Kornimate/medical-research-clean huggingface dataset:
pharmacists intervention to improve hypertension management in primary care

Conditions: Hypertension

Summary: arterial hypertension is the single largest contributor to mortality world-wide, and only 30-50% of diagnosed and treated patients achieve their blood pressure goal. the apothecare trial is designed to identify treated patients with uncontrolled hypertension in community pharmacies in order to improve blood pressure control through intensification of antihypertensive therapy.

patients with medically treated arterial hypertension, who attend a pharmacy in order to obtain their antihypertensive medication are invited to participate in the trial. the main inclusion criteria is uncontrolled hypertension, as determined by an automated office blood pressure measurement at a threshold of 135/85 mmhg. main exclusion criteria include a first-ever prescription of an antihypertensive agent, resistant hypertension, systolic blood pressure ≥ 180 mmhg and dialysis. randomization occurs on the level of pharmacies (cluster randomization). patients in the interventional arm are immediately referred to their treating physician for up-titration of antihypertensive therapy. re-examination of automated automated office blood-pressure occurs in the respective pharmacy, and patients are referred to their treating physician again if required. these measures are accompanied by a structured and educational blood pressure record card. patients in the observational arm undergo periodic automated office blood pressure measurements and are referred to their treating physician at the end of the trial in case of persistently uncontrolled blood pressure.

Eligibility criteria:
inclusion criteria: * written informed consent * age \> 18 years * medically pre-treated arterial hypertension * automated office blood pressure ≥ 135 mmhg systolic or ≥ 85 mmhg diastolic exclusion criteria: * first ever prescription of antihypertensive medication * first prescription of a new antihypertensive substance or dose adjustment * prior therapy with 4 or more different antihypertensive substances * systolic blood pressure ≥ 180 mmhg * dialysis * adherence to the study protocol not to be anticipated * inclusion into the study at another study site
crd-102 for right heart failure in patients with left ventricular assist devices

Conditions: Right Heart Failure; Left Ventricular Assist Device

Summary: this is a phase 1b/iia, single centre, non-randomised open-label uncontrolled study to assess safety, effect and pk of oral crd-102 in patients with rhf associated with the presence of an lvad.

the study will be conducted over a 40 day time period inclusive of screening and follow up time periods. eligible subjects will receive oral crd-102 for 14 days.

Eligibility criteria:
inclusion criteria: patients are enrolled only if they met the following criteria. 1. males and females aged 18-85 years inclusive 2. have received a lvad (heartware hvad, heartmate ii) at least 30 days prior to screening. 3. stable lvad patients with evidence of ongoing right heart failure as evidenced by raised right atrial pressure indicated by jvp \>6cm or measured right atrial pressure ≥12mmhg within the 3 months prior to or at baseline or dilated ivc on echocardiography plus all of the following; 1. ongoing diuretic therapy; 2. echocardiography in the 3 months prior to or at baseline showing at least mild impairment in overall rv systolic function by visual assessment together with a tapse \< 14mm. 4. able to give written informed consent and agree to adhere to all protocol requirements. 5. all patients will be required to have an implanted cardiaoverter defibrillator. (icd) exclusion criteria: 1. hemodynamically unstable patients. 2. hypotension (map\<60 or systolic bp \<90 mmhg) at screening or baseline 3. hypertension (map\>95 or systolic bp \>130 mmhg) at screening or baseline 4. ventricular tachycardia or ventricular fibrillation in the past 30 days or poorly controlled atrial fibrillation (ventricular rate \>120 bpm) 5. concurrent participation in another investigational device study or prior participation in which a device was implanted and remains in place 6. receipt of any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to baseline. 7. current treatment with intravenous inotropes or levosimendan, or treatment within the 2 weeks prior to screening 8. significant renal (egfr\ 3mg/dl) impairment or anemia (hb \<90g/dl) at screening or baseline. 9. expected heart transplantation within the study period. 10. pregnancy 11. history of allergic reaction to milrinone or any excipients in the study drug.
drug eluting balloon in peripheral intervention for in-stent restenosis

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-stenosis.


Eligibility criteria:
inclusion criteria: * age\>18 years * intermittent claudication (fontane iii or iv) * angiographic stenosis\>50% or occlusion of superficial femoral-popliteal artery\>40mm, previously treated with nitinol stent implantation, with at least one below-knee vessel to the ankle exclusion criteria: * allergy to paclitaxel * contraindication for combined antiplatelet treatment * life expectancy \<1 year * hypersensitivity or contraindication to one of the study drugs * lack of consent * need for amputation * angiographic evidence of stent fracture

Keywords: peripheral arterial disease drug-eluting balloon restenosis
characterizing pai-1 modulation on monocyte adhesion

Conditions: Atherosclerosis

Summary: to determine how altering the expression of a gene known as pai-1 may affect the adhesive capacity of cells that play a critical role in the developement of human atherosclerosis.

the principal aim of this study is to determine if molecular regulation of the human gene pai-1 alters the migratory properties of human myeloid and endothelial cells sufficiently enough to regulate entry and exit from the vascular space. human monocyte become the key cellular orchestrators of human atherosclerotic plaque. we believe that a "loss" of pai-1 activity may promote a pro-atherogenic effect in human vasculature thereby defining a novel atheroprotective effect for pai-1 when expressed at normal levels in humans. by using rna interference to achieve pai-1 gene, we hope to elucidate the mechanistic basis of how pai-1 regulation may affect human migration within the vasculature.

Eligibility criteria:
inclusion criteria: * ages 18-50 * no current or past medical problems exclusion criteria: * patients taking prescription drugs (hormonal birth control or herbal supplements may be taken)

Keywords: atherosclerosis metabolic pathways monocyte adhesion,
efficacy and safety evaluation of hcpa-1 silicone stent in the treatment of central airway obstructions

Conditions: Tracheobronchomalacia

Summary: the aim of the study is, primarily, evaluate the safety of the use of the silicone stent hcpa-1 in patients with clinically significant tracheal and/or bronchial stenosis. secondarily, this study aims to evaluate the efficacy of the use of the silicone stent hcpa-1 who are in the same conditions described above and also estimate the costs the use of these silicone stents involve.

* it is a prospective multicenter clinical study, not controlled, with evaluation of clinical variables before and after the intervention (insertion of one or more silicone stents in the trachea or bronchi and main or intermediate bronchus by rigid bronchoscopy under general anesthesia). * 110 patients, both genders, will be followed for one year, total of 8 visits, in order to evaluate the safety of the procedure of stent insertion. it is allowed to include patients for whom it is indicated the combination of treatments (eg, electrocoagulation followed by stent placement) - full anticoagulation or severe disturbance of coagulation. (includes: use of any anticoagulant, by oral, intravenous or subcutaneous administration with full intention of coagulation / therapy; coagulopathy with inr\> 2.0 or aptt \[kttp\]\> 1.5 times control or platelet count \<50000). note: the use of antiplatelet drugs (aspirin, clopidogrel, ticlopidine) is allowed. - the hcpa-1 silicone stent is made of biocompatible silicone, medical grade, via injection process in the matrix using different densities of the same material for a set of prostheses with rigid and flexible variables; available in the following dimensions (diameter x length in mm): 9x30, 9x50, 11x30, 11x50, 13x30, 13x50, 14x30, 14x50, 16x50, 16x70, 18x50 and 18x70. requires specific surgical (applicator) for insertion.

Eligibility criteria:
inclusion criteria: * consent to participate in the study by signing (the patient or family member/ legal guardian) of the informed consent form; * 18 years old or more; * clinically significant stenosis (symptomatic or about to become symptomatic) for the trachea, main bronchus or intermediate bronchus, which can be treated with the stent implement. exclusion criteria: * clinical or absolute anesthesic contraindication of the rigid bronchoscopy under general anesthesia; * constitutional or acquired anatomic limitations that prevent the rigid bronchoscopy; * another indication of exclusive preferential treatment modality for stenosis (surgery, radiotherapy, chemotherapy, other). note: it is allowed to include patients for whom it is indicated the combination of treatments (eg, electrocoagulation followed by stent placement); * full anticoagulation or severe disturbance of coagulation. (includes: use of any anticoagulant, by oral, intravenous or subcutaneous administration with full intention of coagulation / therapy; coagulopathy with inr\> 2.0 or aptt \[kttp\]\> 1.5 times control or platelet count \<50000). note: the use of antiplatelet drugs (aspirin, clopidogrel, ticlopidine) is permitted.
clinical study on the end time of acupuncture and moxibustion therapy for peripheral facial paralysis

Conditions: Peripheral Facial Paralysis

Summary: bell's palsy itself has a certain self-healing tendency. therefore, it is recommended to leave a bit of bell's palsy for self-recovery without treatment. if complete recovery is achieved after treatment, complications such as stiffness, contracture and even hemifacial inversion may occur as time moves. therefore, this study aims to evaluate the optimal end time of acupuncture for facial paralysis.

this is a randomized, double-blind, controlled study, with a total of 120 eligible patients randomly divided into an observation group (n=60) and a control group (n=60). both groups received facial acupuncture combined with infrared irradiation treatment, once a day,10 times as a course, and the next course of treatment will be carried out after a 5-day rest.the treatment duration for both groups will not exceed three months, with the observation group aiming for a sunnybrook score of ≥83 and the control group aiming for a score≥95. the primary outcome measure is sunnybrook scores at 6 months after onset compared with baseline. secondary outcome measures included sunnybrook scores, electroneurography, blink reflex, facial disability index, self-rating depression scale and self-rating anxiety scale.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged 18-75 years. 2. patients diagnosed with peripheral facial paralysis≤7 days before screening and was the first time. 3. all cases have symptoms and signs or have been examined by ct, mri, etc., excluding peripheral facial paralysis caused by central nervous system diseases, ear diseases, and trauma. 4. those who voluntarily sign the research informed consent form exclusion criteria: 1. patients with bilateral facial nerve palsy or recurrent facial nerve palsy (more than two occurrences). 2. pregnant or nursing patients. 3. patients with critically ill which is difficult to make a definite evaluation of the efficacy and safety of treatment 4. those who accept other treatment methods or cannot adhere to this plan, which affects the efficacy observation

Keywords: peripheral facial paralysis acupuncture sequelae
transanal irrigation for low anterior resection syndrome.

Conditions: Low Anterior Resection Syndrome

Summary: the aim of this study is to investigate whether the high-volume transanal irrigation (tai) performed by the peristeen plus® system is superior to the low-volume tai performed by standard 250ml water enema for the treatment of low anterior resection syndrome (lars).

most of the patients operated on for rectal cancer present defecatory disfunction symptoms known as low anterior resection syndrome (lars) of different degree and severity. although, transanal irrigation (tai) has been shown to be useful in improve lars and quality of life of these patients no evidence exists about the best way to realize tai in terms of irrigation volume and systems and frequency of irrigation. this crossover randomized controlled trial aims to evaluate the impact of two different type of tai (high-volume by peristeen plus® and low-volume performed by 250ml water enema) on lars and quality of life in patients with major lars secondary to low anterior rectal resection (lar) for primary rectal cancer. the primary outcome is the reduction of lars score after two months of treatment.

Eligibility criteria:
inclusion criteria: * personal history of lar or ultra-lar with total mesorectal excision (tme) and sphincter preservation with stapled or manual end to end anastomosis for primary rectal cancer. * major lars (score 30-42). * at least 1 year follow-up after lar or ultra-lar or temporary stoma closure. * anastomotic integrity demonstrated by endoscopic, radiologic or clinical examination. * eastern cooperative oncology group (ecog) performance status (ps) between 0-2. * age≥ 18 years exclusion criteria: * side to end mechanical anastomosis or j-pouch colorectal anastomosis * partial or total intersphincteric resection. * personal history of anastomotic dehiscence, chronic pelvic sepsis, anastomotic sinus, anastomotic stricture or other any other anastomotic complications. * persona history of other colorectal, proctologic or pelvis surgery or disease. * personal history of bariatric surgery. * functioning sacral neurostimulator carriers. * previous use of transanal irrigation systems for lars treatment * presence of an ostomy. * local or distant rectal cancer recurrence and/or any other active neoplastic disease. * altered cognitive status. * pregnancy and age \< 18 years * any other diseases that may alter results of the study. * refusal to sign the informed consent.

Keywords: rectal cancer lars low anterior resection syndrome transanal irrigation
dose study of tuberculin purified protein derivative (jhp/dose)

Conditions: Tuberculosis Infection

Summary: dose comparison study of tuberculin purified protein derivative (ppd)aplisol with the standard tuberculin purified derivative (ppd-s2).

jhp proposes to demonstrate clinical comparability of aplisol formulated from the new tuberculin ppd drug substance to the standard ppd-s2.

Eligibility criteria:
inclusion criteria: 1. males or nonpregnant females age 18 to 60 years 2. documented ppd reactivity of 5 to 21 mm in the past, documented in a medical record. self-reported ppd reactivity will be accepted if medical records cannot be obtained. 3. give written informed consent to participate 4. generally healthy, as determined by medical history and targeted physical examination, if indicated 5. possess 2 forearms that are free of burns, scars, eczema, or any physical deformity, which could impair injection of study preparation or the readings of the injections 6. comprehension of the study requirements; expressed availability for the required study period, including readings at the nominal time points of 48 and 72 hours exclusion criteria: 1. prior ppd test within the past 30 days 2. subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating 3. history of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to ppd in the past 4. subject received a bacillus calmette-guérin (bcg) vaccination in the past, or was born or lived outside the us as a child and is uncertain of his/her bcg vaccination status 5. presence of conditions that may suppress tst reactivity
safety, tolerability, pharmacokinetics, and pharmacodynamics of mrg-110 following intradermal injection in healthy volunteers

Conditions: Healthy Volunteer

Summary: mrg-110 is intended to promote the growth of new blood vessels by inhibiting a molecule called mir-92a. mrg-110 is being studied to determine if it can accelerate healing of wounds by improving blood flow into the wound area. the primary objective of this study is to investigate the safety and tolerability of mrg-110 when injected into the skin at the site of a small skin wound in normal healthy volunteers. another objective is to study the pharmacokinetics of mrg-110 (the movement of a drug into, through and out of the body). participants in the clinical trial will receive either a single dose or multiple doses of mrg-110 and/or placebo. blood samples, urine samples and skin biopsies will be collected to measure how mrg-110 is processed by the body, and how the body responds when exposed to mrg-110.


Eligibility criteria:
key inclusion criteria: * normal healthy volunteers. * females must be of non-childbearing potential. * if engaged in sexual relations with a female of child-bearing potential, males must be surgically sterile or must be willing to use a highly effective method of contraception throughout their study participation and for at least 6 months after the last dose of study drug. * must have 2 regions on lower back/upper buttocks that are free of striae, scars, tattoos, or other skin pathologies. * must have no conditions that could increase risk of abnormal or delayed healing. key exclusion criteria: * clinically significant abnormalities in medical history or physical examination. * clinically significant abnormalities in laboratory tests at screening. * history of cutaneous disorder. * hemangioma, history of hemangioblastoma, or other known vascular disorder. * positive for bloodborne pathogen (hepatitis b, hepatitis c, hiv). * use of an investigational drug or device within 28 days prior to day 1, or use of an investigational biological or oligonucleotide drug within 90 days of day 1.

Keywords: healthy volunteers micrornas angiogenesis inducing agents
the influence of bmi on core stability in healthy adults

Conditions: Overweight and Obesity; Balance; Distorted

Summary: this study will be conducted to investigate the influence of body mass index (bmi) on core stability (cs) in healthy subjects. the participants in this study will be 90 healthy subjects with right dominant lower limb (49 females and 49 males) they will be recruited from college of applied medical sciences, jazan university.

subjects will be categorized according to bmi into three groups: group i (normal subjects): 30 individuals (15 male, and 15 female students) with (bmi\<25 kg//m\^2)) group ii (overweight subjects): 30 individuals (15 male, and 15 female students) with (bmi, 25-30 kg//m\^2)). group iii (obese subjects): 30 individuals (15 male, and 15 female students) (bmi\>30 kg//m\^2)). motor control element of cs will be investigated by assessing bilateral static balance with open and close eye, right foot balance test, and dynamic balance test using prokin system for balance. data of this study will be statistically analyzed by performing descriptive (mean and standard deviation) and inferential statistics (one way anova, unpaired t test) at level of significance p=\<0.05.

Eligibility criteria:
inclusion criteria: 1. subjects would not have any diseases of the central nervous system. 2. subjects would not have any orthopedic disorders either of the trunk or the lower limbs in the previous year. 3. none of the subjects has history of balance training ( erkmen et al., 2010, li li, 2012) . exclusion criteria: 1. sign of foot pain, reduced tactile and thermal foot sensibility. 2. peripheral neuropathy. 3. a history of previous back or abdominal surgery/injury 4. a history of patellofemoral pain syndrome, plantar fasciitis, and back pain . 5. limb-length discrepancy, and anterior or posterior tibialis dysfunction. 6. evidence of a systemic or musculoskeletal disease within the past six months (alabdulwahab \& kachanathu, 2016).

Keywords: bmi, core stability, healthy adult
intracorporeal versus extracorporeal roux-en-y esophagojejunostomy during laparoscopic total gastrectomy for gastric cancer

Conditions: Stomach Neoplasms; Minimally Invasive Surgery; Anastomosis

Summary: * to date, roux-en-y esophagojejunostomy transabdominal extracorporeally by circular stapler was the most common used method during laparoscopy-assisted total gastrectomy for gastric cancer, even though it was not totally laparoscopic surgery in which intracorporeal anastomosis should be performed. * to gain potential clinical benefits from a smaller length of minilaparotomy and an easier anastomosis technique than extracorporeal anastomosis, intracorporeal roux-en-y anastomosis using a transorally inserted anvil (orvil™) during totally laparoscopic total gastrectomy was adopted by experienced surgeons recently. * however, the safety of intracorporeal roux-en-y esophagojejunostomy using a transorally inserted anvil (orvil™) has not yet been evaluated. thus, the study comparing the safety of intracorporeal versus extracorporeal roux-en-y esophagojejunostomy by circular stapler based on a well designed randomized controlled trial is needed.


Eligibility criteria:
inclusion criteria: * age from over 18 to under 75 years * primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy * tumor located at middle or upper third of stomach while laparoscopic total gastrectomy is the planning surgery * tumor invasion is less than 3cm above the esophagogastric junction * performance status of 0 or 1 on ecog (eastern cooperative oncology group) scale * asa (american society of anesthesiology) score class i, ii, or iii * written informed consent exclusion criteria: * women during pregnancy or breast-feeding * severe mental disorder * history of previous upper abdominal surgery (except laparoscopic cholecystectomy) * conversion to open surgery before reconstruction

Keywords: roux-en-y anastomosis laparoscopic surgery minilaparotomy stomach neoplasms