Kornimate/medical-research-clean huggingface dataset:
effectiveness of shock wave therapy for upper limb spasticity

Conditions: Stroke

Summary: introduction: shock wave therapy (swt) has a potential interest to treat spasticity. however, the pathophysiology of this treatment remains unknown. some authors assert that it is effective on spasticity itself, while others suggest that it acts more on fibrosis. method: this study will assess the effectiveness of radial swt to treat wrist and finger flexors stiffness in stroke patients, comparing subacute spastic patients (\ 12 months). forty-eight stroke patients (24 in the subacute phase and 24 in the chronic phase) will be included. one real and one sham sessions of swt will be performed with a 2-week interval. the order of the sessions will be randomized. motor control, stiffness and spasticity will be assessed with clinical and objective measures, just after and just before each session, by a blind assessor. the targeted muscles will be flexor carpi radialis, flexor carpi ulnaris and flexor digitorum profundus, and will be the same for the two session.


Eligibility criteria:
inclusion criteria: * history of cerebral lesion * wrist spasticity ≥ 1+/4 on the modified ashworth scale * wrist spasticity ≥ 2/4 on the tardieu scale * passive dorsal extension of the wrist ≥ 10° exclusion criteria: * botulinum toxin injection in the upper limb in the past three months * history of wrist arthrodesis * myopathy * treatment with oral anticoagulants or coagulation disease * tumor or infection of the paretic upper limb
evaluation of the short and long term performance and clinical outcomes of the crux vena cava filter system

Conditions: Pulmonary Embolism; Venous Thromboembolism; Deep Vein Thrombosis

Summary: the crux vena cava filter (vcf) registry is a clinical study, sponsored by volcano corporation, to evaluate the short and long term performance and clinical outcomes of the crux vena cava filter system.

the crux vcf registry is a non-randomized clinical study, sponsored by volcano corporation, to evaluate the short and long term performance and clinical outcomes of the crux vcf system. the registry includes consecutive patients treated with the crux vcf in a post-market (commercial) setting with data collection at the implant procedure through 2 years post implant or to filter retrieval, whichever comes first. patients may also be enrolled (roll-in) from a previous crux vcf implant within the previous 6 months. follow up assessment will be performed at 6, 12 and 24 months post-implant and at the time of retrieval, if performed.

Eligibility criteria:
inclusion criteria: 1. the patient is \>18 years of age. 2. patient or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent. 3. scheduled for and receives a crux vcf implant or; 4. have previously had a crux vcf implanted within the previous 6 months. exclusion criteria: 1. patient is scheduled for filter implant, but did not have a crux vcf filter implanted due to anatomical exclusions or technical failures. 2. patients unwilling or unable to comply with the protocol and provide informed consent. 3. female patient of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to implantation and any retrieval procedure) 4. patient is participating in another device or drug clinical trial that interferes with this protocol follow up schedule.
implementation of carecube negative pressure isolation units

Conditions: Infectious Disease

Summary: pilot study to provide a descriptive analysis of the real-world feasibility of using a carecube for covid-19 patients in a high-volume tertiary care hospital.

the carecube is a modular, disposable, negative pressure, isolation patient care system that can rapidly augment hospital's capacity to care for patients with contagious droplets or airborne pathogens. it is designed as a temporary single-use negative pressure isolation care unit with ppe for common patient care protocols built into the unit. the device is intended to be used in a healthcare setting as a temporary isolation of patients with suspected or confirmed diagnosis of covid-19 to prevent healthcare practitioners (hcp) and patients' visitors from being exposed to pathogenic biological airborne particulates. the system includes three components: an isolation chamber, functional gown, and gloves. the isolation chamber functions in a similar manner to a hospital negative pressure, airborne infection isolation room. the gown and gloves provide an extra layer of barrier protection beyond ppe. the carecube is designed to provide improved protection for front-line healthcare workers, while also conserving the vital supplies of n95 masks, face shields, and gowns, which are not required since there is no direct contact with the patient. the goal of this project is to provide preliminary data to describe the experiences of 'patients', their caregivers, and providers with the carecube.

Eligibility criteria:
inclusion criteria: * adult male or female previously hospitalized during the covid-19 pandemic * at least 21 days post- positive covid-19 test result * able to provide written informed consent exclusion criteria: * under 18 years of age * unable to provide written informed consent on own behalf
firstwind: weight loss interventions after delivery

Conditions: Overweight; Obesity

Summary: this a pilot intervention study in which postpartum women will be randomized to receive a 6-month postpartum weight loss intervention or usual care.

overweight and obesity affect over 15 million adult women in the united states. postpartum weight retention has been shown to be one factor contributing to weight retention, obesity and possible development of type 2 diabetes. african-american women and other minority women are at especially high risk for the development of obesity and type 2 diabetes. we propose to pilot a six-month postpartum-specific lifestyle intervention among urban-based, postpartum african-american women.

Eligibility criteria:
inclusion criteria: * postpartum women with a pre-pregnancy or first trimester body mass index of 28 or greater or a history of gestational diabetes in the most recent pregnancy. exclusion criteria: * current cardiac disease or serious chronic disease, including cancer.

Keywords: weight loss postpartum weight retention
compare smokers' appraisal of proposed plain packs and existing cigarette packs

Conditions: Health Risk Behaviors; Non Communicable Diseases

Summary: 2 objectives 1. to explore the noticeability of pictorial health warnings and perceptions of attractiveness and harmfulness towards plain cigarette packets and existing cigarette packets with 85% pictorial warnings in current smokers; 2. to compare the differences in perceptions of packaging in current smokers with different characteristics (i.e. by sex, age, the consumption level of cigarettes, nicotine dependence levels, and types of tobacco used for polytobacco product users); 3. to evaluate the effectiveness in reducing smoking consumption and promoting quit attempts; and 4. to assess the support for the legislation of plain packaging.

the present study will recruit at least 1,280 current smokers at smoking hotspots in hong kong island, kowloon, and the new territories. land-based, non-institutionalized hong kong residents aged 18 years and over who speak cantonese or putonghua are eligible to participate. subjects will be shown dummies of branded and plain packets that differ in brand names and plain colours. subjects will discuss their perceptions of attractiveness and harmfulness, noticeability of warnings and effectiveness in reducing smoking consumption and promoting quit attempts. their opinions on the legislation of plain packaging will also be asked. after each interview, interviewers will debrief each interviewee on the harms of smoking and distribute a card providing a quitline and quitting methods.

Eligibility criteria:
inclusion criteria: * hong kong residents aged 18 years and over * able to speak cantonese or putonghua * smokers who have tobacco use behaviour of holding a cigarette in the hand or mouth exclusion criteria: * foreign domestic helpers * non-smokers

Keywords: plain cigarette packs current smokers branded cigarette packs
cognitive training for patients with schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder; Other Primary Psychotic Disorders

Summary: this research on cognitive training addresses the following questions: 1. does cognitive training lead to improved cognition, functional abilities, psychiatric symptoms, treatment adherence, or quality of life in patients with psychoses? 2. what are the neurocognitive and non-cognitive factors that predict good outcomes following cognitive rehabilitation? in addition to verbal learning and memory, immediate verbal memory, vigilance, and executive functioning, the cognitive training intervention attempted to improve prospective memory ability (i.e., the ability to remember to do things in the future, such as take medications or attend a doctor's appointment).


Eligibility criteria:
inclusion criteria: * primary psychotic disorder (including schizophrenia, schizoaffective disorder, psychotic mood disorder, or psychosis nos) * age 18 or older * fluency in english exclusion criteria: * dementia * neurological conditions affecting cognition * mental retardation * substance use disorder within the past month * participation in other intervention trials
safety and efficacy of imatinib in chronic myelogenous patients in relapse after stem cell transplantation

Conditions: Chronic Myeloid Leukemia

Summary: the aim of this phase ii trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase who are in relapse after stem cell transplantation.

patients will received imatinib at a dose of 400mg daily. the tolerability of imatinib given at a daily dose of 400mg will be assessed. the hematologic, cytogenetic and molecular responses will be evaluated at various check points. donor/recipient chimerism during imatinib therapy will be assessed. survival will be estimated.

Eligibility criteria:
inclusion criteria: * cml ph+ (assessed by cytogenetic or fish) * age ≥ 18 year at inclusion * ps grade 0 to 2 (ecog) * previous allogeneic stem cell transplantation * molecular, cytogenetic or haematological relapse in chronic phase after transplantation * immune therapy for graft versus host disease stopped within 2 months from inclusion * adequate and organ function, defined as the following: total bilirubin \<3x uln, sgpt \<3x uln, creatinine \<2x uln. * informed consent sign up exclusion criteria: * age less than 18 y * accelerated or blastic phase * previous therapy with imatinib * active malignancy other than cml or non-melanoma cancer of the skin * current treatment with another investigational agent

Keywords: cml imatinib mesylate stem cell transplantation
role of anti mullerian hormone for ovarian reserve determination of preoperative and postoperative endometrioma patients

Conditions: Endometrioma; Surgery

Summary: ovarian reserve influenced by many factor but especially cysts like endometrioma. anti mullerian hormone is recent marker for ovarian reserve. the investigators are searching ovarian reserve pre and post operatively by using antimullerian hormone of endometrioma patient who are operated for their cysts.

long term results of the postoperative follow up for the endometrioma patients

Eligibility criteria:
inclusion criteria: * ultrasonographical symptomatic and benign cysts which has surgery indication. exclusion criteria: * over 42 years old, systemic endocrine disorder, history of ovarian surgery

Keywords: ovarian reserve antimullerian hormone
a study of galcanezumab in participants with chronic cluster headache

Conditions: Chronic Cluster Headache

Summary: the main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.


Eligibility criteria:
inclusion criteria: * participants with a history of chronic cluster headache occurring without a remission period, or with remissions lasting \<1 month, for at least 1 year. * participants are able to distinguish cluster headache attacks from other headaches. exclusion criteria: * current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device. * current use or any prior exposure to any calcitonin-gene-related peptide (cgrp) antibody, any antibody to the cgrp receptor, or antibody to nerve growth factor (ngf). * are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia. * a history of migraine variants that could implicate or could be confused with ischemia. * known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins. * a history or presence of other medical illness that indicates a medical problem that would preclude study participation. * evidence of significant active or unstable psychiatric disease, in the opinion of the investigator. * women who are pregnant or nursing.
effects of an oral multi-vitamin carbohydrate beverage on intraoperative nausea and vomiting

Conditions: Nausea and Vomiting, Aspiration, Intraoperative

Summary: nausea and vomiting are common and unpleasant symptoms for pregnant women during cesarean section, which can lead to aspiration, a serious complication that can cause pneumonia. our study aimed to evaluate the effects of oral multi-vitamin carbohydrate beverage on maternal intraoperative nausea and vomiting by gastric ultrasound.


Eligibility criteria:
inclusion criteria: * at least 37 weeks pregnant, had not eaten for at least 4 h before entering the delivery room, converted from vaginal delivery to cesarean section exclusion criteria: * gestational diabetes mellitus or gastroesophageal reflux disease, cesarean section performed under general anesthesia
study of cabozantinib (xl184) vs placebo in subjects with hepatocellular carcinoma who have received prior sorafenib

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the effect of cabozantinib (xl184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.


Eligibility criteria:
select inclusion criteria: 1. histological or cytological diagnosis of hcc. 2. the subject has disease that is not amenable to a curative treatment approach. 3. received prior sorafenib. 4. progression following at least 1 prior systemic treatment for hcc. 5. recovery to from toxicities related to any prior treatments. 6. ecog performance status of 0 or 1. 7. adequate hematologic and renal function, based upon meeting protocol defined laboratory criteria within 7 days before randomization. 8. child-pugh score of a. 9. antiviral therapy per local standard of care if active hepatitis b (hbv) infection. 10. sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment. 11. female subjects of childbearing potential must not be pregnant at screening. select exclusion criteria: 1. fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma. 2. receipt of more than 2 prior systemic therapies for advanced hcc. 3. any type of anticancer agent (including investigational) within 2 weeks before randomization. 4. radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment within 6 weeks of randomization. 5. prior cabozantinib treatment. 6. known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization. 7. concomitant anticoagulation, at therapeutic doses, with anticoagulants. 8. serious illness other than cancer that would preclude safe participation in the study. 9. subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding. 10. moderate or severe ascites. 11. pregnant or lactating females. 12. diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low-grade tumors.

Keywords: cabozantinib xl184 liver cancer hepatocellular carcinoma tyrosine kinase inhibitor met kinase vascular endothelial growth factor receptor 2 (vegfr2)
mechanisms of insulin resistance and exercise in south asians

Conditions: Insulin Resistance

Summary: this study determines the effect of aerobic and resistance exercise training on whole-body and skeletal muscle insulin sensitivity in south asians and evaluate the mechanisms which contribute to improvements in insulin sensitivity after exercise training.

south asians (sa) have 2-4 fold higher risk of type 2 diabetes and develop the disease at lower body weights and younger ages than white europeans. lower cardiorespiratory fitness and capacity for muscle fat oxidation contributes substantially to sas' greater insulin resistance, the extent to which this can be improved by exercise training is unclear. this randomised controlled trial will investigate the effects of a 12-week aerobic or resistance exercise training intervention on insulin sensitivity (hyperinsulinaemic-euglycaemic clamp) in south asian adults (22 control, 22 aerobic exercise group and 22 resistance exercise group). the study will also explore the mechanisms within skeletal muscle which mediate these changes by evaluating aerobic and resistance exercise-training induced changes: in basal and insulin-stimulated microvascular blood volume (using contrast-enhanced ultrasound); skeletal muscle mitochondrial function; and lipid droplet morphology and spatial interaction with mitochrondria, muscle fibre capillarisation, endothelial content of key enzymes controlling dilation/constriction and glut-4 translocation (using confocal immunofluorescence microscopy and transmission electron microscopy methods). thus, this work will integrate physiological and molecular data to determine the extent to which exercise training can improve insulin sensitivity in sa and the mechanisms underpinning this improvement. this knowledge is important for optimising diabetes prevention interventions in sas and identification of potential novel therapeutic targets.

Eligibility criteria:
inclusion criteria: * male * south asian ethnicity (self-report of both parents of indian, pakistani, bangladeshi or sri lankan origin) * age 30-65 years * at least 10% 10-year risk of developing type 2 diabetes, determined using the qdiabetes®2018 risk score (http://qdiabetes.org/2018/index.php) exclusion criteria: * female * diabetes (physician diagnosed or hba1c ≥48 mmol/mol on screening) * history of cardiovascular disease * hypertension (taking anti-hypertensives or bp consistently ≥ 150/90 mmhg on screening). * regular participation in vigorous physical activity * regular participation in resistance exercise * current smoking * taking drugs or supplements thought to affect carbohydrate or lipid metabolism * taking drugs affecting blood clotting (e.g. aspirin) * current treatment with anti-obesity drugs * any other significant illness that would prevent full participation in the study

Keywords: insulin resistance aerobic exercise resistance exercise exercise training south asians
effect of low protein diet in preventing the progression of diabetic nephropathy

Conditions: Diabetic Nephropathies

Summary: diabetic nephropathy is the leading cause of chronic kidney disease all the world in spite of progress in new treatment for diabetes and anti hypertensive drugs. additional treatments are thus needed to arrest the progression of diabetic nephropathy. although there is insufficient evidence to suggest that a low-protein diet improves renal dysfunction, it is recommended as a mainstay of nutritional management. we here assessed the role of low protein diet in renal function as well as albuminuria in type 2 diabetic patients with nephropathy for a median of 5 years.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * urinary protein excretion 1-10 g/day * serum cr \<2.0 mg/dl * with diabetic retinopathy \> sdr * normal protein intake instruction * patients whose consent is obtained at \>20 or age =\<65 exclusion criteria: * type 1 diabetes mellitus * non-diabetic nephropathy * urinary tract infection * congestive heart failure * unstable angina * myocardial infarction * stroke * severe hepatopathy * life threatening disease such as malignant tumor * patients on ace-i and or arb treatment * patients on instruction of low protein diet * bw\< 80% of ibw * pregnant, lactating, and probably pregnant patients * patients judged as being inappropriate fir the subjects

Keywords: low protein diet, type 2 diabetic nephropathy comparing the effect of low protein diet on diabetic nephropathy to that of normal protein diet
extension study of protocol enb-006-09 - study of asfotase alfa in children with hypophosphatasia (hpp)

Conditions: Hypophosphatasia (HPP)

Summary: this clinical trial studies the long term safety and efficacy of asfotase alfa in children with hpp who completed study enb-006-09 (nct00952484).

asfotase alfa was formerly referred to as enb-0040 hypophosphatasia (hpp) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. there are limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Eligibility criteria:
inclusion criteria: * compliant and satisfactory completion of enobia-sponsored clinical trial enb-006-09 * written informed consent by parent or other legal guardian prior to any study procedures being performed * parent or other legal guardian willing to comply with study requirements exclusion criteria: * clinically significant disease that precludes study participation, in the investigator's opinion * treatment with an investigational drug other than asfotase alfa * enrollment in any study (other than enb-006-09) involving an investigational drug, device, or treatment for hpp * prior treatment with bisphosphonates

Keywords: hypophosphatasia hpp bone disease soft bones low alkaline phosphatase genetic metabolic disorder alkaline phosphatase tissue non-specific alkaline phosphatase rickets osteomalacia
distal radial artery approach to prevent radial artery occlusion (daprao)

Conditions: Radial Artery Occlusion

Summary: the main complication of transradial intervention is radial artery occlusion (rao). this is relevant because it limits the radial approach for future interventions and disables this conduit for coronary bypass grafts and arteriovenous fistula. observational studies suggest that distal radial access could reduce rao incidence. the primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of rao incidence. the safety endpoint is the incidence of complications between these two methods.


Eligibility criteria:
inclusion criteria: * perceptible radial artery pulse * diagnostic or interventional procedure feasible to be performed with radial access. exclusion criteria: * myocardial infarction with st segment elevation in time for primary angioplasty. * cardiogenic shock or hemodynamic instability. * clinical, plethysmography or ultrasound suggestive of occlusion of the radial artery * prior recent radial artery access (1 month)