Kornimate/medical-research-clean huggingface dataset:
peripheral immune system in individuals with schizophrenia

Conditions: Schizophrenia; Schizo Affective Disorder; Schizophreniform Disorders

Summary: the investigators are seeking healthy volunteers and people with schizophrenia or schizoaffective disorder for a clinical study of the immune system in psychotic disorders. this is an observational study, to understand the ways in which the immune system may be contributing to the disease process.

genetic studies have linked the number of copies coding for c4 protein to risk for schizophrenia. studies examining the amount of mrna, the molecules that point to how much c4 protein is likely being made, found more c4 mrna in the brains from individuals with schizophrenia. studies in mice have suggested that expressing more c4 protein in the brain, specifically the a-type of c4, can result in abnormalities in behavior. however, researchers have also found that pathways that involve this protein in the blood to be abnormal in individuals even before they develop schizophrenia and hypothesize these abnormalities change the blood brain barrier. in this work, the researchers are hoping to understand the ways in which c4 protein is abnormal in the peripheral blood and how this may be contributing to the disease process in hopes of finding new ways of helping individuals with schizophrenia and possibly other mental health disorders. a major goal of this study is to collect blood tissue for ongoing translational study of pathophysiological mechanisms of schizophrenia. interested participants will be asked a series of questions about their medical and mental health history, be able to provide informed consent, undergo a urine toxicology screen and be willing to provide a blood sample.

Eligibility criteria:
inclusion criteria for subjects with schizophrenia and schizoaffective disorders: * schizophrenia or schizoaffective disorder diagnosis verified by interview * diagnosis or initiation of antipsychotic medication was within last 5 years inclusion criteria for healthy controls: * no known diagnosis of schizophrenia or schizoaffective disorder * no history of depression, anxiety, bipolar disorder, ptsd, agoraphobia, panic disorder, or generalized anxiety disorder * negative assessment for psychotic symptoms on day of interview exclusion criteria (for both groups): * participants have a history of bleeding disorders or are taking blood thinners. * participants have a history of epilepsy, known genetic disorders * immunocompromised state (eg., receiving immunosuppressive therapy, transplant). * history of brain-related disease (eg., stroke) * any uncontrolled medical disorder such as cancer. * history of substance abuse or positive urine toxicology screen (including test for marijuana) on the day of the blood draw

Keywords: psychosis psychiatry complement immune system
second ovulation induction

Conditions: IVF; Infertility

Summary: studies reported various risk factors for inadequate ovulation induction such as body mass index, low ovarian reserve, low baseline fsh and lh, and previous use of contraception or agonist. the flexibility to use human chorionic gonadotropin (hcg) or gonadotropin-releasing hormone agonist (gnrha) in ovulation induction for antagonist protocol or progestin primed ovarian stimulation (ppos) is an advantage helping fertility doctors to decrease the risk of ovarian hyperstimulation syndrome. however, luteinizing hormone (lh) levels \<15ui/l and progesterone ≤11.13nmol/l eight to twelve hours post gnrha trigger were highly correlated to failed oocyte pickup (fop). rescue hcg have been found to increase favorable outcomes in patients with fop. the presence of false fop could be due pharmaceutical reasons and human error. genuine fop could be due to intrinsic ovarian pathology. the fop is defined as the absence of oocytes after ovarian stimulation and follicular aspiration. it is an uncomfortable situation for the patient and medical team to deal with due to the apparent expectations of favorable results. ovulation induction could be via gnrha, hcg, or both in antagonist protocol and ppos protocol. long or short agonist protocol could be triggered only via hcg.


Eligibility criteria:
inclusion criteria: * participants with no oocytes retrieved in the first ovum pick-up exclusion criteria: * error in trigger medication or timing by the patient/ medical team * major absence of information (primary objective, trigger medication, time interval of trigger and ovum pick-up
clinical management of anxiety and access to health care

Conditions: Dental Anxiety

Summary: dental and health anxiety are common and potentially distressing problems, for both patients and health care providers. anxiety has been identified as a barrier to regular dental visits and as an important target for enhancement of oral health-related quality of life. possible groups, (1) high dental anxiety and (2) low dental anxiety. the study aimed to develop and evaluate a computerized cognitive-behavioral therapy dental anxiety intervention (c-cbt) that could be easily implemented in dental healthcare settings. a cognitive-behavioral protocol based on psychoeducation, exposure to feared dental procedures, and cognitive restructuring was developed. a randomized controlled trial was conducted (n=151) to test its efficacy. consenting adult dental patients who met inclusion (e.g., high dental anxiety) and exclusion criteria were randomized to one of two groups, (1) immediate treatment (it) (n=74) or (2) a waitlist control (wl) (n=77).

analyses of covariance (ancovas) based on intention to treat analyses were used to compare the two groups on dental anxiety, fear, avoidance, and overall severity of dental phobia. baseline scores on these outcomes were entered into the analyses as covariates.

Eligibility criteria:
inclusion criteria: * high dental anxiety * fluent in spoken and written english exclusion criteria: * unable to provide written, informed consent
ultrasound morphometric and cyto/histological combined pre-operative assessment of inguinal lymph node status in women with invasive vulvar carcinoma

Conditions: Vulvar Cancer

Summary: vulvar cancer is a rare and very aggressive cancer, mainly spreading through lymphatics, in which the preoperative evaluation is critical to address surgery between sentinel node biopsy or radical groin lymphadenectomy.

in the absence of clearly an specific guidelines on preoperative vulvar cancer assessment, the investigators decided to better investigate the role of ultrasound in groin nodes evaluation through the study 10 sonographic features of suspicion for nodal involvement: * globular shape (loss of the normal elliptical form) * long/short axis ratio * cortical/medulla ratio * cortical focal bulging or thickening * hilum anomalies * inhomogeneous echostructure * intranodal deposits * extracapsular spread * grouping * vascularization the standard of comparison is histopathology. the prospectively evaluation of these parameters will be obtained on the enrolled patients. the investigators also provided the retrospective review - by specialized staff - of ultrasound images collected in archives associated with information relating to the cyto/histological procedures (performed in case of suspicious lymph nodes) in patients who underwent surgical treatment in the last five years at the study center.

Eligibility criteria:
inclusion criteria: * invasive vulvar cancer (all infiltrating histotypes) * age \>18 years exclusion criteria: * patient unable to follow the study procedures * patient with major depressive disorder

Keywords: vulvar cancer inguinal lymph node lymph node status cytology core biopsy
skin autofluorescence (af) decision tree in detecting impaired glucose tolerance (igt) or diabetes mellitus (dm)

Conditions: Diabetes Mellitus; Impaired Glucose Tolerance

Summary: early detection of (pre)diabetes, including impaired glucose tolerance is currently deficient because the best accepted standard, an oral glucose tolerance test (ogtt), is not feasible in a setting of screening or broad case-finding and other current methods lack in sensitivity. a previously reported study, and analysis of retrospective skin autofluorescence (af) data, suggests that noninvasive skin af may offer an alternative for detection of (pre)diabetes. the objective is to test the validity of a decision tree based on skin autofluorescence, and some simple clinical characteristics, as a detection tool for diabetes and impaired glucose tolerance. sensitivity and specificity, positive and negative predictive value of this skin af based decision model will be compared to those of fasting plasma glucose (fpg), glycated haemoglobin (hba1c), and to two short questionnaires (finnish findrisk, and cambridge score). study design: skin af, hba1c and an ogtt (including an fpg) will be simultaneously performed in at least 120 persons with the characteristics described in the following paragraph. a findrisk and cambridge questionnaire will also be collected.


Eligibility criteria:
inclusion criteria: -age \>20 years * additionally a priori intermediate risk for igt/diabetes: by having at least one criterion from the metabolic syndrome, or by at least once having had an increased glucose or glycated hemoglobin value in the preceding two years, but these outside the range of diabetes/igt exclusion criteria:-known diabetes mellitus * use of oral antidiabetics for other purposes than diabetes such as hepatic steatosis * local skin disease of the lower arm obviating skin autofluorescence measurement * known serious renal insufficiency (s-creatinine \> 180 umol/l). * inability to fill in questionnaires

Keywords: diabetes impaired glucose tolerance
efficacy and safety study of arc-4558 for management of pain associated with painful diabetic neuropathy

Conditions: Painful Diabetic Neuropathy

Summary: the purpose of this study is to determine whether arc-4558 is effective in managing pain associated with painful diabetic neuropathy.


Eligibility criteria:
inclusion criteria: * has type 1 or type 2 diabetes mellitus * has a history of chronic pain attributable to a symmetrical stocking distribution neuropathy in the lower extremities for a duration of at least six months but less than or equal to five years prior to screening exclusion criteria: * has neuropathy secondary to non-diabetic causes * has a significant neurological disorder or a condition that can cause symptoms that mimic peripheral neuropathy or might confound assessment of pdn * has other chronic pain with intensity at or greater than the bilateral pain in the feet/toes * is using an implanted medical device (eg, spinal cord stimulator, intrathecal pump, or peripheral nerve stimulator) for the treatment of pain * is pregnant or lactating
effect of galacto-oligosaccharides (gos) on faecal gut microbiota in adult women

Conditions: Microbial Colonization

Summary: within the denali study the effect of 3 weeks intervention with gos on the abundance of bifidobacterium in faecal samples will be investigated.

this randomized, parallel, double-blinded intervention study of 6 weeks will include 88 females, who will consume gos for three consecutive weeks. faecal samples will be collected at several time points to measure microbiota composition.

Eligibility criteria:
inclusion criteria: * apparently healthy women * aged between 40 - 70 year * body mass index (bmi) between 18.5 - 30 kg/m2 exclusion criteria: * having a gastro-intestinal disease, such as celiac disease, crohn's disease, ulcerative colitis, or diagnosed irritable bowel syndrome; * having a history of intestinal surgery that might interfere with study outcomes. this does not include an appendectomy or cholecystectomy; * diagnosed with diabetes mellitus; * use of medication that may influence the study results, such as laxatives, lactase preparations, metformin, antibiotics, proton pomp inhibitors, antipsychotics, nsaid's (judged by our research physician); * self-perceived and diagnosed constipation; * having a food allergy to cow's milk or being lactose intolerant; * self-reported slimming, medically prescribed or other diets * reported weight loss or weight gain of \>5kg in the month prior to screening * use of (foods with) pre-, pro-, syn- and/or postbiotics\* (should be stopped at least 4 weeks before the start of the study), or other supplements that can influence the study results (to be determined by the medical investigator); * history of side effects with the use of prebiotic supplements * use of antibiotic treatment less than 3 months before start of the study * pregnant or lactating (or having the wish to become pregnant during the study period, self-reported); * not able to comply with study procedures; * use of drugs (should be stopped at least 4 weeks before the study); * alcohol intake ≥7 glasses of alcoholic beverages per week, on average * participation in another clinical trial at the same time; * being an employee of the food, health \& consumer research group of wageningen food \& biobased research or employee of frieslandcampina r\&d.

Keywords: galacto-oligosaccharides prebiotics microbiota
a real-world study of adebrelimab combined with chemotherapy±chest radiotherapy in patients with extensive stage small cell lung cancer

Conditions: Extensive Stage Small Cell Lung Cancer

Summary: the purpose of this study is to assess efficacy and safety of patients who receive adebrelimab combined with chemotherapy±chest radiotherapy as first-line treatment of extensive stage small cell lung cancer in the real world.


Eligibility criteria:
inclusion criteria: 1. age:≥18 years old; 2. patients with extensive stage small cell lung cancer confirmed by histopathology; 3. normal function of major organs; 4. participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up. exclusion criteria: 1. patients with drug allergy sufferers; 2. serious and uncontrolled organic lesions or infections, such as decompensated heart, lung, kidney failure, etc; 3. history of psychiatric drugs abuse and can't quit or patients with mental disorders; 4. the researchers think inappropriate.
effect of topical application of iodex® balm on local surface temperature

Conditions: Pain

Summary: the rationale of this study is to map out changes in temperature distribution brought about by topical application of our test product, and use this physiological phenomenon to visualize the onset of action involved in overall mechanism of action of the product.


Eligibility criteria:
inclusion criteria: * participants suffering from chronic osteoarthritis of knee joint (as per american college of rheumatology criteria) for \> 3 months * participants in good general and mental health with no clinically significant and relevant abnormalities of medical history or physical examination exclusion criteria: * women of child bearing potential, pregnant and lactating women * intolerance/hypersensitivity to study material/ingredient * recent history of alcohol or drug abuse * participants receiving topical non-steroidal antiinflammatory drugs (nsaids), other topical analgesics/counterirritants/mineral oils, or other medication, which might interfere with study results * participants having psoriasis/active atopic dermatitis/eczema/skin infected lesions/burn/wound at the site of application
metabolic safety of raltegravir versus darunavir in hiv naive patients

Conditions: Cardiovascular Disease; HIV Infections

Summary: the advent of new antiretroviral drugs improved the management of hiv naive patients in terms of efficacy. however, the long term metabolic profile of this drugs has not yet been compared and associations between new antiretrovirals and cardiovascular events remains controversial. moreover, the better tolerability and easy dosage of this new drugs might hypothetically influence adherence and qol of hiv patients.


Eligibility criteria:
inclusion criteria: * vih-1 exclusion criteria: * pregnancy * previous antiretroviral exposure

Keywords: cardiovascular disease hiv metabolic disorder hiv naive patients initiating haart with raltegravir or boosted darunavir
functional neural regeneration collagen scaffold transplantation in acute spinal cord injury patients

Conditions: Acute Spinal Cord Injury

Summary: the study is designed to assess the safety and efficacy of functional neural regeneration collagen scaffold transplanted into acute spinal cord injury patients.


Eligibility criteria:
inclusion criteria: 1. male or female, 18-65 years old. 2. completely spinal cord injury at the cervical and thoracic level (c4-t12). 3. classification asia a, occurring within past 21 days. 4. patients signed informed consent. 5. ability and willingness to regular visit to hospital and follow up during the protocol procedures. exclusion criteria: 1. a current diagnosis of any primary diseases affecting limb functions (e.g., trauma, infection, tumors, congenital malformations, peripheral muscular dystrophy, huntington's disease, parkinson's disease). 2. serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans). 3. history of life threatening allergic or immune-mediated reaction. 4. clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis). 5. history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders. 6. severe arrhythmias (e.g., ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter) or cardiac degree ii or above conduction abnormalities displayed via 12-lead ecg. 7. lactating and pregnant woman. 8. alcohol drug abuse /dependence. 9. participated in any other clinical trials within 3 months before the enrollment. 10. a drug or treatment known to cause effect on the central nervous system during the past four weeks. 11. a drug or treatment known to cause major organ system toxicity during the past four weeks. 12. poor compliance, difficult to complete the study. 13. any other conditions that might increase the risk of subjects or interfere with the clinical trial.
net-pd ls-1 creatine in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this trial is to determine if the nutritional supplement creatine slows the progression of parkinson's disease over time.

parkinson's disease (pd) affects nearly a million americans, a number that will increase over the coming decades as the population ages. symptoms of pd may include tremor, rigidity or stiffness of the limbs and trunk, slowness of movement, and impaired balance and coordination. these problems occur because as pd worsens, some of the brain cells that control body movement die. this study will determine if creatine--an investigational compound--is able to slow the progression of pd. creatine, a widely used dietary supplement is thought to improve exercise performance. in animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells. in the net-pd ls-1 study, 1,720 participants will be randomly assigned to receive either creatine or a placebo (inactive substance). participation in this study lasts a minimum of 5 years and includes at least 9 follow-up clinic visits and at least 3 telephone calls.

Eligibility criteria:
inclusion criteria: * willing and able to give informed consent and willing to commit to long-term follow-up * pd (asymmetric features including slowness (bradykinesia) plus resting tremor and/or rigidity) within 5 years of diagnosis * treated/responsive to dopaminergic therapy (dopamine agonists or levodopa) for at least 90 days, but not more than 2 years. exclusion criteria: * use of creatine 14 days prior to baseline or during the study * history of known hypersensitivity or intolerability to creatine * any unstable or clinically significant condition that would impair the subject's ability to comply with long term study follow-up * other know or suspected causes of parkinsonism (e.g. metabolic, drug induced, etc.), or any significant features suggestive of a diagnosis of atypical parkinsonism.

Keywords: parkinson's disease creatine net-pd neuroprotection pd
reduced intensity conditioning regimens for acute myeloid leukemia and myelodysplastic syndrome

Conditions: Acute Myeloid Leukemia, Adult; Myelodysplastic Syndrome(MDS); Allogeneic Hematopoietic Stem Cell Transplantation

Summary: the goal of this clinical trial is to compare outcomes of two reduced intensity conditioning (ric) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation (hsct) for acute myeloid leukemia (aml) or myelodysplastic syndrome (mds) patients. the main questions it aims to answer are: * the safety of two reduced intensity conditioning (ric) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation for adult aml/mds patients with hct-ci≥3 or aged ≥55 years. * the efficacy of two reduced intensity conditioning (ric) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation for adult aml/mds patients with hct-ci≥3 or aged ≥55 years. participants will be randomized to one of two reduced intensity conditioning (ric) regimens (fludarabine plus busulfan and fludarabine plus melphalan)

patients are randomized to one of two reduced intensity conditioning (ric) regimens: the combination of fludarabine (30 mg/m\^2/day, days -6 to days -2, the total dase is 150 mg/m\^2) and busulfan (3.2 mg/kg/day, days -3 to days -2, the total dose is 6.4 mg/kg) (flu/bu) or fludarabine (30 mg/m\^2/day, days -6 to days -2, the total dose is 150 mg/m\^2) and melphalan (70 mg/m\^2/day, days -3 to days -2, the total dose is 140 mg/m\^2) (flu/mel). a total of 200 patients (100 to each arm) will be recruited in this study over a period of two years. patients will be followed for up to 18 months from allogeneic hematopoietic stem cell transplantation.

Eligibility criteria:
inclusion criteria: * age equal or more than 18 years old. * patients diagnosed with aml or mds. * patients who have related or unrelated bone marrow or peripheral blood donors and plan to undergo hematopoietic stem cell transplantation. * hct-specific complication index score (hct-ci) more than or equal to 3 or the age of patients ≥55 years. * sign the informed consent, promise to abide by the research procedures, and cooperate with the implementation of the whole process of the research. exclusion criteria: * patients with central nervous system involvement. * patients with hiv seropositive. * patients with other serious diseases and a life expectancy of less than six months * patients with severe mental or psychological disorders. * patients without written informed consent.

Keywords: hematopoietic stem cell transplantation (hsct) reduced intensity conditioning (ric) acute myeloid leukemia(aml) myelodysplastic syndrome(mds)