who have a two or three-way catheter, or a non-tunnelized central venous catheter * hospital related infection * central venous catheters placed since less than 15 days * neutropenia \< 500 pnn/mm3 * fungal infection, polymicrobial who need ablation of the central venous catheters * no-response to clinical treatment of the infection * septic thrombophlebitis * chemotherapy ongoing * on going malignancy

Keywords: home parenteral nutrition sepsis prevention central venous catheters taurolidine
water hygiene versus waterless hygiene technology for totally dependent hospitalized patients

Conditions: Health Care Associated Infection

Summary: the aim of this randomized controlled trial is to verify whether the efficacy of perineal hygiene procedures performed in dependent patients admitted to medical or geriatric wards with pre-moistened wipes without water is higher than that found after procedures performed with disposable hand grips, soap, and water.

patients hospitalized in medicine and geriatrics wards will be admitted, both for scheduled and urgent hospitalizations. if the patient meets the study inclusion criteria, we will proceed with the description of the study, the delivery of the information form and the collection of informed consent. only after signing the consent, the patient can be enrolled in the study. the day following enrollment, the first perineal hygiene in the morning will be performed with pre-moistened wipes without water or with disposable hand grips, soap and water depending on the study group to which the patient has been randomly assigned. in both groups, a skin swab will be performed before and after the hygiene practice, after which the patient will leave the study.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age inclusive at the time of the study; * patients admitted to medical or geriatric wards with scheduled or urgent hospitalization; * hypothesis of hospitalization of at least 48 hours * totally dependent patients who are bedridden and unable to independently provide for their own personal hygiene. * patient-oriented in time and space/cognitively cooperative. * acquisition of written informed consent. exclusion criteria: * patients who have performed perineal hygiene with wipes or other methods containing antiseptic solutions in the 12-24 hours preceding the execution of the swab for the bacteriological examination. * patients who have undergone a treatment procedure in the groin and/or perineal area that required skin antisepsis (e.g. femoral blood sampling, bladder catheter insertion, etc.). * patients with known allergies to one of the components of the products used. * patients diagnosed with dermatological pathologies. * patients colonized or infected with microorganisms transmissible by contact. * patients in bowel cleansing preparation for diagnostic procedures e therapeutic. * patients with diarrheal bowel. * patients hospitalized on saturdays and sundays due to the difficulty of illustrating information and acquiring informed consent since healthcare professionals are small in number. * patient enrolled and then transferred to another ward or discharged before 48 hours.

Keywords: hygiene