Kornimate/medical-research-clean huggingface dataset:
investigation of a new human model for itch

Conditions: Itch

Summary: this third sub-project aims to evaluate the interaction between the trpm8 receptor and pruritus by studying the anti-pruritic effect of tprm8-agonist l-menthol on histaminergic and non-histaminergic itch induced using three different pruritogens: histamine, cowhage and papain.


Eligibility criteria:
inclusion criteria: * healthy men and women * 18-60 years * speak and understand english exclusion criteria: * pregnancy or lactation * drug addiction defined as any use of cannabis, opioids or other addictive drugs * previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.). * lack of ability to cooperate * current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers, as well as systemic or topical steroids. * skin diseases * moles, scars or tattoos in the area to be treated or tested. * hypersensitivity to papaya and mango fruit, cashew nuts, rubber latex * consumption of alcohol or painkillers 24 hours before the study days and between these * acute or chronic pain * participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
do changes in plasma osmolality influence ventilation?

Conditions: Hyponatraemia; Hypernatraemia

Summary: primary hypothesis: osmolality changes influence the sensitivity of the respiratory center to carbon dioxide, hyponatraemia causing hyperventilation, and hypernatraemia depressing ventilation. secondary hypothesis: there are gender differences in the sensitivity to osmolality changes. 10 women and 10 men will on different occasions drink water or receive hypertonic saline intravenously, in order to lower or increase plasma osmolality. the women will participate during both faces of the menstruation cycle. on each occasion the subject´s sensitivity to carbon dioxide will be tested, and blood samples will be drawn for analysis of blood gases,electrolyte and osmolality.subjects who interrupt participation before completion of all planned occasions, will be substituted, so that 10 subjects of either sex will have participated as planned. all results from all participants will be analyzed.

healthy volunteers will on different occasions be subject to reduced plasma osmolality caused by drinking water, and increased osmolality caused by intravenous infusion of hypertonic saline.before and after each osmolality change, sensitivity to carbon dioxide will be tested by partial rebreathing through a so called bain-system. throughout the whole experiment heart rate, blood pressure and oxygen saturation will be recorded.blood samples will be collected before each rebreathing test and every 20 minutes during the two hours of water or salt load. urine will be collected and analysed.

Eligibility criteria:
inclusion criteria: * females with regular menstruations, males exclusion criteria: * consumption of nicotine, bmi \> 26, * pregnancy,any hormone treatment, * treatment with diuretics, * diabetes or kidney disease, * bmi \> 26,

Keywords: carbon dioxide ventilation gender osmolality menstruation cycle
study of an approved drug in patients with asthma (0476-289)(completed)

Conditions: Asthma

Summary: the purpose of this study is to assess the efficacy and safety of an approved drug on asthma symptoms in patients with chronic asthma which is also active during the allergy season.


Eligibility criteria:
inclusion criteria: * asthma symptoms brought on by allergies exclusion criteria: * patient has any lung disease * currently have a sinus infection or cold symptoms
impact of the severity of pediatric psoriasis on childhood body mass index

Conditions: Psoriasis; Atopic Dermatitis

Summary: the object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population.

several environmental factors and comorbid conditions have been found to be associated with psoriasis in adults, including obesity, depression, smoking, and other cardiovascular risk factors such as high blood pressure. the object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population. this is a multi-center study with a planned total enrollment of about 200 subjects ages 2-17 years old with psoriasis and 100 aged-match controls. patient and family history will be recorded. all subjects will undergo standard height, weight, blood pressure, and waist circumference (wc). for the obese and overweight subjects we will also obtain their growth charts to attempt to correlate weight gain with psoriasis onset and progression. all data will be compiled and then statistically analyzed.

Eligibility criteria:
inclusion criteria: * subjects must be between the ages of 5 and 17 years at the time of enrollment. * subjects of either sex. * subjects who have had psoriatic plaques for more than 6 months. * subjects and guardians of minors must sign the approved irb consent form(s) prior to initiation of the study protocol. * subjects enrolled as "non-inflammatory" normal controls will carry a common non- systemic skin condition, such as acne, nevi, warts and molluscum as their main diagnosis. * subjects enrolled as "inflammatory" normal controls will carry a diagnosis of moderate to severe atopic dermatitis. exclusion criteria: * subjects who are unable to give informed consent or assent. * subjects who have had psoriasis for less than 6 months. * subjects whose condition is deemed unsafe or incapable by the study investigator for study participation.

Keywords: psoriasis obesity bmi atopic dermatitis
study of safety and efficacy of my008211a in paroxysmal nocturnal hemoglobinuria (pnh) patients who are naive to complement inhibitor therapy

Conditions: Paroxysmal Nocturnal Haemoglobinuria (PNH)

Summary: the main purpose of this study is to evaluate the efficacy of my008211a compared to eculizumab in pnh patients.

this is a multi-center, randomized, open-label, active comparator-controlled, parallel group study. the purpose of this study is to determine whether my008211a compared to eculizumab is efficacious and safe for the treatment of pnh patients who were naive to complement inhibitor therapy.

Eligibility criteria:
inclusion criteria: 1. male and female participants ≥ 18 years of age and bmi ≥ 18.0 kg/m2 with a diagnosis of pnh confirmed by high-sensitivity flow cytometry with clone size ≥ 10%. 2. mean hemoglobin level \<100 g/l at screening. 3. ldh \> 1.5 x upper limit of normal (uln) at screening. 4. vaccination against neisseria meningitidis infection is required prior to the start of study treatment. if not received previously, vaccination against streptococcus pneumoniae and haemophilus influenzae infections should be given. exclusion criteria: 1. patients with reticulocytes \<100x10\^9/l; platelets \<30x10\^9/l; neutrophils \<0.5x10\^9/l. 2. history of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus. 3. known or suspected hereditary complement deficiency. 4. previous bone marrow or hematopoietic stem cell transplantation. 5. previous splenectomy. 6. a history of malignancy within 5 years before screening, except cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
estrogen receptor antagonist in patients with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: the main purpose of this clinical trial is to examine the feasibility and effects of fulvestrant in post-menopausal women with pulmonary arterial hypertension (pah). the study will evaluate how well the drug is tolerated. the study will evaluate changes in circulating hematopoietic progenitor cells, plasma hormone levels, nt-probnp, and other plasma biomarkers after the administration of fulvestrant. changes in tricuspid annular plane systolic excursion, stroke volume index, right ventricular fractional area change, and other echo parameters after fulvestrant administration will be evaluated as well as changes in distance walked in six minutes.


Eligibility criteria:
inclusion criteria: * previous documentation of mean pulmonary artery pressure \> 25 mm hg with a pulmonary capillary wedge pressure (or left ventricular end-diastolic pressure) \ 3 wu at any time before study entry. * diagnosis of pah which is idiopathic, heritable, drug- or toxin-induced, or associated with connective tissue disease, congenital heart disease, portal hypertension, or hiv infection. * most recent pulmonary function tests with fev1/fvc \>50% and either a) total lung capacity \> 70% predicted or b) total lung capacity between 60% and 70% predicted with no more than mild interstitial lung disease on computerized tomography scan of the chest. * female, post-menopausal state, defined as: * \> 50 years old and a) have not menstruated during the preceding 12 months or b) have follicle-stimulating hormone (fsh) levels \> 40 iu/l or * \ 40 iu/l or * having had a bilateral oophorectomy. * informed consent. exclusion criteria: * age \< 18. * treatment with estrogen or anti-hormone therapy (tamoxifen, anastrozole, etc.) * who class iv functional status. * history of breast cancer. * clinically significant untreated sleep apnea. * left-sided valvular disease (more than moderate mitral valve stenosis or insufficiency or aortic stenosis or insufficiency), pulmonary artery or valve stenosis, or ejection fraction \< 45% on echocardiography. * initiation of pah therapy (prostacyclin analogues or receptor agonists, endothelin-1 receptor antagonists, phosphodiesterase-5 inhibitors, soluble guanylate cyclase stimulators) within three months of enrollment; the dose must be stable for at least 3 months prior to baseline visit. pah therapy which is stopped and then restarted or has dose changes which are not related to initiation and uptitration will be allowed within 3 months prior to the baseline visit. * hormone therapy. * use of warfarin or other anticoagulant (use of aspirin is permitted). * platelet count \<100,000. * renal failure (creatinine \>/= 2.0). * child-pugh class c cirrhosis. * current or recent (\< 6 months) chronic heavy alcohol consumption. * current use of another investigational drug (non-fda approved) for pah.
immunogenicity and safety study of the 13-valent pneumococcal polysaccharide conjugate vaccine in 2-71 months old healthy infants and toddlers (the youngest could be 6 weeks old)

Conditions: Diseases Caused by Streptococcus Pneumoniae Serotypes

Summary: the purpose of this study is to investigate and valuate the immunogenicity and safety of the 13-valent pneumococcal polysaccharide conjugate vaccine in 2-71 months old healthy infants and toddlers (the youngest could be 6 weeks old)


Eligibility criteria:
inclusion criteria: * 2-71 months (the youngest could be 6 weeks old) infants or toddlers which are positively healthy based on the medical history, the physical examination and the judgment of the investigator; * the statutory guardian (or the consignor) of the subject agree his/her child participate in the study, and is willing to sign the informed consent form; * the subject and his/her statutory guardians (or the consignor) are able to comply with the requests of the clinical study protocol; * never be immunized with any pneumococcus vaccine, and didn't get immunization with any other preventive product in the past 10 days (didn't get immunized with attenuated live vaccine in the past 14 days); * the auxillary temperature ≤37℃. exclusion criteria: * has already been immunized with pneumococcus vaccine no matter it is experimental or marketed; * with the history of invasive disease caused by streptococcus pneumonia by culture; * with the history of serious allergy to any vaccine or drug, has got fever higher than 39℃ related to immunization with preventive biological product; * infant that the birth weight is lighter than 2.5 kg; * with the history or the family history of seizure, epilepsy, cerebropathy and psychosis ; * infant with the abnormal labor (difficult labor, deliver with apparatus) or with the history of asphyxia or nervous damage; * with the history of thrombocytopenia or other coagulation disorders by definite diagnosis; * infant or toddler with pathological jaundice by diagnosis; * be known with or suspected with immunological dysfunction, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroid hormone, antimetabolites, cytotoxic drug), hiv infection etc. ; * be known with serious congenital malformation or serious chronic disease; suffer from congenital malformation or be diagnosed with serious chronic disease (eg. down syndrome, diabetes mellitus, sickle cell anemia or nervous disease, guillain-barre syndrome); * be known with or suspected with diseases including: disease of respiratory system, acute infection or the active period of chronic disease, serious cardiovascular disease, hepatic-nephrotic disease, malignant tumor, skin disease; * has taken blood product or globulin (the hepatitis b immune globulin is allowed); * be participating in other clinical trials; * any other situation which is considered to influence the evaluation of the study by investigators .
analysis on the infection risk, prognosis, and drug sensitivity of klebsiella pneumoniae.

Conditions: Klebsiella Pneumoniae Sepsis

Summary: nosocomial infections are increasing rapidly both internationally and domestically, especially carbapenem-resistant klebsiella pneumoniae infections. however, there were still lack of evidence about the risk and prognosis in taiwan. the choice of drug and related sensitivity test was also limited. we would analyze the infection risk, prognosis, and drug sensitivity of klebsiella pneumoniae and focus on strategy to manage carbapenem-resistant klebsiella pneumoniae infections.


Eligibility criteria:
all adult patients (≥18 years) with k. pneumoniae bloodstream infection were included. patients were excluded if there was other recognized bacteremia within two weeks before or after the first episode of k. pneumoniae bloodstream infection.

Keywords: risk factors ,outcomes,drug susceptibility,klebsiella pneumoniae
a single-center registered clinical research of chinese patients with moderate to severe crohn's disease

Conditions: Serological C Reactive Protein or Erythrocyte Sedimentation Rate

Summary: many studies reveal that infliximab (ifx, an immunoglobulin gamma-1 antibody)can response well to crohn's disease(cd) patients who are intolerant of corticosteroids and immunosuppressant,or steroids-dependent .more over,a complex fistula in cd is an indication for early ifx therapy in conjunction with surgical drainage.some papers claim that ifx may prevent enterectomy cd patients from relapsing. those with risk factors which at diagnosis associated with " disabling disease "include age \< 40 years, initial need for steroid therapy, and the presence of perianal disease are recommended to use ifx early. ifx is approved by state food and drug administration(sfda) in 2007 ,but the safety is still controversial by then.some studies proclaim that the side effect may be infections,acute infusion reactions,anaphylactic reactions,autoimmunity,drug-induced lupus,congestive heart failure,abortion and demyelination,etc. so some problems still need to be settled as follows:1)all the the infliximab dates are from other countries,there is rare date from the chinese,especially the large quantity of random controlled studies and the cd patients with enterectomy.2)despite of the large number of databases from the international ,when to stop and the predictor of the response is still obscure.3)the high cost of ifx may hinder its applications,especially for the moderate to severe active cd patients who take mesalazine and/or immunosuppressant to maintain remission.in addition,the pathogenic age segments in the occurence of cd: from 15\~ 50 years old ,so they suffer from the disability of self-improvements. the main object of the clinical trial is to complete the database of chinese cd patients ,especially the safety and efficacy of ifx and those with enterectomy.then we can record the clinical manifestations of the moderate to severe cd patients with the use of ifx or conventional drugs,including the dose,course and concomitant treatment.we can also study the predictor and the appropriate time to stop using ifx .we can make the mode of cost-benefit help the patients choose the best project.


Eligibility criteria:
inclusion criteria: * cd patients excluded from other diseases who are documented diagnosed with the tissue biopsy from colonoscopy or surgery,or those without tissue biopsy are followed over 6-12months finding that the clinical changs are in line with cd. * the moderate to severe cd patients (best crohn's disease activity index\>220） exclusion criteria: * patients who are not willing to anticipate the trial
a multicenter, prospective, randomized, double-blind, placebo-controlled trial of three preparations of low-dose oral alpha interferon in hiv-infected patients with cd4+ counts >= 50 and <= 350 cells/mm3

Conditions: HIV Infections

Summary: to evaluate the effects of three preparations of low-dose oral interferon alpha (i.e., alferon ldo, veldona, and ferimmune) on hiv symptoms in hiv-infected patients. to evaluate differences in response to oral interferon alpha according to gender, race/ethnicity, and use of antiretrovirals. previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. therefore, three preparations will be compared to evaluate their potential efficacies.

previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. therefore, three preparations will be compared to evaluate their potential efficacies. patients are randomized to receive 6 months of alferon ldo alone, alferon with veldona, alferon with ferimmune, or three placebos, with follow-up visits monthly.

Eligibility criteria:
inclusion criteria patients must have: * symptomatic hiv infection. * cd4 count 50 - 350 cells/mm3. prior medication: allowed: * prior antiretrovirals (dose must be stable for at least 6 weeks prior to study entry). * maintenance therapy for a chronic condition. exclusion criteria patients with the following prior condition are excluded: * change in antiretroviral therapy within past 6 weeks. prior medication: excluded: * oral ifn-alpha or other immune-based therapy within the past month. * therapy for any acute disease within the past week.

Keywords: drug therapy, combination adjuvants, immunologic administration, oral acquired immunodeficiency syndrome aids-related complex interferon-alpha
bevacizumab in metastatic renal cancer

Conditions: Renal Cell Cancer

Summary: this is a non-interventional, multicenter study to evaluate efficacy and safety of intravenous bevacizumab (avastin) in combination with interferon alpha-2a immunotherapy for first-line treatment in participants with advanced and/or metastatic renal cell cancer (mrcc) in daily routine.


Eligibility criteria:
inclusion criteria: * histologically confirmed advanced and/or metastatic renal cell cancer * no contraindications for avastin according to summary of product characteristics (smpc) exclusion criteria: -

Keywords: metastatic renal cell carcinoma avastin bevacizumab
efficacy and speed of action of a product to control gastric hydration and gastroesophageal reflux

Conditions: Oesophageal Reflux; Gastric Reflux; Hyperactivity; Stomach

Summary: a randomised, placebo-controlled clinical trial off the efficacy and rapidity of action of a product containing sodium alginate, calcium and magnesium salts, hyaluronic acid and aloe vera to control oesophageal-gastric ph and reduce symptoms of gastric reflux and hyperacidity.

the investigators will include patients with gastroesophageal reflux disease and heartburn (more than 3 weekly episodes of heartburn for at least 4 consecutive weeks) not related to medication intake and don't use proton pump blockers or h2-receptor antagonists. this is a multicentre clinical trial with two-phase design: phase i: a double-blind, randomised, placebo-controlled clinical trial to assess the efficacy and rapidity of action of the medical device to reduce clinical symptoms of gastric reflux and hyperacidity under normal conditions of use. this phase i will be performed in primary care clinics. phase ii: a non-comparative, non-controlled clinical trial to objectively assess, using continuous ph monitoring, the magnitude and rapidity to control gastric and oesophageal ph after taking the product. this phase ii will be performed at the department of gastroenterology of medic center. the study will begin with the baseline visit (day 0) in which the inclusion and exclusion criteria will be confirmed, the signing of informed consent will be obtained, gerd-q questionnaire will be done and treatment will be prescribed, followed by a home recording where patients will record data on episodes of acidity and heartburn occuring during the follow-up week. a face-to-face visit will be at 7 days after to recollect information about total number of daytime and nighttime episodes of acidity/heartburn since the previous visit and repeat the gerd-q questionnaire.

Eligibility criteria:
inclusion criteria: * patients of both sexes over 18 years of age * patients with gastroesophageal reflux disease and heartburn (more than 3 weekly episodes of heartburn for at least 4 consecutive weeks) not related to medication intake * patients not on proton pump blockers or h2-receptor antagonists * patients able to understand the study implications and who sign the informed consent. exclusion criteria: * pregnant or nursing women * patients who are currently using or have used other medications or antacid products for the treatment of reflux and hyperacidity symptoms within 7 days prior to enrolment in this study. * patients treated with antihypertensive drugs, calcium channel blockers or non-steroidal anti-inflammatory drugs (nsaids) * patients with hypercalcaemia, hypertension, renal failure or other conditions in which the use of the components of the investigational product is not recommended. * patients with serious diseases that, in the physician's opinion, could interfere with the results of the study or prevent their participation in it.

Keywords: oesophageal reflux gastric reflux hyperactivity; stomach sodium alginate calcium magnesium salts hyaluronic acid aloe vera gastroenterology