Kornimate/medical-research-clean huggingface dataset:
efficacy, safety and tolerability of tegaserod in patients with chronic constipation

Conditions: Chronic Constipation

Summary: tegaserod (htf919) is an aminoguanidine indole compound and a member of a new class of subgroup-selective 5-hydroxytryptamine (5-ht) agonists. the aim of this study is to investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients with cc.


Eligibility criteria:
inclusion criteria: * male and females of at least 18 years of age * a 12-month history of constipation (defined as \ 25% of the time: hard stools, sensation of incomplete evacuation and straining) exclusion criteria: * patients with cancer, inflammatory bowel disease or other structural bowel disease * patients who participated in a prior tegaserod study * evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders other protocol-defined inclusion/exclusion criteria may apply.

Keywords: chronic constipation, tegaserod
effect of simulation on emotional expression and perceived family burden of caregivers

Conditions: Schizophrenia; Caregiver Burden; Expressed Emotion

Summary: the aim of this study is to determine the effect of auditory hallucination based voice hearing simulation on the emotional expression and perceived family burden of caregivers of individuals diagnosed with schizophrenia.

objective: the aim of this study is to determine the effect of auditory hallucination based voice hearing simulation on the emotional expression and perceived family burden of caregivers of individuals diagnosed with schizophrenia. method: this study was designed in a pre-test - post-test, randomized controlled design. the study was conducted with 20 caregivers in the intervention group and 20 caregivers of individuals diagnosed with schizophrenia in the control group. data were collected between march 2023 and october 2023 using the emotional expression scale and perceived family burden scale. auditory hallucination based voice hearing simulation was applied to the intervention group. this sound recording is three-dimensional. while the audio recording is played to the caregivers; users were asked to complete two tasks, each lasting 10 minutes. the tasks were carried out under the guidance prepared by the researchers. in the control group, the routine practices of the clinic continued.

Eligibility criteria:
inclusion criteria: * having been living with an individual diagnosed with schizophrenia for at least one year. * being primarily responsible for the care of the individual diagnosed with schizophrenia, * being between the ages of 18-65, * being literate, * speaking turkish, * volunteering to participate in the study. exclusion criteria: * having a physical disability to perform the assigned tasks, * having any health problem related to hearing ability, * having any mental illness, * having received 2 or more points from the general health questionnaire-12.

Keywords: schizophrenia perceived family burden expressed emotion psychiatric nursing
rekovelle pen for s.c. injection general drug use survey (controlled ovarian stimulation in assisted reproductive technologies)

Conditions: Infertility

Summary: this survey targets controlled ovarian stimulation with this drug for the development of multiple oocytes in women undergoing assisted reproduction (art) such as in vitro fertilization (ivf) or intracytoplasmic sperm injection (icsi).


Eligibility criteria:
inclusion criteria: * participants who received the rekovelle in controlled ovarian stimulation in assisted reproductive technologies and have consented to participate in the survey. exclusion criteria: * no exclusion criteria because data are collected under conditions of use in daily practice.
safety of tranexamic acid in reducing blood loss myomectomy.

Conditions: Myoma

Summary: uterine leiomyomas (fibroids) are the most common benign tumors among women . fibroids are found in approximately 15% to 30% of women in the reproductive age group

although most of them are asymptomatic, 20-50% of fibroids may cause problems such as heavy menstrual bleeding, anemia, pelvic pain, pressure symptoms from extrinsic compression of the colorectal and urinary tract, infertility, and recurrent pregnancy losses, where surgical intervention is often indicated

Eligibility criteria:
inclusion criteria: * women with myomas exclusion criteria: * with with malignant lesions
assess bioequivalence of one 150 mg risedronate tablet versus two 75 mg risedronate tablets in healthy subjects

Conditions: Osteoporosis

Summary: this study is a randomized, open-label, crossover study to assess the bioequivalence of 1 risedronate 150 mg tablet versus 2 risedronate 75 mg tablets administered as a single oral dose. approximately 320 subjects will be enrolled from 4 study centers in the u.s.

the data to support the interchangeability of one risedronate 150 mg tablet versus two risedronate 75 mg tablets as monthly dose forms is primarily based on the similarity of in vitro dissolution and an in vivo study, which showed risedronate absorption is not dissolution rate limited. these results suggest that monthly dosing of risedronate may be accomplished by administration of either one risedronate 150 mg tablet or two risedronate 75 mg tablets. the purpose of this study is to provide additional clinical data to support the interchangeability of these 2 dose regimens.

Eligibility criteria:
inclusion criteria: * be in good general health based on medical history, physical examination, and laboratory evaluation * have a body mass index (bmi) ≤ 32 kg/m2 at screening exclusion criteria: * has clinically significant uncontrolled cardiovascular, hepatic, renal, or thyroid disease * has any disease or surgery known to alter normal gi structure or function * has a creatinine clearance of \< 60 ml/min, estimated by serum creatinine using the cockcroft-gault formula
lifestyle internet-based intervention on hypertensive patients with overweight or obesity

Conditions: Hypertension; Obesity

Summary: this study aims to analyze the effects of a 3 months duration self-applied online program, composed of 9 modules focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on obese or overweight adults with hypertension. participants will be recruited from a hypertension unit of a public hospital. these patients will be randomized allocated into two interventional groups: experimental group will receive audiovisual instructions from their hypertension specialist doctor, and the control group from a doctor outside the patient. assessment will include: body composition (bmi), blood pressure, levels of physical activity, functional capacity, fall risk, and quality of life.

hypertension and obesity or overweight related, even other associated comorbidities, involve a worrying public health problem. the evidence shows that healthy eating and regular physical exercise, monitored by different means (internet, face to face, exercise diaries), play an important prevention role to maintain health while ageing. in this way, information and communication technologies (icts) have been demonstrated as a useful tool to promote health, working on barriers at the same time, such as low motivation and difficulties to maintain regular exercise or healthy eating habits. icts also allows to reach a wider audience at a lower cost, due to their good cost-benefit relationship and the possibility of increasing the efficiency of interventions. therefore, this study aims to analyze the effects of a 3 months duration self-applied online program, composed of 9 modules focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on obese or overweight adults with hypertension. participants will be recruited from a hypertension unit of a public hospital. these patients will be randomized allocated into two interventional groups: experimental group will receive audiovisual instructions from their hypertension specialist doctor, and the control group from a doctor outside the patient. assessment will include: body composition (bmi), blood pressure, levels of physical activity, functional capacity, fall risk, and quality of life.

Eligibility criteria:
inclusion criteria: * hypertension * overweight or obesity (25 ≤ bmi ≤ 35 kg/m2) * aged between 18-75 years exclusion criteria: * not having access to the internet or lack of information about it. * treatment with more than 3 antihypertensive drugs. * meet the criteria of the dsm-iv-tr of a food disorder. * presenting some type of severe psychiatric disorder. * disability that prevents or hinders physical exercise. * receiving some treatment for weight loss.

Keywords: hypertension obesity internet exercise nutrition
the effect of frequency modulation in tens on habituation and pain threshold

Conditions: Transcutaneous Electrical Nerve Stimulation

Summary: purpose the purpose of this study is to determine whether application of transcutaneous electrical nerve stimulation (tens) is effective on habituation to electrical current whether delivered at a fixed frequency of 100 hz or at patterned frequency. the secondary purposes are to determine the effectiveness on mechanical pressure pain and the subjective perception of the subjects regarding habituation and comfort of the different stimulations.

low frequency and low intensity tens showed strong evidence of inefficiency while conventional high frequency tens (around 100hz) applied at "strong but comfortable" intensity proved strong evidence of efficacy on pressure pain. in addition, some studies have shown the importance of current intensity in the effect of tens. either in clinical practice and in research, tens intensity is usually adjusted according to the sensation of the subjects "strong but comfortable" "strong just below the motor threshold", ...). usually throughout the tens applications there is a phenomenon called "habituation" that involve a wide decrease of the sensation of the current applied, even though the perception the output-parameters are maintained. in this sense, it has been seem that adjusting the intensity throughout the tens intervention produced a greater hypoalgesic effect than when the intensity remained fixed. on the other hand, most tens devices offer the possibility of modulating current with the aim of preventing habituation phenomenon. the modulation of the electric current consists of changing the characteristics of the current (pulse width, pulse frequency, ...) every few seconds during the intervention. nevertheless, the most common pattern used is the frequency modulation. however, there is a lack of evidence regarding what it is the better methods to avoid habituation during a tens application.

Eligibility criteria:
inclusion criteria: * participants will be volunteer healthy students of university of castilla - la mancha, older than 18 years. exclusion criteria: * neuromuscular disease. epilepsy. trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area. osteosynthesis material in the upper limb. cancer. cardiovascular disease. pacemaker or other implanted electrical device. take any drug (nsaids, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days. presence of tattoos or other external agent introduced into the treatment or assessment area. pregnancy. sensitivity disturbance in upper limb.

Keywords: pain threshold transcutaneous electrical nerve stimulation habituation
evaluation of patient analgesia after bloc serratus

Conditions: Thorax Traumas

Summary: thorax traumas are very common in severe traumatology, including road accidents, representing the second most frequent site (after head injury, according to the first study). these thoracic lesions are the cause of many complications (pneumothorax, hemothorax, lung infections, atelectasis). the national recommendations recommend the use of multi-modal analgesia with the use of regional loco anaesthesia for pain management and prevention of respiratory complications, including infectious complications. the loco-regional anaesthesia of choice is thoracic epidural or paravertebral block, but these techniques are not without risks, and are contraindicated in many situations (severe head trauma, patient under curative anticoagulation, pelvic trauma...). the anterior serratus block appears to be a quality localoregional anaesthesia in thoracic surgery, and a few cases in the literature have shown an interest in severe traumatology. the investigators perform this anterior serratus block almost systematically in patients with thoracic trauma in the hautepierre surgical intensive care unit.


Eligibility criteria:
inclusion criteria: * adult patient (≥18 years old) * gender (male and female) * patient hospitalised in surgical intensive care or continuous trauma care with thorax trauma who received anterior serratus block analgesia from january 1, 2018 to february 28, 2019 * patient who has given his consent to the reuse of his data for the purposes of this research criteria for non-inclusion: * patient who has expressed opposition to participating in the study * impossibility of giving the subject informed information (difficulties in understanding the subject,...) * subject under the protection of justice * subject under guardianship or curatorship

Keywords: thorax trauma head injury multi-modal analgesia paravertebral block thoracic epidural serratus block
a trial of c13-cac breath test in ppi resistant gerd patients

Conditions: Gastroesophageal Reflux Disease

Summary: to investigate the safety of c13-cac and the relationship among c13-cac breath test, gastric ph, and the improvement of symptoms by switching ppi in ppi resistant gerd patients


Eligibility criteria:
inclusion criteria: * gerd patients who have been judged to require additional treatment to improve their symptoms by investigator or subinvestigator. exclusion criteria: * patients suspected to have hypothyroidism or hyperparathyroidism. * patients with hypercalcemia * patients with a history of gastric or duodenal surgery. * patients who have received the eradication therapy of helicobacter pylori within six months prior to participation of the study. * patients with a prior or current history of zollinger-ellison syndrome. * patients with a history of surgery or treatment affecting gastroesophageal reflux. * patients who have been diagnosed with acute upper gastrointestinal bleeding or active gastric or duodenal ulcer within 30 days prior to participation of the study. * patients with serious central nervous system disorders, cardiovascular disease, pulmonary disease, hepatic disease, renal disease, metabolic disease, gastrointestinal disorders, urinary disorders, endocrine disease, or blood dyspraxia. * patients scheduled for surgery requiring hospitalization or required surgery during the study period. * patients who have had either a prior or current history of chest pain due to heart disease or with chest pain suspected to have caused by heart disease within one year prior to participation of the study.
impact of oncotype dx® on treatment recommendation and its economic evaluation under the brazilian society perspective

Conditions: Breast Cancer; Adjuvant Treatment

Summary: 155 pérola byington hospital patients presenting early stage luminal bc were submitted to oncotype dx® evaluation. changes in treatment recommendations and costs were obtained from pérola byington hospital. oncotype dx® incorporation in the brazilian public health system should be considered, as it results in high clinical impact for patient and high economic impact for health system, being a tool that safely and accurately delimits the subgroup of patients who really need ac.

background: it is known that there is significant over administration (and under administration) of adjuvant chemotherapy (ac) when standard clinical parameters (scp) are used for patients diagnosed with early stage re+ breast cancer (bc). although absolute clinical benefit of ac may be modest, its toxicity and economic burden is highly significant; therefore, selecting appropriate patients for ac remains an important issue. oncotype dx® identifies high-risk patients who are likely to benefit from ac, which otherwise might not be identified through scp and low-risk patients who will not benefit from ac, thus avoiding toxicities and inherent risks. this study aimed to evaluate the impact of the oncotype dx® test on treatment decisions in n0 and n1 early-stage breast cancer patients at a public brazilian hospital and to estimate the incremental cost-effectiveness ratio (icer) and budget impact (bi) of incorporating oncotype dx® under the perspective of the brazilian society. changes in treatment recommendations and costs will be obtained from pérola byington hospital. additional data will be obtained from literature. medical costs (test, chemotherapy and adverse events), productivity loss, transportation and employment leave will be considered.

Eligibility criteria:
inclusion criteria: women ≥ 18 years early stage breast cancer, er and/or pr positive with her2 negative breast cancer. exclusion criteria: more than one operable primary breast tumor; multifocal or multicentric tumors; 4 or more lymph node involvement; metastatic breast cancer; previous history of breast cancer; invasive tumor \ 2 and / or other clinical factors that would make the patient a non-viable candidate for adjuvant chemotherapy; previous hormonal or chemotherapy treatment; current medical condition that would interfere with their ability to consent (psychiatric illness, for example)
validation ( endometriosis health profile) ehp-30 (turkish version) for patients with endometriosis

Conditions: Endometriosis

Summary: endometriosis can affect quality of life, including physical, psychological and social aspects. it is important to include quality of life measures in evaluating disease severity and response to any given treatment. the 30-item endometriosis health profile (ehp-30) from in-depth interviews with patients with endometriosis is currently the most reliable questionnaire for the measurement of health-related quality of life in women with endometriosis. it includes specific questions addressing the problems faced by patients with endometriosis. the aim of the present study is to validate the turkish version of eph 30, a self reported questionnaiere already used internationally, in order to determine the quality of life in women with endometriosis, assess their psychological health and the effectiveness of therapies.


Eligibility criteria:
inclusion criteria: * previous surgical and histological diagnosis of endometriosis exclusion criteria: * severe underlying comorbidities (gynecological, cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological) * psychiatric diseases * refusal or inability to sign the informed consent
a study evaluating safety and efficacy of the addition of abt-888 plus carboplatin versus the addition of carboplatin to standard chemotherapy versus standard chemotherapy in subjects with early stage triple negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: this is a 3 arm phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage tnbc.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). clinical stage t2-3 n0-2 or t1 n1-2 by physical exam or radiologic studies. 2. documented breast cancer gene (brca) germline mutation testing. 3. estrogen receptor (er)-, progesterone receptor (pr)-, and human epidermal growth factor receptor (her)2-negative (triple-negative) cancer of the breast. 4. ecog performance status of 0 to 1. 5. women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the investigator or they must have a negative serum pregnancy test prior to randomization. exclusion criteria: 1. previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer. 2. previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a poly-(adp-ribose)-polymerase (parp) inhibitor. 3. concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (serm). subjects must have discontinued use of such agents prior to beginning study treatment. 4. a history of seizure within 12 months prior to study entry. 5. pre-existing neuropathy from any cause in excess of grade 1.

Keywords: oncology triple negative breast cancer german breast group - gbg 81 united states oncology - 12152 national surgical adjuvant breast and bowel project - b-56-i alliance - aft-04 grupo español de investigación en cáncer de mama - geicam/2014-02
chronic pain after inguinal hernia repair, the onstep technique versus the laparoscopic approach

Conditions: Hernia, Inguinal; Chronic Pain

Summary: the objective of this study is to evaluate chronic pain after inguinal hernia repair involving mesh placement with the onstep-technique compared to mesh placement using a laparoscopic approach. the study hypothesis is that an even or smaller proportions of patients operated the onstep technique will have chronic pain that impairs daily function.


Eligibility criteria:
inclusion criteria: * clinical diagnose of a primary groin hernia that requires surgical intervention. * eligible for procedure performed under general anesthesia. * eligible for both laparoscopic and onstep procedure. exclusion criteria: * not able to understand danish/swedish, written and spoken. * emergency procedures. * previous inguinal hernia on ipsilateral side. * asa score more than 3. * irreducible inguinoscrotal hernia. * local or systemic infection. * contralateral hernia being operated at the same time or planned operated during follow-up. * other abdominal hernias being operated at the same time or planned operated during follow-up. * previous surgery that has impaired the sensation in the groin area. * bmi \> 40 or \< 20. * daily intake of alcohol \>5 units, 1 unit = 12g pure alcohol. * known disease which impairs central or peripheral nerve function. * concurrent malignant disease. * impairment of cognitive function (e.g. dementia). * chronic pain that requires medication. * mental disorder that requires medication.

Keywords: hernia, inguinal laparoscopy onstep