Kornimate/medical-research-clean huggingface dataset:
pharmacogenetic clinical trial of nepicastat for post traumatic stress disorder (ptsd)

Conditions: Post Traumatic Stress Disorder (PTSD)

Summary: assess the effect of nepicastat in the treatment of in post traumatic stress disorder (ptsd) in conflict or combat zone experienced veterans, in comparison to placebo.

the primary treatment objective is to assess the global efficacy of nepicastat in the treatment of hyper-arousal in post traumatic stress disorder (ptsd) in conflict or combat zone experienced veterans, in comparison to placebo. the secondary treatment objectives are to assess the ability of nepicastat to induce ptsd remission; treat ptsd and other ptsd symptom clusters and improve quality of life and overall functioning. a medical safety objective is to assess the tolerability and side effects of nepicastat in the treatment of ptsd in veterans who served in conflict zones at least one time between 1990 -2008 \[includes operation iraqi freedom/operation enduring freedom (oif/oef), afghanistan, gulf war, etc . this is a 6-week study with the long-term objective is to define the best approach to treating ptsd and enhancing the quality of life in patients. results from this pilot study will assist clinicians in treating active military service members or veterans with ptsd by developing new treatment algorithms for future larger studies.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. patient understands the risks and benefits and agrees to visit frequency and procedures 3. male or female 4. any race or ethnic origin 5. served in conflict zones at least one time between 1990 -2008 \[includes operation iraqi freedom/operation enduring freedom (oif/oef), afghanistan, gulf war, etc\] 6. currently active duty, national guard, reservist, veteran, and/or retired military 7. dsm-iv diagnosis of post-traumatic stress disorder (ptsd) 8. no substance use disorders (except for nicotine and caffeine) in the previous 2 months 9. free of psychotropic medication for 2 weeks prior to randomization (a low dose sedative hypnotic is allowed for severe insomnia if used sparingly) 10. physical and laboratory panel are within normal limits or not clinically significant 11. women of childbearing potential must be using medically-approved methods of birth control 12. 18 to 65 years of age exclusion criteria: 1. lifetime history of bipolar i, schizophrenia, schizoaffective or cognitive disorders 2. actively considering plans of suicide or homicide 3. psychotic symptoms that in the investigator's opinion impair the patient's ability to give informed consent or make it unsafe for patient to be maintained without a neuroleptic 4. unstable general medical conditions or a contraindication to the use of nepicastat 5. intolerable side effects or allergic reaction to nepicastat 6. women planning to become pregnant or breastfeed during the study

Keywords: ptsd
telerehabilitation in patients with idiopathic pulmonary fibrosis

Conditions: IPF

Summary: it is to determine the effectiveness of different telerehabilitation exercise programs received to 2 groups randomly formed in idiopathic pulmonary fibrosis (ipf) patients. the cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as telerehabilitation exercise group (tgr) and video group (vgr).

patients diagnosed with idiopathic pulmonary fibrosis by a chest diseases specialist and referred to pulmonary rehabilitation will be included in the study. the cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as telerehabilitation exercise group (tgr) and video group (vgr). tgr will be given online exercises, synchronized 2 days a week, and a home program for 1 day, accompanied by a physiotherapist, via videoconference on the group smartphone. as for the vgr group, after 1 session of online simultaneous exercise training in the company of a physiotherapist via videoconference on the smart phone, an exercise video including the exercises will be sent to them and the patients will be asked to do their exercises 3 days a week. the subjects will be asked to keep an exercise diary and the status of the diaries will be followed by calling them once a week. the exercise period will be 8 weeks for both groups.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-75 * having a diagnosis of ipf disease diagnosed according to the following clinical diagnostic criteria according to the american thoracic and european respiratory societies (ats-ers) * presence of dyspnea on exertion * stable clinical state at the time of admission without infection or exacerbation in the previous 4 weeks exclusion criteria: * patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 l \\min). * a history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training. * participation in a pulmonary rehabilitation program within the past 12 months.

Keywords: ipf telerehabilitation videobased rehabilitation exercise physical therapy pulmonary rehabilitation
the effect of foot reflexology on infantile colic symptoms

Conditions: Infantile Colic; Reflexology

Summary: aim: to compare the effect of foot reflexology and placebo foot reflexology on colic symptoms such as pain, ineffective sleep, and colicky crying periods in infants with colic. method: the study was conducted as a single-blind, randomized, placebo-controlled trial in a child hospital between june 2016 and march 2017. to start with, 20 infants with colic were randomly selected for the reflexology group, and 25 babies with colic were randomly selected for the placebo group. simple randomization was used; the parents and statistician were blinded to group assessment. the researcher could not be blinded because of the role played in the study. foot reflexology was implemented with reflexology-group infants. placebo foot reflexology was used with placebo-group infants. both interventions were performed four times, for 20 minutes, each, by the researcher over the course of two weeks. the data were collected by the researcher using the information form, infantile colic scale, behavioral pain scale, crying and sleeping follow-up forms.


Eligibility criteria:
inclusion criteria: infants were included who were aged 1-3 months, infants who were diagnosed ic by a pediatrician according to wessel's rule of threes. exclusion criteria (beckmann \& le quesne, 2005): infants who were using any of analgesic drug until 3 hours before the applications and antibiotic or steroid due to treating an illness, infants who had an acute fever, musculoskeletal disease, active shingles or infection, acute shingles, or tissue in the foot and joint, all infants with any non-ic health problems.

Keywords: complementary therapies infantile colic nurses reflexology
comparison of inflammatory responses subsequent to different cesarean section techniques

Conditions: Delivery; Cesarean Delivery; Inflammation

Summary: in this study, the investigators aimed to find out whether there are any differences in inflammatory reactions occured subsequent to two different cesarean delivery techniques; modified misgav-ladach vs pfannenstiel-kerr techniques.

cesarean section is one of the most undertaken operations in women of childbearing age. however, there is not a unique cesarean surgery technique. pfannenstiel , reported his own technique in 1897. because of the applicability of the technique, it went down well among obstetricians. after three decades, kerr evolved this technique, and pfannenstiel-kerr technique became the method of choice until late 70's. in 1972, stark et al defined the misgav ladach technique and in the following years this technique became popular among obstetricians. in late 80's misgav ladach technique was modified and started to be more popular. but, still pfannenstiel-kerr technique continued to be used frequently and studies comparing clinical outcomes of these two techniques were conducted for several times. however, the inflammatory responses which occured subsequent to application of these techniques were not investigated. this is the first study investigating the inflammatory response emerged after different cesarean surgery techniques.

Eligibility criteria:
inclusion criteria: * cesarean section for the first time * term,singleton pregnancy exclusion criteria: * any inflammatory disease * any pregnancy complication; iugr,preeclampsia,preterm labor,preterm premature rupture of membranes * pregnancies \<37weeks gestational age

Keywords: inflammatory reaction il-6 tnf misgav ladach technique pfannenstiel-kerr technique cesarean delivery cesarean technique
a two-way communication system to coach elderly patients with heart failure

Conditions: Heart Failure

Summary: this is an open randomized clinical trial with two study arms. one group, receiving usual care for heart failure, will be compared to another group, receiving usual care plus active telemonitoring interference. when leaving the hospital, the usual care arm receives a document with a predefined medication scheme and advice for the general practitioner (like it is currently done in usual care). the telemonitoring interference in the other study arm consists of a smartphone application to register medication intake and to transmit the data of an automatic blood pressure device and a balance to a central platform. the goal is to improve medication uptitration (angiotensin-converting-enzyme inhibitor (ace-i) and bètablockers (bb)) in heart failure patients and to improve medication compliance.


Eligibility criteria:
inclusion criteria: * age ≥ 60 * patient has to be followed in ziekenhuis oost-limburg or jessa ziekenhuis hasselt and has to live in the region genk - hasselt * the patient has to be cognitive strong enough and speak enough dutch to communicate about their health situation and to understand the smartphone application * the diagnosis of systolic heart failure or severe myocardial infarction has to be done during consultation or hospitalization * left ventricular ejection fraction (lvef) \<45% * treatment minimally with ace-i and bb on the basis of an interview between the heart failure nurse and patient, one will decide if the patient is eligible to join the study. the patient also needs to speak sufficient dutch to be communicative about his/her medical condition. exclusion criteria: * reversible form of heart failure * heart failure due to severe aortic stenosis * at the time of inclusion a egfr less than 30ml/min/kg * presence of a cardiac resynchronization therapy (crt) device * active treatment with either ace-i/arb or bb * patient that are subscribed in a cardiac revalidation program when leaving the hospital * patients with severe form of copd (gold iii)
trial of surf and hike therapy for major depressive disorder

Conditions: Major Depressive Disorder

Summary: this study uses a randomized controlled trial design to compare the psychological effects of surf therapy to hike therapy in active duty service members who have been diagnosed with major depressive disorder.

this prospective, longitudinal randomized controlled trial will enroll up to 86 active duty service members with major depressive disorder who are seeking surf or hike therapy as part of their standard medical care. participants will be randomly assigned to receive 6 weeks of either surf or hike therapy. assessor-administered and self-report measures will be completed at pre- and post-program, as well as three months following program completion. participants also will complete brief, self-report assessments before and after each program activity session.

Eligibility criteria:
inclusion criteria: * be a military service member seeking surf or hike therapy as part of the wounded, ill, and injured wellness program at naval medical center san diego; * have medical clearance to participate in these programs; * have a current diagnosis of major depressive disorder based on dsm-5 criteria. exclusion criteria: * service members who are currently receiving surf or hike therapy (i.e., have already started attending program sessions); * service members who are currently pregnant

Keywords: major depressive disorder military surf therapy hike therapy randomized controlled trial
impact of the stool color scale on the detection of neonatal cholestasis

Conditions: Neonatal Cholestasis

Summary: the stool color scale was set in 2018 in the health books of french children. the study aim is to see if the scale is usefull for healthcare professionals and if this scale has advanced the detection of neonatal cholestasis.

the first part of the study consist in send a questionnaire to health professionnal to see their use of the stool color scale in the health book of newborn. the second part of the study is to see the age of children with cholestasis at the date of the first consult with a specialist.

Eligibility criteria:
inclusion criteria: * cholestasis exclusion criteria: -
quantitative study on hrct phenotype of copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to explore the hrct phenotype of the combined copd assessment staging system

hrct can be rapidly and safely deployed has enabled copd research to move beyond fev1 by facilitating and amplifying clinical phenotyping measurements, providing quantitative information, and detecting significant responses to therapy even in the absence of significant fev1 improvements. we explore the hrct phenotype of the combined copd assessment staging system,and found that: 1. airway remodeling occurs in copd patients. ct shows varying degrees of bronchial wall thickness, area increasing and emphysema as the new gold classification group a-d arising. 2. the gold combined assessment staging system helps doctors choose an individualized treatment for the copd patients

Eligibility criteria:
inclusion criteria: 1. age between 40 and 80 (including 40 and 80) 2. it meets the diagnostic criteria for copd 3. no language communication barriers, or the family members who know the condition can complete the questionnaire on behalf of the patient, and the data are reliable; 4. voluntarily agree to participate in this study exclusion criteria: 1. older than 80 or younger than 40 2. pregnant women 3. complicating with other lung diseases, such as asthma, pneumonia, bronchiectasis, lung abscess, interstitial lung disease, confirmed and suspected lung cancer of lung shadow, active pulmonary tuberculosis, etc 4. previous lung surgery 5. cognitive dysfunction 6. unable to cooperate with lung function test.

Keywords: pulmonary disease; chronic obstructive; phenotype
vitamin d and the health of blood vessels in kidney disease

Conditions: Chronic Kidney Disease (CKD)

Summary: individuals with kidney disease have a high risk of heart disease. this is not related to traditional risk factors, such as high blood pressure, high cholesterol or being overweight. a lack of vitamin d could be the reason why blood vessels become damaged and could explain the link between heart disease and kidney disease.

most people living in canada do not receive enough vitamin d from the sun or from the food they eat. when a person has kidney disease this is a particular problem as kidney disease stops what little vitamin d we do have being activated in the body. low levels of activated vitamin d causes a domino effect with calcium and phosphate and all the hormones that control calcium and phosphate. some people believe that this imbalance damages the blood vessels causing them to become stiff and inflexible (arterial stiffness) and this in turn could cause heart disease. in addition there are two different types of vitamin d that can be prescribed and it is currently not known whether there is any difference between the two types of vitamin d and the effect they have on the blood vessels. the purpose of this study is to investigate whether providing vitamin d as a medication can have a direct affect on the stiffness of the blood vessels. the findings of this study will help both physicians and dietitians decide whether vitamin d therapy is beneficial to patients and should help decide which type of vitamin d is best to give to people with chronic kidney disease (ckd).

Eligibility criteria:
inclusion criteria: * patients with an estimated glomerular filtration rate (egfr) between 15 - 45 ml/min, and \<2ml/min change in glomerular filtration rate (gfr) over the past 6 months * treated with maximal conventional cardiovascular disease (cvd) risk reduction medications exclusion criteria: * patients with estimated glomerular filtration rate (egfr) change of \>2.1 ml/min over the past 6 months * those who have terminal malignancies * those with planned transplant within 6 months, or who are likely to commence renal replacement therapy (dialysis) within the 6 months after enrolment * those with active infections or active inflammatory diseases (systemic lupus erythematosus (sle), vasculitis) * those who refuse to give informed consent

Keywords: vitamin d pulse wave velocity
safety and efficacy of monthly replacement therapy with recombinant factor xiii (rfxiii) in paediatric subjects with congenital factor xiii a-subunit deficiency

Conditions: Congenital Bleeding Disorder; Congenital FXIII Deficiency

Summary: this trial will be conducted in asia, europe and the united states of america (usa). the aim of this clinical trial is to investigate long-term safety of rfxiii when administered for prevention of bleeding episodes in children aged between 1 and 6 years with congenital fxiii a-subunit deficiency. this trial is an extension to trial f13cd-3760 (mentor™4, nct01230021). if applicable the trial will be extended up to maximum 3 years dependent on when recombinant factor xiii will be commercially available in subject's respective country for use in children of 1-6 years of age.


Eligibility criteria:
inclusion criteria: * completed participation in trial f13cd-3760 (nct01230021) exclusion criteria: * known or suspected hypersensitivity to trial product or related products * known history of development of inhibitors against fxiii (factor xiii) * hereditary or acquired coagulation disorder other than fxiii congenital deficiency * platelet count (thrombocytes) less than 50x10e9 / l * previous history of autoimmune disorder involving autoantibodies e.g., systemic lupus erythematosus * previous history of arterial or venous thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis * any disease or condition which, judged by the trial physician, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome including renal and/or liver dysfunction
amh and pregnancy rate by age during stimulate in-vitro fertilization protocol

Conditions: Infertility

Summary: the woman fertility decrease with the age and there is a closely link with the ovarian reserve, the number of available eggs in the ovaries. therefore, it is important to evaluate the ovarian reserve with specific marker to have a better prediction of the response of the in vitro fertilization treatment and to have a better rate of pregnancy. until now, a lot of clinical criteria (age, duration of the infertility, number of antral follicles) and biological (fsh, oestradiol, inhibin b, effort test, number of the eggs at the retrieval day) was suggested to help for the estimation of the ovarian reserve. since couple of years, the anti-müllerian hormone (amh) is recognize to be one of the best ovarian reserve marker, it corresponding the number of antral follicles, it is more sensitive and predictive. moreover, during the in-vitro fertilization, the anti-müllerian hormone can provide the weak responds at the stimulation and the reverse, the risk of excessive responds (hyperstimulation). to choose the gonadotropin doses to administrate (stimulation ovarian hormone) during an in-vitro fertilization protocol, we need to know the anti-müllerian hormone dosage. however, if the anti-müllerian hormone is recognize to evaluate the quantity of available eggs in the ovaries, his role to determine the quality of these eggs still discussed. the goal of this study is to verify if the serum anti-müllerian hormone (blood) is a good indicator for the quality of the reserve ovarian evaluating the impact of anti-müllerian hormone rate on the pregnancy rate and implantation rate, during stimulate in-vitro fertilization protocol.


Eligibility criteria:
inclusion criteria: * all infertile patients aged between 18 and 43 years * patients with a prescription for a stimulated in-vitro fertilization cycle exclusion criteria: * presence of endocrine disease: diabetes, hyperprolactinemia, abnormal thyroid-stimulating hormone (tsh) or cushing syndrome * renal or hepatic impairment known

Keywords: anti-mullerian hormone in-vitro fertilization
insulin profile of biphasic insulin aspart 70 to that of biphasic insulin aspart 30 in healthy volunteers

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in japan. the aim of this trial is to compare biphasic insulin aspart 70 (nn2000-mix70) in subjects with type 2 diabetes with that of biphasic insulin aspart 30 (nn-x14mix30) in healthy volunteers.


Eligibility criteria:
inclusion criteria: subjects with type 2 diabetes * subjects with type 2 diabetes mellitus * current treatment using intermediate-acting, long-acting or pre-mixed/biphasic insulin preparation (including insulin analogues) in once or twice daily (before breakfast and dinner) treatment regimen for at least 12 weeks (a temporary use \[maximum of one week in total\] of rapid-acting human insulin will be allowed) * age between 20-69 years, both inclusive * hba1c (glycosylated haemoglobin a1c) below 9.0% * body mass index (bmi) 18.5-25.0 kg/m\^2 * total daily insulin dose (per day) above 0.2 u or iu/kg body weight and below 1.0 u or iu/kg body weight healthy volunteers * japanese subjects with considered generally healthy based on medical history and physical examination * age between 20-29 years, both inclusive * body mass index (bmi) 18.5-25.0 kg/m\^2 * subjects with normal glucose tolerance (ngt); defined as fasting plasma glucose below 110 mg/dl and 2-hour post ogtt (oral glucose tolerance test) plasma glucose below 140 mg/dl exclusion criteria: subjects with type 2 diabetes * proliferative retinopathy or maculopathy requiring acute treatment * impaired hepatic function * impaired renal function * serious cardiac diseases * uncontrolled hypertension * known hypoglycaemia unawareness or recurrent major hypoglycaemia * current treatment or expected at the screening to start treatment with systemic corticosteroids healthy volunteers * any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) at the screening * history or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders * subjects with a first-degree relative with diabetes mellitus