Kornimate/medical-research-clean huggingface dataset:
intercultural adaptation and validation of the "orebro musculoskeletal pain questionnaire"

Conditions: Neck Pain

Summary: the aim of this study is to adapt and translate the orebro musculoskeletal pain questionnaire into german.

participants will fill out all questionnaires at baseline and again after three days. if the questionnaires have not been returned by day four the participant receives a reminder telephone call. patients that do not return the questionnaires by day seven are dismissed. the baseline measurement is done at the practice the second measurement will be done by the patient at home. to send the questionnaire back the participant receives a prepaid envelope.

Eligibility criteria:
inclusion criteria: acute: * recently diagnosed with neck pain (\< 30 days) * must be able to speak, read and write german chronic: * neck problems for a longer period of time (\> 90 days) * must be able to speak, read and write german healthy volunteers: * no neck pain * must be able to speak, read and write german exclusion criteria: * does not speak, read and write german * "red flags" e.g. acute trauma * medical knowledge

Keywords: translation validation orebro-g
nerve coaptation in ltp flap breast reconstruction

Conditions: Breast Cancer

Summary: the sensory recovery of the breast remains an undervalued aspect of breast reconstruction and surgical reinnervation is not regarded as a priority by most reconstructive surgeons. a prospective study was conducted of all patients who underwent either innervated or non-innervated lateral thigh perforator (ltp) flap breast reconstruction in maastricht university medical center and returned for follow-up between february 2016 and april 2019. semmes-weinstein monofilaments were used for sensory testing of the breast.


Eligibility criteria:
inclusion criteria: * female patients 18 years or older * unilateral or bilateral ltp flap breast reconstruction * returned for follow-up between february 2016 and april 2019 * informed consent exclusion criteria: * in case of a total flap loss * flaps that required a take-back * follow-up less than six months postoperatively

Keywords: breast reconstruction ltp flap sensory recovery breast sensation nerve coaptation
effects of gait training with assistance of a robot-driven gait orthosis in hemiparetic patients after stroke

Conditions: Stroke

Summary: the purpose of this study is to investigate the effects of robot-assisted gait training on active walking in the patients with stroke.


Eligibility criteria:
inclusion criteria: * 1st-ever-stroke * hemiplegic patient after stroke * who can stand independently, but cannot walk more than 10 meters independently * whose muscle powers of hip and knee are more than poor on manual muscle test exclusion criteria: * previous gait difficulty before stroke onset * arthralgia on lower extremity * uncontrolled hypertension or hypotension * severe medical illness

Keywords: robot gait stroke
study evaluating desvenlafaxine succinate sustained release (dvs sr) versus placebo in peri- and postmenopausal women

Conditions: Depression; Depressive Disorder; Depressive Disorder, Major

Summary: desvenlafaxine succinate (dvs) is a potent and selective serotonin and norepinephrine reuptake inhibitor (snri). the sustained-release (sr) formulation, dvs sr, is being studied in the development program for the treatment of major depressive disorder (mdd), for vasomotor symptoms (vms) associated with menopause, and for pain associated with peripheral diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. this study will investigate the safety, efficacy, and tolerability of dvs sr in women with mdd who are peri- and postmenopausal.


Eligibility criteria:
inclusion criteria: * peri- and postmenopausal women between the ages of 40 and 70 years, inclusive. * a primary diagnosis of mdd, single or recurrent episode, without psychotic features using the modified international neuropsychiatric interview (mini). * montgomery-asberg depression rating scale (madrs) total score \> or = 22 at the screening and baseline visit. exclusion criteria: * use of oral estrogen-, progestin-, androgen-, or selective estrogen receptor modulator (serm)-containing drug products 8 weeks before baseline. * current (within 12 months) psychoactive substance abuse or dependence (including alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder. * a history or active presence of clinically important medical disease. additional criteria apply.

Keywords: major depressive disorder vasomotor symptoms menopause diabetic neuropathy fibromyalgia
comparison between oxomemazine, guaifenesin and potassium iodate versus guaifenesin monotherapy in acute cough treatment

Conditions: Cough

Summary: the purpose of this study is evaluate if efficacy of a combination dose of oxomemazine, guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough treatment.

study design * open-label, superiority, prospective, parallel group, intent to treat trial * experiment duration: 7 days * 3 visits (days 1, 2 and 7) * reduction cough symptoms * adverse events evaluation

Eligibility criteria:
inclusion criteria: 1. patients must be able to understand the study procedures agree to participate and give written consent. 2. patients with productive cough as result an acute urti (i.e., cold or flu) or allergic cough in the last 10 day. 3. cough score superior to 3. exclusion criteria: 1. pregnancy or risk of pregnancy. 2. lactation. 3. fever above 38º c. 4. patients with bacterial infections of the upper respiratory tract. 5. any pathology or past medical condition that can interfere with this protocol.

Keywords: cough symptoms cold flu
elaboration and analysis of a new cardiac risk stratification protocol based on clinical and physical variables

Conditions: Cardiovascular Diseases; Cardiovascular Risk Factor

Summary: this research project has as objective the elaboration and analysis of a new cardiac risk stratification protocol based on clinical and physical variables to predict the occurrence of signs and symptoms during a cardiac rehabilitation program. to this aim, the study will be developed in three stages. the first stage consists of a prospective longitudinal observational study, in which participants of exercise-based cardiac rehabilitation will undergo a physiotherapy evaluation in terms of physical and clinical aspects. after this initial assessment, participants will be followed for 2 months of rehabilitation, when the occurrence of signs and symptoms (chest pain, fatigue, dizziness, arrhythmias, and other minor events) during exercise will be recorded. based on the data from the initial assessment and the occurrence of signs and symptoms a new cardiac risk stratification protocol will be developed. the second stage of this project consists of another prospective longitudinal observational study in which a new sample of individuals attending cardiac rehabilitation programs will be assessed and stratified for the risk of the occurrence of signs and symptoms during exercise by the new protocol developed. after the risk stratification, this sample will be followed for 2 months and the occurrence of signs and symptoms will be recorded. with this data, the reproducibility and efficacy of the protocol will be evaluated. the third stage of this project consists of a cross-sectional observational study, in which a new sample of participants will be evaluated by two independent physiotherapists for clinical and physical variables, and based on these data will be stratified by the new protocol by the same evaluators independently. after these procedures, the protocol´s agreement between evaluators will be analyzed.


Eligibility criteria:
inclusion criteria: * main medical diagnostic of any cardiovascular disease and/or presence of cardiovascular risk factors * be participating in exercise-based cardiac rehabilitation exclusion criteria: * orthopedic and/or neurologic conditions that preclude the realization of any of the physical and clinical evaluations * do not complete 24 cardiac rehabilitation sessions during the follow-up period

Keywords: cardiac rehabilitation cardiac risk stratification exercise cardiovascular diseases
a study to investigate the effectiveness of atezolizumab in patients with inoperable locally-advanced or metastatic urothelial carcinoma of the urinary tract (announce)

Conditions: Urothelial Carcinoma

Summary: the objective of this study is to investigate the effectiveness of atezolizumab with a primary focus on the overall survival (os) rate at 2 years and secondary focuses on quality of life (qol) and the sequence of treatment in muc patients. furthermore, this study aims at collecting data on safety of atezolizumab and on the reason for cisplatin-ineligibility


Eligibility criteria:
inclusion criteria: * metastatic uc (urothelial carcinoma) including cancers of the renal pelvis, ureters, urinary bladder, and urethra * will be receiving atezolizumab for the treatment of inoperable locally-advanced or metastatic uc, per the decision of the treating physician * have adequate hematologic and end-organ functions * have had no prior palliative chemotherapy for inoperable locally-advanced or metastatic uc and are clinically ineligible ("unfit") for cisplatin-based chemotherapy exclusion criteria: * have received prior immune checkpoint therapy * are pregnant or breastfeeding * are included in any other trial
cerebral and peripheral near infrared spectroscopy monitoring in low and high flow anaesthesia in pediatric

Conditions: Child, Only; Inhalation; Vapor; Anesthesia; Cerebral Oxygenation; Cerebral Hypoxia; Peripheral Oxygenation

Summary: to investigate the effects of non-invasive cerebral and peripheral nirs monitoring and low and high flow sevoflurane anaesthesia on cerebral and peripheral nirs in paediatric patients. to determine the effects of two different flows on these monitoring techniques and thus to facilitate intraoperative patient monitoring and to predict complications (hypoxia) that may occur.

the study will involve american society of anesthesiologists physical status classification (asa) i-iii risk group patients, aged between 2 and 12 years, who will under go general anesthesia with a surgical procedure time of 1 hour or more, and who will undergo pediatric surgery, orthopedic and urological surgery, will be included in the study. preoperative patients' age, gender, height, weight, asa score and operation type information will be recorded. patients will be randomized by the sealed envelope method and divided into 2 groups: low-flow anesthesia (lfa) and high-flow anesthesia (hfa) groups. two groups will undergo nirs monitoring alongside routine asa monitoring. cerebral nirs probe will be attached to the right and left frontotemporal region, and a peripheral nirs probe will be attached to the inner surface of the forearm and the basal values will be noted.

Eligibility criteria:
inclusion criteria: * between 2-12 years of age, those who are planned to undergo pediatric surgery, orthopedic and urological surgery, and whose procedure time is 1 hour or more * asa i-iii risk group * patients who agreed to be included in the study * patients whose informed consent form is approved by their parents will be included in the study. exclusion criteria: * patients who do not want to participate in the study * patients with asa score above iii * asa iii patients with decompensated cardiac and pulmonary disease * patients with neurological sequelae * cases with an operation duration of less than 1 hour * patients with contraindications to the use of any anesthetic drugs * patients for whom low-flow anesthesia is contraindicated * smoke and gas poisoning * malignant hyperthermia * septic shock * co2 absorbent depletion * insufficient oxygen monitoring * laparoscopic surgeries * patients who develop unexpected intra-operative surgical complications * patients whose parents do not approve the informed consent form will not be included in the study.

Keywords: near infrared spectroscopy low flow sevoflurane anaesthesia pediatric cerebral and peripheral oxygenation
a study collecting health information to understand and prevent gastric cancer

Conditions: Gastric Atrophy; Gastric Intestinal Metaplasia; Dysplasia; Gastric Adenocarcinoma; Gastric Cancer

Summary: the purpose of this study is to create a registry of participants with precursor lesions for gastric cancer, including gastric atrophy, intestinal metaplasia, and dysplasia. normal controls and individuals with gastric cancer for comparison of baseline characteristics will also be enrolled.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * able to read and understand english * meet criteria for one of three potentially eligible study populations: * individuals with gastric atrophy, gastric intestinal metaplasia, or dysplasia (increased risk): had a previous diagnosis of or have been diagnosed by the investigation team with gastric atrophy, gastric intestinal metaplasia, or dysplasia of the gastric mucosa on pathology review from an endoscopic biopsy. individuals who have a prior history of early gastric cancer may be included, if they were treated endoscopically and have no evidence of disease. individuals who have a prior history of a cancer other than upper gastrointestinal cancer may also be included, if they have no evidence of disease for at least 1 year prior to study enrollment and are not undergoing active treatment for any malignancy at any time throughout the study period. * healthy controls (average risk): individuals with no history of cancer or gastric precursor lesions undergoing a clinically indicated endoscopy at msk for workup or dyspepsia or reflux * gastric cancer cases: individuals with a known diagnosis of early gastric adenocarcinoma undergoing surgical resection at msk exclusion criteria: * age \< 18 years old * women who are pregnant (may be enrolled after delivery) * individuals with a prior history of upper gastrointestinal surgery or a prior cancer who are undergoing active treatment for malignancy or have been diagnosed within 1 year prior to the study enrollment. (this does not include incidentally diagnosed primary gastric adenocarcinoma identified during study follow up. individuals diagnosed with gastric carcinoid limited to the stomach will also be included, given their ongoing parallel risk for gastric adenocarcinoma.) * have severe comorbidities with expected survival time \<2 years or which would prevent them from undergoing routine elective egd (at the discretion of the patient's provider and the study team)

Keywords: gastric cancer gastric adenocarcinoma gastric atrophy gastric intestinal metaplasia dysplasia memorial sloan kettering cancer center 24-083
a clinical study of anetumab ravtansine in adults with solid tumors who have been treated in previous bayer-sponsored anetumab ravtansine studies

Conditions: Solid Tumors

Summary: the purpose of this study is to enable patients with solid tumors, who received anetumab ravtansine in a bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. the patients will be observed to collect information on how safe and efficient the drug is.

the primary objective of the study is to collect long-term safety information on anetumab ravtansine and to enable patients, who received an anetumab ravtansine-containing treatment in any bayer-sponsored anetumab ravtansine parent study, to continue the treatment. the secondary objective is to further investigate the efficacy of the drug.

Eligibility criteria:
inclusion criteria: * participants ongoing in an applicable bayer-sponsored anetumab ravtansine parent study at the time of its planned study closure. * for on-treatment participants: participant is eligible to receive the next dose of study intervention per the parent study protocol. * for on-treatment participants: any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption. for applicable studies: should treatment be permanently interrupted in the parent study, participants may be enrolled in the follow-up portion of the rollover study. exclusion criteria: * for on-treatment participants: a positive serum pregnancy test. * for on-treatment participants: use of one or more of the prohibited medications listed in the respective parent study protocol. * participants who are receiving standard-of-care agent(s) but not anetumab ravtansine in the parent study, and are able to receive standard-of-care agent outside of the clinical study.

Keywords: solid tumors mesothelin mesothelioma
beta-blocker in chronic obstructive pulmonary disease (copd) study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: smoking causes both smoking related lung disease (copd) and ischaemic heart disease. these are very common conditions and many patients have both diseases. beta-blocker drugs are extensively used in the treatment of angina, high blood pressure and after heart attacks to decrease symptoms and prolong life. beta-agonists are used in copd to decrease breathlessness and improve exercise tolerance. it used to be thought that beta-blockers cannot be used in copd patients as they may make the breathlessness worse, but it has now been established that they can be used safely. beta-blocker drugs and beta-agonists have 'opposite' effects on the body and the investigators do not know if they can work together or if they would cancel each other out. the investigators also do not know which of the different types of beta-blockers now available are better for copd patients. this study will investigate what happens to the airways of people taking both of these drugs.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of copd * \> 40 years of age * \> 15 pack year smoking history exclusion criteria: * contra-indication to beta-blocker use * severe copd fev1 \< 30% or 1 l * not responsive the methacholine

Keywords: copd betablockers bronchodilator exercise capacity methacholine challenge
efficacy of hepatitis b vaccine boosters among neonatally vaccinated children in chongqing

Conditions: Hepatitis B Vaccine Adverse Reaction

Summary: worldwide, hepatitis b virus (hbv) infection is a major cause of acute hepatitis, and chronic infection with hbv often leads to chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. so far, the most effective way to prevent hbv infection in susceptible population is to inject hepatitis b vaccine. however, long-term protection against hepatitis b virus (hbv) after vaccination remains widely debated. this study aims to carry out a comprehensive study to evaluate the efficacy of hepatitis b vaccine booster from the aspect of humoral and cellular immunity in neonatally vaccinated children in chongqing.

hepatitis b virus (hbv) infection is a major public health problem around the world. more than 2 billion people have been infected with hbv. although the world health organization (who) has incorporated hepatitis b vaccination into routine immunization programs for infants and adolescents since 1986 to reduce the incidence of chronic liver diseases, liver cirrhosis and hepatocellular carcinoma associated with hepatitis b virus, there are still more than 400 million chronic carriers. although it is currently recognized that the most effective way to prevent hbv infection in susceptible population is to inject hepatitis b vaccine, the protective effect of the neonatally vaccinated children weakened as time goes on, which involves the question of the need of boosters. however, there are still some problems concerning hepatitis b vaccine boosters for healthy children. in china, there has not been a standardized directory to guide hepatitis b vaccine booster. scholars have great controversy on the necessity, age, dosage and other aspects of hepatitis b vaccine booster. researchers conducted an investigation on the anti-hbs level of 93,326 chinese children aged 1 - 16 who completed basic immunization. the results showed that the proportion of hbsab positive in children aged 1 - 8 years old decreased dramatically, with 8 - year - old children having the lowest proportion of protective antibody. therefore, this study is intended to explore the protective effect of hepatitis b vaccine on the body and the effect of multiple vaccines. this study will recruit some healthy children with anti-hbs at a low level (titer \<10miu/ml and \[10,100) miu/ml) in chongqing and conduct selective re-vaccination according to the results of the first detection of hepatitis b surface markers in healthy children. according to the changes of immune status after booster, the efficacy of hepatitis b vaccine boosters was comprehensively evaluated.

Eligibility criteria:
1. born after jan. 1st, 2005 in chongqing, china; 2. completion of the full primary immunization of hepb after birth; 3. no hbv booster vaccine history.

Keywords: hepatitis b vaccine booster immune response
posterior capsule opacification development with two different intraocular lenses

Conditions: Posterior Capsule Opacification; Cataract

Summary: age-related cataract is the main cause of impaired vision in the elderly population worldwide. the only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. cataract operations are generally very successful, with a low risk of serious complications. the most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (pco). pco is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (lecs) undergo hyperplasia and cellular migration. pco is treated with nd:yag capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag. modifications in iol design and material lead to a decrease in the incidence of pco. during the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. nowadays a multitude of microincision iols are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the iol design. the purpose of this study is to compare the development of posterior capsule opacification (pco) and the frequency of treatment between two different microincision iols over a period of 3 years.


Eligibility criteria:
inclusion criteria: * bilateral age-related cataract * good overall physical constitution exclusion criteria: * previous intraocular surgery or ocular trauma * intraocular complication like posterior capsular tear * glaucoma * uveitis * corneal diseases, diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely

Keywords: posterior capsule opacification pco after cataract intraocular lens