Kornimate/medical-research-clean huggingface dataset:
anterior versus posterior laparoscopic mesh rectopexy for rectal prolapse; a randomized controlled trial.

Conditions: Rectal Prolapse

Summary: aim of this work is to compare results between laparoscopic anterior mesh rectopexy and laparoscopic posterior mesh rectopexy for patients with rectal prolapse by assessment of operative time, intraoperative blood loss , intraoperative organ injury, overall length of hospital stay, recurrence,and improvement of incontinence and constipation.

rectal prolapse is a disabling condition, which is more common in females and increases in frequency with age. there are two types of rectal prolapse; external and internal. external rectal prolapse is a circumferential protrusion of all layers of the rectum through the anal sphincter. internal rectal prolapse, also referred to as rectal intussusception. the majority of patients with a rp suffer from symptoms of fecal incontinence and constipation, causing a significant negative impact on quality of life. the aims of the surgical treatment are to correct the anatomical abnormality and to cure the accompanying symptoms of incontinence, constipation and pain, with the lowest rate of complications as possible and an acceptable rate of recurrence. since the emergence of minimally invasive surgery, laparoscopic techniques for the treatment for rp have been applied in patients of all ages.

Eligibility criteria:
inclusion criteria: * all patients with rectal prolapse either external or internal prolapse exclusion criteria: * age below 18 years. * pregnancy or breast-feeding. * recurrence of rectal prolapse. * patients with previous complicated abdominal surgery.
register study of patients with peritoneal carcinomatosis treated with pipac (pressurized intra-peritoneal aerosol-chemotherapy)

Conditions: Peritoneal Carcinomatosis

Summary: the study will follow up patients with peritoneal carcinomatosis from colorectal, ovarian, gastric, pancreatic cancers and primary peritoneal tumors and undergoing a diagnostic laparoscopy / laparotomy, a pipac as single dose or repeated every 6 weeks. the overall response rate (orr), the overall survival (os) and the quality of life will be assessed before every pipac. biopsies of the peritoneal carcinomatosis and blood (plasma and serum) are collected with every pipac intervention to follow up and to document the individual success or progress of the patients. the advice of the tumor board is mandatory to confirm the indication for local chemotherapy (pipac).


Eligibility criteria:
inclusion criteria: * patient with clinical and pathological confirmed peritoneal carcinomatosis from gastric, colorectal, pancreatic, ovarian cancers or primary peritoneal tumors * age \> 18 years * signed informed consent exclusion criteria: * patient can not understand meaning and purpose of the study
mrd-directed donor lymphocyte infusion for reduce of relapse after allo-hsct

Conditions: Minimal Residual Disease; Donor Lymphocyte Infusion; Hematopoietic Stem Cell Transplantation; Relapse

Summary: allogeneic hematopoietic cell transplantation (allo-hsct) is an effective therapy for acute leukemia, but relapse remains an important problem. therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (dli), and another transplantation used alone or in combination. however, the efficacy of these interventions is limited. one approach to the relapse problem is to intervene before hematologic or pathologic relapse occurs based on minimal residual disease (mrd). in this study, the efficacy of mrd-directed dli on transplantation outcomes will be evaluated in patients with acute leukemia receiving allo-hsct.

allogeneic hematopoietic cell transplantation (allo-hsct) is an effective therapy for acute leukemia, but relapse remains an important problem. therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (dli), and another transplantation used alone or in combination. however, the efficacy of these interventions is limited. one approach to the relapse problem is to intervene before hematologic or pathologic relapse occurs based on minimal residual disease (mrd) using immune or molecular techniques.dli is an effective post-transplantation therapy for prophylaxis of leukemia relapse, but is associated with a substantial risk of gvhd. whether mrd-directed dli could improve outcomes remains unclear. in this study, the efficacy of mrd-directed dli on transplantation outcomes will be evaluated in patients with acute leukemia receiving allo-hsct.

Eligibility criteria:
inclusion criteria: * patients with acute leukemia * receiving allo-hsct exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)
evaluation of a physical therapy protocol on quality of life musculoskeletal pain and anxiety in women with preeclampsia

Conditions: Pre-eclampsia or Eclampsia With Pre-existing Hypertension

Summary: the purpose of this study is to verify that the implementation of a protocol physiotherapy musculoskeletal pain and reduces anxiety and improves quality of life in patients hospitalized at the clinic of high-risk pregnancies at the hospital das clinicas of ribeirao preto, with a diagnosis of preeclampsia and chronic hypertension with superimposed preeclampsia. where patients will be recruited, answered questionnaires before and after application of physiotherapy protocol.

the hypertensive disorders in pregnancy affect approximately 5-8% of pregnant women worldwide, contributing significantly to serious maternal and fetal complications. there are various forms of hypertensive disorders that occur during pregnancy and among them are pre-eclampsia and chronic hypertension with superimposed preeclampsia. these two disorders present with high blood pressure and proteinuria, which leads often to hospitalization of these women. it is believed that with such an accent hospitalization occur in pain conditions that often affect pregnant women. given these complications, this study aims to evaluate the effectiveness of a physical therapy protocol used in pregnant women with preeclampsia admitted with respect to blood pressure levels, responses maternal-fetal and perinatal, and measure an expected improvement in quality of life in the reduction of reported pain and anxiety. the study will include the participation of women with preeclampsia and chronic hypertension with superimposed pre-eclampsia, hospitalized, with no significant complications that may hinder the normal progress of pregnancy. pregnant women will answer questionnaires about quality of life, anxiety and scales to identify musculoskeletal discomfort. monitoring will be done both the pregnant woman and the fetus through imaging and laboratory, in addition, pregnant women carry the exercise protocol previously proposed work. this is expected to achieve satisfactory results in the improvement of maternal and fetal hemodynamics in aspects of muscle discomfort and quality of life in a secure way for these women.

Eligibility criteria:
inclusion criteria: * pregnant women with gestational age between 24 and 38 weeks * hospitalized in the sector of high-risk pregnancy clinic of the hospital of ribeirão preto with diagnosis of preeclampsia and chronic hypertension with superimposed pre-eclampsia * with the absence of other maternal diseases and absence of fetal diseases by diagnostic ultrasound examinations and fetal exclusion criteria: * pregnant women who became symptomatic (blurred vision, epigastric pain, headache) secondary to the hypertensive process;
nintedanib (bibf 1120) vs placebo in refractory metastatic colorectal cancer (lume-colon 1)

Conditions: Colorectal Neoplasms

Summary: the objective of this phase iii study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mcrc) after failure of previous treatment with standard chemotherapy and biological agents.


Eligibility criteria:
inclusion criteria: * age \>= 18 years * signed informed consent * histologically or cytologically confirmed colorectal adenocarcinoma * metastatic or locally advanced disease not amenable to curative surgery and/or radiotherapy * eastern cooperative oncology group (ecog) performance status = 1 * at least one measurable lesion according to response evaluation criteria in solid tumours (recist) version 1.1 * progression on standard therapies or withdrawn from standard treatment due to unacceptable toxicity. previous standard treatment must include all of the following: * - fluoropyrimidine * - oxaliplatin: patients treated with oxaliplatin in adjuvant setting should have progressed within 6 months of completion of adjuvant therapy or they must have been treated with oxaliplatin for metastatic disease * - irinotecan * - bevacizumab or aflibercept * - cetuximab or panitumumab for patients with k-ras wt or ras wt tumours * - the remaining standard available therapy as recommended by investigator is best supportive care (note: previous treatment with regorafenib and tas 102 are allowed and these agents should be administered before study if available to patient according to local standards) * - life expectancy of at least 12 weeks * - hepatic function: aspartate aminotransferase (ast)/ alanine amino transferase (alt) = 1.5 x upper limit of normal (uln) and bilirubin = uln for patients without liver metastases. ast/alt = 2.5 x uln and bilirubin = uln for patients with liver metastases. patients with gilbert syndrome and bilirubin \< 2 x uln and normal ast/alt are eligible * coagulation parameters: international normalised ratio (inr) \< 2 and partial prothrombin time (ptt) = 2xuln exclusion criteria: * previous treatment with nintedanib * toxicity attributed to previous anticancer therapy that did not resolve to common terminology criteria for adverse events (ctcae) grade =1 * history of other malignancies in the last 5 years, in particular those that could interfere with interpretation of results. * serious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, * significant cardiovascular diseases * history of severe haemorrhagic or thromboembolic event in the past 12 months * bleeding or thrombotic disorders requiring anticoagulant therapy such as warfarin, or similar agents requiring therapeutic inr monitoring * gastrointestinal disorders or abnormalities that would interfere with absorption of study drug * patient with brain metastases that are symptomatic and/or require therapy. * patients of childbearing potential who are sexually active and unwilling to use a highly effective method of contraception * pregnancy or breast-feeding.
cognitive behavior therapy (cbt) and psychological status and immune function

Conditions: Colorectal Cancer; Cognitive Behavior Therapy; Immune Function

Summary: to explore the effect of cbt on psychological status of colorectal cancer patients undergoing chemotherapy. to explore the effect of cbt on immune function of colorectal cancer patients undergoing chemotherapy.

cancer patients undergoing chemotherapy are often subjected to considerable psychological stress. cbt is considered as one of the effective methods to relieve stress. cbt is effective in alleviating depression and anxiety, but the effect of cbt on cognitive and immune function in patients with colorectal cancer undergoing chemotherapy remains uninvestigated.

Eligibility criteria:
inclusion criteria: 1.18≤age≤75; 2.being scheduled to undergo colorectal cancer surgery; 3.being able to complete all the assessment. exclusion criteria: 1. having a history of tumor, mental disorders(including dementia), brain trauma or other cerebral diseases; 2. having severe depression and anxiety currently; 3. having alcohol dependence or other substance dependence; 4. having serious physical illness; 5. participating in other clinical studies.
microbiology studies of acute head and neck infections

Conditions: Head and Neck Infection

Summary: acute head and neck infections cause significant pain and discomfort for patients and impact on their quality of life. effective antibiotic and surgical treatments have been developed for these infections but they are still able to develop into life-threatening diseases such as meningitis and sepsis. the direct cause of acute head and neck infections is often unknown but it has been suggested that they are due to a disturbance of the normal bacterial growing in the mouth or are from dental origin. the most common microorganisms identified from these infections in published studies are a group of bacteria known as viridans group streptococci (vgs). there are over 30 individual species of bacteria in the viridans group and vgs are difficult to identify to the level of a single species because of their variability. there is a lack of species identification within the hospital setting and this project aims to gain a deeper understanding of the microorganisms causing acute head and neck infections, focusing on identification of individual species of vgs bacteria. the investigators will analyse bacterial dna to determine which species have been identified and will also look at patient data and clinical outcomes (eg. length of hospital stay) to determine if the species causing the infection has any effect on patients.


Eligibility criteria:
inclusion criteria: * over the age of 18 * suffering with acute head and neck infection of streptococci. * samples must come from northampton general hospital. * consent to participate in research with at least 24 hours of consideration. exclusion criteria: * age \<18 years. * samples from other national health service (nhs) hospitals. * infections from other areas of the body. * infection identified as caused by non-streptococcal bacteria. * chosen not to participate in research.
brain activity changes after cognitive behavioral therapy for anxiety in autistic youth from high-need communities

Conditions: Autism Spectrum Disorder; Anxiety

Summary: the goal of this clinical trial is to investigate neural constructs related to anxiety symptoms in response to facing your fears (fyf) treatment in autistic participants with co-occurring anxiety. researchers will compare participants receiving immediate fyf intervention to those in the waitlist control group (receiving treatment as usual) to see if there are differences in neural constructs and anxiety symptom changes over the study period. participants will: * complete the facing your fears (fyf) intervention if assigned to the immediate treatment group * continue their usual treatment during a waitlist period if assigned to the control group, followed by the opportunity to participate in fyf intervention after the waiting period ends * complete assessments of neural constructs, anxiety symptoms, and other measures

aims of the study: * how do brain activity patterns (measured by eeg) relate to anxiety symptoms in autistic youth, as reported by both the youth and their parents? * will brain activity changes line up with improvements in anxiety after fyf treatment in autistic youth from underserved communities? * will brain activity relate to other factors related to anxiety (e.g., a person's ability to handle uncertainty and manage emotions)?

Eligibility criteria:
inclusion criteria: * between the ages of 8 and 14 * have significant deficits in reciprocal social behavior as defined by a score of 11 or above on the parent-report scq questionnaire * are verbally fluent in english, enabling them to participate in the appropriate modules (3 or 4) of the researcher-administered ados-2 * have an estimated verbal iq of 70 or above as determined by the researcher-administered kbit-2 * have clinically significant anxiety symptoms as defined by significant elevations on either the parent-report scared questionnaire or the parent-report pras-asd questionnaire * have a legal guardian who can provide consent for their child's participation as well as their own participation in the intervention alongside their child. if the legal guardian is unable to participate in the intervention themselves but would like for their child to receive the intervention with another caregiver who lives with the child, the legal guardian will still be the one to sign the consent form, but will provide permission for another caregiver (logged on the consent form) to participate in the intervention alongside the child exclusion criteria: * fail to meet any of the above inclusion criteria * if it is determined by the research team via parent report or direct observation that the child has a severe medical or psychiatric impairment (e.g., psychosis, severe aggressive behavior, or other severe clinical symptoms) that require more intensive treatment such as day treatment or hospitalization

Keywords: autism autism spectrum disorder anxiety youth randomized controlled trial cognitive behavioral therapy electroencephalogram
use of molecular breast imaging (mbi) to detect additional disease in women with breast cancer who are about to go to surgery

Conditions: Breast Cancer

Summary: conventional mammography is not a reliable method for determining the extent of disease in women with breast cancer. molecular breast imaging (mbi) is a new nuclear medicine technique that allows the breast to be imaged in a manner similar to mammography, but without the pain of compression. initial results with this method have shown it is very good at detecting small breast cancers (\~1/4 inch). the purpose of this study is to see if mbi is a better method than mammography in determining how much cancer is present before a woman goes to surgery. the study will comprise 120 women with breast cancer who are going to surgery. the investigators hope that this study will demonstrate that mbi will be more accurate in determining how much cancer is present.

the sensitivity of conventional mammography for evaluation of extent of disease, detection of multifocal breast cancers and contralateral breast cancers is poor. molecular breast imaging (mbi) is a new nuclear medicine technique that permits the breast to be imaged in a manner similar to mammography, utilizing a cadmium-zinc-telluride (czt) gamma camera. we have developed the first dual-head mbi system in the world and preliminary results from this system indicate a high sensitivity (\~90%) for the detection of breast cancers \< 10mm. the aim of this study is to determine the sensitivity of mbi relative to mammography in the preoperative evaluation of the extent of disease in the ipsilateral and contralateral breasts in women with biopsy-proven breast cancer. we will test the hypothesis that mbi is more sensitive than mammography for preoperative evaluation and surgical planning. the study will comprise 120 women with biopsy-proven breast cancer prior to surgery. all patients will have a diagnostic mammogram and an mbi study prior to operation. at the time of operation the pathologic findings will be correlated with both the mammogram and the mbi results. this study will demonstrate the use of mbi in three aspects of breast cancer diagnosis: 1) detection of multifocal / multicentric disease elsewhere in the ipsilateral breast, 2) detection of contralateral breast cancer, and 3) correlation of index tumor size on mbi with pathologic size. these results may justify a role for mbi in the routine pre-operative evaluation of breast cancer patients.

Eligibility criteria:
inclusion criteria: * women with biopsy-proven breast cancer (invasive breast cancer or ductal carcinoma in situ) exclusion criteria: * unable to understand and sign the consent form * pregnant or lactating * physically unable to sit upright and still for 40 minutes * currently receiving neoadjuvant chemotherapy or hormonal therapy * currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor * previous mastectomy * previous excisional biopsy of the index breast cancer

Keywords: molecular breast imaging breast cancer mammography
a pharmacokinetics, safety and tolerability study of multiple formulations of bms-986231 in healthy participants

Conditions: Heart Failure

Summary: main objective of this study is to compare the single intravenous (iv) infusion pharmacokinetics (pk) of bms-986231 and its metabolites (bmt-284730, bmt-279554, and car-000463) following of up to 2 test formulations of bms-986231 relative to the reference formulation.

participants will be randomized 1:1:1:1 and dosed with either of the 4 treatments: a, b, c, or d; followed by review of safety and tolerability data during and after the infusion. the study will proceed with treatments a, and c unless one or more of these treatments shows poor tolerability; in which case the study may proceed with treatment b or d in the follow-up cohorts. additional participants will be randomized equally to each of the treatments the study will proceed with.

Eligibility criteria:
inclusion criteria: * participants must be willing to participate in the study and sign the informed consent form (icf). * participants must be willing and able to complete all study-specific procedures and visits. * healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations in the opinion of the investigator. * body mass index of 18.0 to 32.0 kg/m2, inclusive, and body weight ≥ 45 kg and ≤ 110 kg, at screening. * heart rate \> 45 bpm and \< 95 bpm at screening or baseline (within 30 minutes prior to randomization). * systolic bp \> 110 mmhg and \< 140 mmhg at screening or baseline (within 30 minutes prior to randomization). * normal renal function at screening as evidenced by an estimated glomerular filtration rate \> 80 ml/min/1.732 calculated with the chronic kidney disease epidemiology collaboration formula. * males and females, ages 18 or local age of majority to 40 years, inclusive. exclusion criteria: * any significant acute or chronic medical illness * diagnosis of fibromyalgia * history of syncope, orthostatic instability, or recurrent dizziness * history or family history of ocular disorders (eg, glaucoma) * history of bleeding diathesis (unusual susceptibility to bleed \[hemorrhage\] mostly due to hypocoagulability) * personal history or strong family history of sudden cardiac death, myocardial infarction, or other heart disease considered to be clinically significant by the investigator * any major surgery within 4 weeks of study drug administration * history of gilbert's syndrome
intra-gastric fundal and body injection of botulinum toxin a for weight loss, a randomized controlled trial

Conditions: Obesity; Weight Loss

Summary: this is a randomized controlled trial to compare intra-gastric injection of botulinum toxin a (botox; allergan inc. irvine, ca, usa) against non-surgical management for obesity (i.e. exercise/diet). our hypothesis is that intra-gastric injection of botox into the fundus and body of the stomach will result in greater weight loss than just exercise and diet alone.


Eligibility criteria:
inclusion criteria: 1. age 21 to 65yrs old 2. bmi \>32.5 (class ii obesity) exclusion criteria: 1. pregnancy or lactation 2. known pre-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy) 3. patients with known liver cirrhosis or known esophageal/gastric varices 4. known eating disorders 5. known major cardiovascular or pulmonary conditions 6. previous gastric/bariatric surgery 7. pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer) 8. known alcohol or drug abuse 9. known allergy to any ingredients in botox or allergic reaction to any other botulinum toxin product