Kornimate/medical-research-clean huggingface dataset:
exercise following bariatric surgery for severe/morbid obesity (efibar)

Conditions: Obesity, Morbid; Bariatric Surgery Candidate

Summary: severe/morbid obesity is an international public health issue that importantly increases the risk of cardiovascular events and cardiovascular and all-cause mortality. likewise, severe/morbid obesity increases the risk of illness, reduces quality of life, and raises health-care costs. bariatric surgery is the election method for the treatment of severe/morbid obesity, resulting in significant weight loss and remission of comorbidities. however, a relatively large proportion of bariatric patients regain weight and continue to be at high risk for cardiovascular disease and premature mortality. a healthy lifestyle following bariatric surgery is essential for optimizing and maintaining weight loss. observational studies suggest that physical activity following bariatric surgery might be associated with additional weight loss and more effective weigh loss maintenance over time. however, very little experimental evidence exists regarding the effects of supervised exercise on obesity-related outcomes in this specific population. the aim of the efibar (ejercicio físico tras cirugía bariátrica) randomized controlled trial is to determine the effects of a 16-week supervised concurrent (aerobic and strength) exercise intervention program, on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness and quality of life (secondary outcomes) in patients with severe/morbid obesity following bariatric surgery. according to the study aims the investigators pursue the following hypothesis: supervised exercise will result in larger weight loss than control.


Eligibility criteria:
inclusion criteria: * to comply with local bariatric surgery criteria: 1. patients with bmi ≥ 40 kg/m2 (or 35 kg/m2 with comorbidities). 2. acceptable surgical risk (defined by the approval of anesthetist). 3. obesity maintained for over 5 years. 4. failure of previous treatments. 5. to sign informed consent for surgical treatment. * not to present contraindications for supervised physical exercise. * to reside in the city of almeria (spain) or willingness/predisposition to attend the training sessions 3 times a week during 16 weeks exclusion criteria: * severe psychiatric or neurological disorders such as schizophrenia, epilepsia, alzheimer, parkinson, personality disorders, eating behaviour disorders, untreated depression or suicidal tendencies. * adrenal or thyroid pathology that might cause obesity. * uncontrolled addiction to alcohol or drugs.

Keywords: morbid obesity exercise weight loss cardiometabolic risk bariatric surgery
a pilot study of filtrum-sti in children with viral gastroenteritis

Conditions: Viral Gastroenteritis

Summary: this is a phase ii double blind multicenter randomized placebo-controled clinical study aimed to find out whether treatment with filtrum-sti (orally administered 0,4g tablets) is safe and effective in children with viral gastroenteritis. filtrum-sti (lignin hydrolytic) is a drug with a high absorbing ability, that binds and eliminates toxins, pathogenic microorganisms and viruses. filtrum-sti is inoffensive for mucous membranes, enhances colonic propulsion and improves its natural microflora. the drug is not toxic and well combines with other medication


Eligibility criteria:
inclusion criteria: * children aged 0-4 y.o. diagnosed with moderate viral gastroenteritis; * 72 h or less from the onset of gastrointestinal symptoms. exclusion criteria: * severe diseases; * individual intolerance of filtrum-sti * treatment with antiviral, immunomodulatory drugs during the study and 2 weeks before inclusion * treatment with pre- pro- and antibiotics 2 weeks before inclusion * participation in other clinical study 1 month before inclusion and during participation in the study.

Keywords: enterosorbent sorbent gastrointestinal decontamination viral diarrhea rotavirus filtrum filtrum-sti lignin
high versus low dose supplemental external radiation with pd-103 for prostate cancer

Conditions: Prostate Cancer

Summary: objective: the objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates. research design a total of 600 patients with ajc clinical stage t1-t2 prostatic carcinoma (gleason grade 7 to 10 and/or psa 10 to 20 ng/ml) will be randomized to treatment with 44 gy versus 20 gy external radiation plus a pd-103 implant boost (90 gy versus 105 gy, respectively).

objective: the objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates. research design a total of 600 patients with ajc clinical stage t1-t2 prostatic carcinoma (gleason grade 7 to 10 and/or psa 10 to 20 ng/ml) will be randomized to treatment with 44 gy versus 20 gy external radiation plus a pd-103 implant boost (90 gy versus 105 gy, respectively). methodology: patients will be randomized by the method of random permuted blocks. cancer status will be monitored by serial serum psa at 6, 12, 18 and 24 months and yearly thereafter. treatment-related morbidity will be monitored by personal interview, using standard american urologic association and radiation therapy oncology group criteria at 1, 3, 6, 12 and 24 months. the primary endpoint will be based on serum psa. a value above 1.0 ng/ml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy. findings: 566 patients have been randomized and the study was closed due to slowing accrual. a preliminary analysis shows similar morbidity between the treatment arms, and nearly identical cancer control rates between randomization arms.

Eligibility criteria:
inclusion criteria: * males * prostate cancer * psa 10-20 * gleason score 7-10 exclusion criteria: * lymph nodes positive

Keywords: prostate brachytherapy
non-interventional study on time to response and quality of life in relapsed/refractory multiple myeloma when treated with lenalidomide in second line

Conditions: Multiple Myeloma

Summary: the purpose of this study is to quantify the burden of treatment in relapsed or refractory multiple myeloma in patients receiving lenalidomide after one prior treatment for myeloma.


Eligibility criteria:
inclusion criteria: 1. be at least 18 years of age 2. have a confirmed diagnosis of mm 3. starting lenalidomide treatment for mm (due to relapsed or refractory disease) after one prior treatment. 4. have personally signed and dated a legally effective written informed consent form prior to admission to the study. 5. must be willing and able to understand and comply with the study requirements. exclusion criteria: 1. individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening. 2. individuals with significant psychiatric illness or a clinically significant acute/chronic uncontrolled medical condition that might affect their experience of myeloma symptoms or their ability to describe them.

Keywords: relapsed and refractory multiple myeloma
sparing parotid ducts via mri sialography for reduced patient reported xerostomia

Conditions: Oropharynx Cancer; Head and Neck Cancer; Xerostomia

Summary: radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. new radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment. this randomized phase ii study explores the contribution of magnetic resonance imaging (mri) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. the severity of xerostomia will be measured by patient-reported (pro) symptoms, saliva secretion, saliva ph, and buffering.


Eligibility criteria:
in order to participate in this study a subject must meet all of the eligibility criteria outlined below. eligibility must be maintained up for the subject to be considered eligible for treatment. inclusion criteria 1. written informed consent was obtained to participate in the study and hipaa authorization for the release of personal health information. 2. subjects is willing and able to comply with study procedures based on the judgment of the investigator. 3. age ≥ 18 years at the time of consent. 4. t0-4, n0-3, m0 disease american joint committee on cancer (ajcc 7th or 8th edition) of the oropharynx (this includes patients with head and neck cancer of unknown primary origin, often categorized as t0 disease, who will be treated with radiotherapy to the oropharynx) planned for definitive radiotherapy +/- chemotherapy 5 no contraindications to receiving mri such as implanted electrical devices, pregnancy, and significant quantities of metal in the head/neck exclusion criteria 1. patients with sjogren's syndrome or baseline xerostomia (ctcae \> 0 for the question regarding dry mouth) 2. patients with lesions grossly involving the salivary glands 3. patients with an allergy to lemon juice 4. prior history of radiation therapy to the head and neck

Keywords: radiotherapy magnetic resonance imaging parotis parotid duct radiotherapy dosimetry radiotherapy planning
epigenetic priming using azacitidine with neoadjuvant chemotherapy for resectable esophageal cancer

Conditions: Esophageal Cancer; Malignant Neoplasm of Cardio-esophageal Junction of Stomach

Summary: the purpose of this study is to see whether giving azacitidine before each cycle of chemotherapy prior to surgery is safe.

currently patients with resectable (can be removed by surgery) esophageal cancer will receive chemotherapy before surgery to try to shrink the tumor before it is removed. this study will evaluate whether giving azacitidine before each cycle of chemotherapy to increase the shrinkage of the tumor prior to surgery is safe. azacitidine is currently approved by the food and drug administration (fda) for treatment of myelodysplastic syndrome (mds). azacitidine is not approved by the fda for use in this study and is therefore considered investigational. because azacitidine has not been given before in combination with epirubicin, oxaliplatin and capecitabine, we will also evaluate the safety and tolerability of azacitidine and find out what dose of azacitidine is safe to give with this chemotherapy.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the intrathoracic esophagus or gastroesophageal junction (gej) and deemed resectable by the thoracic surgeon. * no prior chemotherapy for esophageal or gej cancer. * ecog performance status 0-2. * adequate bone marrow, kidney and liver function. * ability to understand and the willingness to sign a written informed consent document. * subjects of child-bearing potential must agree to use effective means of contraception (men and women). * prior malignancy is acceptable if the subject is considered to be cured. in most cases this will mean a 5-year disease-free period. exclusion criteria: * patients with cervical esophageal cancer or esophageal cancer with squamous cell carcinoma morphology. * subjects receiving any other investigational agent or received prior chemotherapy for esophageal or gej cancer. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine, epirubicin, oxaliplatin, capecitabine and mannitol. * new york heart association (nyha) grade ii or greater congestive heart failure. * history of myocardial infarction or unstable angina within 6 months prior to study enrollment. * pregnant (positive pregnancy test) or lactating women. * patients with active infection, serious inter-current medical conditions.

Keywords: gastroesophageal junction gej esophageal esophagus
the avert sepsis investigation

Conditions: Sepsis; Severe Sepsis

Summary: the overall objective of this study is to utilize heart rate variability and respiratory rate variability in patients with sepsis to predict clinical deterioration and death. our specific objectives are: 1. to study the ability of a change in composite variability (∆cvi) assessment to act as a prognostic aid in predicting disease progression in sepsis. 2. to study the effect that standard resuscitation interventions will have on the direction and magnitude of ∆cvi in patients with sepsis. b. hypotheses h1: in the initial resuscitation of sepsis, a low or declining multi-parameter composite variability index (cvi) over 4 hours will predict a significant increase in the combined outcome of overt shock, organ dysfunction, and mortality. h2: in the initial resuscitation of sepsis, low volume fluid resuscitation (\<20 cc/kg) over 4 hours will be associated with a low or declining cvi.


Eligibility criteria:
inclusion criteria: * 1. antibiotics ordered or administered (as surrogate for suspected or confirmed infection as primary reason for hospital admission as determined by the primary team) 2. serum lactate ≥ 2.0 mmol/l or transient hypotension (any systolic blood pressure \< 100 mmhg). 3. identification within 12 hours of a qualifying lactate measurement or hypotension episode 4. hospital admission planned for suspected infection as primary reasons for admission (per emergency medicine team). exclusion criteria: * 1. age \< 18 years 2. pregnancy 3. non-sinus cardiac rhythm (atrial fibrillation, active pacemaker, svt) 4. evidence of overt shock upon enrollment: * hypotension: sbp \< 90 mmhg for ≥ 60 minutes * any vasopressor or inotrope use (e.g. norepinephrine, dopamine, vasopressin, dobutamine) 5. acute respiratory support (bipap or mechanical ventilation) before enrollment 6. inability to obtain written informed consent from patient or legally authorized representative 7. inability to wear zephyr bioharness device

Keywords: sepsis shock
cognitive behavioural therapy of early dementia

Conditions: Dementia

Summary: a randomized, controlled, parallel-group trial to evaluate the efficacy of a cognitive behavioral therapy for patients with early dementia.

the kordial study is a randomized, controlled, parallel-group trial evaluating the efficacy of a cognitive behavioral therapy for patients at the early stage of alzheimer's disease. the 3-month experimental intervention consists of 12 individual sessions with regular involvement of carers or other patient proxies. strategies for improving the patient's coping ability and for enhancing their psychological well-being are combined. the primary outcome criterion is functioning in the everyday context after completion of the intervention and after another 6 months. the control condition will be treatment as usual. the study will be conducted in 5 university outpatient units and in 5 specialist offices.

Eligibility criteria:
inclusion criteria: * mild dementia (mmse \> 21) in alzheimer's disease (icd-10), proxy available exclusion criteria: * acute of unstable psychiatric or physical disease, proxy unavailable * participation in another trial

Keywords: early dementia in alzheimer's disease (mmse ≥ 21)
home self-testing for hiv to increase hiv testing frequency in men who have sex with men (the itest study)

Conditions: HIV

Summary: the purpose of this study is to determine whether the availability of home self-testing for hiv will increase hiv testing frequency among men who have sex with men without negatively impacting their risk for hiv acquisition.

hiv counseling and testing remains one of the most effective hiv prevention interventions because many individuals newly diagnosed with hiv infection will alter their behaviors to reduce the risk of hiv transmission to others. in the u.s., men who have sex with men (msm) represent the group with the greatest risk for hiv acquisition despite a high penetrance of testing, in part because their frequent exposures and infrequent testing can result in long intervals between hiv acquisition and diagnosis. efforts to prevent hiv transmission among msm must therefore increase the frequency of hiv testing and thereby decrease the time interval that infected individuals are unaware of their status and their potential for transmission. home self-testing for hiv may increase the frequency of hiv testing, but there are concerns that it may also have negative consequences, including decreased access to risk reduction counseling. we will randomize 246 msm at high risk of hiv acquisition either to have access to home self-testing for hiv using the oraquick advance® rapid hiv-1/2 antibody test or to standard, clinic-based hiv testing for 15 months to determine the effects of home self-testing availability on hiv testing frequency and markers of risk for hiv acquisition and to assess the acceptability and ease of use of home self-testing. after screening to determine eligibility, study visits will occur at baseline and at 15 months. both visits will include hiv/std screening and surveys regarding hiv testing and risk behaviors. during follow-up, participants will be asked to complete brief online surveys after testing for hiv.

Eligibility criteria:
inclusion criteria: * male * age ≥18 * has sex with men * hiv-negative * meets phskc hiv/std program definition of "high risk" * plans to live in seattle for the next 15 months exclusion criteria: * unable to safely and confidentially receive or store a home testing kit

Keywords: hiv home testing self-testing hiv infections/diagnosis hiv infections/prevention and control aids serodiagnosis oral fluids homosexuality, male sexually transmitted diseases sexual behavior
feasibility of fluorescence imaging with bevacizumab-800cw during bronchoscopy

Conditions: Lung Neoplasms; Pulmonary Neoplasms; Lymph Node Involvement

Summary: in this feasibility study, bronchoscopy will be combined with fluorescence molecular imaging using the near-infrared fluorescence (nirf) tracer bevacizumab-800cw for assessment of pulmonary lesions and/or lymph nodes considered to be malignant.


Eligibility criteria:
inclusion criteria: 1. signed informed consent prior to participation in the study. 2. age ≥ 18 years. 3. patient has at least one intrabronchial, near-to-airway located or peripheral pulmonary nodule - with or without pathological lymph nodes - which is considered malignant (independent of its primary origin). 4. patient is considered fit to undergo a diagnostic and/or therapeutic bronchoscopy (with or without addition of virtual navigation and/or endobronchial ultrasound; including propofol sedation or general anesthesia if either is indicated) to obtain tumor material according to standard care protocols. exclusion criteria: 1. history of infusion reactions to bevacizumab. 2. medical or psychiatric conditions that compromise the patient's ability to give informed consent.
metabolic pathway analysis in intensive care unit patients with refeeding syndrome

Conditions: Critical Illness; Refeeding Syndrome; Hypophosphatemia

Summary: the overall aim of the study is to improve understanding of refeeding syndrome (rfs) in patients admitted to the intensive care unit (icu) using metabolomics. patients are included as part of a prospective multicenter observational study on phosphate disorders in the icu. blood samples are collected day 1-7 of icu stay. samples from patients who develop refeeding hypophosphatemia and matched controls without hypophosphatemia are analysed for metabolomics and proteomics. untargeted analyses will be performed to identify the affected metabolic pathways. the investigators will also perform auroc analyses to identify potential biomarkers for early detection of rfs.

a nested case-control study situated within gutphos part b: a prospective, multicenter non-interventional cohort study investigating the incidence of abnormal phosphate levels and associated outcomes in adult patients admitted to the icus of participating sites. inclusion/exclusion criteria for gutphos part b are described in the separate study protocol. at sites participating in the nested substudy, an additional 2 ml edta blood sample is drawn once daily in all patients included in gutphos part b from icu admission up to a maximum of calendar day 7 in icu. the sampling for metabolomics analysis should be performed in close proximity with daily routine blood tests, and always before treatment of hypophosphatemia with phosphate supplementation or restricted nutritional intake. plasma samples are obtained through centrifugation within 20 minutes and frozen to -80 degrees celcius within 60 minutes until analysis. the timing and handling of samples according to standard operating procedures will be documented on a separate case report form. in icu patients diagnosed with refeeding hypophosphatemia, comprehensive metabolomic profiling is performed in the plasma sample from icu admission and the sample drawn in conjunction to the blood phosphate measurement diagnostic of rh. cases with rh are matched in a 1:1 ratio to icu patients without rh. controls are matched according to sex, age, illness severity on admission and energy delivery (kcal/kg adjusted body weight) in the 24 hours preceding the diagnosis of rh. refeeding hypophosphatemia is defined as new onset hypophosphatemia (\ 0.16 mmol/l from any previous pi value during icu stay and where no other likely cause of hypophosphatemia is present.

Eligibility criteria:
inclusion criteria: * admission to icu during the study period * age ≥18 years exclusion criteria: * age \<18 years * patients with restrictions of care such as "no intubation" or "no renal replacement therapy" on icu admission and patients admitted for treatment as organ donors * continuous chronic home ventilation for neuromuscular disease; * declined participation or informed consent (if the local ethics committee requests the latter for this non-interventional study); * readmission to icu during the study period
predictors of mortality after pelvic fractures: a retrospective cohort study from a level-1 trauma center in upper egypt

Conditions: Registries; Pelvic Bone Injury; Morality

Summary: a retrospective cohort study was carried out for all pelvic fracture patients admitted to assiut university trauma unit (autu), a level-1 trauma center. (autu) is located in upper egypt and provides healthcare to over 30,000 patients per year.

in 2010, a pelvic injury registry was developed to document treatment and outcomes in a standardized manner. all patients admitted to autu sign an informed consent to permit using their data for research purposes. patients' data are prospectively collected and stored in a local database specifically designed for this purpose. data collected included age, gender, mechanism of injury, fracture classification, associated injuries, and admission to icu, the length of hospital stay and presence of abdominopelvic collection as diagnosed by focused assessment with sonography for trauma (fast) at admission. the primary outcome measure was in-hospital mortality. predictors of in-hospital mortality were identified by comparing characters of survivors and non-survivors. secondary objectives were to analyse the differences between adults and children and to analyse the causes and timing of death.

Eligibility criteria:
inclusion criteria: * first-time admissions and patients whose treatment was completed at our hospital * all pelvic fracture patients admitted to our trauma unit. exclusion criteria: * penetrating injuries * isolated acetabular fractures * patients who were discharged on their own will against the medical advice or whose treatment was continued at another hospital * re-admitted patients * firearm injuries

Keywords: pelvic fractures mortality predictors trauma registry