Kornimate/medical-research-clean huggingface dataset:
effect of low-calorie diet and lifestyle intervention on reversal of t2dm

Conditions: Diabetes Mellitus; PreDiabetes; Diet Habit

Summary: an increase in body fat, even when within the normal bmi range is one of the essential drivers of t2dm in asian indians. in this context, the relationship between excess hepatic fat and pancreatic fat appears to be necessary. a low-calorie (high protein and low carb) vegetarian diet with appropriate exercise, in a protocol similar to the direct study, may lead to weight loss, reversal of diabetes, and decrease in ectopic fat.

diabetes is one of the biggest global public health problems. india has 100 million people living with diabetes as per the 2023 data. reversal of t2dm, the holy grail of diabetes management, was not deemed possible until recently. primary care-led weight management for remission of type 2 diabetes (direct) trial has been conducted in obese patients with t2dm patients for a period of 2 years in the uk. research on the effect of dietary intervention would be necessary for asian indians since liver fat deposition is more severe than in white caucasians. although some nutritionists and physicians are replicating methods of direct study in their patients, it is not clear if similar diets will work effectively in community-dwelling asian indians.

Eligibility criteria:
inclusion criteria: * diagnosed with t2dm within the previous 3 years * age 20-65 years * bmi \>25-45kg/m2 * hba1c\> 6.5% at baseline (on current treatment, if any) exclusion criteria: * recent or screening hba1c of 9% or higher * weight loss of \>5 kg within the previous 6 months * significant cardiopulmonary * hepatic, or another endocrine disease * current participation in any other research drug study in the previous three months * past history of bariatric surgery malignancy other than minor skin lesions and possibility of pregnancy

Keywords: type 2 diabetes, low calorie diet, asian indians, hepatic fat, pancreatic fat
structured light plethysmography against standard of care in the diagnosis and monitoring of dysfunctional breathing

Conditions: Dysfunctional Breathing

Summary: this is an observational, controlled, single-centre study to validate the thora3di™ against standard practice in patients who are undergoing investigation for disproportionate breathlessness. the core methodology involves capturing of data during a short period of measurement of breathing using slp.

cohort a: this study is a pilot study with four study visits (screening, baseline, week 13 and week 26) to generate data to characterise the tidal breathing patterns and parameters with thora3di™. subjects will have a screening visit within 0 to 14 days prior to the first study visit. for each study visit, subjects will be seen in the clinical research facility and have two 5-minute slp measurements (at rest and on exertion). the slp measurement should be performed prior to standard lung function tests with minimal impact on clinical time and not change to hospital attendance. also, each visit subjects will be asked to report concomitant medications and adverse events, and fill several questionnaires forms as outlined in the soas. cohort b: healthy subjects will have only one visit for this study. after signing the informed consent form, subjects will undergo two 5-minutes slp measurements (at rest and on exertion).

Eligibility criteria:
inclusion criteria: * • cohort a: any adult who is presenting with controlled disproportionate breathlessness will be considered for inclusion as a diseased subject (with excluded comorbidities as cause of breathlessness e.g. uncontrolled asthma (gina 2019 guidelines), uncontrolled cardiac disease, ilo). * cohort b: any adult who is in good respiratory health will be considered for inclusion as a normal in the study. exclusion criteria: * subject unable to sit in an upright position for required period * subjects with significant co morbidities (assessed by the clinician at screening only): * chest wall or spinal deformity e.g. scoliosis osa, apnoea hypopnoea index \> 30 (if known) * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participants' ability to participate in the study * bmi \> 40 * height \> 194 cm * female participant who is pregnant, lactating or planning pregnancy during the course of the study * inability to consent/comply with trial protocol
compassionate use protocol for pf-03084014 in patients with advanced solid tumor malignancies

Conditions: Neoplasm; Desmoid Tumor

Summary: this is a single-center, open label, non randomized, compassionate use protocol in patients with advanced solid tumor malignancies who were previously enrolled in the phase i study (nct00878189) of this agent.

this is an expanded access-physician sponsored trial of pf-03084014, a novel gamma-secretase inhibitor being developed for cancer therapy. this trial is designed for patients who have been on a previous industry-sponsored phase i trial using pf-03084014 for\> 1 year. the study is designed to evaluate the safety of prolonged oral administration of single agent pf-03084014. there are two study subjects with desmoid tumor who have been on the trial for a prolonged period of time (54 and 77 months, respectively) with either stable disease or response, indicating significant clinical benefit for a patient population in which there are few options. the goal of this protocol is to allow these subjects, who are clearly benefiting from pf-03084014, to continue to receive it

Eligibility criteria:
inclusion criteria: - patients who are currently enrolled in a8641014 for \> 1 year are eligible exclusion criteria: * prior treatment with a gamma secretase inhibitor for treatment of cancer * patients taking tamoxifen * patients with active graft versus host disease * known human immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids) related illness * patients who are pregnant or breast-feeding * patients with clinical evidence of central nervous system disease

Keywords: refractory tumors advanced solid tumors
cohort of deafness-gene screening

Conditions: Hearing Loss

Summary: this study was based on a concurrent newborn genetic and hearing screening program in nantong city. from january 2016 to december 2020, newborn infants were recruited and received combined screening for free, funded in part by the municipal government and research project foundations. the population-based longitudinal databank for all children with hearing loss in nantong city commenced in january 2016 and maintained indefinite recruitment and ongoing follow-up.

the severity of hearing loss was graded as mild (26-40 db), moderate (41-60 db), severe (61-80 db), and profound (≥81 db). genomic dna was extracted by a blood filter paper nucleic acid extraction kit (capitalbio, beijing, china) and tested using a deafness gene variant detection array kit (capitalbio, beijing, china) with luxscan 10k-b microarray scanner (capitalbio, beijing, china). the genetic screening entailed genotyping 15 variants in 4 genes: c.35delg, c.176_191del16, c.235delc, c.299_300delat (gjb2 gene); c.1174a\>t, c.1226g\>a, c.1229c\>t, c.1975g\>c, c.2027t\>a, c.2168a\>g, c.ivs7-2a\>g, c.ivs15 + 5g\>a (slc26a4 gene); m.1494c\>t, m.1555a\>g (mt-rnr1 gene); c.538c\>t (gjb3 gene). the results were categorized as (1) negative, (2) carrier (gjb2 or slc26a4, heterozygous mutations; mt-rnr1 mutations; gjb3 mutations; or heterozygous mutations in multiple genes), and (3) refer (gjb2 or slc26a4, homozygous or compound heterozygous mutations). this study was approved by the ethics committees of nantong municipal health commission and all hospitals involved. written informed consent was obtained from the infant's parents. this study followed the strengthening the reporting of observational studies in epidemiology (strobe) reporting guideline for cohort studies.

Eligibility criteria:
inclusion criteria: 1. the infants were born between january 2016 and december 2020; 2. the infants' health condition was good enough to tolerate the screening procedures; 3. the parents were urban residents of nantong city; 4. the parents agreed to have their babies participating in the combined hearing and genetic screening program. exclusion criteria: 1. the infants' blood samples were unqualified for the genetic tests according to criteria of the national health commission of china's technical specification for neonatal screening of congenital diseases; 2. the infants were lost to follow-up.

Keywords: newborn hearing screening genetic screening cohort study
limb girdle muscular dystrophy type 2e recruitment study

Conditions: Limb-Girdle Muscular Dystrophy, Type 2E

Summary: this study is to recruit and establish baseline measurements for potential subjects that may be eligible for a gene therapy trial. specifically, this trial is recruiting individuals who are suspected or have been confirmed to have limb girdle muscular dystrophy type 2e (lgmd2e).

this is a longitudinal observational study. it is a 24-month study with the possibility of extending the data time points. visits will occur monthly. however, at the discretion of the pi, subjects may not be required to return monthly. these subjects may return at intervals ranging from 2 months to a max of 6 months apart. in the situation that the subjects would fall out of the inclusion criteria or not be eligible for the lgmd2e gene therapy trial, they will be given the opportunity to roll over into the natural history for lgmd (irb17-01086). if a subject is invited to screen for the gene therapy trial they will discontinue this trial. by being in this study, it is not a guarantee that subjects will be invited to screen for the lgmd2e gene therapy trial.

Eligibility criteria:
inclusion criteria: * age 3-15 inclusive * males or females of any ethnic group * sgcb dna gene mutations at both alleles or suspected to have lgmd2e based on family and medical history. if suspected, genetic testing will be performed to confirm diagnosis. * weakness demonstrated based on history of difficulty running, jumping and climbing stairs * ability to complete 100mw timed test within 30-90% predicted * perform assessments to the best of their ability with reliable results as deemed by the evaluator. * ability to attend scheduled appointments * ability to provide informed consent (or assent for ages 9-15) exclusion criteria: * confirmed diagnosis of neuromuscular disorder other than lgmd2e * has a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the subject's ability to comply with the protocol required testing or procedures or compromise the subject's wellbeing, safety, or clinical interpretability * subjects with aavrh74 binding antibody titers \> 1:400 as determined by elisa immunoassay. if endpoint titer is positive at screening, testing may be repeated in 1 month. antibody testing will be performed on a separate study (irb17-01101). * diagnosis of (or ongoing treatment for) an autoimmune disease

Keywords: lgmd2e limb girdle muscular dystrophy sarcoglycanopathy β -sarcoglycan natural history
in-home assessment of a smart foot mat for prevention of diabetic foot ulcers

Conditions: Foot Ulcer, Diabetic

Summary: the purpose of this study is to investigate the accuracy of a smart foot mat for signals associated with diabetic foot ulcers in high-risk patients.


Eligibility criteria:
inclusion criteria: * male/female, 18 years or older * diagnosis of type 1 or type 2 diabetes mellitus, controlled or uncontrolled * ankle brachial index (abi) \>0.5 * patient with history of previous foot ulcer. exclusion criteria: * active charcot foot disease * one or more plantar foot ulcers (ut grade 1a-c, 2a-c \& 3a-c) * active infection/gangrene * active malignancy * immunosuppressive disease * history of alcohol or drug abuse * pregnant women (verbal confirmation or confirmation obtained within current medical records) * cognitive deficit * 2+ or great lower extremity edema * end stage renal disease * history of major lower extremity amputation (below knee or above knee amputation) * other issue that, at the discretion of the investigator, renders the subject ineligible for participation.
subtypes and prognostic factors in erdheim-chester disease

Conditions: Erdheim-Chester Disease

Summary: erdheim-chester disease (ecd) is a rare form of histiocytosis characterized by the proliferation of blood cells, known as histiocytes, which infiltrate various organs and tissues, often causing irreversible damage. the causes of the pathology are still unknown. although the disease typically affects adult individuals, cases of pediatric-onset ecd have been described. however, there is a lack of detailed information on the phenotypic characteristics of these patients, and reliable data on response to specific therapies and long-term outcomes are missing. three patients referred to our reference center for histiocytosis present a concomitant braf-mutated neoplasm. such an association could be due to the presence of mosaicisms for the braf v600e mutation. mosaicism is a biological event defined as the presence of more than one genetically dissimilar cell population in the same organism and is an increasingly studied field, both in normal and pathological conditions. if proven in ecd as well, this mechanism could contribute to providing answers to the still open questions regarding the development of this disease.


Eligibility criteria:
inclusion criteria: * prevalent and incident patients (adults and pediatric), with histologically confirmed diagnosis of erdheim-chester disease according to the latest diagnostic recommendations; * signing of informed consent for study participation. exclusion criteria: * patients for whom clinical and imaging data are not available and for whom it is not possible to retrieve histological samples."
kagoshima collaborate trial in metabolic syndrome (kact study)

Conditions: Hypertension; Obesity

Summary: the purpose of this study is to consider the following points in patients with hypertension who complicated by metabolic syndrome for valsartan basis treatment and an existing, standard treatment. * blood pressure control * changing of adiponectin and plasminogen activator inhibitor-1 * influence metabolizing and cardiac function, etc.

the primary endpoints are: * blood pressure control * adiponectin and plasma type1 plasminogen active inhibitor the secondary endpoints are * homa-ir * hba1c * tnf-α * il-6 * plasma b-type natriuretic peptide * lvmi * e/a ratio * tei-index * apo-j

Eligibility criteria:
inclusion criteria: * out patients with hypertension male and female * systolic blood pressure (sbp)≧140mmhg and/or diastolic blood pressure (dbp)≧90 mmhg * waist surrounding diameter male≧85cm female≧90cm * patient who is treating either high triglyceride,low hdl,or diabetes mellitus * patient who is untreatment high triglyceride blood syndrome and low hdl blood syndrome,diabetes mellitus is triglceride≧150mg/dl and/or hdl cholesterol \< 40 mg/dl or fasting blood glucose ≧110 mg/dl * untreated patients with hypertension,or patients is treated with antihypertensive agents except for ace-i and arb exclusion criteria: * patient who is using ace-i and arb * serum creatinine ≧ 3 mg/dl * liver impairment * history of allergy to valsartan * pregnant women * judgment by the physician that participation was unwise on the basis of patient characteristics and drug safety

Keywords: valsartan metabolic syndrome
treatment by therapeutic body wraps in children and adolescents suffering from autism with severe injurious behavior.

Conditions: Autism Spectrum Disorder

Summary: severe injurious behaviors in children with autism spectrum disorder are challenging. first line treatment approaches include behavioral techniques but pharmacotherapy is frequently required despite frequent adverse effects in youths. therapeutic body wraps has been reported in small series or case reports, but has never been assessed in the context of a randomized controlled trial. the present study is an exploratory, multicenter, randomized, controlled, open label with blinded outcome assessment (probe design) trial of the effect of wet versus dry therapeutic body wraps in children presenting with autism spectrum disorder and severe injurious behavior.

packing therapy has never been assessed, namely in children with severe injurious behavior and autism spectrum disorder. the aim of the present study is to evaluate the beneficial effect of wet versus dry therapeutic body wraps through an exploratory randomized controlled open label blinded outcome assessment approach. the primary objective is the comparison of change in abc irritability scores from baseline to 3 months between the two groups. according to the potential recruitment, we plan to recruit 30 subjects in each group. this sample size could allow us to detect a minimum effect size of 0.74 between the 2 groups (considered large in literature) with a power of 80% (two-sided test and type i error of 5%). as described elsewhere, wet or dry session will be organized through twice-a-week sessions for a 3-month duration. comparison in primary outcome (abc irritability score) between the 2 groups will be performed using analysis of covariance (ancova) adjusted for the baseline value. the standardized difference (effect size) will be computed taking into account the adjustment for baseline and its 95% confidence interval will be estimated using a bootstrap resampling. the validity of the ancova model will be checked by examining the model residuals. the same methodology will be used for the secondary outcomes.

Eligibility criteria:
inclusion criteria: * a current diagnosis of autism, asperger syndrome, atypical autism according icd-10 criteria confirmed by specialized clinical assessment; * presenting severe behavioural disturbances such as hetero and self-injurious behaviours, automutilation, severe motor hyperactivity, severe stereotypies. * having a systematically consultation by a neuro pediatric. exclusion criteria: * children with known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities. * patients with stabilized seizure condition, antiepileptic medication should be stable for at least 4 weeks.

Keywords: autism therapeutic body wraps
efficiency of presurgical basal cell carcinoma margin mapping

Conditions: Carcinoma, Basal Cell

Summary: this interventional randomised controlled study is intended to establish that presurgical margin mapping of bccs with oct results in a reduction of the number of mms surgery stages without adversely impacting clinical outcome, resulting in shorter patient stays and more efficient use of surgical and operating room resources.

basal cell carcinoma (bcc) is the most common malignancy in humans. its incidence is continuously increasing. the head and neck areas are most commonly affected due to their increased lifetime exposure to sun compared to other body parts. bcc is often treated by surgical excision which has high cure rate compared to other treatment modalities, but leaves a visible scar which can affect the quality of life of the patient, depending on the location and size of the excision. mohs micrographic surgery (mms) was developed to minimize the size of the surgical excision whilst maintaining very high cure rate. the main drawback of mms is that repeated surgery procedures are usually required to eliminate all of the tumour using specialist resources located at the clinic. optical coherence tomography (oct) allows non-invasive in-vivo imaging of superficial skin lesions. it is in routine clinical use for diagnosis of bccs, and the diagnostic sensitivity and specificity is well established in published multi-centre trials. a further potential application of oct is the pre-surgical mapping of the lateral margins of bcc. if the margins of a bcc were accurately known prior to commencing an mms treatment, the treatment could be performed much more quickly, resulting in shorter patient stays and more efficient use of surgical and operating room resources. previously published research has already shown that oct mapping of bcc margins is more accurate than clinical assessment; the objective of the present study is to demonstrate that pre-surgical mapping of bcc margins with oct is also more efficient.

Eligibility criteria:
inclusion criteria: * patients with biopsy-proven bccs who have been referred for mms exclusion criteria: * patients with bccs larger than 6 cm2
evaluation of myocardial viability by means of low-dose dobutamine gated spect (the dogs study)

Conditions: Coronary Arteriosclerosis; Heart Failure, Congestive; Myocardial Infarction; Myocardial Ischemia; Myocardial Stunning

Summary: viability assessment remains a clinical challenge in patient with coronary artery disease and left ventricular dysfunction. several imaging modalities are available for evaluating myocardial viability, based either on perfusion or on contractile reserve analysis. briefly, perfusion analysis is highly sensitive and contractile reserve highly specific. a combined analysis of both perfusion and contractile reserve has been proposed to improve the diagnostic accuracy in patient referred for a revascularization procedure. however, the value of this combined analysis has not been validated in unselected patients referred for viability assessment. the patients enrolled in the study will undergo a nitrate enhanced rest gated spect using a tc-99m labeled tracer (sestamibi or tetrofosmine) followed by a second gated spect acquired during a low-dose dobutamine infusion (10 mcg/kg/mn). all patients will have a 6-month clinical and imaging follow-up, including physical examination and a nitrate enhanced rest gated spect using the same radiopharmaceutical. all treatments received during this 6-month period will be recorded, including medical therapy and coronary revascularization (angioplasty, stenting and cabg). finally, the value of baseline perfusion and contractile reserve analysis in predicting left ventricular ejection fraction changes at 6-month follow-up will be evaluated.


Eligibility criteria:
inclusion criteria: * documented coronary artery disease * left ventricular dysfunction (lvef \< 50%) * patients referred to the nuclear medicine department for myocardial viability assessment * sinus rhythm * acceptance of a 6-month follow-up * signed informed consent exclusion criteria: * recent acute coronary syndrome (\< 21 days) * atrial fibrillation or significant arrhythmias * implanted pacemaker * contra indication to dobutamine * non ischaemic cardiomyopathy * pregnancy

Keywords: coronary arteriosclerosis heart failure, congestive myocardial infarction myocardial revascularization tomography, emission-computed, single-photon dobutamine myocardial stunning myocardial hibernation