Kornimate/medical-research-clean huggingface dataset:
effects of physical exercise on cardio-vascular efficiency and quality of life in breast cancer survivors

Conditions: Breast Cancer Female

Summary: to examine the effects of different physical exercise protocols (aerobic training and resistance training) on cardio-vascular efficiency and quality of life in a population of breast cancer survivors (bcs), not treated with chemotherapy.

the present study enrolled a population of bcs women who underwent surgical treatment for breast cancer at the "ospedale g. bernabeo" of ortona, chieti, italy. the participants were randomized to the following physical exercise protocols: aerobic training, walking or nordic walking; resistance training. all the participants have been examined utilizing transthoracic echocardiography, carotid ultrasound and photo-plethysmographic method for the analysis of arterial stiffness, before and after the physical exercise protocol (t0-t1). the two-dimensional speckle-tracking analysis was performed with an offline, dedicated software from the apical 4-chambers-view. moreover, ventricular-arterial coupling, epicardial fat thickness and intima-media thickness were also analyzed. quality of life was assessed using sf-36 score at t0, t1 and at a mean follow-up of 34 months. moreover, at follow-up, we evaluated spontaneous physical activity and cardiovascular quality of life using ipaq and saq-7 scores.

Eligibility criteria:
inclusion criteria: * age \< 65 years; * history of breast cancer surgery in the previous 12 months; * no history of chemotherapy; * no ongoing radiotherapy; * eventual hormonal therapy; * cardiovascular and orthopedic eligibility. exclusion criteria: * adjuvant chemotherapy; * any history of cardiovascular disease; * abnormal exercise stress test at the screening; * any systemic inflammatory disease or any orthopedic condition potentially limiting the physical training.

Keywords: physical exercise adherence to physical exercise global longitudinal strain ventricular-arterial coupling arterial stiffness epicardial fat thickness intima-media thickness endocrine therapy
a study to investigate the efficacy and safety of canagliflozin in children and adolescents (>=10 to <18 years) with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (hba1c) after 26 weeks of treatment, and to assess the overall safety and tolerability of canagliflozin.


Eligibility criteria:
inclusion criteria: * participants with a diagnosis of type 2 diabetes mellitus (t2dm) * random c-peptide at screening greater than (\>)0.6 nanogram/milliliter (ng/ml) (\>0.2 nanomole/liter \[nmol\]/l\]) * hba1c of greater than or equal to (\>=)6.5 percent (%) to less than or equal to (\<=)11.0% and meets 1 of the inclusion criteria below: 1. on diet and exercise only for at least 4 weeks prior to screening 2. on diet and exercise and a stable dose of metformin monotherapy \>=1,000 mg per day or mtd per day for at least 8 weeks prior to screening 3. on diet and exercise and a stable insulin monotherapy regimen for at least 8 weeks prior to screening (stable dose is defined as no change in the insulin regimen \[that is, type{s} of insulin\] and \<=15% change in the total daily dose of insulin \[averaged over 1 week to account for day to day variability\]) 4. on diet and exercise and a stable combination therapy with metformin and insulin for at least 8 weeks prior to screening exclusion criteria: * history of diabetic ketoacidosis (dka), type 1 diabetes mellitus (t1dm), pancreas or cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy or maturity onset diabetes of the young (mody) * participants on any antihyperglycemic agents (ahas) other than metformin, or injectable insulin within 8 weeks of the first dose of study drug (that is day 1) * repeated (2 or more over a 1-week period) fasting self-monitoring of blood glucose (smbg) measurements \>270 milligram/deciliter (mg/dl) (\>15 millimole/liter \[mmol/l\]) during the pretreatment phase, despite reinforcement of diet and exercise counseling * severe hypoglycemia within 6 months prior to day 1 * history of hereditary glucose-galactose malabsorption or primary renal glucosuria * alanine aminotransferase level \>5.0 times the upper limit of normal (uln) or total bilirubin \>1.5 times the uln at screening (for elevations in bilirubin: if, in the opinion of the investigator and agreed upon by the sponsor's medical officer, the elevation in bilirubin is consistent with gilbert's disease, the subject may participate)
safety and immunogenicity of live attenuated influenza h5n2

Conditions: Influenza Due to Influenza A Virus Subtype H5N2

Summary: the purpose of this study is to evaluate immune response and safety of live attenuated influenza h5 vaccine candidate strain a/17/turkey/turkey/05/133 (h5n2) manufactured by gpo, thailand in healthy thais.

it is a double blind randomized study using 7.5-8.5 log eid50 dose which is the same dose as being tested in phase i. 150 participants (100 vaccinees and 50 placebos) age 18-49 years old will be enrolled. all will be separated in 4 batches; batch 1: 36 participants (24 vaccinees and 12 placebos) batch 2: 38 participants (25 vaccinees and 13 placebos) batch 3: 38 participants (25 vaccinees and 13 placebos) batch 4: 38 participants (26 vaccinees and 12 placebos) each batch will be admitted in the isolation ward for 5 days after each immunization mainly for safety assessment. two doses of live attenuated influenza h5 vaccine candidate strain a/17/turkey/turkey/05/133 (h5n2) will be given by intranasal route 28 days apart. total follow up is 60 day.

Eligibility criteria:
inclusion criteria: * healthy * age 18-49 years old * having thai id card or equivalent * are seronegative to the specific h5 influenza virus determined by antibody titer less than 1:40 by hai test to the corresponding antigen. * anti hiv - negative * all hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not more than 1.5 times of normal value) * able to read and write and sign written informed consent. exclusion criteria: * known history of egg allergy * having had recently influenza infection confirmed as h5 * history of bronchial asthma * history of chronic lung diseases * history of chronic rhinitis * history of immunodeficiency state * history of immunosuppression * history of heavy smoking (more than 5 rolls per day) * history of alcoholic (pure drink 200 ml per day) * acute infectious and noninfectious diseases (within 2 weeks) * exacerbation of chronic diseases or cancer or hiv positives * anamnestic leukocytosis, hepatitis b and c positives * the volunteers who have been taking immunoglobulin products or have had a blood transfusion during past three months before the beginning of the experiment * participation in other research study or stop participant less than 1 month * pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding * any concomitant medication with aspirin * poultry workers
safety and efficacy of autologous insc-dap in the treatment of parkinson's disease

Conditions: Parkinson's Disease

Summary: this is a phase i, interventional, single arm, open-label, clinical study to evaluate the safety and efficacy of the striatal transplantation of autologous induced neural stem cell-derived da precursor cells in parkinson's disease patients.

parkinson's disease (pd) is the second most common neurodegenerative disease, caused by progressive depletion of midbrain dopaminergic neurons in the substantia nigra pars compacta. this clinical study will include the preparation of dopaminergic neural precursor cells derived from neural stem cells through reprogramming of patient's peripheral blood mononuclear cells (pbmcs), and transplantation of the obtained cells into the brains of pd patients by stereotaxic injection. safety, tolerability, evidence of cell survival (using pet scan), and the efficacy on pd symptoms will be assessed at different time points up to 12 months post-transplantation.

Eligibility criteria:
inclusion criteria: ages between 30 and 85 years, males or females; diagnosed to be parkinson's disease patients according to mds parkinson's disease diagnostic criteria; disease history over 3 years; hoehn and yahr stage less than or equal to 4 during the medication "on" time; responsive to levodopa treatment (maximum rate of improvement in mds-updrs, part 3, is over 30%). exclusion criteria: atypical parkinsonian syndrome or secondary parkinsonian syndrome; accompanied with other central nervous system diseases; with other severe systemic diseases or dysfunction; with severe psychiatric disorders; subjects are using hormone or cytotoxic drugs and cannot stop taking the drug during the trial; with cognitive disorders (mmse\<24); with severe dyskinesia (mds-updrs part 4, score in 4.1/4.2 ≥ 2); subjects have undergone previous brain surgery; subjects are long-term user of anticoagulant; subjects have intracranial lesions which may affect the surgery or follow-up studies as assessed by imaging; subjects are unable to undergo mri or av133 pet examination; pregnancy or in preparation for pregnancy; not suitable to participate in this clinical trial as assessed by the study investigators/physicians.

Keywords: autologous; insc; da precursor cells; parkinson's disease; cell therapy; stereotaxic injection
understanding and optimizing care for young adults with type 1 and type 2 diabetes mellitus transitioning to adult care

Conditions: Type 1 Diabetes; Type 2 Diabetes

Summary: in this study, we will determine the feasibility of an innovative care model for young adults with diabetes and compare the primary and secondary outcomes in the innovative model to those in the usual care model for adult diabetes management at massachusetts general hospital (mgh) diabetes center.

this study is a quasi-randomized mixed methods evaluation of the implementation of an innovative collaborative care model to assess whether it is feasible and improves indicators of diabetes and mental health, while exploring themes that will inform redesign of the care model to improve healthcare delivery to young adults with diabetes transitioning to the adult care setting. we will compare primary and secondary outcomes in this model to those in the usual care model for adult diabetes management at mgh diabetes center. those who agree to the research study will be asked to complete a series of three survey questionnaires over the timeframe of the study. the electronic health records (ehrs) of these patients who agree to the research study will also be examined. all patients who successfully complete all 3 survey questionnaires will be eligible for a structured interview portion of the study to explore themes that will inform care model redesign.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus * between ages 18 and 30 years * any duration of diabetes * must self-manage diabetes * a new patients at the massachusetts general hospital (mgh) diabetes center at 50 staniford street as of september 1, 2021. * the patient does not have to be diagnosed with diabetes in youth or have been previously seen at mgh for children (mghfc) pediatric diabetes clinic to be included exclusion criteria: * patients with gestational diabetes, diabetes during pregnancy, mody, or other forms of diabetes * patients with type 2 diabetes who are on no medications (diet-controlled), or metformin only unless they are within one year of diabetes onset * patients with significant cognitive, physical, or mental disability requiring that their diabetes care be managed by another individual (i.e. parent, spouse, guardian, nurse, residential facility) more than 25% of the time * non-english speaking * patients who are pregnant

Keywords: young adults emerging adults diabetes
moderate vs deep neuromuscular block on biotrauma during laparoscopy

Conditions: Pneumoperitoneum

Summary: the purposes of this study is to investigate the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy.

mechanical ventilation results in the disruption of the alveolar-capillary barrier and increased permeability, a hallmark of experimental ventilator-induced lung injury. these mechanical forces also induce an increase in the concentrations of inflammatory cytokines. the benefits of deep neuromuscular blocks for laparoscopic procedures are controversial and most of the studies undertaken have only sought to improve surgical conditions. theoretically, deep neuromuscular block permits a lower abdominal insufflation pressure, which leads to better respiratory mechanics and gas exchange. the investigators examined the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy. the investigators hypothesized that deep neuromuscular block (ptc 1 or 2) and low pressure pneumoperitoneum (8 mmhg) would improve respiratory mechanics and reduce inflammatory processes associated with biotrama during mechanical ventilation compared with moderate neuromuscular block (tof count 1 or 2 ) and standard pressure pneumoperitoneum (12-15 mmhg).

Eligibility criteria:
inclusion criteria: * asa physical status i or ii, aged 25 to 80 years, scheduled for laparoscopic surgery with trendelenburg position exclusion criteria: * cerebrovascular disease * uncontrolled hypertension, asthma, copd * neuromuscular disorder * patients who have had abdominal surgery * morbid obesity (body mass index \> 35 kg/m2)

Keywords: biotrauma laparoscopic surgery neuromuscular block sugammadex
comparison of resistance training and core strengthening exercises vitamin d in postmenopausal women with low back pain

Conditions: Menopausal; Pain, Low Back

Summary: this study aims to evaluate the effectiveness of resistance training, core strengthening exercises, and vitamin d supplementation in reducing low back pain (lbp) among postmenopausal women.

postmenopausal women are particularly susceptible to lbp due to physiological changes such as reduced estrogen levels, decreased muscle mass, and bone density. the randomized controlled trial (rct) will be conducted over six months in various clinical settings in lahore, with a sample size of 36 participants, divided into two groups. the inclusion criteria focus on postmenopausal women aged 50-70 years experiencing lbp for at least three months and who are not currently taking vitamin d supplements. data on pain intensity, functional disability, muscle strength, endurance, and vitamin d levels will be collected and analyzed to assess the interventions' impact. the study's findings could provide evidence-based recommendations for managing lbp in postmenopausal women, combining physical activity with nutritional supplementation.

Eligibility criteria:
inclusion criteria: * postmenopausal women aged 50-70 years. * experiencing low back pain for at least 3 months. * capable of engaging in light to moderate physical exercise. exclusion criteria: * history of spinal surgery. * currently taking vitamin d supplements. * diagnosed with severe osteoporosis. * chronic use of pain medication that cannot be temporarily ceased. * current participation in another clinical trial.
a pharmacokinetic/pharmacodynamic study of ro5185426 in previously treated patients with metastatic melanoma

Conditions: Malignant Melanoma

Summary: this open-label study will assess the pharmacokinetics, efficacy and safety of ro5185426 administered as 240mg tablets in previously treated patients with metastatic melanoma. patients will be randomized to receive one of four dose-levels of ro5185426 \[rg7204; plexxikon; plx4032\] orally twice daily on days 1 to 15 (morning dose). starting on day 22, treatment with ro5185426 may be resumed at a dose of 960 mg twice daily and continued until disease progression. target sample size is \<100 patients.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * histologically confirmed metastatic melanoma, stage iiic or iv (ajcc) * failure of at least one prior standard of care regimen * positive for braf v600e mutation (by roche codx braf mutation assay) * ecog performance status 0 or 1 * adequate hematologic, renal and liver function exclusion criteria: * active cns lesions on ct/mri within 28 days prior to enrollment * history of spinal cord compression o carcinomatous meningitis * anticipated or ongoing anti-cancer therapies other than those administered in this study * previous treatment with braf inhibitor (sorafenib allowed) or mek inhibitor * severe cardiovascular disease within 6 months prior to study * previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix
dose ranging study - macroflux parathyroid hormone (pth) in postmenopausal women with osteoporosis

Conditions: Osteoporosis

Summary: a multi-center study to determine effects of various doses of macroflux parathryroid hormone (pth) in women with osteoporosis


Eligibility criteria:
inclusion criteria: * healthy postmenopausal women age 50 years or older * at least three lumbar vertebrae (l1-l4) must be evaluable by dual energy x-ray absorptiometry (dxa) for bone mineral densitometry that is, without fracture or significant degenerative disease, as determined by the central imaging facility * have osteoporosis defined as: either a t-score of ≤ -2.5 at the lumbar spine, femoral neck, or total hip, and a t-score of at least \< -1.0 at the lumbar spine; or a t-score of ≤ -2.0 at the lumbar spine, femoral neck, or total hip, and at least one vertebral fracture; exclusion criteria: * active hepatitis; * active pancreatitis; * unstable cardiac disease; * unstable pulmonary disease; * celiac disease; * hyper- or hypo-parathyroidism; * hyperthyroidism; * cushing's disease; * osteomalacia; * paget's disease; * osteogenesis imperfecta; * known blood disorders; * history of kidney stones; * impaired renal function; * autoimmune diseases; * bone metastases or a history of skeletal malignancies; * cancer history that includes any cancer within the previous 5 years, with the exception of squamous or basal cell carcinoma of the skin in which the lesions were fully resected with clear margins described in a written report by a pathologist, and the patient has had no recurrence of lesions for at least 1 year from the time of original resection; * any condition or disease that may interfere with the ability to have or the evaluation of a dxa scan, for example, severe osteoarthritis of the spine, spinal fusion, pedicle screws, history of vertebroplasty, or degenerative disease that results in insufficient number of evaluable lumbar vertebrae, or \>1 lumbar vertebral fracture in l1-l4; * more than 4 vertebral fractures in t4-l4; * bilateral hip replacements; * use of fluoride (e.g. fluoride therapy for osteoporosis) or strontium at any time; * have received methotrexate or immunomodulatory agents with antiproliferative activity; * with known dermatological disorders that would interfere with the study procedures or assessments, or with a history of contact dermatitis; * with known allergy or sensitivity to tapes, adhesives, pth, teriparatide or its analogs, or components of the macroflux® systems; * who, in the opinion of the investigator, should not participate in the study, or may not be capable of following the study schedule for any reason; and * unwillingness or inability to abide by the requirements of the study. * have received any intravenous (iv) administered bisphosphonates in the past 24 months, or \>2 doses of iv administered bisphosphonates total; * use of oral bisphosphonates before randomization, including investigational bisphosphonates, unless: \ 12 months of treatment and off for 5 years;
vital signs blood pressure trial

Conditions: Cardiovascular Diseases; Hypertension; Blood Pressure

Summary: the purpose of this study is collect subject vitals with a blood pressure cuff, electrocardiogram (ecg), and photoplethysmogram (ppg). this data can then be used to develop a reliable, accurate, noninvasive, and continuous blood pressure monitoring device.


Eligibility criteria:
inclusion criteria: * age \>17 and \<65 years * bmi \>20 and \<35 exclusion criteria: * age \ 64 * bmi \ 35 * pregnancy
immediate effect analysis of vocal techniques

Conditions: Voice Disorders

Summary: the objective of this clinical and experimental study was to verify the immediate effect of vocal techniques: vibration, nasal sound and articulation in women without vocal complaints.

vocal techniques have been used, but few studies had as their aim to effectively verify its use and effect produced in voice and the larynx. the objective of this clinical and experimental study was to verify the immediate effect of vocal techniques: vibration, nasal sound and articulation. material and method: 32 female subjects with normal to mild dysphonia participated in the research, with ages from 20 to 45 years. all subjects were submitted to realization of vocal techniques of vibration of the lips, articulation and nasal sounds for twenty minutes. the subjects were submitted to record the voice and laryngostroboscopic exams for perceptual analysis and laryngostroboscopic exams before and after the use of vocal techniques.

Eligibility criteria:
inclusion criteria: * female subjects * with normal voices or slightly altered voice * without vocal complaints exclusion criteria: * subject with altered voices of moderate and severe grades * with lesions in the vocal folds; fusiform or double gap on the phonation * subjects with neurological disorders * subjects who had been treated earlier speech by voice changes and / or surgery in the larynx

Keywords: voice voice quality voice training evaluation
quality of life, recombinant tsh (thyrogen) and thyroid cancer

Conditions: Thyroid Cancer

Summary: to evaluate quality of life in patients after 10 days pause of thyroid medication (liothyronine) compared to treatment with recombinant tsh (thyrogen) before radioiodine uptake and treatment in a double-blinded, randomised cross-over design.

patients with a thyroid follicular or papillary cancer referred to radioiodine treatment in oncological department . the patients after thyroidectomy will be treated with liothyronine and this treatment will be paused 10 days before radioiodine. as a routine these patients will be re-evaluated with iodine uptake 4 months later. the patients will be randomised to either t3 pause related to the first radioiodine treatment and thyrogen injection (recombinant tsh) related to the second treatment/uptake - or thyrogen related to the first treatment and t3 pause related to the second treatment /uptake. all medication given in the 10 days period right before radioiodine treatment/uptake will be delivered to the patients and marked with a protocol number. in the period with t3 pause the patients will be given placebo tablets and an injection of saline (instead of thyrogen) before treatment/uptake at the similar time as given the thyrogen injection. a nurse otherwise not involved in the study will give the injection. patients will be evaluated by vas, sf-36, and eortc qlc30 (version 2.0) before radioiodine treatment and 3 weeks after treatment.

Eligibility criteria:
inclusion criteria: * follicular or papillary thyroid cancer exclusion criteria: * \ 75 years old * pregnant or lactating women

Keywords: quality of life