Kornimate/medical-research-clean huggingface dataset:
study on exercise safety of patients with cardiovascular diseases

Conditions: Cardiovascular Diseases

Summary: to retrospectively observe the cardiovascular safety during exercise in patients with cardiovascular diseases


Eligibility criteria:
inclusion criteria: patients with confirmed or suspected cardiovascular disease who completed the trial exclusion criteria: refusing to participate in the study
relationship between strain and stroke volume in cardiac surgery

Conditions: Right Ventricular Dysfunction; Stroke Volume Index; Longitudinal Heart Strain

Summary: patients undergoing coronary artery bypass grafting up tp 30% will develop postoperative right ventricle dysfunction. its imperative for the physician to fully understand the severity of this complication in order to perform an early diagnosis and carry out the appropriate treatment. aim: investigate the correlation between echocardiographic measurements and hemodynamic changes at different time points in patients undergoing coronary artery bypass graft surgery hypothesis: 1. weak correlation between echocardiographic measurements and hemodynamic changes during coronary artery bypass graft surgery 2. echocardiographic measurements would change across different time points during surgery independent of hemodynamic values.


Eligibility criteria:
inclusion criteria: - elective coronary artery bypass graft patients who require pulmonary catheter placement for intraoperative monitoring. exclusion criteria: * patients with contraindication to swan-ganz catheter placement, * pre-existing atrial arrhythmias, * patients with moderate and/or severe mitral/tricuspid valve stenosis or regurgitation * patients with contraindication to transesophageal echocardiogram probe placement (i.e. esophageal stenosis).

Keywords: echocardiography coronary artery bypass graft thermodilution
new phototherapy device to treat patients with crigler-najjar disease

Conditions: Crigler Najjar Syndrome; Children

Summary: evaluating the efficacity of a new device phototherapy by comparing it with conventional phototherapy. jaundice occurs in many newborns, and is, in most cases benign, however, owing to the potential neurotoxicity of unconjugated bilirubin, newborns must be monitored to identify those who might develop severe hyperbilirubinemia an, in rare cases, acute bilirubin encephalopathy or kernicterus. treatment of jaundice in newborn relies on phototherapy, exposing their skin to light of a specific wavelength . fluorescent tubes or halogen lamps have been used as light sources for phototherapy for many years. light-emitting diodes (leds) are more recent sources which are power efficient, have a longer life and are portable with low heat production. several technologies and devices are developed using leds and specially a compact system.

crigler-najjar (cn) syndrome is a congenital inborn error of hepatic bilirubin metabolism caused by the deficiency of bilirubin uridinediphosphate glucuronosyltransferase activity cn patients are at permanent risk of life-threatening bilirubin encephalopathy (kernicterus). treatment of cn disease relies on daily prolonged phototherapy (10-12 h/day). to date, liver transplantation is the only curative treatment available. to date, no phototherapy device exists for teenagers and adults. cn patients use homemade systems or add several neonatal systems together to reach a better efficacy. a new device has been designed by weaving optical fibers into a sheet connected to leds. this new technology, marketed by several manufacturers of phototherapy devices, is used in pediatric wards for treating jaundiced newborns. a prototype of 80× 100cm was thus developed, which combines numerous advantages : important surface of treatment, easy use and transportation, user-friendliness. before going to a therapeutic trial for assessing the benefits of this new device in ambulatory current practice, it is essential to make sure of both its feasibility and efficiency on the control of bilirubinemia, under medical supervision. hypothesis: the new phototherapy sheet is as effective as, and better tolerated than the usual devices used in cn patients.

Eligibility criteria:
inclusion criteria: * genetic diagnosis of crigler najjar disease * child whose height is between 60cm and 100cm * patients with follow-up in reference center, exclusion criteria: * opposition of parents * no social security insurance

Keywords: rare disease crigler-najjar disease paediatric experimental device
sunitinib in metastatic renal cancer

Conditions: Carcinoma, Renal Cell

Summary: sunitinib is the registered treatment for first-line therapy of metastatic clear-cell carcinoma of the kidney.data from the expanded access study have shown activity also in non-clear cell renal cancer (nccrc). the aim of this study is to prospectively evaluate the anti-tumor activity and safety of sunitinib as a first-line therapy in metastatic nccrc patients.

this is a prospective, open label, multicenter phase ii study to evaluate efficacy of sunitinib (in advanced/metastatic renal cancer with non-clear cell histology (papillary or chromophobe). sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks on treatment followed by 2 weeks off. treatment with the study drug will continue until tumor progression or unacceptable toxicity. the planned total sample size for this study is 55 patients. approximately 10 study sites will be involved.

Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of metastatic renal cancer with non-clear cell * no previous treatment exclusion criteria: * prior treatment with an antiangiogenetic compound * symptomatic and/or unstable pre-existing brain metastases * severe or uncontrolled cardiovascular diseases
analysis of dentine sialophosphoprotein (dspp) for root resorption

Conditions: Root Resorption

Summary: this study was conducted after obtaining approval from ukm research ethics committee. gingival crevicular fluid (gcf) from orthodontic and non-orthodontic patients was collected with the consent of patients to detect dentine sialophosphoprotein. spectrometry analysis of gingival crevicular fluid was conducted in collaboration with mimos berhad.

thirty patients were recruited having met the following inclusion criteria of (1) good general health, (2) good periodontal health, (3) caries-free, (4) good oral hygiene. the subjects were divided into 3 groups based on a radiographic assessment on the level of root resorption; normal (no root resorption), mild (less than 2 mm), and severe (more than 2 mm). the gcf samples were taken from the permanent central incisors of untreated subjects in the normal control group (n=14), while in the mild group, samples were collected from the permanent central incisors with mild root resorption (\ 2 mm) were those with primary second molars undergoing physiological root resorption (severe group, n=11). the gcf samples were collected from the mesial and the distal gingival crevicular sulcus of the involved teeth using gingival fluid collection strips (periopaper, oraflow, smithtown, n.y.). the paper strips were placed within the sulcus (intrasulcular method) approximately 1 to 2 mm into the gingival sulcus and left in situ for 60 seconds. every sample collection was taken 3 times at the same site with one-minute resting intervals to allow gcf to be replenished into the gingival sulcus.

Eligibility criteria:
inclusion criteria: * good general health, * good periodontal health, * caries-free, * good oral hygiene exclusion criteria: * consumption of anti-inflammatory drugs and antibiotics

Keywords: dspp
dfmo maintenance for patients with relapsed/refractory ewing sarcoma or osteosarcoma

Conditions: Osteosarcoma Recurrent; Ewing's Tumor Recurrent

Summary: the purpose of this study is to determine the feasibility of administering dfmo to patients with relapsed ewing sarcoma and osteosarcoma who have completed all planned therapy and have no evidence of disease.

approximately 30-35% of patients diagnosed with osteosarcoma or ewing sarcoma will develop relapsed/refractory disease and carry a very poor prognosis. dl-alpha-difluoromethylornithine, commonly known as dfmo or eflornithine, is a synthetic analog of the amino acid ornithine. dfmo has been studied in a number of different cancers as either a therapeutic or a chemopreventative agent and is now fda approved to reduce the risk of relapse in patients with newly diagnosed high-risk neuroblastoma. as dfmo has now been given to over 100 children with metastatic cancer, dosing and safety in this population is well established. given the stagnant survival rates for children, adolescents, and young adults with relapsed ewing sarcoma and osteosarcoma over the past few decades, this study will explore the feasibility of using dfmo in patients with relapsed osteosarcoma and relapsed ewing sarcoma who are without any evidence of disease at the end of therapy in order to prevent disease recurrence.

Eligibility criteria:
inclusion criteria: * patients \< 40 years of age at the time of enrollment * diagnosis of relapsed osteosarcoma or relapsed ewing sarcoma who have completed all planned therapy for their relapse, as described in the protocol, and have no evidence of disease * patients must have a performance status corresponding to eastern cooperative oncology group (ecog) scores of 0, 1, or 2 * adequate bone marrow function defined as: * peripheral absolute neutrophil count (anc) greater or equal to 750/microliters * platelet count greater or equal to 75,000/microliters (transfusion independent) * adequate renal function defined by serum creatinine based on age and gender * adequate liver function defined as: * total bilirubin ≤ 1.5 x the upper limit of normal (uln) for age and * sgpt (alt) ≤ 5.0 x uln for age. for this study the uln is 45 u/l exclusion criteria: * pregnant or breastfeeding females * patients must not have an uncontrolled infection * patients must not have any significant intercurrent illness
effect of amifampridine on neuromuscular transmission in patients treated with onabotulinumtoxina

Conditions: Botulism; Iatrogenic Botulism

Summary: if amifampridine can improve neuromuscular transmission in muscles previously injected with onabotulinumtoxina (btx-a)

amifampridine may also be effective in treating the sequelae of botulinum toxin injections and this study will determine if neuromuscular transmission as measured by single fiber electromyography is improved in patients treated with btx-a following administration of amifampridine

Eligibility criteria:
inclusion criteria: * age: 18-80 years of either gender and of any racial background * underwent btx-a injection of facial muscles including frontalis with a total dose between 100-200 units between 80 and 150 days prior to study * have decision-making capacity to provide informed consent to study drug dosing and single fiber electromyography (sfemg) exclusion criteria: * history of cardiac arrhythmia * history of seizures or uncontrolled asthma * history of renal or hepatic disease * history of any generalized neuromuscular disease * history of bell's palsy or facial nerve trauma * history of treatment with or sensitivity to amifampridine, 3,4 diaminopyridine (dap) or 4-aminopyridine (ampyra®) * currently experiencing sequelae of previous btx-a treatment * current use of pyridostigmine (known to alter neuromuscular transmission) * use of any investigational drug or device within 30 days of enrollment

Keywords: botulinum toxin injections systemic botulism neuromuscular transmission single fiber electromyography amifampridine
radicle revive 24: a study of health and wellness products on menopausal health and related health outcomes

Conditions: Menopause; Sleep Disturbance; Anxiety; Depression; Cognitive Function; Fatigue; Libido

Summary: a randomized, double-blind, placebo-controlled, direct-to-consumer trial assessing the impact of health and wellness products on hormonal health and associated health outcomes in women with menopausal health issues

this is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the united states. eligible participants (1) are females, (2) have menopausal health issues for 3 months or longer, (3) have the opportunity to improve by at least 30%, and (4) express acceptance in taking study products and not knowing the formulation identities until the end of the study. participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. heavy drinkers and women who are pregnant or breastfeeding will be excluded. participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. self-reported data are collected electronically from eligible participants for 7 weeks. participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. all study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Eligibility criteria:
inclusion criteria: * adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities * resides in the united states * endorses less pain as a primary desire * selects pain and/or looking to improve their pain as a reason for their interest in taking a health and wellness product * expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study exclusion criteria: * reports being pregnant, trying to become pregnant, or breastfeeding * unable to provide a valid us shipping address and mobile phone number * the calculated validated health survey (pro) score during enrollment represents less than mild severity * reports a diagnosis of liver or kidney disease * reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) * unable to read and understand english * reports current enrollment in a clinical trial * lack of reliable daily access to the internet * reports current or recent (within 3 months) use of chemotherapy or immunotherapy * reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, or mao
incidence and outcomes associated with the management of adenovirus infections in allogenic hematopoietic cell transplant recipients

Conditions: Adenovirus Infections, Human

Summary: to depict the incidence, outcomes and standards of care (soc) of adenovirus (adv) infections and associated practice patterns in allogeneic hematopoietic cell transplant recipients. it is expected that participating centers will be in the united kingdom, france, spain, germany, and italy.


Eligibility criteria:
inclusion criteria: * at least one adv positive test, regardless of specimen within 6 months following the first allo-hct * subjects first allo-hct must have been performed between 1 january 2013 and 30 september 2015 exclusion criteria: * adv negative
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for pulmonary diseases

Conditions: Pulmonary Disease; Asthma; Chronic Obstructive Pulmonary Disease

Summary: this trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of pulmonary diseases

in this patient funded trial, patients with pulmonary disease will receive a single intravenous infusion of uc-mscs. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria:
inclusion criteria: * diagnosis of pulmonary disease * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur

Keywords: pulmonary disease asthma stem cell treatment chronic obstructive pulmonary disease
the effect of grounding during pregnancy

Conditions: Cramp, Limb; Pregnancy Related

Summary: the study was planned as a randomized controlled trial. the research data included a pregnant informed form, leg cramps evaluation form, pittsburgh sleep quality index, visual analog scale for fatigue, pregnancy-related anxiety scale, short form-12 quality of life scale, food consumption record form, and pregnancy follow-up form will be used. questionnaires will be evaluated every two weeks, and the intervention will continue for four weeks in total for each pregnant woman.

the aim of the research is to investigate the effect of grounding on muscle cramps, sleep quality, fatigue, anxiety, and quality of life in pregnant women. the study was planned as a randomized controlled trial. the study is going to perform in the obstetrics and gynecology clinic of ege university medical faculty hospital. the research will be carried out by face-to-face interview method. the research data included a pregnant informed form, leg cramps evaluation form, pittsburgh sleep quality index, visual analog scale for fatigue, pregnancy-related anxiety scale, short form-12 quality of life scale, food consumption record form, and pregnancy follow-up form will be used. the pregnant women included in the study will be divided into two groups as intervention and placebo groups by randomization and will be asked to take a walk for 30 minutes every day with a grounding/sham grounding pole. questionnaires will be evaluated every two weeks, and the intervention will continue for four weeks in total for each pregnant woman.

Eligibility criteria:
inclusion criteria: * between 27-34 weeks of pregnancy, * having leg cramps, * normal blood levels of calcium and magnesium in her current pregnancy, * no risky pregnancy, or chronic disease (heart disease, hypertension, thyroid diseases, diabetes mellitus, kidney disease, etc.) * not having multiple pregnancies, exclusion criteria: * risky pregnancy, chronic disease (heart disease, hypertension, thyroid diseases, diabetes mellitus, kidney disease, etc.), * emerging rheumatic disease, * varicose veins in the legs, * diagnosed with restless legs syndrome, * pregnant women with blood levels of calcium and magnesium below the normal level will be excluded from the study.

Keywords: cramp, fatigue, pregnancy
assessment of serum asprosin level in male patients with acne vulgaris

Conditions: Acne Vulgaris

Summary: subject of interest is to evaluate serum level of asprosin in male patients with acne vulgaris, demonstrate the relation between acne vulgaris severity and level of asprosin in these patients \& the relation between metabolic syndrome in acne vulgaris and level of asprosin.


Eligibility criteria:
inclusion criteria: * acne vulgaris male patients (\>18 years) will be included. exclusion criteria: * age \<18 years. * females. * patients with other inflammatory skin disorders. * patients with associated systemic diseases. * current or previous treatment with isotretinoin in the last 3 month ,anti-inflammatory drugs, systemic antibiotics, androgen or anti androgen therapy, and steroid therapy). * patients known on treatment of diabetes, hypertension and dyslipidemia. * athletes. * patient refusal.

Keywords: asprosin
investigation of ascending concentrations of glycopyrronium bromide (gpb) in a topical formulation in subjects with axillary hyperhidrosis

Conditions: Primary Axillary Hyperhidrosis

Summary: the aim of the study is to assess the safety, tolerability, pharmacokinetics (pk) and efficacy of escalating concentrations of gpb in subjects with axillary hyperhidrosis.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe primary axillary hyperhidrosis whose hdss score is 2, 3 or 4 * at least 50 mg in males or 25 mg in females of spontaneous resting axillary sweat production in one axilla measured gravimetrically at room temperature/humidity (about 25°c / 20-50%) over a period of 5 minutes. * male and female subjects in the age of 18 to 65 years at the time of informed consent and a body mass index (bmi) of 18-32 kg/m2. * corrected qt (qtc) ≤450 msec, or qtc \<480 msec in subjects with bundle branch block. * able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol subjects. * willing and able to provide written informed consent. exclusion criteria: * known allergy to any of the components in the investigational product. * hypersensitivity against glycopyrrolate * secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria, climacteric hyperhidrosis. * previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery. * botulinum toxin treatment in the prior 9 months. * present or history of neuromuscular disease. * angle closure glaucoma or its precipitation (narrow angle). * mycotic, other skin infections and other dermal disorder including infection at anticipated application sites in either axilla. * significant cardiac arrhythmia such as tachycardiac atrial fibrillation and very frequent extrasystoles. * subject with diabetes mellitus. * subjects with ileus, gastrointestinal stenosis, pronounced chronic inflammatory bowel disease, toxic megacolon. * subjects with epilepsy. * use of antiperspirants containing aluminium chloride and deodorants, any oral herbal medicine treatments or any other topical treatments for hyperhidrosis within 7 days prior to study treatment.

Keywords: excessive sweating
proton therapy for post surgical treatment of gynecologic cancer

Conditions: Cervical Cancer; Uterine Cancer; Endometrial Cancer

Summary: this is a single institution, multi-center, phase ii, single-arm study, using whole pelvis (wp) pencil beam scanning proton radiation (pbs prt) in the post-surgical, adjuvant setting for definitive treatment of gynecologic cancers. the purpose of this study is to estimate rate of acute clinician-reported gastrointestinal (gi) toxicity using wp pbs prt in the definitive treatment of gynecologic cancers in the post-surgical, adjuvant setting.

this is a single institution, multi-site study, and thus will include patients from geographic locations with penn proton centers in the philadelphia, lancaster and south new jersey area. the study will be conducted at the university of pennsylvania department of radiation oncology and associated clinical facilities. the study intervention is whole pelvis (wp) pencil beam scanning proton radiation (pbs prt) as part of the definitive treatment of gynecologic cancers in the post-hysterectomy, adjuvant setting. patients will be treated with doses of 45 or 50.4 gy in 1.8 gy daily fractions.

Eligibility criteria:
inclusion criteria: * histologically confirmed cervical or endometrial cancer * indication for adjuvant whole pelvic radiation therapy, with or without systemic therapy * age of 18 years or older * written informed consent * ecog of 0-2 within 3 months of enrolling exclusion criteria: * prior course of pelvic radiation * metastatic disease outside of the pelvis * active inflammatory bowel disease * incapacity to provide informed consent