Kornimate/medical-research-clean huggingface dataset:
insulin resistance before and during pregnancy in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome; Insulin Resistance; Insulin Sensitivity; Obesity; Pregnancy

Summary: the polycystic ovary syndrome (pcos) affects about 10% of reproductive-age women. women with pcos are at a higher risk of gestational diabetes, which may lead to more pregnancy complications. it is unknown if there are factors that may predict which women are more at risk. the goal of this study is to evaluate the risk factors of gestational diabetes, such as dietary and physical activity factors, race, and how the body handles its own hormones during pregnancy. our long term goal is to contribute in finding ways to successfully prevent gestational diabetes.

the polycystic ovary syndrome is the leading cause of female infertility in the united states. the disorder affects approximately 6-10% of women of reproductive age. insulin is a hormone that helps the body to take up sugar from the bloodstream. it is widely accepted that "insulin resistance" may be responsible for the polycystic ovary syndrome. women are insulin resistant when their bodies do not respond to insulin's action to handle sugar as they normally should. because of this insulin resistance, when women with the polycystic ovary syndrome become pregnant, they are at a higher risk of developing gestational diabetes. gestational diabetes carries risk to both the mother and the baby. the purpose of this study is to determine whether certain factors in women with the polycystic ovary syndrome are linked to risk of gestational diabetes. we propose to look at demographic factors, as well as the body's handling of estrogen (a female hormone present in high quantities during pregnancy) in this study.

Eligibility criteria:
inclusion criteria: * diagnosis of pcos prior to pregnancy * 18-40 years of age * documented bmi 30-40 kg/m2 (within 3 months prior to pregnancy or within 8 weeks of gestation) * either of caucasian or african-american decent by self report. * pregnant or attempting pregnancy exclusion criteria: * preexisting diabetes (impaired glucose tolerance will not be an exclusion criterion because of the high prevalence of impaired glucose tolerance in the pcos population). * hemoglobin \< 8 or hemoglobin \<10 with symptoms of anemia. * use of tobacco, alcohol or illicit substances.

Keywords: polycystic ovary syndrome (pcos) insulin sensitivity insulin resistance gestational diabetes pregnancy estrogen glucose intolerance obesity ovulatory disorder racial differences hyperandrogenism
the effect of arsenic trioxide on eliminating hiv-1 reservoir combined with cart

Conditions: HIV/AIDS

Summary: to evaluate the safety and efficacy of arsenic trioxide combined with cart in eliminating latent hiv-1 reservoir, providing potential strategies for aids functional cure.

although combined antiretroviral therapy (cart) could control human immunodeficiency virus type 1 (hiv-1) infection, the persistence of hiv-1 viral reservoir make it extremely difficult to achieving cure of aids. the shock and kill strategy has been extensively practiced. the latency reversing agents (lras) could reactivate latent hiv-1 and then the reactivated virus could be eradicated. however, no appropriate activator has been found nor manufactured. our previous work found that the arsenic trioxide, clinically approved for treating acute promyelocytic leukemia,could efficiently reactivate latent provirus in cd4+t cells from hiv-1 patients and simian immunodeficiency virus (siv)-infected macaques, without significant systemic t cell activation and inflammatory responses. in this study, we are going to study the safety of and efficacy of arsenic trioxide combined with cart in 20 hiv-1 infected patients, by observing adverse events,hiv-1 reservoir, hiv-1 load, and some immune index.

Eligibility criteria:
inclusion criteria: 1. hiv infection confirmed 2. receiving haart more than 12 months. 3. hiv viral-load \< 50 copies/ml and cd4+ cell count more than 350 cells/ul. 4. without serious heart, lung, liver or kidney disease. 5. participants know about the study and sign informed consent. exclusion criteria: 1. with serious active hbv or hcv infection or opportunistic infections 2. with serious chronic disease such as diabetes, mental illness,et al 3. history of suffering from pancreatitis during haart. 4. pregnant or breast-fed. 5. with poor adherence. 6. unable to complete the follow up.

Keywords: arsenic trioxide cart hiv-1 reservoir functional cure
utilization of target ranges to treat persons with parkinson's disease by objective measurement using the pkg

Conditions: Parkinson Disease

Summary: the main objective of this study is to evaluate whether persons with parkinson's disease (pwp) whose parkinson's disease (pd) symptoms are uncontrolled have improved clinical patient outcomes and quality of life when managed with the aid of objective measurement and use of pkg target ranges compared to pwp treated using only standard of care (soc) (medical history, physical examination).

this is a randomized controlled trial (rct) to compare the value of the personal kinetigraph® (pkg®) system and soc vs. the soc alone for treatment of pwp. the study aims to evaluate clinical outcomes, quality of life outcomes, health economic benefits, duration of controlled status, and need for additional pd treatment through 3 years follow-up of pwp specifically treated to a target range when using the pkg data in the clinical management of pd in routine clinical care compared to those managed with soc alone. all subjects will be treated by movement disorder specialists and general neurologists with expertise in pd. both groups will be recommended to undergo treatment changes until they reach a "controlled state" that is determined by either the clinician using soc (pkg- group) or using recommended target ranges for pkg scores and soc assessments (pkg+ group). investigators will utilize standard available treatments to manage these pwp in both groups.

Eligibility criteria:
inclusion criteria: * able and willing to sign a written informed consent for study participation and comply with all required follow-up visits * presumed to have levodopa responsive pd * taking levodopa for at least 30 days prior to screening visit * planning to continue using levodopa for pd throughout study participation * able to increase levodopa by a minimum of 100mg/day * age inclusive at the time of consent of 55-80 years * has not received a pkg in the last 12 months exclusion criteria: * evidence of atypical or secondary parkinsonism * presence of any non-parkinsonian tremors * contraindication to increasing levodopa * requires the addition of or dose adjustment of an anti-dyskinesia medication within the next 4 months * those who have received advanced therapies including individuals no longer actively utilizing these therapies, or planning to receive advanced therapies in the next 6 months * moca score \<23 at screening visit * bedridden, wheelchair confined, or requires the regular use of an assistive gait device * predominant sleep period is during the daytime hours of 9am to 6pm (e.g. third shift worker) * in the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to comply with study requirements or interfere with interpretation of the study endpoints

Keywords: personal kinetigraph® (pkg®) system objective measurement
rate of residual clubfoot deformity with correlation to absence of peroneus tertius muscle

Conditions: Clubfoot

Summary: rate of residual clubfoot deformity with correlation to absence of peroneus tertius muscle , a prospective study.


Eligibility criteria:
inclusion criteria: * patients aged 5-17 years , which were treated with the ponseti technique for clubfoot in haemek medical center, and have sufficient data/follow-up about them in medical records / exclusion criteria: * patients aged\< 5 years * neurological clubfoot * patients with insufficient data in medical records * clubfoot caused by arthrogryposis , connective tissue diseases and congenital fibular hemimelia

Keywords: peroneus tertius muscle
complication in laparoscopic renal and adrenal surgery (claras)

Conditions: Adrenal Disease; Renal Cancer; Surgery--Complications

Summary: the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.

the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.

Eligibility criteria:
inclusion criteria: renal diseases with indication to surgery adrenal masses exclusion criteria: open surgery in principle

Keywords: laparoscopic surgery renal surgery adrenalectomy complication in laparoscopic surgery
hypoglycemic and hyperglycemic disorders

Conditions: Hypoglycemia in Newborn Infants; Hyperglycemia

Summary: definition of low birth weight: low birth weight infants are those born weighing less than 2500 g. these are further subdivided into: * very low birth weight : birth weight \<1,500 g * extremely low birth weight : birth weight \ 90% of those between 1,250 and 1,500 g surviving. perinatalcare has improved the rate of survival of low birth weight infants.

causes of low birth weight: * premature birth * intrauterine growth restriction, which are most often due to different placental problems and health problems of the mother or new-born risk factors: * age: teen mothers have a much higher risk of having vlbw infant. * multiple birth babies are at increased risk of being vlbw because they often are premature. more than 50% of twins and other multiple gestations are vlbw if \<15 years * maternal health: women exposed to drugs, alcohol, and cigarettes during pregnancy are more likely to have low birth weight babies. mothers of lower socioeconomic * race: african-american babies are twice as likely as caucasian to be very low birth weight

Eligibility criteria:
inclusion criteria: * all neonates admitted to neonatology unit 1. from 0-28 days 2. weighting less than 2500gm exclusion criteria: * any neonate weighting more than 2500 gm
risk factors that increase the chance of developing primary graft dysfunction after lung transplantation

Conditions: Primary Graft Dysfunction; Lung Transplantation

Summary: primary graft dysfunction (pgd) is a severe lung complication that can occur in the days after lung transplant surgery. this study will analyze blood samples to determine if high levels of certain chemicals may increase the risk of developing pgd after a lung transplant.

pgd is a severe complication that affects up to 25% of lung transplant patients following surgery. pulmonary edema, which is an abnormal build-up of fluid in the lungs, and hypoxemia, which is low blood oxygen levels, are two common symptoms that individuals with pgd experience. treatment for pgd is often expensive, and it is the leading cause of death following lung transplantation. many potential lung donors and recipients are considered unsuitable for lung transplantation because of concern for the development of pgd. increased levels of chemicals that are involved in bleeding and clotting, including protein c, and certain markers of oxidant stress, which can cause damage to the body's cells and tissues, may increase a person's risk of developing complications following a lung transplant. the purpose of this study is to analyze blood samples to determine if elevated levels of certain chemicals may be associated with an increased risk of developing pgd after lung transplantation. this study will enroll individuals who are undergoing lung or heart and lung transplantation. blood samples will be collected from participants prior to surgery, immediately following surgery, and 24 hours after surgery. study researchers will also review participants' medical records. there will be no additional study visits.

Eligibility criteria:
inclusion criteria: * undergoing lung or combined heart and lung transplantation exclusion criteria: * undergoing combined organ transplantation other than heart and lung transplantation
coronary physiology testing in acute coronary syndromes

Conditions: ST Elevation Myocardial Infarction

Summary: this is an interventional, prospective, multicenter study (5 irccs hospitals belonging to the italian cardiology network) in patients with stemi treated with successful primary pci to assess the ability of coronary physiology parameters measured soon after recanalization to predict myocardial tissue characterization assessed with cardiac magnetic resonance (cmr) within a week of the acute event. furthermore, patients will be followed up for a period of 12 months to assess the incidence of major adverse cardiovascular events (death, death from cardiovascular causes, re-infarction, new coronary revascularization interventions, development of heart failure) based on their stratification according to coronary physiology parameters.

in the present study the investigators will enroll consecutive patients with stemi acute myocardial infarction treated with successful primary pci, to assess the ability of coronary physiology parameters, i.e. coronary flow reserve (cfr) and index of microvascular resistance (imr) measured after recanalization to predict myocardial tissue characterization (mvo, msi, is, t2-rt, t1-rt and ecv) assessed with contrast cmr within a week of the acute event. furthermore, the relationship between left ventricular end-diastolic pressure and of coronary physiology parameters will be evaluated.

Eligibility criteria:
inclusion criteria: * patients with stemi (defined according to esc guidelines 2017), with symptom onset within 12 hours (class i), or between 12 and 48 hours (class iia), (1) successfully treated with primary pci. (1) exclusion criteria: 1. patients with previous myocardial infarction in the territory of the infarct-related artery; 2. patients with previous coronary artery bypass grafting; 3. patients with cardiogenic shock at presentation; 4. patients with need for mechanical support of the circulation; 5. patients with known severe aortic stenosis / insufficiency; 6. patients with known cardiomyopathy; 7. patients with malignant neoplasm or systemic pathology with a "quoad vitam" prognosis of less than 1 year; 8. patients affected by known active infectious diseases; 9. women who are pregnant or breastfeeding; 10. patients who are unable to express valid informed consent upon enrollment; 11. patients with hypersensitivity to the active ingredients used for the study of coronary physiology (nitrates and adenosine); 12. patients with specific contraindications to cardiac magnetic resonance imaging, including: * patients with allergies and / or with other specific contraindications to the use of paramagnetic contrast media (gadolinium), including chronic renal failure with glomerular filtrate (egfr) \<30 ml / min; * patients with non-resonance-compatible devices or who have undergone previous surgical interventions with placement of non-resonance-compatible vascular clips; * claustrophobic patients.

Keywords: coronary microcirculation coronary physiology cmr
clinical research on treatment of psoriasis by human umbilical cord-derived mesenchymal stem cells

Conditions: Psoriasis

Summary: to evaluate the effect and safety of treatment of psoriasis by human umbilical cord-derived mesenchymal stem cel

psoriasis is a chronic and recurrent inflammatory skin disease and its histological features are characterized by epidermal hyperplasia, increased angiogenesis and immune cell infiltration. psoriasis prevalence is about 0.1%-3%, affecting approximately 125 million people worldwide. in china, there are about 10 million psoriasis patients. human umbilical cord-derived msc (huc-msc) has many advantages for the treatment of immune disease. because it was demonstrated that huc-mscs are effective in modulating immune cells and treating diseases and it has low immunogenicity. furthermore, huc-mscs do not raise ethical issue for clinical applications. some experimental results and cases has showed that mesenchymal stem cell (msc) can prevent or treat psoriasis. this clinical study is conducted to provide more data to evaluate the effect and safety of treatment of psoriasis by human umbilical cord-derived mesenchymal stem cell.

Eligibility criteria:
inclusion criteria: 1.understanding the whole process of the study, voluntary participation and signed the informed consent; 2.18 years to 65 years old, body mass index (bmi) between 18.5-35; 3.diagnosed according to biopsy for psoriasis vulgaris for more than 6 months and resistance to phototherapy, systemic therapy, or a combination of these therapies,bsa(body surface area)\>10%, pga≥3 and pasi\>10 at baseline; 4. patients participated in any stem cell therapy within 6 months; exclusion criteria: 1. wbc(white blood cell count ) \ 1.5 x uln(upper limit of normal), bilirubin \> 1.5 x uln(upper limit of normal), ast(sgot,glutamic-oxalacetic transaminase)/alt(sgpt,glutamic-pyruvic transaminase) \>2.0 x uln(upper limit of normal);either hiv-antibody(human immunodeficiency virus-antibody), hbv-antibody (hepatitis b virus-antibody ) or syphilis antibody is positive; 2. have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history,patients suffering from any acute or chronic infectious diseases, patients suffering from malignant tumor; mental disorders, history of alcohol abuse, drug or other substance abuse; 3. patients who have received systemic therapy within recent one month or topical therapy in two weeks; 4. having a serious allergic history or being allergic to two or more than 2 kinds of food or drugs; 5. pregnant women, or women who ready for pregnancy or lactating; patients participated in any clinical trials within 3 months; other cases which researchers believe that can not enroll.

Keywords: mesenchymal stem cells
myhand-sci: an active hand orthosis for spinal cord injury

Conditions: Spinal Cord Injuries; Tetraplegia

Summary: the purpose of this study is to develop and test the hardware and software components of the myhand-sci device to assist with hand function for individuals with c6-c7 spinal cord injury.

the purpose of this study is to develop and test the hardware and software components of the myhand-sci device to assist with hand function for individuals with c6-c7 spinal cord injury. this is a non-randomized exploratory study to determine feasibility of device use, provide user feedback on device features and function to allow further refinement of the device, and assess the utility and responsiveness of several clinical outcome measures.

Eligibility criteria:
inclusion criteria: * individuals with c6-c7 spinal cord injury, at least 6-months post-injury with impaired upper limb function * substantially reduced motor control and strength below the level of their sci with regard to hand and finger function * able to provide informed consent exclusion criteria: * fixed upper limb contractures that limit functional use of the hand and arm or ability to use the device * severe spasticity (modified ashworth \>2) at elbow, wrist, or fingers * any open wounds or unusual skin fragility * persistent severe pain in their upper limb

Keywords: spinal cord injuries tetraplegia rehabilitation robotics assistive technology wearable devices
study to investigate adherence of patients to clodronate (bonefos) treatment

Conditions: Breast Neoplasms; Prostatic Neoplasms; Multiple Myeloma; Osteolysis

Summary: adherence (or compliance with) a medication regimen is generally defined as the extent to which patients take medication as prescribed by their health care providers. the adherence to medications has close relation to effectiveness of the therapy. the primary objective of this study is to observe the adherence to treatment with oral clodronate (pdc, proportion of days covered, number of days in which clodronate is taken according to treating physician recommendation) in patients with malignancy. the secondary "hypothesis generating" objective is to describe the relation between adherence to treatment with oral clodronate and efficacy of the therapy (skeletal events, pain).


Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer, prostate cancer, multiple myeloma and other skeletal events causing tumors * bone metastases * therapy with clodronate (1600 mg per day, 800 mg tablets) according to smpc (summary of product characteristics) bonefos. * by agreeing to usage of patients diaries and goodwill with accounting of tablets exclusion criteria: * according to smpc (summary of product characteristics) bonefos.

Keywords: clodronate compliance
immunogenicity and safety of a fractional booster dose of ipv intradermally versus full dose intramuscularly

Conditions: Poliomyelitis

Summary: the purpose of this study is to investigate the use of a fourth fractional booster dose of sanofi pasteur's imovax polio injected intradermally (using the mantoux technique) as booster dose between 15 to 18 months of age, in terms of immunogenicity and safety. objectives: * to describe in each group the immunogenicity of imovax polio administered intradermally or intramuscularly, one month after the booster dose given at 15-18 months of age in toddlers previously primed with three doses of imovax polio vaccine during the ipv25 study. * to describe in each group the safety of the booster dose of imovax polio vaccine administered intradermally or intramuscularly.


Eligibility criteria:
inclusion criteria: * aged 15 to 18 months on the day of inclusion * informed consent form signed by the parent(s) or other legally acceptable representative * subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures * child having completed all visits of the ipv25 study (nct00604058), including the three-dose primary vaccination series with the study vaccine (imovax polio), using the route of administration as designated by randomization. exclusion criteria: * participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination * planned participation in another clinical trial during the present trial period * known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy * known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances * chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator * receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response * receipt of any vaccine in the 4 weeks preceding the trial vaccination * planned receipt of any vaccine during the present trial period * known personal or maternal human immunodeficiency virus (hiv), hepatitis b antigen or hepatitis c seropositivity * history of seizures * history of poliomyelitis infection (confirmed either clinically, serologically or microbiologically) * previous fourth dose vaccination against the poliomyelitis disease with either the trial vaccine or another vaccine * thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating im injection * febrile illness (temperature ≥38.0 °c) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.

Keywords: poliomyelitis intradermal