Kornimate/medical-research-clean huggingface dataset:
effects of functional postural control training on functional performance in people with parkinson's disease with freezing of gait

Conditions: Parkinson Disease

Summary: the purpose of this single-blinded, randomized controlled study aims to establish the effects of functional postural control training on functional performance and fog in pd individuals with fog as compared with treadmill training.

background and purpose: freezing of gait (fog), is a common sign in patients with parkinson's disease (pd), especially at the advanced stage. advanced functional activities, such as dual task walking, turning, or crossing a door often induce the fog. fog is a complex phenomenon which pathophysiology is currently unknown. however, previous studies have found that postural instability may be a risk factor for fog. in addition, previous studies have suggested the interactions between fog and postural instability. treadmill training has been shown to be relatively more effective to improve fog than other interventions. on the other hand, postural control training was demonstrated to improve the severity of fog and postural control in freezers. however, no study has investigated the effectiveness of functional postural control training on functional performance and fog. therefore, this study aims to establish the effects of functional postural control training on functional performance and fog in pd individuals with fog as compared with treadmill training. methods: this study is a single-blinded randomized controlled trial. twenty pd people with fog will be recruited and randomized to the experimental and control group. the experimental group will receive functional postural control training, and the control group will receive treadmill training. each intervention is 30 minutes/ session, 3 sessions/ weeks, for 4 weeks. the primary outcome is functional performance, which will measure the walking speed, cadence, and step length in the four conditions, including (1) time up and go test, (2) dual task time up and go test, (3) 360º turning in place, and (4) walking through the door. the secondary outcome is the severity of fog which is assessed by the new freezing of gait questionnaire (nfogq). all outcomes will be assessed before and after the training program. demographic data at baseline will be analyzed by using chi-square test or independent t-test. two-way repeated anova will be performed to analyze the primary and secondary outcomes. the significance level is set at p\<0.05.

Eligibility criteria:
inclusion criteria: * hoehn and yahr stage 2\~4 * age between 50 to 80 years * new freezing of gait questionnaire score \> 1 * able to walk independently for at least 10 meters * mmse score ≥24 exclusion criteria: * neurological diseases other than pd * any cardiovascular, pulmonary, or orthopedic conditions that would impact participation in the study

Keywords: freezing of gait functional postural control training functional performance parkinson's disease
prosight: a multi-centre interventional study evaluating mced in asymptomatic population

Conditions: Lung Cancer; Colorectal Cancer; Liver Cancer; Grastic Cancer; Esophageal Cancer

Summary: this is a prospective, multi-centre interventional study evaluating the feasibility of blood-based multi-cancer early detection test in asymptomatic screening cohort.

approximately 2527 participants will be enrolled and offered the multi-cancer early detection (mced) test along with standard-of-care (soc) cancer screenings and usual medical care. the investigational test is designed to detect five cancer types at a curable stage, which are lung cancer, colorectal cancer, liver cancer, gastric cancer and esophageal cancer. the test provides a binary result and predicts the signal origins if a cancer signal is detected. those with "cancer signal detected" test results as well as those with warning signs of cancer during health check-up will undergo diagnostic procedures. the diagnostic work-up will be at the discretion of qualified oncologists, instead of being dictated by protocol. both the safety and performance of mced in the screening setting will be evaluated. the extent of diagnostic testing, including laboratory and imaging tests and procedures required to achieve diagnostic resolution, will be recorded and assessed. additionally, patient-reported outcomes relating to the testing experience will also be collected at specified time points using the electronic clinical outcome assessment (ecoa) app. participants will be actively followed for 1 year from the date of the blood draw.

Eligibility criteria:
inclusion criteria: * 40-74 years old * able to provide a written informed consent and willing to comply with all parts of the protocol procedures exclusion criteria: * with cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen * have definite contraindications of cancer screening examination and diagnostic procedures * unable to comply with the protocol procedures * personal history of cancer, diagnosed within the 3 years prior to expected enrollment date * have received or are undergoing curative cancer treatment within three years prior to recruitment. adjuvant endocrinotherapy for cancer is not an exclusion criterion. * recipients of anti-tumor therapy within 30 days prior to screen * pregnancy or lactating women * recipients of organ transplant or prior bone marrow transplant or stem cell transplant * recipients of blood transfusion within 7 days prior to screen * with autoimmune diseases * have an acute infection or inflammation or uncontrolled chronic infection within 14 days prior to blood draw * unsuitable for this trial determined by the researchers (eg. hemorrhagic diseases)

Keywords: multi-cancer early detection mced cancer screening circulating cell-free tumor dna methylation
low-dose computed tomography-guided core needle biopsy for lung nodules

Conditions: Lung Cancer; Lung; Node

Summary: investigators aim to compare the diagnostic accuracy and radiation exposure between low-dose and standard-dose computed tomography-guided core needle biopsy for lung nodules.

at present, low-dose scanning protocol is widely used in computed tomography-guided interventions because these procedures usually require repeat scans, which causes more radiation exposure to the patients. computed tomography-guided core needle biopsy is widely used in diagnosis of lung nodules with an overall diagnostic accuracy of 93%-97%. compared with the large lung lesions, computed tomography-guided core needle biopsy for lung nodules might require more scanning to adjust the position of needle tip. therefore, it might expose the patients to more radiation. however, studies regarding computed tomography-guided core needle biopsy for lung nodules are still lacking. in this study, investigators aim to compare the diagnostic accuracy and radiation exposure between low-dose and standard-dose computed tomography-guided core needle biopsy for lung nodules.

Eligibility criteria:
inclusion criteria: 1. non-diagnostic lung lesions (no definitive pathological diagnosis); 2. lesion size between 5 and 30 mm; 3. solid lung lesions. exclusion criteria: 1. the lesion which has been punctured previously; 2. a lesion that had shrunk in size or a lesion with a stable size for 1 year; 3. severe dysfunction in heart, lung and coagulation function; 4. patients who refused to provide informed consent.
low-level laser in head and neck chronic lymphedema

Conditions: Head and Neck Cancer; Lymphedema; Fibrosis

Summary: the purpose of this study is to evaluate the effect of low-level laser treatment (lllt) on the severity of lymphedema, symptom burden, functional status, and quality of life in hnc survivors.

primary aim: to determine the impact of lllt, as compared to wait-list control, on changes in severity of lymphedema. secondary aim: to determine the impact of lllt, as compared to a wait-list control, on lymphedema-related symptom burden (e.g., tightness), functional impairments (e.g., range of motion in jaw and neck), and quality of life.

Eligibility criteria:
inclusion criteria: * \>18 years of age * \>6 months post hnc treatment * no evidence of cancer confirmed with imaging tests * having head and neck lymphedema with or without fibrosis * completion of initial lymphedema therapy * lymphedema duration between 3-24 months * ability to speak and read english * ability to provide informed consent exclusion criteria: patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of lllt: * pregnancy * acute infection * photosensitivity * chronic inflammatory diseases * venous thrombosis * carotid artery stenosis * history of severe trauma * medication that affects body fluid and electrolyte balance * use of high doses of non-steroidal anti-inflammatory drugs * pre-existing skin rash, ulceration, open wound in the treatment area * active lymphedema therapy or physical therapy * allergic and other systemic skin diseases
sodium risedronate tablets - special drug use surveillance in patients with osseous paget's disease (all-case surveillance) -48-week surveillance -

Conditions: Osseous Paget's Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets administered once daily (one tablet per dose) in patients with osseous paget's disease for 48 weeks from baseline in daily medical practice.

this special drug use surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets 17.5 mg administered once daily (one tablet per dose) in patients with osseous paget's disease in daily medical practice. the usual dosage for adults is 17.5 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 ml) of water once daily after waking for 8 consecutive weeks. for at least 30 minutes after administration, participants should avoid lying in a supine position and taking food, drink (except for water) or other oral drugs.

Eligibility criteria:
inclusion criteria: * osseous paget's disease patients treated with sodium risedronate tablets 17.5 mg exclusion criteria: -

Keywords: pharmacological theapy
stick together - pilot intervention study

Conditions: Breast Cancer Female

Summary: this pilot study investigates the acceptability and feasibility of 'stick together', a self-guided online intervention, for younger women with breast cancer and their cohabiting partners.

this one-arm feasibility study pilots the 'stick together' intervention among 20 women newly diagnosed with breast cancer at age 25-49 and their cohabiting partners. the intervention aims to strengthen couples' positive dyadic coping and communication, as well as participants mental health and quality of life, as well as quality of life of underage children.

Eligibility criteria:
inclusion criteria (patients): * women newly diagnosed with first primary breast cancer, treated with curative intent at department of breast surgery, gentofte hospital * living with a romantic partner inclusion criteria (partners): * living in romantic partnership with a patient eligible for the intervention exclusion criteria (both patients and partners): * severe relationship difficulties or current couples counselling * severe, untreated mental illness in one or both partners * capable of participating (mastery of danish language, available smartphone, tablet or other device, no cognitive impairment)
relationship of central blood pressure and pulse wave velocity with target organ damage

Conditions: Diabetes; Cardiovascular Disease

Summary: diabetic patients show an increased prevalence of non dipping arterial pressure pattern, target organ damage and elevated arterial stiffness. these alterations are associated with increased cardiovascular risk. the objectives of this study are the following: to evaluate the prognostic value of central arterial pressure and pulse wave velocity in relation to the incidence and outcome of target organ damage and the appearance of cardiovascular episodes (cardiovascular mortality, myocardial infarction, chest pain and stroke) in patients with type 2 diabetes mellitus.

methods/design: type of study: this is an observational prospective study with a duration of 5 years, of which the first year corresponds to patient inclusion and initial evaluation, and the remaining four years to follow-up. setting: the study will be carried out in the urban primary care setting. study population: consecutive sampling will be used to include patients diagnosed with type 2 diabetes between 20-80 years of age. a total of 110 patients meeting all the inclusion criteria and none of the exclusion criteria will be included. measurements: patient age and sex, family and personal history of cardiovascular disease, and cardiovascular risk factors. height, weight, heart rate and abdominal circumference. laboratory tests: hemoglobin, lipid profile, creatinine, microalbuminuria, glomerular filtration rate, blood glucose, glycosylated hemoglobin, blood insulin, fibrinogen and high sensitivity c reactive protein. clinical and 24-hour ambulatory (home) blood pressure monitoring and self-measured blood pressure. common carotid artery ultrasound for the determination of mean carotid intima-media thickness. electrocardiogram for assessing left ventricular hypertrophy. ankle-brachial index. retinal vascular study based on funduscopy with non-mydriatic retinography and evaluation of pulse wave morphology and pulse wave velocity using the sphygmocor system. the medication used for diabetes, arterial hypertension and hyperlipidemia will be registered, together with antiplatelet drugs. discussion: the results of this study will help to know and quantify the prognostic value of central arterial pressure and pulse wave velocity in relation to the evolution of the subclinical target organ damage markers and the possible incidence of cardiovascular events in patients with type 2 diabetes mellitus.

Eligibility criteria:
inclusion criteria: * diagnosed of diabetes mellitus type 2, and * aged 20-80 years. exclusion criteria: * psychological and/or cognitive disorders, * failure to cooperate, * educational limitations and problems for understanding written language, failure to sign the informed consent document * patients participating or who will participate in a clinical trial during the study, * patients with serious comorbidities representing a threat to life over the subsequent 12 months.
mowoot device treatment for adults with chronic constipation

Conditions: Constipation - Functional; Constipation-predominant Irritable Bowel Syndrome; Constipation Chronic Idiopathic; Constipation; Neurogenic; Constipation

Summary: the primary objective is to compare the effectiveness of the experimental intermittent colonic exoperistalsis (ice) treatment with mowoot, with the active control of trans-anal irrigation (tai) as standard-of-care. the secondary objectives are to further compare the ice treatment with mowoot to the tai standard-of-care clinically and economically.

the rct will assess clinical effectiveness by means of quantitative and qualitative variables, and the cost effectiveness by means of economic outcomes.

Eligibility criteria:
inclusion criteria: 1. any gender 18 years or older 2. symptoms meeting the american college of gastroenterology definition of chronic constipation: unsatisfactory defaecation characterized by infrequent stool, difficult stool passage or both for at least previous 3 months 3. bothered by their constipation 4. pac-qol ≥1.8 5. using tai for at least 3 months 6. able to undertake the treatment with tai or with the device themselves or with a carer willing to do it 7. able to understand the study requirements 8. able to understand written and spoken english (due to questionnaire validity) 9. able and willing to provide written informed consent to participate exclusion criteria: disease phenotype exclusion criteria: 1. irritable bowel syndrome with diarrhoea (ibs-d) or alternating constipation and diarrhoea (ibsmix): (not due to laxative use) 2. inflammatory bowel disease (ibd) device-related exclusion criteria: 3. abdominal perimeter ≤65cm or ≥130cm 4. unable to independently use the mowoot or tai technology, unless a carer is available daily to assist other medical conditions, medications and contraindications: 5. previous large bowel resection 6. the presence of a stoma 7. external rectal prolapse 8. active anorexia or bulimia 9. active abdominal cancer 10. large inguinal or umbilical hernia 11. recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable 12. pregnancy or attempt to become pregnant in the next 6 months 13. use of strong opioids\* 14. use of antidepressants, bladder stabilisers or any other medication inducing, or treating, constipation unless used at a stable dose for at least 4 weeks before screening visit (this excludes laxatives which may be used as required up to three days before the screening visit) 15. subjects already undertaking or have undertaken abdominal massage unless they underwent a previous washout period of at least 2 months 16. participation in another parallel interventional clinical trial or less than 2 months from participation in a previous interventional clinical trial 17. planned surgery for constipation if it might be within trial dates
a study of safety, pharmacokinetics, pharmacodynamics of jnj-61610588 in participants with advanced cancer

Conditions: Advanced Cancer

Summary: the purpose of this study is to evaluate the safety and tolerability of jnj-61610588 in participants with advanced cancer in order to determine a recommended phase 2 dose (rp2d) for further evaluation in specific tumor types.

the purpose of this study is to see if jnj-61610588 is safe and useful for treating participants with advanced cancer. this study consists of up to 4 parts. part 1 will determine what dose of jnj-61610588 can be given safely to advanced cancer participants. part 2 will look at how participants with metastatic non-small cell lung cancer respond to a safe dose of jnj-61610588. parts 3 and 4 will test whether the dose of jnj-61610588 identified in part 1 is a safe and effective therapy for participants with specific types of advanced cancers (lung, pancreas, cervical, colorectal, head and neck). participants will receive study drug in an outpatient setting. participants safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * the participant has a solid tumor. parts 2 and 3 are limited to participants with non-small cell lung cancer. part 4 is limited to participants with small cell lung, head and neck, pancreatic, colorectal, and cervical cancers * tumor progression following at least one prior standard therapy * the participant has a radiographically measurable tumor. evaluable disease is acceptable for part 1 only * the participant is willing to consent to provide a tumor tissue sample (fresh biopsy) before (parts 2 and 3) and after (part 2 only) receiving the study drug * the participant is able to carry out daily life activities without difficulty * the participant does not have significant side effects from previous anti-cancer treatment * the participant has adequate organ and blood cell counts * sexually active participants must use medically acceptable methods of contraception during the course of this study exclusion criteria: * the participant has a history of major surgery or treatment other cancer therapy within 2-6 weeks before starting the study * the participant has an untreated brain tumor * current severe, uncontrolled systemic disease including an ongoing, active infection requiring treatment with antibiotics * the participant has high blood pressure or diabetes that is not well-controlled with medication * history of clinically significant heart problems * history of severe side effects toimmunotherapy * the participant is pregnant, breastfeeding, or planning to become pregnant or father a child * positive for hepatitis b, hepatitis c, or hiv * the participant has received anticoagulant therapy with the exception of aspirin within 1 week of starting the study

Keywords: advanced cancer jnj-61610588
a phase 1 dose escalation study of vx-973 in healthy adults

Conditions: Pain

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of vx-973 in healthy participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * a total body weight of more than (\>) 50 kg * participants of non-childbearing potential * nonsmoker or ex-smoker for at least 3 months before screening key exclusion criteria: * history of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * any condition possibly affecting drug absorption other protocol defined inclusion/exclusion criteria may apply.
mk0859 dose-ranging study (0859-003)

Conditions: Hypercholesterolemia; Mixed Hyperlipemia

Summary: to assess the cholesterol changing effects of mk0859 in patients with primary hypercholesterolemia or mixed dyslipidemia.


Eligibility criteria:
inclusion criteria: * eligible patients will be men and women of non-child bearing potential, 18 through 75 years of age diagnosed with high cholesterol exclusion criteria: * patients with chd or chd-equivalent disease (except diabetes) * diabetics on statins