Kornimate/medical-research-clean huggingface dataset:
predictors of de-novo development of obstructive sleep apnea in pregnancy

Conditions: Obstructive Sleep Apnea; Pregnancy; Obesity; Sleep

Summary: this study seeks to understand the physical, physiologic and biologic features that predispose a woman to the development of obstructive sleep apnea once they are exposed to the cardiopulmonary and metabolic physiological changes of pregnancy. knowing these specific predictive factors can help identify a population at risk and guide clinicians to develop suitable targeting screening strategies.

patients will be recruited from multiple community and hospital-based practices that care for pregnant women. subjects will have: 1. measurements of body composition 2. anthropometric measures 3. sleep and mood questionnaires 4. home sleep studies 5. blood testing for biological markers 6. salivary testing for hormonal markers 7. pulmonary function tests and upper airway patency measurements women without sleep apnea at enrollment will then be followed longitudinally for the development of obstructive sleep apnea during pregnancy with repeat assessment during their third trimester. women diagnosed with sleep apnea at enrollment will have no further assessment in late pregnancy. monetary incentives will also be issued at data collection points. subjects will receive small gift incentives such as baby-related items.

Eligibility criteria:
inclusion criteria: * \<13 completed weeks of gestation * bmi \>30 kg/m2 at recruitment * \>18 years of age * ability to give informed consent exclusion criteria: * unable to meet inclusion criteria * twin pregnancies

Keywords: obstructive sleep apnea pregnancy obesity fluid shifts body composition sleep
a study of the effects of co-administration of sitagliptin (mk-0431) and metformin on incretin hormone concentrations (mk-0431-110)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * female subjects must have a negative pregnancy test * subject has type 2 diabetes and is not currently receiving treatment with an oral aha agent, has not received such treatment for 3 months prior to study, and/or has not received more than 4 total weeks treatment with an oral aha agent for 12 to 18 months prior to the study * subject is a nonsmoker or has not smoked and/or used nicotine for at least 6 months exclusion criteria: * subject has a history of stroke, seizures, or major neurological disorders * female subject is breastfeeding * subject cannot refrain from use of any prescription or non-prescription drugs beginning 2 weeks prior to first dose of study drug * subject consumes more than 3 alcoholic beverages per day * subject consumes more than 6 caffeinated beverages per day * subject has had major surgery, or has donated or lost 1 unit of blood within 4 weeks of screening * subject has a history of cancer, except certain skin or cervical cancer or other cancers treated more than 10 years prior to screening * subject has a history of multiple and/or severe allergies or intolerance to drugs or food
secondary prevention with the lifestyle tool

Conditions: Cardiovascular Diseases

Summary: in this study participants will be randomized to use a digital lifestyle tool over three years or to a control group without access to the tool. the investigators will prospectively follow the incidence of major cardiovascular events in patients who have previously suffered from a myocardial infarction in those using the tool regularly and those in the control group.

cardiovascular disease (cvd) remains a leading cause of death in most european countries, and new strategies for prevention are urgently needed. previous studies on primary and secondary prevention have shown that lifestyle interventions can affect risk factors for cvd and reduce cardiovascular morbidity and mortality. many prevention programmes are, however, time-limited and fail to provide continuous support. they also require substantial costs and healthcare resources. furthermore, accessibility to primary and secondary cardiac prevention programmes is highly variable, as is long-term adherence to lifestyle advice. in light of this, international associations have emphasized the need for innovative, scalable and cost-effective lifestyle interventions that could be integrated into pre-existing healthcare structures. digital tools have large potential for clinical utility, but there are several important knowledge gaps. first, data on long-term efficacy is scarce. second, most studies to date have included only small number of individuals, and there is a need for large randomized controlled studies. third, cost-effectiveness remains to be demonstrated. the objective or this study is to evaluate a new web-based tool, developed at the university gothenburg, sweden, that aims to support patient autonomy and motivation to make sustainable lifestyle changes. in individuals who have previously suffered from a myocardial infarction the investigators will test the hypothesis that those who access to the tool have lower incidence of further major cardiovascular events (mace) compared with control individuals. the study is an investigator-initiated single-center study conducted over three years. the tool is web-based and used via a computer or mobile phone. it is used at each individual's preferred pace but participants are recommended to login at least every other week. every round the participants choose a themes (out of appr. 80 possible covering e.g. food, exercise, stress, self-reflection aspects), which takes appr. 15-30 minutes to complete. participants then reflect on the content and how it could be implemented in daily life. when returning for next round participants are asked to reflect on any changes done since last time.

Eligibility criteria:
inclusion criteria: * age 35 to 80 years * myocardial infarction within one year prior to enrolment * access to computer or mobile phone. exclusion criteria: * conditions or treatments that in the judgement of the investigator could affect the study evaluation
emotional proactive brain study in adults with autism spectrum condition

Conditions: Autism Spectrum Disorder

Summary: this project aims: * to study behavioral and cerebral activity specificity (latency and amplitude of evoked potentials, time frequency maps and cerebral connectivity) in predictive process (top-down regulation) during visual recognition of static and dynamic stimuli in adults participants with autism spectrum conditions compared to typically developed participants. * to study the relation between predictive process and autonomous response (heart activity and electrodermal activity) * to explore potential sex differences between autistic males and females

once eligibility criteria would have been verified, information on the study will be given and non opposition of the participant will be collected.then, the participant will be comfortably installed in order to pass the landolt c task (visual acuity task) on a computer. if his vision is normal, electroencephalogram (eeg), electrocardiogram (ecg) and electrodermal activity (eda) of participants, will be recorded during visual processing and recognition tasks. stimuli will include emotional and non emotional pictures and films, filtered in coarse-to-fine versus fine-to-coarse sequences in order to stimulate or not predictive process described by bar (2007). the participant will also have to complete an abbreviated version of the wechsler adult intelligence scale, ivth edition (wechsler, 2003), and the autism spectrum quotient (baron-cohen et al., 2001) if he never did it before. the aim is to pair as much as possible group by iq and to verify that control participants don't present autistic traits above the autism spectrum quotient cutoff. groups will also be paired by age and education level.

Eligibility criteria:
inclusion criteria: * affiliation to the french social protection care * information and non opposition of the participant * information and non opposition of tutor/curator if the case presented * normal or corrected to normal vision * capacity to understand and apply instruction required by the task * no participation in another research * for autistic person: formal diagnosis of autism spectrum condition (autism/asperger/pdd-ns) according to cim-10/dsm-iv/dsm-5 criteria exclusion criteria: * adults with no ability to express their consent * adults on judiciary protection * perceptive/motor/neurological/psychiatric issue * major health issue (cardiac, metabolic ...) * alcohol or drug consumption

Keywords: autism spectrum condition predictive coding visual perception electroencephalography autonomous nervous system heart rate variability electrodermal reactivity
o-glcnac modified proteomics study of the maturation of hemodialysis arteriovenous

Conditions: Arteriovenous Fistula Occlusion

Summary: we divided into three parts to carry out. firstly, evidence the pre-existing fibrosis in vein of avf failure patients. investigation of expression, the role, and the mechanism by which the identified o-glcnaac proteins promote, maturation of av fistula. finally, ddress and compare the proteomics differentiation between failure and maturation of avf patients.

end stage renal disease (esrd) patients requires hemodialysis to maintain bloodstream functions. before the hemodialysis, the patients requires a long-term vascular access, which best choice is arteriovenous fistulas (avf). however, 1/3 of patients were failure in avf maturation, and it is still unknown. our preliminary data have shown that pre-exisiting fibrosis in vein of avf failure. here, we will investigate whether pre-existing fibrosis of vein is asssociated with circulating fibrocytes in avf failure, and further to address molecular mechanism of fibrocytes differentiation. we will divide into three parts to carry out. firstly, evidence the pre-existing fibrosis in vein of avf failure patients. secondary, investigation of expression, the role, and the mechanism by which the identified o-glcnaac proteins promote, maturation of av fistula. finally, address and compare the proteomics differentiation between failure and maturation of avf patients. we hope that through this project, we can obtain signifiture molecules for precision detection and solve the current clinical unmet need.

Eligibility criteria:
inclusion criteria: * age of 20 and older adult patients, and preoperatively clinical and ultrasound assessment of the arm vessels are fisible for the creation of a native hdavf that include:the augmented diameters of the veins is \> 2.0 mm and the diameter of the radial artery is\> 2.0 mm. besides, there is no obvious stenosis of vessels in the forearm. exclusion criteria: * the patient refused to join the study * too weak * serious heart failure * unconsciousness * bedridden for long time * systemic lupus erythematosus(sle), or other known autoimmune diseases * the physician excludes the possibility of creating a wrist hdavf before surgery * surgeon preoperatively identifies vessel inadequacy for the creation of a wrist hdavf * choose a site other than the wrist for surgery * unexpected negative complications happen during surgery that prevent the completion of a wirst hdavf

Keywords: arteriovenous fistula vascular smooth muscle histological technique o-glcnac proteomics
comparison of whole mesh and split mesh use in laparoscopic inguinal hernia repair

Conditions: Hernia, Inguinal

Summary: at least 80 patients who will undergo laparoscopic inguinal hernia repair surgery will be randomized into 2 groups. for the patients in the first group, the whole mesh will be laid on the area without being fixed. the patients in the second group will be given a mesh of the same size, but partially divided horizontally and wrapped around the spermatic cord. demographic data of patients in both groups, quality of life data(carolinas comfort scale) at postoperative 1st, 7th, 30th, 3rd and 6th months, postoperative pain (vas values), clinical seroma rate, recurrence and other complications will be monitored. when the desired number of patients and follow-up period are reached, the data in the 2 groups will be compared.


Eligibility criteria:
inclusion criteria: * clinical or/and radiological diagnosed primary inguinal hernia * tep or tapp surgical methods exclusion criteria: * recurrent hernias * patients with previous groin operations on same side * pregnant women * patients who did not accept to participate in the study * asa score of 3 or higher,

Keywords: laparoscopic inguinal hernia laparoscopic hernia whole mesh split mesh tap tepp inguinal hernia
bioavailability study for new atorvastatin formulation

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to estimate the relative bioavailability of the commercial tablet with one prototype extemporaneous preparation suspension formulation, to assist with internal decision making on formulation development.

estimation of relative bioavailability

Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects * body mass index (bmi) of approximately 18 to 30 kg/m2 exclusion criteria: * any condition possibly affecting drug absorption * a positive urine drug screening

Keywords: cardiovascular diseases
phase 3 study of 10-valent pneumococcal conjugate vaccine (pneumosil) in healthy infants

Conditions: Pneumonia, Pneumococcal

Summary: this study will examine the consistency of 3 batches of the pneumosil vaccine by looking at the immune response in infants. in addition, the study will compare the immunogenicity of the pneumosil vaccine to another who-prequalified vaccine, synflorix.

this is a randomized, active-controlled, double-blind, phase 3 study in 2,250 healthy infants (6 to 8 weeks of age). subjects will receive 3 doses of either pneumosil (3 groups receiving vaccine from different lots) or synflorix (1 group) at 6, 10, and 14 weeks of age. the first 675 randomized subjects will receive a booster dose of either pneumosil or synflorix at 9 months of age that matches the treatment assignment for the priming phase. standard epi vaccinations in the gambia will be given concomitantly with all 4 doses of the study vaccines. out of the 675 booster subjects, subjects who consented for further evaluation will participate for the assessment of immune persistence 12 (+1) months after the booster vaccination the primary objectives are to demonstrate that the three lots of the pneumosil vaccine is consistent by evaluating the immune responses, and to demonstrate that the immune responses generated by pneumosil are non-inferior to those generated by synflorix. the safety and tolerability of pneumosil will also be evaluated.

Eligibility criteria:
inclusion criteria: * they are healthy infants based on medical history and clinical assessment. * they are between 6 and 8 weeks (ie 42 to 56 days) old, inclusive. * subject's parent must provide voluntary written/thumb-printed informed consent and be willing to comply with study requirements and procedures. exclusion criteria: * use of any investigational medicinal product prior to randomization. * previous vaccination against or infection with s. pneumoniae. * history of anaphylactic shock or an allergic reaction to any prior vaccination. * any fever, illness (including malaria). * receipt of another vaccine within 30 days of study start. * chronic administration of an immunosuppressant or administration of immunoglobulins * history of blood disorder, primary immunodeficiency, or a sibling who has such a diagnosis or who died of suddenly without apparent cause. * history of meningitis, seizures or any neurological disorder.
metabolic characteristics of sarcoma in vivo using hp 13-c magnetic resonance spectroscopic imaging (mrsi)

Conditions: Sarcoma, Soft Tissue

Summary: investigators will determine whether mrsi using hyperpolarized \[1-13c\]pyruvate provide useful information of tumor malignancy in mri-indeterminate cases. metabolite maps of hyperpolarized \[1-13c\]lactate and h13co3- produced from hyperpolarized \[1-13c\]pyruvate will be compared to the biopsy results of mri-indeterminate patients and the 13c-maps of age-matched healthy subjects.

a non-randomized, interventional (nontherapeutic), feasibility trial to detect metabolic changes in participants with musculoskeletal sarcoma using hyperpolarized \[1-13c\]pyruvate magnetic resonance spectroscopy imaging (mrsi). all measured quantities will be tabulated and the analysis will be descriptive and obervational in nature. participants in this study will receive the study drug, hyperpolarized \[1-13c\]pyruvate, as a bolus injection during an mrsi of either a soft tissue sarcoma or healthy tissue. after the study drug injection and mrsi, participants will then receive contrast material, gadavist, via injection during continuation the mri.

Eligibility criteria:
inclusion criteria: sarcoma patients: - mri indeterminate solid enhancing lesion in the pelvis or extremity. all subjects: * age 18 through 100 years. * women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * ability to understand and the willingness to sign a written informed consent. * all races and ethnicities will be included; subjects must be able to read and speak the english or spanish language. exclusion criteria: sarcoma patients: -subjects who have had radiotherapy to the indeterminate lesion. all subjects: * subjects who have had chemotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * subjects may not be receiving any other investigational agents. * any contraindication per mri screening form including implants contraindicated at 3t, pacemakers, implantable cardioverter defibrillator (icd), claustrophobia. * metallic foreign bodies in the field of view which may interfere with mri acquisitions. * since each subject is receiving a gadolinium based contrast agent intravenously, additional contraindications would include: egfr ≤ 30 ml/min/1.73m2, sickle cell disease, or hemolytic anemia. * uncontrolled psychiatric illness/social situations that would limit compliance with study requirements. * subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Keywords: musculoskeletal sarcoma
optimized pilot study

Conditions: Depression; Depressive Disorder

Summary: this pilot study aims to explore and refine the trial procedures that will be implemented in a larger-scale clinical trial scheduled to commence in march 2024 (nct05944926). as part of this study, 60 patients with moderate to severe depression will be randomized to either psychotherapy based on behavioral activation called the healthy activity program (hap) or antidepressant medication. the pilot study has two primary objectives: 1. evaluate the feasibility and acceptability of the study 2. collect essential outcome data in preparation for the larger trial

this pilot study will play a pivotal role in preparation for the forthcoming larger clinical trial, named the optimized study, scheduled for launch in march 2024 (nct05944926). the primary objective of the optimized study is to explore whether different patients respond differentially to a brief psychological treatment, known as the healthy activity program, or a widely used generic selective serotonin reuptake inhibitor (fluoxetine). if such differences exist, this study aims to explore whether one can develop a machine learning-generated precision treatment rule to predict the most effective treatment based on individual baseline characteristics. the pilot study has two primary objectives: 1. evaluate the feasibility and acceptability of the study: this pilot study will focus on assessing the feasibility and acceptability of the research protocol, including recruitment strategies, data collection methods, interventions, and risk management procedures. this evaluation will help refine and tailor the study procedures and play a critical role in setting the stage for the subsequent optimized study. 2. collect essential outcome data in preparation for the larger trial: this study will test and refine the data instruments, gather initial data on efficacy, and refine the baseline assessment (which will serve as the cornerstone for the development of the precision treatment rule).

Eligibility criteria:
inclusion criteria: * participants will be adults aged 18 or over of any gender attending one of eight primary health care centers with a "diagnosis" of moderate to severe depression based on scores of 10 or above on the patient health questionnaire-9 (phq-9). exclusion criteria: * women who are pregnant or are breastfeeding or lactating * patients with a history of psychosis including schizophrenia spectrum disorders or bipolar disorder. * participants planning to move out of the study area during the follow-up period. * patients over 65 years of age with evidence of cognitive impairment - patients who do not speak the study or local language (english or hindi) * patients who are undergoing treatment for depression at the time of recruitment
umbilical cord blood therapy for children with cerebral palsy

Conditions: Cerebral Palsy

Summary: this study aims to evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy.

cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. it is a leading cause of childhood onset disability. many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain. on the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.

Eligibility criteria:
inclusion criteria: * cerebral palsy with abnormal muscle tone * gross motor function classification system (gmfcs): i, ii, iii, iv, v * willing to comply with all study procedure exclusion criteria: * medical illnesses including pneumonia or renal function at enrollment * presence of known genetic disease * presence of drug hypersensitivity which is related to this study remedy * poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up * decision by the principal investigator when there are unexpected events that may affect the outcomes

Keywords: cerebral palsy umbilical cord blood rehabilitation
a study to investigate tonlamarsen for the treatment of adults with uncontrolled hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who, despite taking 2 or more antihypertensive medications, have not achieved their target blood pressure (bp).


Eligibility criteria:
key inclusion criteria: * age 18 to 80, body weight ≥ 50 kg * has uncontrolled hypertension while receiving between 2 and 5 antihypertensive medications prescribed for hypertension * has mean office seated systolic blood pressure \> 135 to ≤ 170 mmhg key exclusion criteria: * has known history of secondary hypertension * has documented history of poor adherence to antihypertensive medication * has unstable/underlying known cardiovascular disease * has abnormal thyroid function with clinical significance