Kornimate/medical-research-clean huggingface dataset:
cold versus room temperature storage of platelets for bleeding in hematologic malignancy - a pilot trial

Conditions: Hematologic Malignancy

Summary: this is a pilot trial to discover the feasibility of recruiting 50 pts over the course of 12 months. the trial is testing the efficacy of using cold-stored vs. room temperature stored (current standard of care) platelets to treat bleeding in persons with hematological disorders and thrombocytopenia.

patients with hematologic malignancies or marrow aplasia are at increased risk of bleeding. while prophylactic platelet transfusions reduce the risk of bleeding compared with no prophylaxis, a significant risk of bleeding remains, with 43-54% of patients with a hematologic malignancy or marrow aplasia receiving chemotherapy, immunotherapy, or hematopoietic stem cell transplant (hsct) experiencing who grade 2 or higher bleeding \[stanworth et al. nejm 2013; gernsheimer et al, blood 2020\]. improved efficacy of therapeutic platelet transfusions would benefit this patient population. in vitro data suggests that cold-stored platelets have greater hemostatic responsiveness than those stored at room temperature. this study will evaluate the feasibility of a randomized clinical trial comparing cold- and room temperature storage in patients admitted to hospital with a hematologic malignancy or marrow aplasia. results will inform estimates of transfusion requirements and changes in bleeding severity for power calculations, inform management of a cold-stored platelet inventory, and will provide data on the use of cold-stored platelets in the canadian health-care setting.

Eligibility criteria:
inclusion criteria: 1. adult patients (age ≥ 18) admitted to malignant hematology ward with hematologic malignancy or marrow aplasia, undergoing chemotherapy, immunotherapy, or hematopoietic stem cell transplant 2. moderate thrombocytopenia, platelet concentration 10-100 x109/l 3. platelet transfusion ordered to treat bleeding exclusion criteria: 1. severe thrombocytopenia (platelet concentration \<10 x 109/l) 2. known platelet refractoriness requiring hla or hpa selected platelet concentrates 3. international normalized ratio (inr) \>2.0 4. activated partial thromboplastin time (aptt) \>40 seconds 5. therapeutic anticoagulation (unfractionated heparin, low molecular weight heparin, warfarin, direct oral anticoagulant) 6. known congenital bleeding disorder 7. history of unprovoked venous thromboembolic disease 8. transfusion of platelet concentrate for \>greade 2 bleeding in preceding 24 hours 9. order for multiple platelet transfusion at once 10. refusal of blood transfusion 11. prior participation in coverts-hm trial 12. participation in other clinical trials with interventions that may affect coverts-hm treatment or outcome
verify if amelogenins had some benefits in improving lower 2nd molar periodontal healing after 3rd molar extraction

Conditions: Attachment Loss, Periodontal; Teeth, Impacted

Summary: background: prevention of periodontal defects after the extraction of lower third molars remains a challenge. various methods have been proposed in the literature, but there are no studies which evaluated the effectiveness of amelogenins. methods: a single-blind split-mouth randomized controlled clinical trial (rct) was performed on 5 patients to verify if amelogenins had some benefits in improving lower second molar periodontal healing after adjacent third molar extraction. a ppd ≥ 8 mm associated with a radiographic bone defect of at least 5 mm were the main inclusion criteria.


Eligibility criteria:
inclusion criteria: * patients aged \< 27, for which the extraction of both lower third molars was indicated * bilateral total (bone or osteo-mucosal) third molar impaction * bilateral bone defect ≥ 5mm distal to the lower second molars, evaluated on pre- operative periapical radiographs performed with rinn's film holders * ppd ≥ 8mm distal to the second lower molars, in at least one of the following probing sites: buccal, disto-buccal, disto-central, disto-lingual * intra-operative integrity of both third molar buccal and lingual alveolar cortices exclusion criteria: * smoking habit * systemic disorders with serious immunologic impairment * taking cortisone or other drugs that might interfere with healing process * allergy to penicillins * previous periodontal treatment * less than 2 mm of adherent gingiva at second molar level * second molars with a prosthetic crown * previous endodontic treatment of second molars * furcation involvement of the second molars

Keywords: third molar surgery amelogenin periodontal pocket
data analysis for 04-c-0234 tenofovir disoproxil fumarate salvage therapy in hiv-infected children and a study of its effect on bone metabolism

Conditions: HIV-Infected Children

Summary: we plan to analyze the data to meet the primary objective of the study: to characterize the change in bone mineral density (bmd), as measured by lumbar spine dexa, during and following treatment with tenofovir df-containing antiretroviral therapy in hiv-infected children. in addition, we plan to analyze the data to meet 2 secondary objectives of the study: 1. to study and monitor markers of bone metabolism - calcium, phosphorus, parathyroid hormone (pth), vitamin d levels, bone resorption markers (urinary collagen cross-linked n-telopeptide and free deoxypyridinoline), bone formation markers (bone specific alkaline phosphatase and osteocalcin) - in hiv-infected children treated with tenofovir df-containing antiretroviral therapy. 2. to study immunologic, virologic and clinical effects of tenofovir df administered to hiv-infected children in combination with other antiretroviral therapies.

we plan to analyze the data to meet the primary objective of the study: to characterize the change in bone mineral density (bmd), as measured by lumbar spine dexa, during and following treatment with tenofovir df-containing antiretroviral therapy in hiv-infected children. in addition, we plan to analyze the data to meet 2 secondary objectives of the study: 1. to study and monitor markers of bone metabolism - calcium, phosphorus, parathyroid hormone (pth), vitamin d levels, bone resorption markers (urinary collagen cross-linked n-telopeptide and free deoxypyridinoline), bone formation markers (bone specific alkaline phosphatase and osteocalcin) - in hiv-infected children treated with tenofovir df-containing antiretroviral therapy. 2. to study immunologic, virologic and clinical effects of tenofovir df administered to hiv-infected children in combination with other antiretroviral therapies.

Eligibility criteria:
* data analysis only

Keywords: pediatric data analysis
type 1 diabetes recurrence in pancreas transplants

Conditions: Diabetes Mellitus, Type 1

Summary: the hypothesis is that humoral and cellular islet-specific responses are an early risk factor for recurrence of autoimmunity and hyperglycemia in simultaneous pancreas-kidney (spk) recipients independent of alloimmunity. this study will test the hypothesis and will assess their individual and combined predictive value.

to identify the factors associated with recurrence of diabetes in subjects who received a simultaneous pancreas-kidney (spk) or pancreas transplant. the study will see if there are changes in the participant's blood that will help the investigator know whether diabetes has returned after the transplant. spk patients will be retrospectively analyzed to determine frequency, levels and time course of autoantibody recurrence and predictive value of autoantibodies for recurrence of the disease. this study will prospectively follow our existing and our new pancreas transplant recipients to monitor autoantibody levels, monitor and phenotype autoreactive t cells in peripheral blood. this will happen monthly for 24 months. this study will assess the presence or absence of insulitis in the transplanted pancreas from biopsies performed in recipients with consistent recurrence of multiple autoantibodies. it will also monitor and phenotype autoreactive t cells from the pancreatic infiltrate obtained by pancreatic transplant biopsies.

Eligibility criteria:
inclusion criteria: * patient has been fully informed and has signed a dated irb approval informed consent form and is willing to follow study procedures for the extent of the study (24 months). parent or legal guardian must provide written consent for patients \<18 years of age. * age 18-75 years. * recipient of simultaneous pancreas and kidney transplant * primary or secondary renal allograft: living or deceased exclusion criteria: * patient has previously received or is receiving an organ transplant other than a pancreas-kidney.

Keywords: type 1 diabetes (t1d) autoimmunity
carbidopa for the treatment of excessive blood pressure variability

Conditions: Dysautonomia, Familial; Baroreflex Failure Syndrome

Summary: the overall study objectives are to determine whether carbidopa (lodosyn®) is safe and well tolerated and to assess whether it can inhibit catecholamine-induced paroxysmal hypertension and normalize or reduce the exaggerated blood pressure variability in patients with familial dysautonomia (fd, also called hereditary sensory and autonomic neuropathy type iii or riley-day syndrome). funding source- fda oopd.

the investigators propose to perform a double-blind randomized trial with a cross over design to compare high dose (600 mg/day) and low dose (300 mg per day) carbidopa blockade with placebo. patients will be randomly assigned to a high-dose/low-dose/placebo sequence, lowdose/placebo/high-dose sequence or placebo/high-dose/low-dose sequence. participants will remain on each treatment period for 28-days. aim 1: to evaluate the safety and tolerability of carbidopa in fd patients with particular emphasis on the orthostatic fall in blood pressure. aim 2: as proof of concept, examine the hemodynamic effects of carbidopa and determine its effects on norepinephrine production, bp variability and paroxysmal hypertension. aim 3: in a dose finding study, compare the effects of low (300 mg/day) and high (600 mg/day) dose carbidopa blockade vs. placebo on bp variability and paroxysmal hypertension.

Eligibility criteria:
inclusion criteria: * male or female patients with familial dysautonomia (fd) age 10 or older * unstable blood pressure, defined as: * systolic bp standard deviation \>15 mmhg * or coefficient of variation \>15% * or documented episodic hypertensive peaks (\>140mmhg) * confirmed diagnosis of fd (genetic testing) * providing written informed consent (or ascent) to participate in the trial * ability to comply with the requirements of the study procedures. exclusion criteria: * patients taking monoamine oxidase (mao)-inhibitors * patients taking: metoclopramide, domperidone, risperidone or other dopamine blockers * patients taking tricyclic antidepressants * patients taking neuroleptic drugs (haloperidol and chlorpromazine) * patients with a known hypersensitivity to any component of this drug. * patients with atrial fibrillation, angina or significant ecg abnormality * patients with significant pulmonary, cardiac, liver, renal (creatinine \>2.0 mg/ml) * patients who have a significant abnormality on clinical examination that may, in the investigator's opinion might jeopardize their healthy participating in this trial. * women who are pregnant or lactating.

Keywords: familial dysautonomia (hsan iii) norepinephrine sympathetic nervous system autonomic nervous system blood pressure variability hypertension carbidopa/lodosyn afferent baroreflex failure clinical trial
the effects of an oral hair supplement on hair density, growth, and microbiome

Conditions: Hair Thinning

Summary: the purpose of this study is to assess how an oral herbal supplement influences hair density, shine, growth, and microbiome.

hair thinning and hair loss are highly prevalent conditions affecting both men and women. various factors can contribute to hair thinning and loss, including nutrition, medications, family history, and more. overall, hair thinning and loss have a significant impact on quality of life and patients with these concerns have limited options. for example, minoxidil, finasteride, hair transplantations, and platelet rich plasma are effective options but each are paired with their own limitations. thus, those with hair thinning or loss are increasingly turning to natural therapies shown to improve hair density and self-perceived hair thinning. nutrition is closely related to hair health, as evidenced by hair thinning and loss that occur with malnutrition or restrictive diets. additionally, the hair follicle microbiome has been shown to modulate inflammation that exacerbates inflammatory scalp diseases, and ultimately hair thinning and hair loss. thus, an oral supplement that addresses nutrient deficiencies and targets the hair follicle microbiome could support hair health. in this study, we examine the effects of an herbal oral supplement on hair density, shine, and growth.

Eligibility criteria:
inclusion criteria: - men and women between the ages of 25 years old and 65 years old with self-perceived hair thinning. exclusion criteria: * individuals who are pregnant or breastfeeding. * prisoners. * adults unable to consent. * individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study. * subjects with scarring forms of alopecia. * any history of procedures affecting hair growth, such as transplantation * any known allergy to any of the ingredients in the study product. * any laser treatments for hair growth in the past 3 months * use of any over-the-counter or pharmaceutical or dietary products known to affect hair growth * subjects unwilling to not alter hair color or style for the duration of the study. * subjects taking any hair growth oral supplementation within the past 3 months. * current tobacco smoker or a tobacco smoking history of greater than 10 pack-years. * those who have been on an oral antibiotic within 1 month prior enrolling * those who are unwilling to discontinue oral probiotics-based supplementation or supplement ingredients found in the study's oral, product 1 month prior to enrollment
prefabricated endodontic posts: glass fiber versus titanium - a randomized controlled pilot- trial

Conditions: Endodontically Treated Teeth; Tooth Fractures

Summary: a randomized parallel-group clinical pilot study was designed to evaluate the impact of glass fiber reinforced composite posts compared to prefabricated titanium posts on long term survival of adhesively restored endodontically treated abutment teeth.

compared to vital teeth the complication rate of restorations fixed on endodontically treated abutment teeth is higher. endodontically treated teeth are more prone to fracture due to the higher amount of calcified tooth structure loss. to level the biological short coming the choice of the mechanically appropriate post material is still a major concern. there a two major approaches. one is to use a rigid material to stiffen the post-endodontic complex and the other is to use a material which shows dentin-like material properties to allow the post-endodontic complex to flex under load. it was aim of the presented randomised controlled trial to compare the survival rates of abutment teeth self-adhesively restored with either prefabricated glass-fiber reinforced composite posts or titanium posts. the null-hypothesis was that there is no difference regarding survival rate between glass-fiber and titanium post restored endodontically treated abutment teeth with two or less remaining cavity walls.

Eligibility criteria:
inclusion criteria: * two or less cavity walls of the crown remaining, * residual root canal thickness at the orifice of more than 1 mm, * symptom free tooth with a root canal filling without radiologically visible periapical lesion, * minimum of radiologic root-to-alveolar bone ratio of 2 after prospective crown lengthening, * no or treated periodontitis with maximum probing depth of 4 mm and no bleeding on probing, * tooth mobility not more than score ii, * willingness to return for follow-up examination for at least 5 years exclusion criteria: * tooth was aimed to serve as telescopic crown abutment

Keywords: glass fiber posts titanium posts postendodontic restoration self-adhesive resin cement
effects of vitamin d supplementation on antimycobacterial immunity

Conditions: Tuberculosis

Summary: the purpose of this study is to determine how vitamin d supplementation (ergocalciferol) affects the immune response to mycobacterial infection.


Eligibility criteria:
inclusion criteria: * adult * tuberculosis (tb) contact or tb patient exclusion criteria: * pregnancy * breastfeeding * hyperparathyroidism * sarcoidosis * renal failure * hiv infection

Keywords: latent tuberculosis infection active tuberculosis infection
autoantibodies and direct-acting antivirals

Conditions: Viral Hepatitis C; Therapy Adverse Effect

Summary: the investigators assessed non-organ-specific antibodies before and 24 weeks after the end of therapy with direct-acting antivirals, in order to better clarify the clinical relevance of these antibodies in terms of treatment response and prognostic value. to achieve this goal patients with hepatitis c virus related advanced liver disease, with detectable circulating autoantibodies on at least two determinations before treatment, were enrolled.

about 40-70% of hepatitis c virus patients develop at least an autoimmune extra-hepatic disorder presumably due to the interaction between hepatitis c virus e2 envelope protein and b lymphocyte cluster of differentiation-81 receptor. in addition, the same interaction is responsible for the production of different serum non-organ-specific antibodies. the clinical significance of the latter phenomenon has not been fully understood except for the presence of liver kidney microsome-1 antibody, which is linked to a molecular mimicry between the cytochrome enzyme cyp2d6, primarily expressed in the liver, and hepatitis c virus proteins in genetically predisposed subjects. actually, no data are available about the prevalence and clinical significance of serum non-organ-specific antibodies in hepatitis c virus patients treated with second generation direct-acting antivirals.

Eligibility criteria:
inclusion criteria: hcv positive patients presence of advanced liver fibrosis eligibility to the treatment with direct-acting antiviral therapy. exclusion criteria: history of autoimmune hepatitis and/or cholangitis evidence of active hepatocellular carcinoma human immunodeficiency virus coinfection hepatitis b virus coinfection.

Keywords: hepatitis c virus infection non-organ-specific antibodies prognostic value sustained virological response
using diagnostic tools to stage breast cancer

Conditions: Breast Cancer

Summary: this project is aimed at investigating the relative diagnostic and synergy of four state of the art breast imaging techniques (magnetic resonance imaging (mri), full-field digital mammography (dmam), ultrasound, and positron emission tomography (pet)) with respect to determining the extent of breast cancer.


Eligibility criteria:
inclusion criteria: * women recently diagnosed with breast cancer * will be undergoing surgery (after study) at the hospital of the university of pennsylvania exclusion criteria: * contraindications to mri * previously diagnosed with breast cancer (in the smae breast) within the past 5 years * patients with known locally advanced cancer (prior to study entry) being treated with preoperative adjuvant therapy. * pregnant women
coronary artery disease: a case- control study

Conditions: Coronary Artery Disease

Summary: atherosclerosis is a chronic inflammatory condition, which is associated by the involvement of several pathological events, and alteration in the serum levels of pro- and anti-inflammatory, and lipid markers. the investigators evaluated the contribution of serum biomarkers levels to the pathogenesis of coronary artery disease, namely their association with risk factors, clinical presentation, extent and severity of atherosclerotic changes accompanying coronary artery disease.


Eligibility criteria:
inclusion criteria: * coronary artery disease exclusion criteria: * severe respiratory disease * liver disease * kidney disease * inflammatory diseases (infections, autoimmune disorders, malignancy).

Keywords: coronary artery disease risk factors inflammation biomarkers atherosclerosis
safety study of danshenduofensuanyan(a chinese medicine injection)used in hospitals in china

Conditions: Coronary Heart Disease; Angina Pectoris

Summary: this study was advocated by institute of basic research in clinical medicine, china academy of chinese medical sciences in january 2013. it was funded by china major scientific and technological specialized project for 'significant new formulation of new drugs'. danshenduofensuanyan is kind of chinese medicine injection used for treating coronary heart disease and angina pectoris in many chinese hospitals. the purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.

it is very common that chinese medicine injection used in hospitals in mainland china. however safety problems rose in recent years. there could be many uncertain factors influence chinese medicine injection in clinical practice. in order to ensure the safety of public drug use and lower drug-induced risks, a registry study for danshenduofensuanyan injection safety surveillance with 30000 patients will be conducted from jan.2013 to dec.2015. eligibility criteria patients who will use danshenduofensuanyan injection in selected hospitals.

Eligibility criteria:
inclusion criteria: * patients using danshenduofensuanyan injection from 2013 to 2014 exclusion criteria: * none