Kornimate/medical-research-clean huggingface dataset:
osteoporosis in rett syndrome

Conditions: RETT Syndrome With Proven MECP2 Mutation

Summary: based on our clinical observations, many girls with rett syndrome, a severe neuro-developmental encephalopathy, suffer from osteoporosis which can appear at a very early age (before age 10) and can lead to fractures, pain and a limitation in mobility. few epidemiological studies have estimated the frequency of osteoporosis in girls with rett syndrome and showed that they are more exposed then children with other neuro-developmental diseases with a same degree of neurological handicap. however, the mechanisms that lead to early osteoporosis in rett syndrome remain unknown. mutations in the mecp2 gene are found in 95% of rett patients and preliminary experimental studies have shown that this can lead to abnormal expression of the gene that codes for osteoprotegerin, a protein implicated in bone remodelling by interacting with rank-ligand. in order to identify risk factors of osteoporosis in rett syndrome and to understand the pathophysiological mechanisms the study protocol includes: 1. clinical evaluation of bone health (history of bone fractures, pain, nutritional status, pubertal stage, daily caloric/calcium intake, anti-epileptic drugs, walking ability, vitamin d satus) 2. evaluation of the mineral density at the lumber spine using dexa 3. measuring concentrations of osteoprotegerin and rank-ligand

based on our clinical observations, many girls with rett syndrome, a severe neuro-developmental encephalopathy, suffer from osteoporosis which can appear at a very early age (before age 10) and can lead to fractures, pain and a limitation in mobility. few epidemiological studies have estimated the frequency of osteoporosis in girls with rett syndrome and showed that they are more exposed to osteoporosis then children with other neuro-developmental diseases with a same degree of neurological handicap. however, the mechanisms that lead to early osteoporosis in rett syndrome remain unknown. mutations in the mecp2 gene are found in 95% of rett patients. preliminary experimental studies on the transcriptional consequences of mecp2 mutations showed that the expression of 13 genes were significantly dysregulated and one of them is the gene that codes for osteoprotegerin, a soluble receptor that binds to rank-ligand. rank-ligand is an osteoclastic differentiation factor expressed by osteoblasts. in order to identify risk factors of osteoporosis in rett syndrome and to understand the pathophysiological mechanisms the study protocol includes: 1. clinical evaluation of bone health (history of bone fractures, pain, nutritional status, pubertal stage, daily caloric/calcium intake, anti-epileptic drugs, walking ability, vitamin d status) 2. evaluation of the mineral density at the lumber spine using dexa 3. measuring concentrations of osteoprotegerin and rank-ligand

Eligibility criteria:
inclusion criteria: * rett syndrome * mecp2 mutation exclusion criteria: * no identified mecp2 mutation * history of drugs that interfere with bone metabolism

Keywords: rett syndrome mecp2 osteoporosis rank-ligand osteoprotegerin
deutsches dual therapy stent register

Conditions: Coronary Artery Disease

Summary: the dts.de registry is an initiative for the collection of high quality process and historical data of implantations with the combo dual therapy stent in germany. dts.de was designed as a national, non- randomized, prospective, multicenter registry without a comparison group. the responsible steering committee is of the opinion that the combo stent qualifies for further documentation of treatment results in the form of a german registry, based the ce certification of the combo dual therapy stent in 2013 and its clinical and scientific investigation in the context of the remedee study program, as well as company independent externally initiated studies with the combo dual therapy stent. it is expected that by mid- 2015, at least 1,000 patients will be enrolled and documented in the dts.de registry with the combo dual therapy stent. a clinical follow-up is performed after 6 weeks and 12 months.

it is the objective of the dts.de registry to capture the documentation of all patients who have been treated with a combo dual therapy stent in germany, and who have been properly informed and consented with regards to their participation in the registry. all of these patients will be registered in the electronic data capturing system (ecrf) of the dts.de registry and will be followed and documented for a period of 12 months.

Eligibility criteria:
inclusion criteria: * patients has at least one coronary lesion, suitable for pci treatment with the combo stent in accordance with european society of cardiology guidelines and local guidelines of the deutsche gesellschaft für kardiologie for drug eluting stents exclusion criteria: * patient has previously received murine therapeutic antibodies and exhibited sensitization through the production of human anti- murine antibodies (hama) * patient in whom anti-platelet and/or anticoagulant therapy is contraindicated * patient in whom a complete inflation of the angioplasty balloon or correct stent placement is thought to be inhibited

Keywords: dts stents stent des drug eluting drug eluting stent (des) drug eluting stents endothelial progenitor cell (epc) endothelial progenitor cell capturing sirolimus sirolimus eluting percutaneous coronary intervention (pci) pci registry registries multi center multi centre
recovery after laparoscopic hysterectomy with deep neuromuscular blockade and low intra-abdominal pressure

Conditions: Neuromuscular Blockade; Pain; Laparoscopy

Summary: the purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain. patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure (8 mmhg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmhg). primary hypothesis: deep neuromuscular blockade and low intra-abdominal pressure (8 mmhg) reduces postoperative pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmhg).


Eligibility criteria:
inclusion criteria: * elective laparoscopic hysterectomy (total/subtotal) * can read and understand danish * informed consent exclusion criteria: * bmi \> 30 kg/cm2 * known allergy to medications that are included in the project * severe renal disease, defined by s-creatinine \> 0,200 mmol/l, gfr \< 30ml/min or hemodialysis) * neuromuscular disease that may interfere with neuromuscular data * lactating * impaired liver function * indication for rapid sequence induction (esophageal reflux/ hiatus hernia/other cause)
endophenotype characterization of a family psychiatric disorder

Conditions: Healthy Volunteer

Summary: bipolar disorder is a chronic and frequent mood pathology, that impacts on emotional and socio-professional life of sick subjects, and also increase mortality by suicide. suicide is considered as a bipolar disorder result. the main goal of this study is the endophenotype characterization from a clinical and cognitive point of view, of a bipolar spectrum's disorder present in a family, and then highlight a mutation of one of the genes involved is this disorder.

heritability of bipolar disorder is now well established, but seems to be multifactorial in most of the cases. the use of an endophenotype characterized in a family presenting numerous bipolar sufferers enable to reflect the expression of simpler genetic variants than those involved in the disease, and might enable the identification of genes involved in the etiopathogenesis of this endophenotype.

Eligibility criteria:
inclusion criteria: * members of a family adult (more than 18 years) * signed informed consents * registered to a french social security or possesor of the european health insurance card exclusion criteria: clinical part : * refusal to sign the participation study consent. * organic affection likely to affect cognitive abilities and brain structures or acute decompensation of a bipolar disorder. genetic part : * refusal to sign the genetic sample consent.

Keywords: bipolar disorder endophenotype family autosomal dominant expression sequencing heritability
immune benefits of coffee

Conditions: Immune Senescence; Low-grade Inflammation

Summary: this study will assess whether coffee consumption: * increases immune responses * decreases inflammatory status

epidemiological studies suggest that coffee consumption is associated with protective effects against several types of chronic diseases. recent data have shown that certain coffee components may possess anti-inflammatory and immune-enhancing properties. low-grade inflammation and poor capacity of immune response is highly prevalent in elderly subjects. the purpose of this study is to evaluate whether coffee consumption improves immune and inflammatory status in healthy elderly subjects. to sort out the role of antioxidants, we will test 2 different soluble coffee, i.e. fully torrefied coffee and partially torrefied coffee.

Eligibility criteria:
inclusion criteria: * healthy, self-sufficient, free-living chilean elderly * having the ability to comprehend the procedures of the study * having obtained his/her informed consent after verbal and written information exclusion criteria: * subjects drinking more than 2 cups of coffee per day * subjects with rapidly deteriorating health status at enrolment in the study * subjects with terminal or acute disease, or unstable health status * subjects with chronic disease: chronic respiratory illness; chronic diseases of the pulmonary or cardiovascular systems (including asthma); chronic metabolic disease (diabetes); chronic renal disease, organ failure * subjects with serious neurological disorder, including dementia (mmse \< 20) or alzheimer's disease * subjects who have experienced rapid weight loss, chronic diarrhea (loose stools, 3 times daily), or crohn's (ibd) * subjects with gastrointestinal problems * subjects with a hospitalization planned during this study * subjects who have received any antibiotic treatment during the last 3 months prior to the beginning of this study * subjects who had a colonoscopy performed during the last 3 months prior to the beginning of this study * subjects with immune deficiency diseases (e.g. hiv infection) * subjects with a history of allergy - especially to egg protein, egg, shellfish or the antibiotics polymyxin or neomycin * subjects receiving medication that may influence the immune system (i.e. corticosteroids, immuno-suppressors and immuno-modulators, antimicrobials) * subjects who have received any vaccination during the last 15 days prior to baseline * subjects who are expected to be non-compliant * subjects currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study * subjects participating in another research study involving any type of medication related to the study

Keywords: coffee elderly immune response inflammatory status
treatment of complaints following sports injuries with traditional chinese medicine

Conditions: Athletic Injuries

Summary: the purpose of this observational study is to investigate the treatment of complaints following sports injuries with traditional chinese medicine by therapists in switzerland.

in switzerland, still very little is known about the treatment with tcm (acupuncture, chinese medicinal therapy, tuina massage, nutrition, qigong) under everyday conditions. the importance of non-medical therapists in the healthcare system is rarely investigated. it is likely that patients with chronic injuries use several therapies (including conventional medicine) in a pragmatic way. they may apply tcm either due to primary preference or because other forms of therapy fail to produce satisfactory results. there is evidence from randomized controlled trials and systematic reviews that acupuncture can be effective in the treatment of acute and chronic back pain, chronic shoulder pain and ankle sprains. randomized controlled trials usually investigate a single tcm method, in which therapists or physicians are limited in the selection of acupuncture points or herbal formulas. this does not reflect the complex practice, where several tcm methods and auxiliary techniques are combined. the investigators aim to investigate in a prospective observational study how complaints following sports injuries are treated by non-medical tcm therapists in switzerland under everyday conditions.

Eligibility criteria:
inclusion criteria: * 18 years or older * minimum of 3 hours sports per week * complaints following sports injury * first tcm treatment for this complaint exclusion criteria: * rheumatic disease * arthrosis * previous tcm treatment for this complaint
aed log analysis of 19 cases in out-of-hospital environment

Conditions: Cardiac Arrest, Sudden

Summary: the study performed to demonstrate a reasonable assurance of safety and effectiveness of the heart guardian hr-501 when used in an out-of-hospital environment.

the defibrillation study was conducted by analyzing the logs of heart guardian hr-501 with radian ecg viewer. the product analysis was studied whether the device was operated normally in ecg analysis and electric shocks.

Eligibility criteria:
inclusion criteria: * out-of-hospital cardiac arrest * \> 12 months exclusion criteria: * age under 12 months
contrast-enhanced ultrasound in predicting treatment response in patients with liver cancer receiving transarterial chemoembolization with drug eluting beads

Conditions: Hepatocellular Carcinoma

Summary: this pilot clinical trial compares the use of contrast-enhanced ultrasound to contrast-enhanced magnetic response imaging (mri), the current clinical standard, in predicting treatment response in patients with liver cancer receiving transarterial chemoembolization with drug eluting beads. comparing results of diagnostic procedures before and after transarterial chemoembolization may help doctors predict a patient's response to treatment and help plan the best treatment. it is not yet known if contrast-enhanced ultrasound works better than contrast-enhanced mri in predicting treatment response in patients with liver cancer.

primary objectives: i. evaluate if contrast-enhanced ultrasound of hepatocellular carcinomas at one to two weeks and one month correlate with the clinical evaluation standard of a contrast-enhanced mri at one month (the current clinical standard) in patients who have undergone transarterial chemoembolization with drug eluting beads. secondary objectives: i. establish whether changes in quantitative blood flow parameters relative to baseline correlate with effective embolization.

Eligibility criteria:
inclusion criteria: * be scheduled for a transarterial chemoembolization using drug eluting beads for treatment of hepatocellular carcinoma * be medically stable * if a female of child-bearing potential, must have a negative pregnancy test * have signed informed consent to participate in the study exclusion criteria: * females who are pregnant or nursing * patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example: * patients on life support or in a critical care unit * patients with unstable occlusive disease (eg, crescendo angina) * patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia * patients with uncontrolled congestive heart failure (new york heart association \[nyha\] class iv) * patients with recent cerebral hemorrhage * patients with clinically significant and unstable renal disease (eg, transplant recipients in rejection) * patients who have undergone surgery within 24 hours prior to the study sonographic examination * patients with known hypersensitivity to perflutren * patients who have received any contrast medium (x-ray, mri, computed tomography \[ct\], or ultrasound \[us\]) in the 24 hours prior to the research us exam * patients with cardiac shunts * patients with congenital heart defects * patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli * patients with respiratory distress syndrome
a phase ii, multi-center, open-label, uncontrolled study to evaluate the efficacy and safety of sorafenib given daily in combination with repeated 21-day cycles of dacarbazine (dtic) chemotherapy in subjects with advanced metastatic melanoma

Conditions: Melanoma

Summary: the purpose of this study is to see whether a new type of anti-cancer drug, known as bay 43-9006, can be given safely and with good effect in combination with dacarbazine (dtic). dtic is the current standard chemotherapy drug given for melanoma that has spread through the body. although this drug can be effective on its own and is generally well tolerated, not all patients will benefit, so there is a need to test new drugs and drug combinations for treating melanoma.

issues on "safety" outcomes are addressed in the adverse event section.

Eligibility criteria:
inclusion criteria: * subjects with advanced, metastatic, histologically confirmed melanoma, for whom treatment with dacarbazine is considered medically acceptable * age \>= 18 years * subject has measurable and evaluable disease defined as at least one metastatic lesion that can be accurately and serially measured by computed tomography (ct) or magnetic resonance imaging (mri) scan as per the response evaluation criteria in solid tumors (recist) criteria. cutaneous lesions measuring at least 20mm in longest diameter can be considered measurable (and therefore target lesions) via color photography including a ruler * subject has biopsiable disease at baseline and is willing to provide biopsy samples, or does not have biopsiable disease at baseline * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * primary ocular or mucosal melanoma (cutaneous vulval melanoma is permitted) * previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors \[ta, tis \& t1\] or any cancer curatively treated \> 3 years prior to study entry * (active coronary artery disease or ischemia (myocardial infarction more than 6 months prior to study entry is allowed) * uncontrolled hypertension (\> grade 2 national cancer institute - common terminology criteria for adverse events (nci-ctcae) version 3.0) * active, clinically serious infections (\> grade 2 nci-ctcae version 3.0) * subjects with seizure disorder requiring medication are excluded * history of or suspected human immunodeficiency virus (hiv) infection, or chronic hepatitis b or c * symptomatic metastatic brain or meningeal tumors unless the subject is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks prior to study entry and is clinically stable with respect to the tumor at the time of study entry. also the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies) * pregnant or breast-feeding subjects
clinical and biomarker effects of depot medroxyprogesterone acetate in females with sickle cell disease

Conditions: Sickle Cell Disease (SCD); Vaso-Occlusive Pain Episode in Sickle Cell Disease

Summary: this research is being conducted to see if using an injectable contraception, depot medroxyprogesterone acetate (depo-provera), can reduce the pain experienced by women with sickle cell disease. participants in this study will be adult women with sickle cell disease who regularly experience sickle cell pain. they will complete a 3-month "baseline "with no use of hormonal contraception, and then a 3-month follow-up after receiving an injection of depo-provera. participants will complete 6 to 7 in-person visits with a urine pregnancy test, blood draw, and surveys, as well as complete remote weekly surveys and monthly home pregnancy tests.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. female, aged 18-50 years old 3. diagnosis of sickle cell disease (ss, sb0,sb+,sc) 4. report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months 5. at least 1 and no more than 10 medical presentations (e.g. hospitalization, emergency room visit, outpatient infusion visit) for sickle cell-related pain during the past year 6. willing to discontinue any hormonal contraception at the time of enrollment. washout period of 1 month since last use of all hormonal contraception, and 4 months since most recent administration of depot medroxyprogesterone, is required prior to enrollment in the study. 7. stable dose of hydroxyurea and other sickle cell-related medications for the past 6 months 8. access to a device with text-messaging capability 9. must be able to read and understand english 10. willing to comply with study procedures exclusion criteria: 1. chronic inflammatory conditions, such as lupus or inflammatory bowel disease 2. history of vte or stroke 3. current use of crizanlizumab, voxelotor, or red cell exchange transfusion, or history of hematopoietic stem cell transplantation 4. current use of hormonal contraception or the copper intrauterine device 5. current pregnancy or pregnancy within the last 6 months 6. current lactation 7. polycystic ovary syndrome or irregular periods 8. blood pressure \>= 160 systolic or \>=100 diastolic at screening visit

Keywords: sickle cell disease depot medroxyprogesterone acetate (depo-provera) contraception vaso-occlusive pain
pain and safety of microneedles in oral cavity

Conditions: Oral Cavity Disease

Summary: a randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed to access pain and safety of microneedle topical application in different regions of the oral cavity.

a randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed by applying a microneedle patch in the following regions of the oral cavity: lip (inner lower), buccal (cheek: 1 cm behind the month angle), tongue (dorsal surface), hard palate (anterior region), and attached gingiva (between central and lateral upper incisors). a 30 gauge hypodermic needle and an identical patch but without microneedles sticking out, were used as positive and negative controls, respectively. the application force was standardized to 10n by an applicator composed of a 5 ml syringe and a spring. insertions were performed with a gap of 30 seconds. pain and discomfort associated to the procedure was evaluated with a visual analogue scale (vas), by a blinded-dentist. the safety associated to microneedle application was verified immediately after the application (0h) and after the next day (24h). the different application sites were inspected visually for bleeding, ulceration, bruising, redness or swelling.

Eligibility criteria:
inclusion criteria: - healthy male exclusion criteria: - volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic.

Keywords: microneedles buccal mucosa transbuccal administration