Kornimate/medical-research-clean huggingface dataset:
safety study of capecitabine with radiation in elderly rectal cancer

Conditions: Rectal Neoplasms

Summary: this phase i study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old.

it is proved that preoperative concurrent chemo-radiotherapy can improve both local control and overall survival in stage ii/iii rectal cancer patients. but elderly patients, especially patients over 75 years were hardly involved in related clinical trials considered of their fragility. several retrospective study showed that old rectal cancer patients would also benefit from concurrent chemo-radiation, with acceptable toxicity. several new drug, such as capecitabine, also seem to be safety for elderly cancer patients. but few prospective study has been carried out. the investigators designed this phase i study, to explore the maximum tolerant dose of capecitabine in preoperative concurrent chemoradiation for elderly stage ii/iii rectal cancer patients, as well as to evaluate safety.

Eligibility criteria:
inclusion criteria: * rectal adenocarcinoma, clinical stage ii/iii(t3-4 or n+, ajcc 7th). * kps status no less than 70; charlson comorbidity no more than 3. * life expectancy more than 6 months. * hemoglobin \>= 100g/l, white blood cell \>= 3.5\*10e9/l, neutrophil \>= 1.5\*10e9/l, platelet \>= 100\*10e9/l.creatin normal, total bilirubin normal, ast and ast normal, akp normal. * do not have allergy history to thymidine phosphorylase. * do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment * no previously pelvic irradiation history * informed consent signed exclusion criteria: * other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma * previous pelvic irradiation history * receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment * allergy history to thymidine phosphorylase * active infection existed * severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( plasma glucose concentrations in any time of a day≥11.1mmol/l）, severe cardiac arrhythmia， etc. * anticipate other clinical trials in four weeks before enrollment

Keywords: rectal neoplasms aged chemoradiotherapy clinical trials, phase i capecitabine
uganda birth cohort study

Conditions: Birth Outcomes; Stunting; Wasting; Anemia

Summary: the ubc was a usaid-funded longitudinal prospective cohort study of pregnant women (n= 5030) aged 15-49 years from rural north and south-western regions of uganda, conducted between 2014 and 2016. the aim of the ubc study was to observationally follow pregnant women and their newborns until 2 years of age and compare changes over time in communities that were part of an ongoing usaid project called the community connector (cc) compared to those communities that were not included in the community connector project.

this study aimed to assess the role of livelihoods, agriculture and nutrition in improving maternal and child nutrition and health in rural uganda in communities that were a part of an ongoing program that was un-related to the study. the overall aim of this study was to understand the effect of participating in an ongoing program that provided support on nutrition, agriculture, water, hygiene and sanitation and the change over time in the nutritional status of mothers and children under two years of age. the specific objectives of this observational study were as follows: 1. to compare health and nutrition status of pregnant women in communities participating in the community connector project to those that were not participating in the program 2. to assess the aflatoxin levels in pregnancy and test its association with birth outcomes and early life growth as measured by weight and length 3. to assess environmental enteropathy in pregnancy and test its association with birth outcomes and early life growth 4. to assess access to coverage and adherence to information/messages and engagement in community connector project's activities 5. to determine heterogeneity in program exposure and variability in household and agro-ecological characteristics and its relationship with maternal and infant health and nutrition status

Eligibility criteria:
inclusion criteria: inclusion into pregnancy surveillance: * participant is a woman aged 15-49 years * participant intends to reside in the study area through the enrollment period * participant provides informed consent herself or through a legal guardian inclusion into main study: * pregnancy is confirmed by urine pregnancy test * mother is aged 15-49 years * mother intends to reside in the study area through completion of follow-up * mother intends to deliver in the study area * mother provides informed consent (potentially as an emancipated minor) exclusion criteria: -none

Keywords: birth outcomes pregnancy aflatoxin environmental enteric dysfunction (eed) growth stunting wasting uganda anemia
alcohol, suicide and hiv prevention for teens in mental health treatment

Conditions: Suicide; Alcohol Abuse; Drug Abuse; HIV

Summary: this study examines whether an integrated alcohol/substance abuse, suicide, and hiv prevention protocol is associated with lower onset and frequency of alcohol and other drug use, suicidal behavior, and high risk sexual behavior among adolescents receiving community based mental health care.

the purpose of this study is to compare an integrated adolescent alcohol/drug, suicide, and hiv prevention program to an assessment only control condition in a randomized clinical trial. this prevention protocol is designed as an "add-on" intervention to standard mental health care. we will examine the extent to which the addition of this prevention protocol is associated with lower rates of alcohol use and drug use, suicidal behavior, and hiv related risk behaviors.

Eligibility criteria:
inclusion criteria: * ages 13-18 * english speaking adolescent and at least one english speaking parent * receiving mental health treatment * living with a parent or guardian willing to participate exclusion criteria: * active alcohol or marijuana dependence diagnosis * hiv infection * pregnant * current psychosis * cognitively unable to give assent

Keywords: suicide alcohol marijuana hiv prevention adolescent
real-world dapagliflozin experience in patients with heart failure in united kingdom.

Conditions: Heart Failure

Summary: heart failure (hf) is a global, public health issue that affects more than 63 million people worldwide; this burden is expected to increase substantially as the population ages. despite advancements in treatment, a hf diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients' health-related quality of life (hrqol). on may 5, 2020, the us food and drug administration (fda) announced the approval of dapagliflozin for heart failure with reduced ejection fraction (hfref), regardless of whether the patient has diabetes. subsequently, there have been additional approvals for this indication by regulatory authorities across the globe." real-world observational data are necessary to describe dapagliflozin use in real-world settings with detailed clinical data on heart failure symptoms, outcomes, and hrqol


Eligibility criteria:
inclusion criteria: * age ≥18 years as of study index date; the study index date is date of initiation of treatment with dapagliflozin * patient received/receiving treatment with dapagliflozin for hfref (ef ≤40%) in accordance with the local dapagliflozin product label * signed and dated informed consent prior to enrolment in the study exclusion criteria: * patient is enrolled less than 14 days or more than 60 days following initiation of dapagliflozin * prior treatment with dapagliflozin or other sglt2i treatment * initiation of dapagliflozin outside of local hf label * diagnosis of type 1 diabetes prior to enrolment
assessment of safety and efficacy of estetrol in postmenopausal women with advanced estrogen receptor positive (er+) breast cancer

Conditions: Breast Neoplasms

Summary: this is a multi-center, open-label, phase i/iia trial, dose-escalation study with a 3 + 3 cohort design to determine the recommended dose of estetrol for the treatment of patients with advanced breast cancer. after completing phase i part of the study (i.e. 4 weeks of treatment), patients will receive further treatment for 8 weeks at their individual phase i dose level (phase iia part of the study).


Eligibility criteria:
inclusion criteria: * postmenopausal women with er-positive and her2-negative locally advanced and/or metastatic breast cancer, who progressed on standard therapies or for whom standard therapies are intolerant; * patients should have experienced a natural or surgical menopause at least 5 years ago; * failure of anti-estrogen treatment with tamoxifen and aromatase inhibitor(s) due to the development of resistance or unacceptable side effects with this treatment; * no undiagnosed vaginal bleeding; * no treatment with fulvestrant within 6 months of start of treatment; * life expectancy at least 6 months; * tumour assessment (ct scan) before the start of the e4 treatment; * body mass index (bmi) between (≥) 18 and (≤) 35 kg/m2; * able to swallow an oral medication; * acceptable values of hematological parameters, liver and kidney function and calcium levels; * acceptable values of hemostasis parameters (as of second cohort); * eastern cooperative oncology group (ecog) performance status: 0-2 (as of second cohort); * reasonable physical and mental health as judged by the investigator and determined by physical examination, clinical laboratory assessments and vital signs; * willing to give informed consent in writing. exclusion criteria: * uncontrolled nausea, vomiting, or diarrhea; * history of venous or arterial thromboembolic disease or a known defect in the blood coagulation system; * history of severe cardiac events or life threatening cardiac dysrhythmia (as of second cohort); * patients who have unstable angina or clinical congestive heart failure (as of second cohort); * uncontrolled hypertension, i.e. systolic blood pressure 160 mmhg and/or diastolic blood pressure 100 mmhg in the last 6 months with or without medication; * diabetes mellitus with poor glycaemic control in the last 6 months (hba1c above 7.5%); * any other serious disease including systemic lupus erythematosus and untreated cholelithiasis; * smoking \>10 cigarettes/day; * use of any other cancer therapy including radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy, chemotherapy, or use of other investigational agents at the start of treatment.

Keywords: dose-escalation safety dose-limiting toxicity
a naturalistic study investigating sleep and cognitive learning in children with and without tic disorders

Conditions: Tic Disorders

Summary: this study will explore the relationship between sleep, learning, cognition, mood and behaviour in children with tic disorders (tourette syndrome and chronic tic disorder) compared to typically developing peers.

this project explores the relationship between sleep and learning in childhood with tic disorders, such as tourette syndrome (ts) and chronic tic disorders (ctd). ts/ctd are movement disorders characterized by repetitive involuntary movements and/or vocalizations called tics. sleep related problems are commonly reported for children with ts/ctd and may include problems getting to sleep, waking up frequently during the night, early wakening and tic-related movements in sleep. for typically developing children, sleep disturbances have been linked to problems with mood, behaviour and learning. to date, the relationship between sleep and learning has not been explored for children with ts/ctd. the aim of this project is to investigate whether there is a relationship between sleep efficiency and learning in boys with and without ts/ctd aged 11-14 years. sleep efficiency will be measured using a small actigraphy watch, which will collect information about movements during sleep, night time waking and light exposure. children will be required to wear the watch for 14 days and nights. before one night of sleep and again the next morning, children will be asked to complete some tasks on an ipad air to assess learning. these include 1) 'popping' balloons with faces on them according to specific rules (e.g. boys faces, happy faces), 2) learning novel animal names, 3) navigating a 3d maze. children will also be administered some standard tests to look at level of intellectual functioning, memory and other thinking skills that may contribute to performance on the computerized tasks. additionally, children and their parents will be asked to complete questionnaires to assess tics, quality of life, mood and behaviour. the findings of this study will help improve understanding of sleep problems for children with tic disorders to aid the development of specific interventions for this group.

Eligibility criteria:
inclusion criteria: * diagnosis of tourette syndrome or chronic tic disorder (for clinical group) exclusion criteria: * diagnosis of intellectual disability (i.e. full scale iq (intelliigence quotient) below 70), autism spectrum disorder or depression * currently taking medications to support tic, mood and/or behaviour management
treatment of benign breast deformities and post-segmental mastectomy breast deformities with autologous fat grafting (aft)

Conditions: Breast Cancer; Lumpectomy; Mastectomy, Segmental

Summary: the investigators will assess changes in breast appearance, graft retention and quality of life over one year in patients who have received direct autologous adipose tissue injection for the treatment of objectionable post-surgical breast deformities. these patients have undergone the resection of breast tissue to treat either benign or malignant breast disease.

during the past decade there has been increased awareness of the potential of free adipose cell grafting to treat a variety of problems in both reconstructive and cosmetic plastic surgery. there have been encouraging reports describing the use of autologous fat grafts (fat tissue harvested by standard liposuction techniques in a given patient and then re-injected at another site) for treating breast deformities in the setting of benign and previously treated malignant breast problems. there has been a corresponding large scale laboratory investigation effort into the potential of adipose derived stem cells (adsc's) harvested during liposuction and induced to differentiate into various cell types in the mesenchymal cell line. the potential clinical utility of these cells in the treatment of patients who present with a breast deformity after segmental mastectomy (lumpectomy) and radiation therapy has been described, but not studied in rigorous prospective manner. the investigators believe that the clinical use of these autologous fat cell grafts have unique advantages in the treatment of breast deformities. the technique is minimally invasive, easily repeated and is associated with minimal surgical morbidity (indeed it may have the advantage of improving the appearance of both the breast deformity and the area from which they are harvested), it typically displays a rapid recovery, a complication rate that is no greater (and probably less than ) established and currently used surgical treatment(s) of these breast problems, and is oncologically safe.

Eligibility criteria:
inclusion criteria: * age 18 through 70 years of age inclusive and able to provide informed consent and * subject is 6 months post chemotherapy or radiation treatment and is scheduled for physician evaluation for a standard of care breast fat graft procedure. * per pi's discretion is stable post-surgery or who has a benign breast deformity or post segmental breast deformity * willing and able to comply with the study schema for research procedures. exclusion criteria: age less than 18 years * inability to provide informed consent * active chemotherapy or radiation therapy treatment for cancer diagnosis * not clinically stable to have a surgical intervention * active infection anywhere in the body * known coagulopathy * pregnancy * per the pi's discretion, subject is not a candidate for participation in this clinical trial.

Keywords: breast cancer lumpectomy mastectomy, segmental
strength training augmenting rehabilitation

Conditions: Muscle Disuse Atrophy

Summary: this project aims to determine whether a novel strength training rehabilitation protocol can diminish the negative consequences of limb immobilization and expedite the restoration of muscle function during retraining in healthy individuals.

the present study will examine the time course of muscle strength and size adaptations in two groups of volunteers during immobilization and retraining. both groups will undergo temporary muscle disuse by wearing a shoulder sling and swathe on their non-dominant arm for \~≥10 hours/day for four weeks. one group (immobilization + unilateral training) will perform progressive unilateral strength training of the free limb throughout the immobilization period. the other group (immobilization control) will not undergo any training during the immobilization period. following immobilization, both groups will undergo four weeks of bilateral strength training to retrain the immobilized arm.

Eligibility criteria:
inclusion criteria: * a body mass index between 18 - 35 kg/m2 * 18-35 years of age * right-hand dominant * willingness to comply with the immobilization requirements * willingness to refrain from strength training outside of the study * willingness to comply with the strength training procedures of the study exclusion criteria: * a personal or family history of blood clots * a personal or family history of thyroid disorders * previous orthopedic surgeries to the upper limbs and/or joint pain of the upper limbs in the last 6 months * neuromuscular or metabolic disorders * osteoarthritis * use of hormone replacement therapy (ie., testosterone, estrogen, and/or growth hormone pharmaceuticals) * pregnancy and/or nursing
hyperthermia combined with immune checkpoint inhibitor therapy for advanced gastrointestinal tumours

Conditions: Gastrointestinal Tumor

Summary: gastrointestinal tumours (gits) are the most common and fatal cancers worldwide; 96% of gits show the microsatellite-stable (mss)/proficient mismatch repair (pmmr) phenotype, and these tumours have a poor response to immune checkpoint inhibitor (ici) therapy. hyperthermia combined with ici treatment (hit) has been reported to show a synergistic sensitisation effect in numerous basic studies. this study aimed to validate the effectiveness, safety, and feasibility of water-filtered infrared a radiation (wira) whole-body hyperthermia combined with pd-1 inhibitor therapy and evaluate the real-world clinical application prospects of hit. this open-label single-arm phase 2 clinical trial aimed to enrol advanced git patients with the mss/pmmr phenotype in the east asian population who had received third-line or higher treatment. the patients were treated with whole-body hyperthermia on days 1 and 8 of each hit cycle along with administration of tislelizumab 200 mg on day 2 (24 h after the hyperthermia at day 1). the primary outcome was the disease control rate (dcr), while the secondary outcomes were progression-free survival (pfs), overall survival (os), safety, and improvement in quality of life.

the specific treatment process is shown in the trial flow diagram. the patients underwent wira whole-body hyperthermia on days 1 and 8 of each hit cycle. on day 2 (24 h after hyperthermia on day 1), 200 mg of tislelizumab prepared with 100 ml of normal saline was intravenously administered for less than 30 min. after six hit cycles, tislelizumab was administered intravenously every 21 days until drop-out. for quality control of hyperthermia, the core temperature was set to 38·5-39·5 °c and measured using a rectal temperature-sensing probe. hyperthermia was considered to have been achieved when this temperature range was recached and maintained for 60 min. each hyperthermia session lasted for 2 h, including a 30-min heating stage, a 60-min insulation stage, and a 30-min cooling stage. clinical data were collected every two hit treatment cycles and evaluated using the recist version 1.1 standard.

Eligibility criteria:
inclusion criteria: * patients with advanced git who have previously received third-line or above treatment. * patients are aged 18-75. * patients with at least one measurable tumor lesion. * patients' all physiological indexes meet the hit requirements. exclusion criteria: * patients have participated in other clinical trials within 4 weeks before enrollment. * patients contraindicate to whole-body hyperthermia. * patients contraindicate to immunotherapy. * patients cannot fully cooperate with hit and follow-up. * pregnant or lactating women. * other circumstances may affect the results.

Keywords: hyperthermia immune checkpoint inhibitor
low intensity resistance training with vascular occlusion in coronary heart disease patients

Conditions: Coronary Disease; Coronary Artery Disease

Summary: in our clinical controlled trial, patients with coronary heart disease will be randomly assigned into the exercise intervention (low intensity resistance training with vascular occlusion) or usual physical activity group (control group).

physical activity in patients with coronary heart disease improves health, quality of life, and reduces risk of coronary events, morbidity and mortality. aerobic training is preferred as a part of cardiac rehabilitation with its well established evidence-based guidelines. on the other hand, the resistance training was first introduced as a part of cardiac rehabilitation just over a decade ago, due to its positive effects on performance, quality of life and muscle hypertrophy and strength. despite the positive effects of resistance training, there still lacks evidence about its effect on cardiovascular health. furthermore, guidelines still do not specify the exact training volumes, doses and types of resistance training for patients with coronary heart disease. in clinical practice, it is often difficult and contraindicated to use near-maximal loads (e.g., in the early stages of cardiac rehabilitation, after sport injury, etc.). muscle atrophy and weakness often occur rapidly in the affected area due to the effects of trauma (or disease) and inactivity. consequently, training modalities that promote hypertrophy or counteract atrophy without the use of heavy loads should be of special interest in the rehabilitation of some chronic diseases for which high musculoskeletal forces are contraindicated. occlusive strength training with tourniquet cuffs was first used nearly twenty years ago. studies have shown that low to-moderate intensity (20-50% of 1rm) resistance training with vascular occlusion leads to gains in muscle strength and volume comparable to those seen after conventional heavy resistance training. this effects suggest, that ischemic strength training may be a useful method in rehabilitation and other contexts. to conclude, the aim of this study is to compare the effect of low intensity resistance training with vascular occlusion vs. normal physical activity on: 1. muscle hypertrophy, strength and neuromuscular parameters; 2. vascular function; 3. and blood parameters (anabolic and catabolic hormones, catecholamines, inflammations factors, parameters of oxidative stress etc.)

Eligibility criteria:
inclusion criteria: * above 18 years old and below 75 years old * coronary heart disease documented with clinical event * stable coronary heart disease patients exclusion criteria: * unstable phase of coronary heart disease * dysfunction of left ventricle * residual myocardial ischemia * contraindications for physical activity, * intellectual development disorder, * recent dissection of aorta * recent vein thrombolysis

Keywords: blood flow restriction resistance training coronary heart disease