Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of aliskiren 300 mg, 150 mg and 75 mg in patients with essential hypertension compared to ramipril 5 mg

Conditions: Hypertension

Summary: this study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.


Eligibility criteria:
inclusion criteria: * patients must have msdbp ≥ 90 mmhg and \< 110 mmhg at the visit immediately prior to visit 3 * patients must have msdbp \>or= 95 mmhg and \< 110 mmhg at visit 3 * patients must have an absolute difference of \< or =10 mmhg in their mean sitting diastolic blood pressure (msdbp) from visit 2 to visit 3 exclusion criteria: * severe hypertension (grade 3 who classification; msdbp \>or= 110 mmhg and/or mssbp \>or = 180 mmhg). * history or evidence of a secondary form of hypertension. * history of transient ischemic cerebral attack within 12 months of visit 1. * current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates) * type 1 or type 2 diabetes mellitus with glycosylated hemoglobin (hba1c) \> 8% at visit 1. * known or suspected contraindications to the study medications, including history of allergy to ramipril or other ace inhibitors. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hypertension, aliskiren, ramipril
osteoarthritis bedside testing kit

Conditions: Osteoarthritis

Summary: develop and test a bedside testing kit for evaluating pain and symptoms of osteoarthritis

conduct a focus group of subjects with painful osteoarthritis of the knee to evaluate potential kit for acceptability to subjects and investigators, and usability, clarity of instructions, appropriateness of the data capture, simplicity, subject and investigator burden, and overall impressions of the procedures. conduct a reliability and usability study with subjects with painful osteoarthritis of the knee to determine intra-rater reliability, inter-rater reliability, kit reliability.

Eligibility criteria:
inclusion criteria: * subject is 50 years of age or older and has osteoarthritis of the knee. * subject is able to communicate meaningfully in english and comply with all study procedures. * subject is willing to voluntarily sign and date an informed consent form, approved by an institutional review board (irb)/independent ethics committee (iec), prior to the conduct of any study-specific procedures. * subject has experienced a minimum duration of pain of at least 6 months. * for each of the last 15 days, pain level has remained at least a 3 on a pain intensity numerical rating (p-nrs) scale from 0 to 10; 0 means "no pain" and 10 means "worst pain imaginable". * subject is ambulatory. * subject has a primary diagnosis of osteoarthritis of the knee by medical history. * subject must be willing to abstain from any pain medicine for 12 hours prior to the study. exclusion criteria: * • subject is pregnant and/or breast-feeding. * subject has a medical condition, other than oa, that is not well-controlled with treatment; or the subject has any clinically significant condition that would, in the opinion of the investigator, preclude study participation or interfere with the assessment of pain and other symptoms of oa. * subject is not able to hold a stylus or pen. * subject is not able to read a computer screen. * subject has any chronic pain syndrome (e.g., fibromyalgia) that, in the investigator's opinion, would interfere with the assessment of pain and/or other symptoms of oa. * in the judgment of the investigator, the subject has a psychiatric or psychological disorder that would interfere with the completion of the study, confound the study results or pose patient risk.

Keywords: osteoarthritis testing kit knee
blood sample collection to evaluate biomarkers for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Hepatocellular Carcinoma Surveillance

Summary: the primary objective of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma (hcc).

subjects with untreated hepatocellular carcinoma (hcc) and subjects undergoing hcc surveillance will be enrolled and have blood samples collected. subjects undergoing hcc surveillance will be followed for up to 6 months. another blood sample will be collected at the 6 month visit which will be scheduled no longer than 6 months from enrollment.

Eligibility criteria:
inclusion criteria: * all subjects: 1. subject is 18 years of age or older 2. subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of data, including personal health data, to the study investigator and sponsor hcc subjects: 1. subject has a recent (within 6 months of enrollment) untreated clinically diagnosed hepatocellular carcinoma as defined by ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance and/or capsule by 4 phase ct scan or multiphase contrast enhanced mri or biopsy is positive for hcc. control subjects: 1. non-cancer subject undergoing routine imaging surveillance for hcc 2. definitive lack of hcc within 3 months prior to enrollment as defined by negative imaging, for hcc. 1. control group 1 - negative by ultrasound 2. control group 2 - negative by ct or mri exclusion criteria: 1. known cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers). 2. chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection. 3. prior or current treatment with sorafenib, regorafenib, or other treatment indicated for hcc. 4. any hcc treatment prior to enrollment/blood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for hcc). 5. iv contrast (e.g. ct and mri) within 1 day \[or 24 hours\] of blood collection. 6. less than 3 days between fine needle aspiration (fna) of target pathology and blood collection. 7. less than 7 days between biopsy (other than fna) of target pathology and blood collection. 8. individual has a condition the investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
rtms-enhanced psychotherapy for borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: this project assesses the effectiveness and lasting impact of combining dialectical behavioral therapy (dbt) with prefrontal repetitive transcranial magnetic stimulation (rtms) in patients with borderline personality disorder.

the proposed project aims to evaluate the effectiveness of combining dialectical behavioral therapy (dbt) with prefrontal repetitive transcranial magnetic stimulation (rtms) in individuals with borderline personality disorder (bpd). the study includes four groups of patients: 1) dbt combined with active prefrontal rtms treatment (rtms-dbt group), 2) dbt combined with sham rtms treatment (sham-dbt group), 3) active prefrontal rtms treatment only (rtms-only group), and 4) sham rtms treatment only (sham-only group). the study will include assessments conducted before (t1) and after the rtms treatment (t2) composed of self-reported questionnaires, clinical interviews assessing self-harming behavior and healthcare utilization, ecological momentary assessment of emotional variability, functional magnetic resonance imaging (fmri) during emotional task, and control clinical eeg measurements. follow-up measurements will be conducted at t3 (three months after rtms), and for dbt group also at t4 (six months after rtms), and t5 (twelve months after rtms) for to track long-term effects.

Eligibility criteria:
inclusion criteria: * diagnosis of borderline personality disorder according to diagnostic and statistical manual 5th edition (dsm-5) criteria (rated by structured clinical interview for dsm-5 for personality disorders, bpd section) * minimum age 16, informed consent of the patient * informed consent of patient's legal representative in case of patients under age 18 exclusion criteria: * neurological disorder * comorbid affective disorder or schizophrenia-related disorder * intelligence quotient\<70 * contraindications for mri measurement * contraindication for rtms treatment * pregnancy

Keywords: dialectical behavioral therapy repetitive transcranial magnetic stimulation borderline personality disorder
the impact of technology in obstructive sleep apnea myofunctional therapy

Conditions: Obstructive Sleep Apnea (OSA); Snoring; Sleep Quality

Summary: this is a study to test if performing airway exercises to improve snoring and sleep apnea using a mobile phone app is better than using a hardcopy guide.

outcomes will be measured using tone analysis, snoring recording apps, and oximeters.

Eligibility criteria:
inclusion criteria: * subjects with mild, moderate, and severe osa who rejected/failed cpap or other therapeutic options will be invited to participate in the study. exclusion criteria: 1. age lower than 18 or higher than 75. 2. bmi \> 40 3. alcoholism or drug abuse 4. a-fib, pacemaker, chf, strokes, narcotics 5. neuromuscular disease 6. use of benzodiazepine hypnotics (may affect muscle tone) 7. restricted tongue movement 8. permanently blocked nose 9. tmj disorder. 10. lost to follow-up 11. gained or lost ≥5% of body weight during 3 months

Keywords: osa myotherapy myofunctional exercises snoring sleep apnea sleep quality
the effect of ischaemic-reperfusion on the endogenous fibrinolysis in man

Conditions: Ischaemic Heart Diseases

Summary: heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. current treatments are designed at relieving this blockage as quickly as possible to minimise damage to the heart muscle. however in restoring the supply of blood local damage known as "ischaemia-reperfusion injury" may occur. the aim of this study is to assess how clot forming and clot dissolving pathways are affected during this process, and examine the role of a natural inflammatory hormone, bradykinin. this will help us to understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for heart attacks.


Eligibility criteria:
inclusion criteria: * healthy males between 18-65 years of ages, non-smokers. exclusion criteria: * any concurrent illness or chronic medical condition. concurrent use of vasoactive medication. smoking history.

Keywords: ischaemia reperfusion t-pa fibrinolysis endothelial function
safety and efficacy of obatoclax mesylate (gx15-070ms)in combination with docetaxel for the treatment of non-small cell lung cancer

Conditions: Lung Cancer

Summary: defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic signal is present. obatoclax is designed to restore apoptosis through inhibition of the bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells. this is a multi-center, open-label, phase i/ii study of obatoclax administered in combination with docetaxel in 3-week cycles to patients with relapsed or refractory non-small cell lung cancer. treatment may be administered on an outpatient basis. no investigation or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. supportive care measures including those directed at controlling symptoms resulting from non-small cell lung cancer are allowed.


Eligibility criteria:
inclusion criteria: * pathological confirmation of non-small cell lung cancer (nsclc) * must have been previously treated with a single platinum-based chemotherapy regimen and shown evidence of disease progression; no further limitations * must have normal organ function * must be willing to submit to blood sampling for planned pk and pd analysis * must have the ability to understand and willingness to sign a written informed consent form exclusion criteria: * no other agents or therapies administered with the intent to treat malignancy * patients with prior exposure to obatoclax or docetaxel * uncontrolled, intercurrent illness * pregnant women and women who are breast feeding
the effect of rubber band ligation in bleeding internal hemorrhoids.

Conditions: Hemorrhoids, Internal

Summary: in this study, the researchers planned to compare the treatment results of patients undergoing rubber band ligation in addition to drug therapy in hemorrhagic internal hemorrhoids patients and those treated only with anti-hemorrhoidal drugs.

introduction: band ligation is one of the most frequently used methods in the treatment of hemorrhagic internal hemorrhoidal disease. also, phlebotonic use and surgical excision options are available as an anti-hemorrhoidal drug in the treatment of the disease. many studies have shown that these methods are safe to use. band ligation is used quite often in our clinic. whether or not band ligation is performed, these patients are prescribed phlebotonics as an anti-hemorrhoidal drug. purpose: in this study, investigators aimed to investigate the benefit of adding rubber band ligation to treatment in hemorrhagic internal hemorrhoidal disease treated with the anti hemorrhoidal drug. method: the study was planned prospectively and observationally. patients are not assigned to groups by the researcher. the researcher cannot interfere with the treatment method given to the patient. the method of treatment is the method approved by the patient's doctor. patients diagnosed with internal hemorrhoids will be examined in a group of patients who are prescribed anti-hemorrhoidal drugs and rubber band ligation in the context of routine treatment. in the other group, again, in the form of routine treatment, patients who are not given rubber band ligation and who are given only anti-hemorrhoidal drugs will be examined. group 1: patients who have been prescribed 450 mg diosmin + 50 mg hesperidin as an anti-hemorrhoidal drug and rubber band ligation will be included in this group. group 2: patients who have been prescribed only 450 mg of diosmin + 50 mg of hesperidin as treatment, without rubber band ligation will be included in this group. patients will undergo a control examination in the 21 days after treatment. * whether the bleeding continues? * which bleeding day stopped? * the comfort of the anal area will be evaluated * did the side effect develop? * did any complications occur? the above information will be entered into the spss program, and statistical analysis will be done.

Eligibility criteria:
inclusion criteria: * patients diagnosed with internal hemorrhoids with an anamnesis + examination + rectoscope. exclusion criteria: * patients under 18 years old * patients over 65 years old * pregnant * chronic liver patients * those with bleeding disorders * patients taking anti-coagulants and anti-aggregates * patients with colorectal cancer. * those who have had hemorrhoid surgery before
uscom in newly diagnosed fgr cases

Conditions: Fetal Growth Restriction; USCOM

Summary: the purpose of this research study is to study the use of an ultrasound measurement system (uscom) for patients with newly diagnosed fetal growth restriction (fgr). this system uses a technology to measure how much blood is being pumped in and out of the heart, which is important for understanding the heart's function in relation to pregnancy.


Eligibility criteria:
inclusion criteria: * pregnant patients with a new diagnosis of fetal growth restriction (estimated fetal weight \ 27w6d) exclusion criteria: * multiple gestation * fetal anomalies * gestational diabetes or pregestational diabetes.
a sham controlled study of the effects of ultrasonic shockwaves as a treatment for chronic pelvic pain

Conditions: Chronic Pelvic Pain

Summary: introduction: chronic pelvic pain with unknown pathology is a condition that affects both men and women. the condition is defined as pelvic pain lasting for a minimum of 6 months without any known etiology eg. cancer, infection or inherent anatomical abnormalities. low intensity extracorporeal shockwave therapy (lieswt) enables the practitioner to deliver a small amount of energy approximately 5 cm under the skin of the patient without damaging the skin. this have been shown to increase blood flow and accelerate healing which could also be beneficial in chronic pelvic pain patients.the purpose of this study is to investigate the effects of lieswt on chronic pelvic pain. methods: all patients will be treated at the birthe bonde clinic, in copenhagen, denmark. the investigators anticipate to include 100 chronic pelvic pain patients in the study. included patients will be randomized into two groups: active treatment or sham treatment. all patients will be required to provide a urine sample and a semen sample prior to final inclusion. samples will be analyzed for microbial growth. furthermore, patients will undergo a digital rectal exploration and finally all patients is required to provide an informed consent in order to be included in the study. a storz doulith sd1 t-top (ce1275) will be used to generate shockwaves. patients will receive the treatment once a week until their symptoms have seized or for a maximum of 6 times. each treatment consists of 3000 shockwaves applied to the perineum with a energy density of 0.25-0.40 millijoule(mj)/mm2 and a frequency of 3 hz. participants will fill out a questionnaire one week before the treatment, one week, four weeks, and twelve weeks after the last treatment. possible gains from this study: the investigators hope to provide further evidence for this treatment and consequently be able to offer the treatment as an alternative to the very limited array of treatments existing for this group of patients today. ethics, funding, and publication: the study is performed in compliance with the helsinki declaration. external funding have been applied for but not yet received. participants will be informed of sources of external funding. the result of the study will be published as soon as possible, preferably in a peer-reviewed international journal.


Eligibility criteria:
inclusion criteria: * pelvic pain with a duration of more than 6 months * be able to read and understand the study information exclusion criteria: * known etiology for pelvic pain eg. cancer, infection, inherent abnormalities. * diagnosed with hemophilia * receiving anti thrombotic therapy other than hearth magnyl * diagnosed with thrombocytosis * active cancer * treated with iv glucocorticoids within the last 6 months * disease in the rectal area * abnormal digital rectal exploration * bacteriospermia

Keywords: eswt chronic pelvic pain randomized sham controlled
randomized, blinded, sham-controlled trial of acupuncture for the management of joint pain in patients with psoriasis

Conditions: Psoriasis; Arthralgia

Summary: the purpose of this study is to determine whether acupuncture is helpful for patients with joint pain associated with psoriasis

in this study, patients with psoriasis and joint pain will receive either real acupuncture or sham acupuncture to see if acupuncture can be an effective treatment of joint pain in patients with psoriasis.

Eligibility criteria:
inclusion criteria: * plaque psoriasis * pain from at least two peripheral joints and/or inflammatory back pain * no or stabile treatment of the psoriasis the last 3 months * no or stabile pain treatment the last 3 months * oral and written information given * written consent signed exclusion criteria: * arthritis with ultrasound verified intra articular fluid og clinical verified joint swelling * pregnancy og breastfeeding * previous treatments with acupuncture * treatment with anticoagulants (vitamin k-antagonists, low molecular weight heparin, unfractionated heparin, direct thrombin inhibitors, direct factor xa inhibitors) * unwilling to follow protocol
effects of bisphosphonates on oi-related hearing loss

Conditions: Osteogenesis Imperfecta

Summary: osteogenesis imperfecta-related hearing loss usually occurs in individuals with mild (type i) oi and is much earlier in onset than age-related hearing loss, with the majority of individuals experiencing some minor hearing loss in their 20s. bisphosphonates have been successfully used to treat otosclerosis, a common cause of hearing loss similar to oi-related hearing loss. as many individuals with oi-related hearing loss also present with otosclerosis and because of their mechanistic similarities, the investigators propose studying the effects of bisphosphonate treatment on individuals diagnosed with both oi type i and hearing loss, thereby determining its effectiveness as a potential treatment for hearing loss. the investigators will enroll 50 individuals diagnosed with type i oi and age 18-100. 25 adults will be enrolled into the treatment arm and receive bisphosphonate treatment (must have at least mild hearing loss), while 25 adults will be enrolled into the control arm. the investigators will enroll 25 children (6-17 years of age) diagnosed with oi who are currently receiving bisphosphonate treatment as part of their care for orthopedic symptoms. the investigators will also observe 25 children (6-17 years of age) diagnosed with oi who are not currently receiving bisphosphonate treatment. the study duration is 63 months (approximately 5 years). enrollment is anticipated to begin in november 2019.


Eligibility criteria:
inclusion criteria (adult treatment arm): * diagnosis of oi type i * diagnosis of at least mild hearing loss (\>20db pure tone average) by audiogram testing * 18+ * vitamin d level \> 30 inclusion criteria (adult control arm): * diagnosis of oi type i inclusion criteria (child observational bisphosphonate arm) * diagnosis of oi * age 6-17 years * currently receiving bisphosphonate treatment as standard of care inclusion criteria (child observational no treatment arm) * diagnosis of oi * age 6-17 years * not receiving bisphosphonate treatment and will not receive bisphosphonate treatment for the duration of the study exclusion criteria (all arms): * family history of hearing-loss (not related to oi or occupational hearing loss) * pregnancy

Keywords: hearing loss bisphosphonate skeletal dysplasia brittle bone disorder osteogenesis imperfecta oi