Kornimate/medical-research-clean huggingface dataset:
maintenance treatment with bgb-290 versus placebo in participants with platinum-sensitive recurrent ovarian cancer

Conditions: Ovarian Cancer

Summary: to evaluate the efficacy, safety and tolerability of maintenance therapy with bgb-290(pamiparib) versus placebo in chinese participants with recurrent ovarian cancer who achieved a complete response (cr) or partial response (pr) after platinum-based chemotherapy


Eligibility criteria:
key inclusion criteria: 1. histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer) 2. completion of ≥2 previous platinum-containing regimens (eg, carboplatin or cisplatin) 3. complete response (cr) or partial response (pr) achieved with last platinum-based chemotherapy regimen as determined by investigator per response evaluation criteria in solid tumors (recist) version 1.1 4. ability to be randomized ≤8 weeks after last dose of platinum key exclusion criteria: 1. prior treatment with a poly (adp-ribose) polymerase (parp) inhibitor 2. progressive disease (pd) as per ca-125 criteria before randomization 3. diagnosis of myelodysplastic syndrome (mds) 4. known history of intolerance to the excipients of the pamiparib capsule note: other protocol defined inclusion/exclusion criteria may apply.
anti-sars-cov2 vaccination study in lung cancer patients

Conditions: Lung Cancer; Covid19

Summary: observational and multicenter retrospective study of data collection in hospital centers throughout the spanish geography. this study aims to be nationwide in order to study general common variables of the patients, as well as the correlation with the cancer treatments received.

observational and multicenter retrospective study of data collection in hospital centers throughout the spanish geography. this study aims to be nationwide in order to study general common variables of the patients, as well as the correlation with the cancer treatments received. disease and study population patients with lung cancer of any histology and stage who receive an anti-covid-19 vaccine approved by the health authorities. patients would be eligible whether they have suffered from sars-cov2 infection or have not had covid19. the study will be extended to all the centers of the spanish lung cancer group, more than 170 centers and 500 professionals, and it is expected that around 500 cases will be collected. the main objective of the study is to collect the safety and efficacy of the vaccine against sars-cov-2 in cancer patients, as well as its potential interactions with antineoplastic therapies. the data collection will take place throughout the year 2021

Eligibility criteria:
inclusion criteria: * patients diagnosed with lung cancer of any stage and histology who have or have not contracted covid-19 and who have been vaccinated with an ema approved covid-19 vaccine. * age equal to or greater than 18 years exclusion criteria: * patients who have not received an ema approved covid-19 vaccine.

Keywords: covid-19 vaccine
echocardiography by non-cardiologist in early management of patients with chest pain

Conditions: Cardiology; Acute Coronary Syndrome; Echocardiography

Summary: the aim of the study is to find out the benefit of echocardiography, which is performed by a physican without a cardiological or radiological specialty. in this case the echocardiography is used in the first contact with a patient with chest pain of unclear etiology. possible benefit is rapid risk stratification of acute non-stemi coronary syndromes and differentiation from other serious conditions, such as pulmonary embolism or aortic dissection.

emergent echocardiography is reproducible method providing clinically significant information during primary survey of acute cardiovascular diseases. possible benefit is the risk stratification of acute non-stemi coronary syndromes and differentiation from other serious conditions, such as pulmonary embolism or aortic dissection. step one - education in cardiac ultrasound. all physicians involved in endemic study have to undergo education program of heart ultrasonography. this curriculum fulfills bse level one requirements. candidates of this program have to make a defined number of echocardiography studies under supervisor control. every curriculum is finished by exam. step two - focus in clinical practise patients with chest pain are randomized into two groups by the even-odd rule. inclusion criteria: chest pain ( cardiovascular ethiology possible depends on anamnesis, physical examination and ecg ) higher age than 18 exclusion criteria: stemi pacemaker / icd pregnancy performance status 4 ( zubrod scale ) informed consent unsigned prisoners step three - evaluation aims.: compare time to make a decision in these groups compare time of stay at emergency department in these groups compare time to invasive coronary angiography and revascularization (if available) compare time to hospital dimission occurrence of mace in following 30 days

Eligibility criteria:
inclusion criteria: * chest pain ( cardiovascular ethiology possible depends on anamnesis, physical examination and ecg ) * higher age than 18 exclusion criteria: * stemi * pacemaker / icd * pregnancy * performance status 4 ( zubrod scale ) * informed consent unsigned * prisoners

Keywords: echocardiography point-of-care ultrasound
prednisolone novel endpoint study in patients with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: prednisolone will be used as a model medication to identify new clinical outcomes for future evaluation of new therapies in short-term studies (up to 4 weeks) in patients with chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * an established clinical history of copd * evidence of bronchitis * current or ex-smoker exclusion criteria: * copd exacerbation requiring steroid and/or antibiotics in the last month * taking oral or inhaled steroids for more than 14 days in the last 6 months * unable to withhold salbutamol/albuterol for a 6 hour period * history of alcohol, substance or drug abuse within the last year. * other significant medical condition e.g. diabetes * cancer that has not been in complete remission for at least 5 years * as a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study.

Keywords: ct scan breathing tests lung function tests biomarkers prednisolone ios copd clinical outcomes
one step versus two step approach for gestational diabetes mellitus screening

Conditions: Gestational Diabetes

Summary: our study will assess if there is a difference in incidence of gestational diabetes using different screening approaches, either using a one-step approach with a 2 hour glucose tolerance test or using a two-step approach. prior studies have proven similar incidences including a randomized controlled trial.

gestational diabetes is screened for in pregnancy by drinking a solution containing a certain amount of glucose and testing blood glucose level one hour after drinking it. if this value is above a certain cut-off (\>135mg/dl), the patient is subjected to another test involving drinking a solution containing a higher amount of glucose and checking blood glucose while fasting, 1 hour after drinking the solution and 2 hours after drinking the solution. (two step approach). cut off values will be: 3 hour\>180 mg/dl, 2 hour \> 155 mg/dl, 1hour \>140 mg/dl, fasting \>95mg/dl. two abnormal values will meet the diagnosis of gestational diabetes. in other parts of the united states, and most of the rest of the word, screening for gestational diabetes uses a one-step approach by drinking a solution containing 75g of glucose (as recommended by the american diabetic society, the endocrine society, who and the international association of diabetes and pregnancy study groups1-3). blood glucose values are checked at fasting, one hour and two hours after solution drinking. the diagnosis of gestational diabetes is based on one elevated values. (cut off: fasting ≥92mg/dl, 1hour ≥180 mg/dl, 2 hours ≥153 mg/dl). our study will assess if there is a difference in incidence of gestational diabetes using these different screening approaches. prior studies have proven similar incidences including a randomized controlled trial.

Eligibility criteria:
inclusion criteria: * 16-50 year of age * pregnant women (limits the participants to female gender) exclusion criteria: * pregestational diabetes mellitus * history of bariatric surgery
effect of two exercise programs on bone strength and architecture

Conditions: Osteoporosis

Summary: bone responds according to the load placed on it. in this study, investigators want to know if exercise that loads the body in exercises, like walking or jogging (ground reaction forces: grf), affects bone differently than exercises that load the joints, like weight lifting (joint reaction forces: jrf). participants will exercise at least 3 times a week for 6 months. measures of bone strength and mass, muscular strength, and aerobic fitness will be taken at the beginning and the end of the 6 month program. period blood samples will be taken for future analysis of blood markers.


Eligibility criteria:
inclusion criteria: * non-smoker * in generally good health * not physically active (less than 60 minutes of purposeful exercise/week) * able to travel to the exercise facility a minimum of 3 times/week exclusion criteria: * use of glucocorticoids * abnormal resting ekg * angina and/or evidence of acute myocardial ischemia during a treadmill test * resting blood pressure above 150 mmhg systolic of 90 mmhg diastolic * anti-resorptive drug use in the last 2 years * initiation of treatments that could impact bone metabolism (diuretics, hormones, bine anabolic agents) in the prior 6 months * dual-energy x-ray absorptiometry (dxa) t-score \<+ -2.5 at the femoral neck and/or lumbar spine * serum vitamin d concentration \<20 ng/ml * uncontrolled thyroid disease * any contraindications to regular exercise
reconstruction of digital nerve lesions with muscle-in-vein conduits

Conditions: Peripheral Nerve Injury Upper Limb

Summary: muscle-in-vein conduits (mvcs) provide an alternative for bridging digital nerve defects when tension-free suture is not possible. low donor site morbidity and absence of additional costs are favorable advantages compared to autografts or conduits. 37 patients with 43 defects of proper palmar digital nerves were retrospectively enrolled. primary repair by mvcs was performed in 22 cases while 21 underwent secondary reconstruction. recovery of sensibility was assessed by static and moving two-point discrimination (2pds, 2pdm) and semmes-weinstein monofilaments (swm). results were compared with contralateral side serving as intraindividual control. outcome data were stratified according to international guidelines and evaluated for differences in terms of age, gap length, time of reconstruction and concomitant injuries.


Eligibility criteria:
inclusion criteria: - patients with reconstruction of digital nerves with muscle-in-vein conduits exclusion criteria: * subtotal or total amputations * pre-existing neurological disorders (e.g. polyneuropathy) * symptoms of nerve entrapment
the predictive value of complement c3 in patients with advanced gastric cancer

Conditions: Gastric Cancer; Complement Component Deficiency; Surgery

Summary: this study is designed to investigate whether complement c3 depletion is associated with poor short-term outcomes in postoperative patients with gastric cancer.

the complement system plays an important role in the development of digestive malignancies. the complement c3 is the point of convergence for the three complement activation pathways. however, the concrete effect of c3 in the development of gastric cancer is still obscured. this study is designed to explore whether complement c3 can be regarded as a predictive factor of postoperative outcomes for postoperative patients with gastric cancer. this study is designed as a prospective cohort study and included consecutively treated patients. the perioperative plasma value of complement components, such as c3, c4, and ch50, are detected to explore the incidence rate of complement depletion. all enrolled patients are divided into two groups mainly according to the levels of preoperative c3 levels (c3 depletion and non-c3 depletion groups). the primary endpoints are the 1-year overall survival and disease-free survival, while the secondary endpoints are postoperative complications, length of hospital stay, and hospital charges. this study would be helpful to confirm the role of complement depletion in anticipated outcomes of postoperative patients with gastric cancer.

Eligibility criteria:
inclusion criteria: * pathological diagnosis of gastric adenocarcinoma * radical operation and adjuvant chemotherapy endurable * informed consent approved exclusion criteria: * age \ 75 years old * pregnancy or lactating woman * any primary diagnosis other than gastric cancer * confirmed complement deficiency due to immunity dysfunction or other disease * required blood transfusion, plasmapheresis, or emergent operation

Keywords: gastric cancer complement system overal survival
d1 vs d2 lymphadenectomy in gastric cancer

Conditions: Gastric Cancer

Summary: this study is a retrospective study with a propensity score-matched analysis in order to balance differences between patients with d1 and d2 lymphadenectomy for gastric cancer.the main aim is to analyse differences in the postoperative and oncological outcomes of patients with gastric cancer (gc) who underwent d1 and d2 gastrectomy.

in this propensity score-matched analysis of 128 patients, d2 lymphadenectomy improved long-term outcomes compared with d1 in patients with curative intent surgery for gastric cancer except for the group of patients older than 75 years and with early tumors.

Eligibility criteria:
inclusion criteria: * patients diagnosed with gc stage i-iii who underwent a curative gastrectomy +/- perioperative chemotherapy exclusion criteria: * patients with adenocarcinoma siewert type i/ii, palliative surgery, r1/r2 resections and pathological stage (pstage) iv.

Keywords: gastric cancer lymphadenectomy outcomes
efficacy and safety study of jnj-32729463 for treating complicated skin and skin structure infections compared to linezolid (zyvox)

Conditions: Complicated Skin and Skin Structure Infections

Summary: the purpose of this study is to determine the clinical efficacy, safety, and tolerability of a 250 mg bid oral dose of jnj-32729463 compared with linezolid in subjects with complicated skin and skin structure infections (csssis).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of a complicated skin and skin structure infection (csssi) including wound infection, deep cellulitis or severe abscess * women of childbearing potential must agree to use an acceptable form of contraception * infection site offers ability to obtain a microbiological specimen * received only 1 dose of any potentially effective systemic antibiotic within 24 hours of beginning study treatment exclusion criteria: * history of hypersensitivity or allergic reaction to quinolones or to linezolid * female and pregnant or breastfeeding or may be pregnant * chronic or underlying skin condition surrounding the area of infection that may complicate the assessment of response (e.g. atopic dermatitis, eczema, or psoriasis) * subject has infections with a high cure rate after surgical incision alone after aggressive local skin care * subject has infection(s) suspected to be caused by gram-negative rods, anaerobic bacteria or unusual pathogens * subject has an infection that is expected to require other antifungal, antimycobacterial, or antibacterial agents in addition to study medication other protocol-specific eligibility criteria may apply

Keywords: csssi complicated skin and skin structure infections acute bacterial skin and skin structure infections abscess cellulitis bacterial infections anti-bacterial agents anti-infective agents skin diseases, infectious skin diseases wound infection
probucol combined with valsartan in reducing proteinuria in diabetes nephropathy

Conditions: Type 2 Diabetes Mellitus; Nephropathy

Summary: this is a prospective randomized controlled, open-labeled study to identify the efficacy of probucol in combination with valsartan in patients with diabetes nephropathy. the reduction of urinary albumin or proteinuria will be the primary outcome studied. the expected study duration will be 48 weeks.

a prospective randomized controlled, open-labeled study in patients with diabetes nephropathy * arm 1: valsartan + probucol valsartan (160mg/day) + probucol (750mg/day) * arm 2: valsartan + placebo valsartan (160mg/day) + placebo

Eligibility criteria:
inclusion criteria: * type 2 diabetes nephropathy * urinary albumin excretion 1-3g/24hours * serum creatinine \< 3mg/dl exclusion criteria: * type 1 diabetes mellitus * renal diseases other than type 2 diabetes nephropathy * renal artery stenosis * severe heart diseases * tuberculosis

Keywords: type 2 diabetes mellitus nephropathy valsartan probucol proteinuria
eccentric exercise in patients with non-specific neck pain

Conditions: Neck Pain

Summary: neck pain is one of the most frequently investigated and common musculoskeletal disorders that cause disability in the community.if neck pain is due to multifactorial etiology, it is defined as non-specific neck pain.eccentric exercises are used to increase muscle strength and muscle mass. non-specific neck pain affects negatively and often leads to severe disability. various rehabilitation techniques are available to reduce pain and disability and increase functional level. this study aimed to compare the pain and functional status of eccentric exercise training and home program exercise groups of people with non-specific neck pain.

it is known that exercise treatments are useful in strengthening neck muscles and controlling postural disorders in patients with neck pain, which is currently accepted. eccentric exercises are used to increase muscle strength and muscle mass. home exercise and eccentric exercise training groups were included in a total of 24 sessions (8 weeks\*3 days); home exercise program was applied to the individuals in the control group. visual analog scale, mc gill melzack pain assessment, neck disability index, hand grip strength, and skin resistance assessments.

Eligibility criteria:
inclusion criteria: * diagnosed with non-specific neck pain by a physician * having a complaint of non-specific neck pain for at least 3 months * neck pain severity \>40mm according to vas * voluntary participation of the individual in the study exclusion criteria: * radiculopathy and structural defect in the cervical region, * surgical history on the cervical region, * inflammatory disease, * severe psychological illness, * presence of infection in bone and soft tissue in the cervical spine, * malignancy, * advanced osteoporosis, * having upper extremity pathologies, * having a neurological disease that will prevent treatment * having previously undergone cervical region and spine surgery * to be included in the physiotherapy program from the neck and back region in the last 6 months, * in case of administration of drugs such as nsaids, opioids in the last 24 hours

Keywords: neck pain exercise eccentric strengthening pain disability
comparison between custom and non-custom serious games poststroke

Conditions: Stroke

Summary: serious games for rehabilitation are delivered through systems that are either customised or non-customised. custom serious games allow for control of feedback, setting of game speed and difficulty, while non-custom games are less adaptable but provide attractive graphics and sounds. the study compared the activity intensity and user experience of persons after stroke while playing custom and non-custom virtual reality balance games that were both game- and self-paced.

persons in chronic phase poststroke will play 12 games (6 self- and 6 game-paced games) over two sessions (in randomised order). within each game-type, custom and non-custom games will be played in random order. all games will be played on a balance board, whereby each pair of a custom and non-custom game will require comparable movement directions of the center of pressure. the custom system will be compared to the non-custom system in terms of number of repetitions, movement amplitude, users' enjoyment, flow state, likeability and perception of exertion.

Eligibility criteria:
inclusion criteria: * chronic phase (\>6 months) after stroke * ability to walk with supervision or independently with or without walking aid on flat ground or all surfaces * stable health condition * ability to follow simple instructions exclusion criteria: * additional neurological condition * musculoskeletal impairments that would interfere with execution of the required tasks or completing the questionnaires

Keywords: chronic stroke active video games balance
tailored computerized mobilization of the cervical spine utilizing the occiflex device for the treatment of chronic neck pain

Conditions: Neck Pain

Summary: the study is intended to examine the safety and efficacy of computerized mobilization of the neck for the treatment of patients with chronic neck pain. this is a third continuation study aimed at examining the occiflex robotic system. this time we will be studying tailored or personalized three dimensional movement of the neck.


Eligibility criteria:
inclusion criteria: * patients with chronic neck pain: post-whiplash injury, myofacial pain, cervical facet joint disease and idiopathic chronic neck pain exclusion criteria: * patients with cervical radiculopathy myelopathy discopathy malignancy involving the neck or cervical spine severe osteoporosis severe skin disorder psychiatric disorders cervical disc herniation

Keywords: chronic neck pain, occiflex, computerized mobilization
urine methylation markers in utuc

Conditions: Upper Tract Urothelial Cancer

Summary: this is a research study to measure dna markers in the urine of patients with upper tract urothelial cancer (utuc) before surgery and during follow-up visits. identifying these dna markers could improve diagnosis before surgery, help assess risk, and predict early recurrence of the cancer. urine samples will be de-identified and sent to zymo/pangea research corporation for analysis. the results of this test will be compared to the traditional tests in upper tract urothelial cancer, such as cells in the urine and tissue biopsy.


Eligibility criteria:
inclusion criteria: * \>=18 years * primary utuc exclusion criteria: * patients who do not understand and/or are unwilling to sign a written informed consent

Keywords: utuc