Kornimate/medical-research-clean huggingface dataset:
a study characterizing pharmacodynamic profiles in subjects with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to characterize the pharmacodynamic profile of formoterol fumarate and foradil aerolizer


Eligibility criteria:
inclusion criteria: * able to understand the requirements of the study and provide informed consent * a clinical diagnosis of copd * a current or prior history of at least 10-pack years of cigarette smoking * women of child-bearing potential (wocbp) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study exclusion criteria: * a clinical diagnosis of asthma * other significant disease than copd * subjects who radiation or chemotherapy within the previous 12 months * subjects who had any lung resection * qtcb greater than 0.460 seconds * history of illegal drug abuse or alcohol abuse within the past 5 years

Keywords: copd
nasogastric tube after laparoscopic heller-dor myotomy

Conditions: Achalasia; Achalasia Cardia

Summary: the goal of this prospective observational study is to evaluate the role of nasogastric tube (ngt) in patients with achalasia underwent to heller-dor laparoscopic. the main question it aims to answer are: • if it is possible to remove ngt at the end of surgery. participants will be dived in two groups: the first one with ngt after surgery and second one without ngt (nongt). if there is a comparison group: researchers will compare group ngt and group nongt to see if routine placement of ngt is useless.

achalasia is a rare disease characterized by dysfunction of low oesophageal sphincter. this disease is divided according to chicago classification into three subtypes. laparoscopic heller - dor is a important treatment of types i and ii achalasia. there are several studies evaluating the ngt in colorectal, hepatic, urologic, thoracic, otorhinolaryngology, gastric and esophageal surgery. its use in postoperative period in achalasic patients is not yet clear. historically, ngt has been used to reduce gastric distention, nausea, vomiting and chest pain. the aim of our study is to value the role of ngt for this surgery. we prospectively enrolled achalasic patients undergoing laparoscopic heller -dor . the ngt group and nongt were compared in terms of perioperative outcomes.

Eligibility criteria:
inclusion criteria: * patients with achalasia of type i and ii * patients undergoing laparoscopic heller-dor * patients older than 18 years * both sexes exclusion criteria: * pregnant patients; * patients a history of abdominal surgery; * body mass index (bmi) \>40; * american society of anesthesiology (asa) score \>4; * megaesophagus; * iii type achalasia; * previously treated for this disease.

Keywords: heller laparoscopic dor laparoscopic
quality of life after laparoscopic inguinal- incisional and umbilical herniotomy.

Conditions: Inguinal Hernia; Incisional Hernia; Umbilical Hernias

Summary: life-in. quality of life after operation for hernias are not well investigated and lack a good and easy-to-understand-tool to measure it. carolina comfort scale (ccs) is a disease-specific quality of life questionnaire, designed by an american group, to monitor quality of life in patients undergoing operation for hernias. the investigators wish to test this questionnaire against visual analogue scale (vas) scores for core-hernia symptoms, to see if the ccs is a good way to monitor the changes in quality of life and other well-known core-symptoms before and after herniotomies.

the investigators include consecutively all in all 140 patients. 100 with inguinal hernias; 50 who is getting a lichtenstein operation and 50 who is getting a laparoscopic operation. furthermore minimum 20 patients who is getting a laparoscopic operation for incisional hernia and minimum 20 who went through umbilical herniotomy. the investigators monitor their pain, sensation of mesh, movement limitations, over-all well-being, fatigue and life-quality, with both ccs and vas questionnaires 5 times. one time preoperative and 4 times after operation, on the 1sth, 7th, 30th and 90th day after operation.

Eligibility criteria:
inclusion criteria: * elective laparoscopic and open operations for inguinal hernia * elective laparoscopic operation for incisional- and umbilical hernia * primary hernia * uni-bilateral hernias and one or more incisional hernias exclusion criteria: * expected bad compliance to the study * acute operations * re-operations * secondary operations * primary operation with reoperation within 30 days

Keywords: inguinal hernia incisional hernia quality of life disease-specific
smart program for paroxysmal atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation; Stress

Summary: this is a pilot study to test the effects of the smart-3rp (stress management and resiliency training relaxation response resiliency program) on quality of life, mental health, arrhythmia burden, and heart rate variability (hrv) in patients with paroxysmal atrial fibrillation (paf).

mind-body practices that elicit the relaxation response (rr) have been used worldwide to prevent and treat disease. the stress management and resiliency training - relaxation response resiliency program (smart-3rp) is an 8-week manualized psycho-educational program that incorporates rr methods such as meditation or seated yoga along with cognitive skills building and lifestyle approaches to increase resiliency to stress. this study will use a randomized, wait-list controlled trial design to test the effects of the smart-3rp on quality of life (qol), mental health, arrhythmia burden, and hrv in patients with paf. the program will be delivered virtually (via computer video conferencing), questionnaires will be completed, and physiological data as well as blood will be collected.

Eligibility criteria:
inclusion criteria: * diagnosed with documented recurrent symptomatic paf. * currently on stable medical therapy for af and willing to continue on the same treatment regimen while participating in the study. * no current daily practice of yoga, meditation, guided imagery or other techniques that elicit the rr. * able to provide informed consent and to understand written and spoken english. exclusion criteria: * allergy to adhesives that prevents wearing the hrv monitor. * patients unable or unwilling to participate in an intervention delivered via video conferencing. * end stage renal failure or heart failure, severe unstable medical or psychiatric disease. * patients deemed unable to complete protocol due to cognitive or other reasons. * patients on psychoactive medications will have eligibility determined by the pi or md co-investigator on a case-by-case basis, and will be admitted to the study if medication is deemed stable

Keywords: mind-body
diabetes reversal and the subgingival microbiota

Conditions: Diabetes type2; Bariatric Surgery Candidate

Summary: this study seeks to examine the impact of bariatric surgery on oral bacteria in diabetic compared to non-diabetic patients. the purpose of this research study is to examine how diabetes changes the bacteria in the mouth. this is an important question since bacterial changes may impact oral health. participants will attend a screening and baseline visit prior to bariatric surgery and three post bariatric surgery appointments (3 weeks post, 6 months post and 1 year to 18 months post). samples collected at each study visit include blood, plaque, and other oral samples. at the last study visit there is an optional dental cleaning.


Eligibility criteria:
inclusion criteria: * men and women undergoing bariatric surgery who are 25-65 years old. * bmi \> 35 kg/m2. * diabetic subjects: hba1c\> 6.0% or fasting plasma glucose \>126 mg/dl). * normoglycemic subjects: hba1c\<5.75% or fasting plasma glucose \<100 mg/dl). * dental criteria: minimum of 4 posterior teeth. * signed and dated informed consent form. * willing to comply with all study procedures and be available for the duration of the study. exclusion criteria: * subjects diagnosed with type 1 diabetes, maturity onset diabetes of the young (mody), or latent autoimmune diabetes in adults (lada). * women who are considering pregnancy or are currently breastfeeding. * individuals with a history of chronic inflammatory or autoimmune diseases or taking medications that affect immune function or affect body weight such as chronic systemic steroids. * currently smoke more than 10 cigarettes per day. * periodontal treatment within 3 months of bacterial sampling. * acute periodontal infection (abscess) within 1 month of bacterial sampling or abscess in teeth or adjacent teeth within 1 month of sampling. * treatment with antibiotics within one month of sample collection (except as part of the surgical regimen of prophylactic antibiotic immediately prior to surgery). * a treatment regimen of steroids within 1 month of sample collection.
observational study to evaluate the correctness of the use of inhaler device in patients with asthma or chronic obstruct

Conditions: Asthma,; Chronic Obstructive Pulmonary Disease

Summary: the correct use of inhalation devices is an inclusion criterion for all studies comparing inhaled treatments. in real life, however, patients may make many errors with their usual inhalation device, which may negate the benefits observed in clinical trials. in real life, many errors seem to be made, but no wide-scale evaluation has been performed. the correct use of inhalation devices is essential to ensure the effectiveness of the treatment. it has been recently demonstrated that inhaler misuse is associated with decreased asthma control in asthmatics treated with an inhaled corticosteroid. the aim of our observational study was to evaluate the inhaler device usage in patients with asthma or chronic obstructive pulmonary disease (copd).

observational study to evaluate the correctness of the use of inhaler device in patients with asthma or chronic obstruct

Eligibility criteria:
inclusion criteria: * provision of subject informed consent * females or males aged \> 18 years exclusion criteria: - if participating in any other clinical trial, the subject cannot take part in this study

Keywords: respiratory disease copd
role of tele-physical therapy in patients with type 2 diabetes mellitus following covid-19 infection.

Conditions: Type 2 Diabetes Mellitus; COVID-19

Summary: diabetes mellitus (dm) is a chronic metabolic disease where the body is unable to metabolize carbohydrates properly either due to a lack of insulin production or abnormal insulin function. in recent times, it has been considered a global healthcare concern because of its high prevalence rate (9.2 %) and other associated health consequences. after being infected with coronavirus disease-2019 (covid-19), the type 2 diabetes mellitus (t2dm) sufferer experiences the following symptoms; reduced exercise tolerance, decreased muscle strength, altered respiratory functions, cognitive impairments and abnormal psychosomatic behaviour, which affects the overall well-being of the patient. to prevent or delay these clinical features and the associated consequences of type 2 diabetes mellitus, the regular body works out and physical training is suggested either alone or in combination with diet modification. in this study, we tested the hypothesis that 12 months of supervised tele-physical therapy can positively influence patients with type 2 diabetes mellitus following covid-19 infection. the reports of the study would be helpful for the clinicians and the physical therapists to make this as evidence for using tele-physical therapy in type 2 diabates mellitus patients.


Eligibility criteria:
inclusion criteria: * participants between 18-60 years of age and being diagnosed with covid-19 with mild dyspnea and type 2 dm and the ability to use smart mobile phones were selected to be included in the study. exclusion criteria: * participants who had neurological (radiculopathy, myelopathy and disc problems) and orthopedic problems, cardio-pulmonary diseases (stroke, hypertension and syncope), other metabolic and endocrinal problems, metastasis, pregnancy, taking analgesics or corticosteroids, any contra indications to physical exercises (fracture, instability, osteoporosis, arthropathy and neural symptoms) and cognitive and mental disorder were excluded.
efficacy and safety of a-prexa compared to zyprexa in patients with schizophrenia

Conditions: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder

Summary: the purpose of this study is to evaluate the efficacy and safety of a-prexa compared to zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder.


Eligibility criteria:
inclusion criteria: * 20 years to 65 years * schizophrenia patient with an acute exacerbation * understand the requirement of the study and voluntarily consent to participate in the study exclusion criteria: * patients who have another psychiatric disorders * patients who have unstable medical conditions * patients who have clinically important abnormalities of liver function test (\>2.5 fold of upper normal limit), ecg and vital sign at screening visit * uncontrolled diabetic patients (plasma glucose level is more than 126 mg/dl in fasting condition) * patients who have a history of an allergic reaction to olanzapine * patient who have no clinical response to take two or more different atypical anti-psychotics for more than 4 weeks. * patient who take clozapine within 12 weeks before screening visit
study to evaluate the pharmacokinetics, safety and efficacy of two treatment modules in chinese subjects with moderate to severe crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of adalimumab following subcutaneous (sc) administration of 2 dosing regimens in chinese subjects with crohn's disease.


Eligibility criteria:
inclusion criteria: 1. subjects of chinese descent with full chinese parentage. 2. diagnosis of crohn's disease (cd) for at least 3 months prior to week 0 confirmed by endoscopy, radiologic evaluation, and/or histology during the screening period. 3. crohn's disease activity index (cdai) ≥ 220 and ≤ 450 despite treatment with oral corticosteroids and/or immunosuppressants. 4. subject has a negative tuberculosis (tb) screening assessment. exclusion criteria: 1. subject with ulcerative colitis or indeterminate colitis. 2. subject who has had a surgical bowel resection within the past 6 months or who is planning any resection at any time point in the future. 3. subject with an ostomy or ileoanal pouch. 4. subject who has short bowel syndrome. 5. subject with symptomatic known obstructive strictures. 6. subject with an internal or external fistula (with the exception of an anal fistula without abscess). 7. chronic recurring infections or active tb.

Keywords: crohn's disease pharmacokinetics
comparison of cdb-2914 versus placebo in the prevention of follicular rupture post-luteinizing hormone (lh) surge

Conditions: Contraception

Summary: evaluation of the effect of a single dose of cdb-2914, as compared to placebo, administered after the onset of the lh surge on the outcome of the leading ovary follicle: * echographic follicle rupture * inhibition of follicle rupture * luteal phase progesterone levels * anovulatory progesterone levels


Eligibility criteria:
inclusion criteria: * women of good general health aged 18 - 35 years * not at risk of pregnancy * regular menstrual cycles of 24-35 days duration * not pregnant * intact uterus and ovaries * haemoglobin ≥ 11 g/dl * normal laboratory tests and normal tsh * willing to abstain from any use of hormonal contraception until study completion * no current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since termination of previous hormonal contraception * had at least one complete menstrual cycle (2 menses) following delivery, miscarriage or induced abortion * able to give voluntary, written informed consent, and agreeing to observe all study requirements for 5 complete menstrual cycles exclusion criteria: * current participation in any other trial of an investigational medicine * known hypersensitivity to the ingredients of the test active substances or excipients * suspected hyperplasia or carcinoma of the endometrium * current pregnancy as confirmed by positive serum beta-hcg at screening * desire to get pregnant before the planned end of the study participation * currently breastfeeding * abnormal pap smear * cancer (past history of any carcinoma or sarcoma) * known or suspected alcoholism or drug abuse * abnormal thyroid status * body mass index \> 32 * current use of hormonal contraception * use of hormonal emergency contraception since last menstrual period * severe asthma insufficiently controlled by oral glucocorticoids * hereditary galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
covid booster in pregnancy and lactation

Conditions: COVID-19

Summary: this is a prospective longitudinal cohort study to evaluate the impact of covid-19 vaccination and booster on maternal and infant immunity against covid-19 variants over time.

we will enroll 100 pregnant patients who have received covid-19 mrna booster as well as 100 breastfeeding patients who have received covid-19 mrna booster. participants will be following longitudinally through 3 months post partum, or 3 months post enrollment for those in the breastfeeding cohort. maternal blood will be collected, as will cordblood at delivery, breastmilk, and infant samples.

Eligibility criteria:
inclusion criteria: * singleton gestation * received mrna bivalent covid-19 booster during 1) pregnancy or 2) breastfeeding exclusion criteria: * multifetal gestation * unable to provide consent

Keywords: vaccine covid-19 vaccine booster pregnancy breastfeeding immunity
leuplin sr 11.25 mg injection kit specified drug-use survey "long-term use survey in prostate cancer patients (96 weeks)"

Conditions: Prostate Cancer

Summary: the purpose of this survey is designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate sr 11.25 milligram (mg) injection kit (leuplin sr 11.25 mg injection kit) in prostate cancer participants in daily medical practice.

this survey was designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate 3 months depot injection kit (leuplin sr 11.25 mg injection kit) in prostate cancer participants in daily medical practice. for adults, 11.25 mg of leuprorelin acetate is usually administered subcutaneously once every 12 weeks. prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. the powder is then fully suspended in the fluid while ensuring that bubbles are not generated.

Eligibility criteria:
inclusion criteria: prostate cancer participants who meet all the following criteria: 1. participants for whom prostate cancer was initially diagnosed on or after january 1, 2005 2. participants with no prior history of treatment with leuplin sr 11.25 mg injection kit (as an exception, participants with prior history of treatment with leuplin 3.75 mg injection kit may be enrolled in the survey ) 3. participants with prostate-specific antigen (psa) level determined at baseline or within 3 months prior to the start of treatment with leuplin sr 11.25 mg injection kit exclusion criteria: -

Keywords: pharmacological therapy
alternative delivery of dose adjustment for normal eating (dafne) trial in patients with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the best format for the delivery of structured education for adults with type 1 diabetes is unclear. currently some hospitals invite their patients to attend a 5 day outpatient course run over one week (dose adjustment for normal eating (dafne)). other centres offer 1 day a week for 3 to 5 weeks. we aim to find out whether or not the benefit of benefits are the same then it would mean that the course could routinely be offered to patients in either format, thus allowing more patient choice and flexibility.

the dafne (dose adjustment for normal eating) course is a 1-week structured education course teaching skills in insulin use and dietary freedom to individuals with type 1 diabetes. at the moment, we do not understand enough about why some people get more out of the dafne programmes than others. currently dafne is always taught over 1 week. we aim to find out whether or not the benefit of dafne is the same whether it is delivered over 5 consecutive days, or one day a week for 5 consecutive weeks. if the benefits are the same then it would mean that the course could routinely be offered to patients in either format, thus allowing more patient choice and flexibility. at present there have been no rcts to address approximately 170 people will take part in this study over the next 2 years. half the people who participate will be allocated to attend a dafne course over 5 consecutive days, and the other halfwill attend one day a week for 5 consecutive weeks. we will perform routine biomedical assessments as part of the dafne programme and normal diabetes care (e.g. hba1c (a measure of long-term blood glucose control), weight, blood pressure, blood biochemistry), and ask patients to recall hypoglycaemic (low blood sugar) events. we will also ask participants to fill in some research questionnaires, they will take 45-60 minutes to fill in each time. they will include questions about their diabetes, quality of life, well-being and diabetes knowledge. these assessments will be made at 3 time points; baseline, 6 and 12 months. the main outcome measure is change in hba1c, with the other biomedical and psychosocial parameters being of secondary importance. these evaluations will help us develop the dafne programme further and inform us how best to deliver the course in the future.

Eligibility criteria:
inclusion criteria: * adults with type 1 diabetes for at least 6 months * hba1c \<12% * willing to undertake intensive insulin therapy exclusion criteria: * severe diabetic complications (making group education difficult) * inability to communicate in english * strong preference for on attending a one week course or one day a week for 5 consecutive weeks * inability to give informed consent
effects of a multidisciplinary outpatient rehabilitation program in patients with ehlers-danlos syndrome.

Conditions: Ehlers-Danlos Syndrome

Summary: the management of patients with ehlers-danlos syndrome (eds) is still underdeveloped in healthcare institutions in france. although multidisciplinary management through exercise rehabilitation has demonstrated its benefits in many chronic pathologies, it has not been evaluated for eds. as a result, to date there is no evidence of its effectiveness in patients with eds. the objective of this study is therefore to objectively evaluate the effectiveness of such a treatment on the different dimensions of these patients' health.


Eligibility criteria:
inclusion criteria: * eds diagnosis. * inclusion in the rehabilitation program. exclusion criteria: * absolute and relative cardio-vascular contraindications to rehabilitation. * other contraindications to exercise. * psychological contraindication (beck questionnaire score ≥ 20)

Keywords: rehabilitation; ehlers-danlos syndrome; quality of life; physical capacity