Kornimate/medical-research-clean huggingface dataset:
precision medicine for preterm birth

Conditions: Premature Birth

Summary: this project is examining genetic and metabolic markers for the use of 17 hydroxyprogesterone caproate (17ohpc) in pregnant women with a history of preterm birth (ptb). 17ohpc has been associated with a 30-35% reduction in repeat ptb in women carrying a singleton gestation. however, it is not well known why it works for some women but not for others. there are limited available interventions for the prevention of recurrent ptb. this study will enroll 150 women at risk for ptb and eligible to receive 17ohpc, and expect that 80% will use 17ohpc and 20% will decline use. we will obtain blood samples and samples of cervical cells and cervical vaginal fluid. the objective of the study is to identify genetic, microbial and molecular markers that help to identify which women at risk for recurrent preterm birth will respond to 17ohpc and which women will not. the ultimate goal is to develop a personalized screening test based on these markers.

women with a prior preterm birth will be recruited between 16 and 22 weeks gestation. at this initial time point, samples of cervical epithelial cells and cervicovaginal fluid will be collected. approximately 8 weeks later, those samples will be collected a second time, along with a blood sample. outcome data will be collected after delivery.

Eligibility criteria:
inclusion criteria: * women with a prior spontaneous preterm birth of a singleton pregnancy (delivered at 16-36 6/7 weeks gestation) * singleton in the current pregnancy * eligible to use 17 hydroxyprogesterone caproate (17ohpc) in this pregnancy for clinical indications * 16-22 weeks gestation at the time of visit 1 assessments exclusion criteria: * major fetal anomaly * allergy to 17ohpc

Keywords: premature birth premature delivery metabolomics microbiota genetics 17 hydroxyprogesterone caproate
gait training with executive functions tasks in subjects with parkinson´s disease: a study protocol

Conditions: Parkinson´s Disease

Summary: the aim of this study is the development and implementation of a new protocol of a physical therapy training, based on a gait training associated with executive tasks, for treatment of individuals with parkinson's disease. the hypothesis is that this group of patients who will carry out training of this study protocol will show improvement in measured parameters (functionality of gait and cognitive ability), which allows this protocol to be improved and published as a proposal of physiotherapeutic treatment.

the aim of this study is the development and implementation of a new protocol of physical therapy training, based on a gait training associated with executive tasks for treatment of individuals with parkinson's disease. the proposed motor training consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and after this, 30 minutes of gait training in a dual-task condition, associated with distracting tasks that require handling of the main executive functions. it will be an open label study, non randomized, where 30 patients with pd in stages 1 to 3 on hoehn \& yahr scale will participate in the study, to be held in brazil parkinson association. the training will consist of 10 sessions, two times per week for five weeks. the executive tasks concomitant with gait training cover the following executive functions: volition, self-awareness, planning, response inhibition, response monitoring and attention. the main outcome measures are: (1) dynamic gait index (dgi), (2) montreal cognitive assessment (moca), (3) trail making test a and b, (4) unified parkinson's disease rating scale (updrs) and (5) falls efficacy scale (fes).

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pd performed by a neurologist specialist in movement disorders; * in use of dopaminergic medication; * disease severity of 1 to 3 according to hoehn \& yahr scale; * absence of other neurological disorders or co-morbidities that may affect gait; * absence of dementia (score above 24 on the mini mental state examination - mmse); * vision and hearing adequate or corrected to normal; * ability to walk independently; * absence of prolonged off state; * age 50 to 85 years. exclusion criteria: * biomechanical alterations (other pathologies) that could compromise the completion of training; * presence of depression, detected by the geriatric depression scale (gds-15); * presence of any neurological, auditory or visual deficit that could compromise distracting task performance during gait training; * any changes in drug treatment for pd.

Keywords: parkinson´s disease rehabilitation cognition
endoscopic submucosal dissection versus gastrectomy

Conditions: Early Gastric Cancer

Summary: gastrectomy is curative treatment for early gastric cancer (egc). recently, endoscopic submucosal dissection (esd) has been accepted as standard treatment in selected patients with negligible risk of lymph node metastasis. however, there are limited data regarding the long-term outcomes of esd in comparison with surgery. this protocol aims to compare overall survival rate, tumor recurrence, development of metachronous cancers after esd and surgery.

the prevalence of gastric cancer is high in asia, especially in korea and japan. in korea, the detection rate of egc has increased with mass screening for the prevention of gastric cancer-related death. egc is defined as mucosal or submucosal cancer, regardless of regional lymph node metastasis. the presence of lymph node metastasis has been reported to range from 2% to 18%. for this reason, radical gastrectomy with lymph node dissection was considered as the only curative treatment. in egc patients, surgical outcome demonstrated excellent 5-year survival rate above 90%. in 2000, egc subgroups with negligible risk of lymph node metastasis were proposed on the basis of large scale retrospective data. thereafter, the result was adopted as expanded criteria for endoscopic resection of egc. esd is useful technique to dissect the tumor along the submucosal layer using various endoscopic knives. compared to endoscopic mucosal resection (emr), esd achieved a higher complete resection rate and a lower local tumor recurrence rate. although curative resection is pathologically achieved by esd, post-resection surveillance is needed to confirm the presence of nodal metastasis. recently, several studies reported that 5-year overall and disease-specific survival rate were highly favorable in egc patients who underwent curative esd. however, there is no comparative study about long-term outcomes after esd and gastrectomy. therefore, this protocol aims to evaluate overall survival rate, tumor recurrence, development of metachronous cancers between esd and surgery groups.

Eligibility criteria:
inclusion criteria: * differentiated type mucosal cancer without ulceration, regardless of tumor size * differentiated type mucosal cancer with ulceration ≤ 3 cm in diameter * superficial (sm1 \< 500 μm) submucosal cancer ≤ 3 cm in diameter * undifferentiated type mucosal cancer without ulceration ≤ 2 cm in diameter exclusion criteria: * early gastric cancer in a remnant stomach * gastrectomy due to metachronous lesions during follow-up period * post-esd additional surgery due to high risk of lymph node metastasis or the possibility of residual tumor

Keywords: endoscopic submucosal dissection gastrectomy survival outcome
telestar (telotristat etiprate for somatostatin analogue not adequately controlled carcinoid syndrome)

Conditions: Carcinoid Syndrome

Summary: the primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (bms) from baseline averaged over the 12-week double-blind portion (treatment period) of the trial in patients not adequately controlled by current ssa therapy.


Eligibility criteria:
inclusion criteria: * histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor * documented history of carcinoid syndrome and currently experiencing ≥4 bowel movements per day during the run-in period * currently receiving stable-dose somatostatin analog (ssa) therapy * minimum dose of long-acting release (lar) or depot ssa therapy * octreotide lar at 30 mg every 4 weeks * lanreotide depot at 120 mg every 4 weeks * patients who cannot tolerate ssa therapy at a level indicated above will be allowed to enter at their highest tolerated dose * ability and willingness to provide written informed consent exclusion criteria: * presence of diarrhea attributed to any condition(s) other than carcinoid syndrome * karnofsky performance status ≤60% * treatment with any tumor directed therapy, including interferon, chemotherapy, mechanistic target of rapamycin (mtor) inhibitors \<4 weeks prior to screening, or hepatic embolization, radiotherapy, radiolabelled ssa, and/or tumor debulking \<12 weeks prior to screening * history of short bowel syndrome (sbs) * clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study * previous exposure to telotristat etiprate
the manchester short splint in the rehabilitation of zone ii flexor tendon repairs

Conditions: Tendon Injuries

Summary: the project sets out to compare two different splints in the outcome of zone ii flexor tendon injury hand therapy rehabilitation programme. traditional hand therapy is based on using a long forearm-based splint for 6 weeks in zone ii flexor tendon injuries. manchester university nhs foundation trust have devised a new shorter splint to use as an alternative to the traditional longer splint as there are cogent reasons for believing that permitting more wrist movement during rehabilitation will improve the range of finger movement ultimately (tendonesis effects). patients will be randomised to receive either the traditional long splint, or the short splint. patients will be followed up and data will be collected at routine hand therapy appointments.


Eligibility criteria:
inclusion criteria: * adult male and female patients 16 years and over, undergoing surgical repair of zone ii flexor tendon injury in a single digit exclusion criteria: * adult patients lacking capacity or motivation to participate in the planned physiotherapy * adult patients with special needs and vulnerable groups * adult patients who undergo surgical repair of their flexor tendon more than 4 days after the initial injury * patients unable to understand english adequately * adult patients unable to attend the hospital facility for the requisite number of planned physiotherapy sessions (social reasons) * adult patients with multiple level injuries * injuries with soft tissue loss requiring coverage * adult patients with two nerve injuries on the same finger * adult patients with multiple digit flexor tendon injury * adult patients with concomitant bony injury to the hand * children under 16 years age
the efficacy of shear-wave elastography-guided aspiration and biopsy for diagnosis in lung tumor

Conditions: Lung Tumor

Summary: to use the shear-wave elastography to assist the transthoracic ultrasound-guided aspiration biopsy of peripheral lung tumor 1. to identify the intra-tumor heterogeneity of elasticity 2. to increase the diagnostic yield in ultrasound-guided transthoracic biopsy of subpleural pulmonary tumor


Eligibility criteria:
inclusion criteria: (1) patients with radiographic evidence of pulmonary lesions exclusion criteria: 1. age \< 20 y/o 2. patients who cannot hold their breath for 5 seconds 3. inadequate shear-wave propagation of lung tumor
investigation of the reliability of ultrasonography usage in the diagnosis of temporomandibular joint diseases

Conditions: Device Reliability

Summary: in the literature, temporomandibular joint diseases on the diagnostic value of the use of ultrasonography in diagnosis studies are lacking. in this study in the diagnosis of temporomandibular joint diseases revealing the reliability of the use of ultrasonography. it is aimed to contribute to the literature in terms of.


Eligibility criteria:
inclusion criteria: * patients over the age of 18 who apply with tmj problems * patients with pain in the joint and chewing muscle area exclusion criteria: * syndromic patients * patients under the age of 18 * patients with a history of orthognathic surgery * pregnants * antidepressant users * patients using removable dentures * patients who have had joint treatment in the past six months

Keywords: ultrasonography
reflexology's effect on polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is very common, affecting approximately 5% of women of reproductive age, and impacts not only on quality of life, but also has long-term health consequences for many sufferers, such as increased risks of developing type ii diabetes, cardiovascular disease and cancer of the womb. the symptoms that may occur such as irregular periods; lots of body hair; thinning hair on scalp, obesity and infertility, can also lead to poor self-esteem. whilst treatments can help fertility, other treatments to correct the other symptoms are less successful. alternative methods to regulate periods would be helpful, especially ones which avoid the long-term use of steroids in patients who may already be overweight. reflexology is poorly represented in scientific papers, with nothing published regarding reflexology and its effect upon pcos. however patients who use reflexology report more regular periods, thicker hair on scalp and greater wellbeing. therefore we aim to investigate the effect of reflexology on: 1. the menstruation cycle (normal being every 21-35 days). 2. imbalances in hormone, insulin and blood sugar levels associated with pcos. 3. other problems associated with pcos such as thinning hair on scalp, excessive body hair, and obesity. 4. quality of life. government and nhs agendas agree that if there's evidence of an effective complimentary therapy the nhs should provide it. therefore the results may have an influence on the care pathways of patients with pcos towards a more holistic, patient centred and empowered approach. it is also non invasive and liable to result in higher patient satisfaction regarding their treatment. this research may also inform policy makers so that complementary medicine provision is provided on a wider basis within the nhs, which at the moment is dictated by the individual trust's budget allocation. however this research could save money overall as in america, the yearly cost of treating pcos is $4.36 billion.


Eligibility criteria:
inclusion criteria: * women with pcos exclusion criteria: * use of complimentary therapies within 6/12 prior to recruitment * bmi \>35 * taken combined oral contraceptives, metformin, or cyclical progestogens within 3/12 prior to recruitment

Keywords: polycystic ovary syndrome reflexology complementary and alternative medicine endocrinopathy oligo amenorrhoea
epidemiology of coronary heart disease in blacks

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Infarction

Summary: to conduct an analysis of the epidemiology of coronary heart disease (chd) in blacks using data collected from the 'survival and ventricular enlargement (save) following myocardial infarction' study.

background: ample data now exist to dispel the prevailing clinical impression that coronary heart disease (chd) occurs infrequently in united states blacks. it is well known that chd is the leading cause of death among united states blacks. among patients with acute myocardial infarction who often present with typical ischemic chest pain, it has been shown that blacks present more often without chest pain when compared to whites and hispanics. in addition, more than 25 percent of the myocardial infarction patients have unrecognized infarctions. morbidity and mortality associated with angina pectoris, cardiovascular disease, and myocardial infarction occurs in united states blacks at rates which are at least comparable to their white counterparts. yet, there are limited epidemiological studies designed to identify the determinants of chd in the black population. the patients were originally screened to participate in a multicenter clinical trial on 'survival and ventricular enlargement (save) following myocardial infarction.' only 28 patients out of 599 screened subjects were eligible for the save study. the baseline data obtained from the 599 screened subjects comprised the database. design narrative: data analysis was performed to: determine the prevalence of coronary heart disease in blacks presenting with chest pain; identify the correlates of chd in blacks; determine the sensitivity and specificity of a rose questionnaire angina in blacks; determine the association between the rose questionnaire angina and chd manifestations in blacks, and identify predictive and causal models of chd. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
improving thrombolysis implementation based on electronic monitoring in acute ischemic stroke (item)

Conditions: Thrombolysis Rate

Summary: a cluster randomized controlled trial will be conducted. hospitals in zhejiang province, china, will be randomized into two arms (1:1): an intervention arm and a control arm. hospitals in the intervention arm will receive a multilevel intervention based on the aactt theory, whereas hospitals in the control arm will receive no intervention and maintain routine care. all the hospitals will receive electronic monitoring. hospitals with no stroke center or with \<20 cases received thrombolysis per year will be excluded from the study.


Eligibility criteria:
inclusion criteria: 1. patients presented with clinical signs of acute ischemic stroke within 4.5 hours of stroke onset 2. patient's age is \>18 years exclusion criteria: contraindication for intravenous thrombolysis

Keywords: acute ischemic stroke electronic monitoring intravenous thrombolysis
administration of ketamine to prevent the post-operative pain

Conditions: Postoperative Pain; Breast Cancer

Summary: the surgery of breast cancer is responsible for post-operative pain, needing in about 30% some morphine consumption; like that, the association of ketamine with general anaesthesia may decrease morphine's use and so its adverse effects. the purpose is to evaluate the analgesic effect of a receptor nmda's antagonist ( ketamine)


Eligibility criteria:
inclusion criteria: * patients 18 years older * asa class 1 or 2 * with surgery of breast cancer (mastectomy or tumorectomy) exclusion criteria: .kétamine hypersensitivity * major psychiatric disorders * major cardio-vascular disorders * major neurologic disorders * major ocular disorders * morphine in pre-operative period

Keywords: post-operative-pain breast cancer morphine analgesia
preventing excessive weight gain and maternal and infant fat accretion

Conditions: Gestational Weight Gain; Maternal Fat Accretion; Infant Fat Accretion

Summary: the purpose of this study is to learn if consuming a high fiber diet will reduce gestational weight gain and maternal and infant fat accretion.


Eligibility criteria:
inclusion criteria: * pre-pregnancy bmi 18.5 - 45.0 kg/m2 exclusion criteria: * comsuming more than 20 g/day of fiber * no phone and internet access * pre-gestational diabetes * diagnosed with diabetes * pre-eclampsia * hypertension * other metabolic abnormalities * asthma * heart disease * smoking * drug abuse * recent antibiotic use * pregnancies of multiples

Keywords: fat mass gestational weight gain infant fat mass high fiber microbiome
electrical impedance tomography in one-lung ventilation

Conditions: Ventilator Lung

Summary: mechanical ventilation can cause damage to the lung parenchyma, this is known as ventilatory induce lung injury (vili).to avoid this damage, ventilatory strategies have been created, focused on the reduction of tidal volume, airway pressures and use of peep (positive end-expiratory pressure), which together are called "protective ventilation". although ventilation with protective parameters seems to reduce vili in one-lung ventilation, the optimal parameters are not clear.

this research aims to describe the ventilation, perfusion and pulmonary mechanics on one-lung ventilation with different levels of tidal volume and peep. an extreme situation of vili occurs in thoracic surgery, where the atelectasis of a lung is required, ventilating throughout the surgery only the contralateral one. this generates an inflammatory state, with the release of alveolar cytokines from both the non-ventilated and ventilated lungs, which potentiates the development of damage in the lung parenchyma. in addition, one lung ventilation has traditionally been performed with high tidal volume (vt) values and low peep. in this context, the development of vili is even more probable, so extreme measures of protection in this kind of ventilation are necessary. the electrical impedance tomography will allow the investigators to obtain a visual and quantitative representation of the areas of ventilation and perfusion of the lung. by relating the tidal volume and peep with the tomographic results, it is expected to define mechanical ventilation parameters that achieve the best ventilation/perfusion ratio for patients in one-lung ventilation. specifically, analyze the distribution and deformation of the ventilated areas in the different lung regions and its correlation with respiratory mechanics and volumetric capnography. this will allow the investigators to make a better definition of the tidal volume and peep in patients undergoing one-lung ventilation. .

Eligibility criteria:
inclusion criteria: * asa (american society of anesthesiologists) classification i-iii * age 18-75 years * elective thoracic surgery * one-lung ventilation * healthy non ventilated lung exclusion criteria: * asa classification \> iii * bmi (body mass index) \> 30 * emergency surgery * pregnancy * patients includes in other protocols

Keywords: electrical impedance tomography one-lung ventilation protective ventilation ventilator- induce lung injury
to investigate the safety and tolerability of repeated subcutaneous injections of cad106 in alzheimer's patients

Conditions: Alzheimer Disease

Summary: this study will evaluate the safety and tolerability of repeated subcutaneous injections of cad106 in patients with alzheimer's disease.


Eligibility criteria:
inclusion criteria: * patients who have completed the core study with no significant safety concerns exclusion criteria: * diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression). * diagnosis or presence of an active, uncontrolled seizure disorder and/or cerebrovascular disease. * diagnosis or presence of an active autoimmune and/or with an acute or chronic inflammation.

Keywords: active immunization alzheimer disease antibody central nervous system diseases neurodegenerative diseases vaccine
study evaluating of recombinant human factor ix (benefix) and a new formulation of benefix (rfix-r) in moderate to severe hemophilia b

Conditions: Hemophilia B

Summary: the primary objective of this clinical research study is to establish the bioequivalence of 2 treatments, rfix and rfix-r, when given as a 10-minute intravenous bolus infusion.


Eligibility criteria:
inclusion criteria: * moderate to severe hemophilia b (fix: c ≤2%) * previously treated patients (ptps) with ≥150 documented exposure days * age ≥ 12 years (us sites only) exclusion criteria: * detectable factor ix inhibitor defined as ≥0.6 bethesda units for pooled plasma reported by the local laboratory (family history of inhibitors will not exclude the patient) * patient history of factor ix inhibitor replacement therapy * patient unable to be off factor ix replacement therapy for at least 5 days without bleeding