Kornimate/medical-research-clean huggingface dataset:
comparison of the efficacy and safety of duloxetine augmented with gabapentin and duloxetine augmented with amitriptyline vs duloxetine alone in chemotherapy -induced neuropathy

Conditions: Neuropathy in Cacer Patien

Summary: this study aimed to elucidate the relationship between the efficacy and safety of comparison of the efficacy and safety duloxetine augmented with gabapentin and amitriptyline augmented with duloxetine vs duloxetine alone in chemotherapy -induced neuropathy in cancer patients.


Eligibility criteria:
inclusion criteria: * -patients of any age must have histologically or cytologically confirmed cancer by the laboratory of pathology. * patients must sign an informed consent form (icf) voluntarily and be able to understand and comply with the requirements of the study; * patients must be 18 to 75 years of age (including cut-offs) on the date of signing the informed consent form, regardless of gender; * patients must received treatment with a chemotherapy regimen . * patients must have ≥ grade 1 sensory chemotherapy-induced peripheral neuropathy (cipn) with nrs ≥ 4/10 according to the nci common toxicity criteria for adverse events (ctcae) v.5.0 grading scale * eastern cooperative oncology group performance status (ecog ps): 0-2; * expected survival of ≥ 3 months * there is no maximum number of prior medical therapies. exclusion criteria: * history of allergic reactions attributed to compounds of similar chemical or biologic composition to duloxetine, amitriptyline and gabapentin * pregnant women are excluded from this study. * life expectancy less than 6 months * inability or unwillingness to comply with research protocols. * patients with the presence of active brain or meningeal metastases. * patients with the presence of uncontrolled closed-angle glaucoma. * patients with the presence of neuropathy caused by any type of nerve compression as diabetes. * the presence of mental illness, epilepsy, mania, suicidal depression, dementia or alcohol or drug abuse that may have an impact on compliance with trial requirements. * the presence of comorbid cardiovascular disease, including but not limited to: (1) new york heart association (nyha) criteria ≥ grade 2 heart failure; (2) severe/unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months prior to first dose; (4) atrial fibrillation and supraventricular or ventricular arrhythmias requiring treatment; (5) pre-existing symptomatic superior vena cava syndrome; (6) corrected qt interval (qtc) \> 450 ms (men); qtc \> 470 ms (women); (7) hypertensive disease not controlled by antihypertensive medication: systolic blood pressure ≥ 140 mmhg or diastolic blood pressure ≥ 90 mmhg; * patients with other medical history or evidence of disease that has the potential to confound trial results are excluded from the study,
the effects of barberry juice consumption in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the aim of this study was to investigate the effect of barberry juice (bj) as a natural antioxidant, on cardiovascular risk factors in patients with type 2 diabetes (t2dm). in a randomized clinical trial study, 46 t2dm patients, 30-70 years old recruited from "diabetes association of iran-babul ". patients were randomly allocated to either the bj group (n=23) who consumed 200 ml of bj daily for eight weeks, or the control group (n=23) with no intervention. at the baseline and the end of 8-week intervention, blood pressure and biochemical markers were conducted.


Eligibility criteria:
inclusion criteria: * fasting blood glucose\>100 mg/dl (5.6 mmol /l) * systolic blood pressure\>130 mmhg or diastolic blood pressure\>85mmhg * triglycerides\> 150 mg/dl (1.7 mmol/l) exclusion criteria: * taking insulin * smoking * using antioxidant supplements
a study to describe vascular and renal effects and safety of valsartan in patients with high blood pressure

Conditions: Hypertension

Summary: one hundred twenty patients with arterial hypertension and albuminuria (some amount of albumin in urine) are given valsartan 80 mg and then160 mg to normalize blood pressure. hydrochlorothiazide (diuretic) 12.5-25 mg added if necessary.


Eligibility criteria:
inclusion criteria: * arterial hypertension without previous regular treatment * urinary albumin excretion rate above 30 mg / 24h * 30-65 years old exclusion criteria: * reno-vascular arterial hypertension * therapy resistant edema * chronic heart failure, angina pectoris * diabetes mellitus other protocol-defined exclusion criteria may apply

Keywords: arterial hypertension albuminuria valsartan
does hemodialysis affect upper extremity functional capacity, physical activity and physical function of patients?

Conditions: Chronic Kidney Diseases

Summary: this study was planned to determine the effects of upper extremity functional capacity, physical activity level and physical functions of patients receiving hemodialysis treatment.

upper extremity functional capacity, physical activity level and physical functions were evaluated in healthy subjects and hemodialysis patients.

Eligibility criteria:
inclusion criteria: in study group, * with cooperation * hemodialysis treatment for at least 3 months * with single-sided fistula in the control group, * healthy volunteers with no history of trauma or surgery in the upper extremity, * with cooperating exclusion criteria: * individuals with orthopedic problems associated with chronic renal failure, * upper limb functions affected

Keywords: hemodialysis chronic renal failure upper extremity physical activity physical function
comparison of iv 10, 20, and 30mg for renal colic pain in the ed

Conditions: Pain; Renal Colic

Summary: hypothesis: intravenous administration of ketorolac 10 mg and 20 mg is as effective as 30 mg in treating renal colic pain in patients presenting to the emergency department

ketorolac is a non-steroidal anti-inflammatory drug (nsaid) that is widely used in the emergency department (ed). because of the ketorolac significant analgesic potency, it is usually used for moderate-to-severe pain. however, ketorolac has several side effects, of which gastrointestinal hemorrhage is most concerning. "analgesic ceiling" is defined as the dose beyond which no additional analgesia can be achieved and on the other hand, more side effects might be encountered. several studies suggested 10 mg as analgesic ceiling. despite this, many recommendations are still advocating several folds higher doses (e.g. 30, 60 mg).

Eligibility criteria:
inclusion criteria: * severe flank and abdominal pain which pertains to renal colic according to emergency physician's gestalt exclusion criteria: * age \>65 * active peptic ulcer disease * acute gastrointestinal hemorrhage * known history of renal or hepatic insufficiency * history of allergies to nsaids
prospective sensor controlled compliance analysis of shoulder abduction splint after rotator cuff repair

Conditions: Rotator Cuff Tear

Summary: the postoperative shoulder rehabilitation in an abduction brace after rotator cuff reconstruction of the shoulder is crucial for a successful healing of the reconstruction. in this study the investigators want to analyse the abduction brace-wearing time using a electronic sensor, which is implanted in the abduction brace. the participants will be informed about the sensor after completion of the abduction brace rehabilitation 6 weeks postoperatively.

after arthroscopic reconstruction of a rotator cuff tear the healing depends on a tension free positioning of the reconstructed tendon. therefore a abduction brace is administered routinely for 6 weeks. the re-rupture rate of rotator cuff reconstruction is about 30%. one of the reason may be mechanical overuse caused by non wearing of the abduction brace. from experience the investigators suggest that the abduction brace wearing behaviour differs among patients. the participant´s wearing compliance has been evaluated by silverio et al. with a questionary but never with a sensor. in this study the investigators want to analyse the participant´s abduction brace wearing compliance by using an sensor, which is implanted in the abduction brace and monitors the wearing time, which reveals the objective wearing time. the sensor is a certificated sensor, which measures temperature in °c every 15 min. if the abduction brace is worn by the participants the body temperature can be captured by the sensor. if the measured temperature is over 33°c the sensor capture the time period as a "worn" time. with this measurements the abduction brace wear time should be captured objectively. a similar kind of sensors were used to evaluate the wearing time of scoliosis-braces in patients with adolescent idiopathic scoliosis (miller dj eta al., morton a et al., takemitsu et al.) with a questionary the participants are asked of the wearing time before they will be informed about the implanted sensor. this answer represents the subjective wearing time. the first endpoint of the study is the evaluation of the objective and subjective abduction wearing time. the second endpoint is the evaluation of the correlation between compliance and subjective outcome.

Eligibility criteria:
inclusion criteria: * patients with rotator cuff repair and postoperative abduction for 6 weeks exclusion criteria: * revision surgery

Keywords: abduction brace compliance rotator cuff tear rotator cuff repair
a study to test a measure of symptoms of older men with low testosterone on and off testosterone replacement treatment (p05815)

Conditions: Hypogonadism

Summary: hypogonadal males, particularly those whose condition manifested later in life, may experience common symptoms associated with their hypogonadism. questionnaires developed to assess these symptoms need to be tested. the primary purpose of this study is to test or validate the patient-reported symptom measure, androgen deficiency quality of life questionnaire and the patient global impression scale.


Eligibility criteria:
inclusion criteria: men with late-onset hypogonadism who are either on testosterone treatment or naïve of treatment: * have symptoms of androgen deficiency at screening (after wash-out if applicable) i.e. with a positive score on the androgen deficiency in the aging male (adam) questionnaire (a "yes" answer to questions 1 or 7 or any three other questions). * morning total t levels of \<=3 ng/ml (\<=300 ng/dl; \<=10.4 nmol/l) on two separate days prior to randomization (after appropriate wash-out, if applicable). * calculated free t \<=0.074 ng/ml. * at least 50 and at most 75 years of age. * bmi of at least 18 kg/m\^2 or at most 32 kg/m\^2 inclusion criteria for normogonadal men: * morning total t levels \<=3 ng/ml (\<=300 ng/dl; \<=10.4 nmol/l). * calculated free t \<=0.074 ng/ml. * at least 50 and at most 75 years of age. * bmi of at least 18 kg/m\^2 or at most 32 kg/m\^2 exclusion criteria: * history or current diagnosis of prostate cancer or any clinically significant finding on prostate examination * severe obstructive symptoms of benign prostate hypertrophy * prostate specific antigen (psa) levels greater than 4 ng/ml at screening * history or current diagnosis of carcinoma of the breast * known chronic polycythemia and/or hematocrit greater than 50% at screening * treatment-naïve subjects with hyperprolactinemia at screening (serum prolactin level \>=50 ng/ml) * hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator * clinically significant abnormal physical finding prior to randomization * sensitive to trial medication or its components * history or presence of hepatic or renal disorder considered as clinically relevant in the opinion of the investigator. exclusion criteria for normogonadal men: * presence or previous diagnosis of androgen deficiency. * previous or present use of testosterone preparations * use of medication within the 12 weeks prior to the visit that may interfere with the objectives of the trial: hypothalamic/pituitary hormones and analogues (e.g., gonadotropins, acth, sth, gn-rh agonists and antagonists, etc.); sex steroid * any other disease that in the opinion of the investigator might compromise or confound the subject's symptomatology (e.g., presence of clinically significant depression or other psychiatric disorders, unstable endocrine disorder, sleep apnea, cardiovascular and cerebrovascular diseases, etc.)
pilot study comparing the efficacy and safety of a new pain patch and placebo in delayed onset muscle soreness (doms)

Conditions: Delayed Onset Muscle Soreness

Summary: the purpose of this study is to evaluate the analgesic efficacy and safety of a new pain patch compared to placebo and no treatment in subjects experiencing delayed onset muscle soreness (doms).


Eligibility criteria:
inclusion criteria: * males or females, 18 to 40 years of age * are in good general health, with a bmi less than or equal to 32, and able to perform the exercise regimen * develops muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the numerical rating scale (nrs) (numerical rating scale) and at least "moderate" on the categorical scale exclusion criteria: * has engaged in upper extremity exercise for a minimum of 6 months prior to study participation * has been working heavy manual or physical labor jobs within 3 months prior to study participation. * has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroidal anti-inflammatory drugs * has skin lesions such as psoriasis at the application site * has abnormal skin condition such as eczema, contact dermatitis, pigment anomaly, etc. * has an allergy-related skin condition
attention-bias modification treatment for ptsd

Conditions: Posttraumatic Stress Disorder (PTSD)

Summary: emerging research implicates biased attention to threat in the pathophysiology of anxiety disorders. recent findings demonstrate significant associations between attention bias and stress vulnerability. this work has motivated the development of a novel therapy, attention-bias-modification (abm) treatment . abm is designed to implicitly modify patients' biased threat attendance via computerized training protocols. emerging evidence indicates that abm is effective in modifying threat-related attention biases and in ameliorating anxiety symptoms. however, it is unclear whether abm is efficacious for posttraumatic stress disorder (ptsd). the present pilot study is a double blind trial that seeks to examine feasibility, acceptability, safety, efficacy, and risk/benefit ratio of abm in individuals with ptsd. in addition this pilot study seeks to identify specific genes associated with anxiety disorders and to examine whether these can predict the success of the abm.

abm is designed to implicitly modify patients' biased threat attendance via computerized training protocols. emerging evidence indicates that abm is effective in modifying threat-related attention biases and in ameliorating anxiety symptoms.

Eligibility criteria:
inclusion criteria: * males or females between the ages of 18 and 60; * current dsm-iv ptsd for the last 12 months or more; * fluent in english and willing and able to give informed written consent and participate responsibly in the protocol; * attention bias toward or away from threat assessed by dot-probe attention bias task exclusion criteria: * current dsm-iv axis i disorder other than ptsd. * patients with comorbid (i.e., secondary diagnosis of) major depressive disorder (mdd) will be allowed for enrollment if their ham-d score doesn't exceed 25; * prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, and schizoid personality disorders; * suicidal ideation or behavior that poses a significant danger to the subject. unstable clinical condition such that participation in a controlled trial would pose a significant danger; * prior participation in attention bias modification treatment (abmt); * current or past history of seizure disorder (except febrile seizure in childhood); * currently on psychotropic medication. (excluding the use of hypnotics); * currently participating in formal psychotherapy. this includes: * psychodynamic, * cognitive behavioral and interpersonal therapies * current unstable or untreated medical illness; * vision loss.

Keywords: ptsd attention bias to threat attention bias modification treatment
post-operative impact of nasogastric tubes on rates of emesis in infants diagnosed with pyloric stenosis

Conditions: Pyloric Stenosis

Summary: the overall objective of this research study is to determine the effect of a pre-operatively placed nasogastric tube compared to no nasogastric tube, on post-operative emesis rates and postoperative length of stay in infants with a primary diagnosis of pyloric stenosis treated with pyloromyotomy. this study will also examine the feasibility data of the pilot data to develop estimates of treatment effect of a pre-operative nasogastric tube on post-operative rate of emesis and length of stay to be used to determine the sample size of the definitive trial.


Eligibility criteria:
inclusion criteria: 1. male or female infant ≤ 6 months of age 2. primary diagnosis of pyloric stenosis confirmed by ultrasound 3. amendable to circumumbilical pyloromyotomy 4. amendable to a minimum size 10 french nasogastric tube 5. able to undergo general anesthesia 6. parent or legal guardian able to give free and informed consent exclusion criteria: 1. contraindicated for circumumbilical pyloromyotomy 2. contraindicated for a size 10 french nasogastric tube 3. prematurity before 35 weeks' gestation 4. bronchopulmonary dysplasia 5. viral infection in the past 7 days 6. cardiac malformation 7. patent ductus arteriosis 8. previous abdominal surgery 9. concurrent surgical procedure scheduled 10. parent or legal guardian unable to read, speak and understand english 11. co-enrolled in a different interventional trial

Keywords: pyloric stenosis nasogastric tube pyloromyotomy
efficacy of novel titania nanoparticles enriched mouth wash in treating dentine hypersensitivity

Conditions: Dentine Hypersensitivity

Summary: randomized clinical trial to compare the reduction in dentin hypersensitivity after incorporating biogenically fabricated titania nanoparticles enriched mouth wash and conventional mouth wash.participants ranging between 20-50 years were allocated in two groups. group a will use conventional mouth wash without nanoparticles. group b will use titania nanoparticles enriched mouth wash. both will use them for three months and then their vas scoring will be checked.

in this study novel biogenically fabricated titania nanoparticle reinforced mouth wash will be evaluated for dentine sensitivity . participants following inclusion criteria will be allocated in this study by consecutive random sampling technique. participants will be divided into two groups i.e group-a and group-b with dentin sensitivity of 30-80. group a will be given conventional mouth wash for three months and group-b will be given titania nanoparticles enriched mouth wash for three months for the sensitivity. sensitivity will be assessed using visual analog scale (vas) mean score after 1 month and then three months.

Eligibility criteria:
inclusion criteria: * participants ranging between 20-50 years, good general health but developed dentine sensitivity associated with tooth surface wear and loss during the past 6 months. * there was no history of allergy. * participants did not use any mouth wash , dentifrice or medication in the last 3 months. * the involved teeth were viable, non-shaky, devoid of any decay, cracks and fillings. * there was an essential positive response to the provoking air stimuli. * these teeth should display the visible signs of tooth loss and wear such as : attrition, abrasion, erosion and abfraction. exclusion criteria: * participants that might have developed allergy or used medications during the last 2 weeks or more. * the teeth having cracks, decay and fillings were also excluded. patients who have undergone any periodontal surgery or gross periodontal issues. * participants who used any desensitisizing toothpastes/mouthwashes and tooth bleaching agents within 2 months of the trial were also excluded positively.

Keywords: bacillus coagulans biogenic dentin hypersensitivity nanoparticles titanium oxide (tio2 nps)
his pacing feasibility and cardiac electrical activation

Conditions: Pacing-Induced Cardiomyopathy; AV Block; Heart Failure

Summary: this study will examine the clinical feasibility of his pacing in patients with expected high demand for ventricular pacing and no established indication for cardiac resynchronization therapy. secondarily, examine differences in electrical and mechanical cardiac activation between traditional pacing and his pacing.

after being informed about the study and potential risks, all eligible patients giving written consent will be included. the study is a clinical single-center interventional study. the patients (n = 25) need to have an expected high demand for ventricular pacing and no established class i indication for cardiac resynchronization therapy. they will receive a pacemaker implant with a traditional right ventricular pacing lead and an additional his pacing lead in a basal high septal position at the level of the proximal electrical conduction system (his). an atrial lead is implanted if dual chamber pacing is needed. all leads are connected to a biventricular pacemaker with the his lead in the lv port. postoperatively, the baseline examinations will include: transthoracic echocardiography, 12-lead ecg with a 3d photography of the chest wall to document ecg electrode location, and a contrast-enhanced cardiac ct scan. the echocardiography and ecg will be performed during traditional right ventricular pacing only and his pacing only. his pacing will be used as the permanent programming of choice if feasible during follow up. the ct scan is used for documenting the final positions of the pacing leads and to create a patient-specific 3d model of the cardiac electrical activation using a software which enables merging of a ct scan and ecg and a ct chest photography. during follow up (1-3 and 12 months), transthoracic echocardiography, 12-lead ecg and 3d chest photography are repeated for assessment of mechanical and electrical function during pacing. the performance of all implanted pacing lead will be evaluated at each follow up visit.

Eligibility criteria:
inclusion criteria: * permanent pacemaker indication with expected high demand of right ventricular pacing (\>40%) and left ventricular ejection fraction \>40%. exclusion criteria: * no class i indication for crt pacemaker (hrs 2018 pacing guidelines) * hemodynamically unstable patients * severely reduced kidney function * former serious adverse reactions to contrast media * pregnant or lactating * severe psychiatric disorder which can compromise compliance with protocol