Kornimate/medical-research-clean huggingface dataset:
reshape intragastric balloon for the treatment of obesity

Conditions: Obesity

Summary: a prospective, non-randomized, open-label, multi-center study designed to implant up to twenty-six (26) ce-marked reshape™ balloons in twenty-six (26) patients with body mass index (bmi) 30-40 to assess the effectiveness of the device. the rib devices will be used within their labeled indications and as per their instructions for use. enrolled patients will be followed for seven months. the patient will be prescribed a controlled diet, exercise and counseling. one group of 26 patients will receive treatment as follows: placement, inflate to 900 cc, remove at 180 days, follow-up 30 days post removal (endoscopic video capture of placement and removal required).


Eligibility criteria:
inclusion criteria: * the patient is male or female between the ages of 20 and 60 years of age. * the patient presents with a body mass index (bmi) 30-40 kg/m2. * the patient is geographically stable and willing to return to the implant center for follow-up visits. * the patient has been adequately informed of risks and requirements and consents to his/her participation in the post market clinical study. exclusion criteria: * the patient presents with 20 years \> age \> 60 years. * the patient has a progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 12 months. * the patient is a pregnant or lactating female. * the patient presents with a 30 kg/m2 \> bmi \> 40 kg/m2. * the patient has had previous abdominal surgery. * the patient has digestive tract disorders such as active peptic ulcers, bleeding disorders, esophageal varices, crohn's disease. * the patient presents with psychiatric disorders. * the patient is participating in concomitant research studies of investigational products that would interfere with this study. * the patient has inability to return for follow-up assessments. * the patient is an alcohol or drug abuser.

Keywords: obesity intragastric balloon
effect of different exercises on quality of life of leukemia patients.

Conditions: Quality of Life; Acute Lymphoblastic Leukemia; Exercise

Summary: * to compare between modified strength training program and aerobic exercises on quality of life on children with acute lymphoblastic leukemia. * to compare between modified strength training program and aerobic exercises on functional capacity on children with acute lymphoblastic leukemia.

this study will be done to determine any exercise from aerobic exercises or modified strength training program will be more effective on quality of life and functional capacity on children with acute lymphoblastic leukemia .acute lymphoblastic leukemia is wide spread in the world and the children with this disease are fragile so must know the most program effect.

Eligibility criteria:
inclusion criteria: * age range from8-12years. * children during 3rd phase( maintenance phase of the treatment). according san et al(2007) who found children with acute lymphoblastic leukemia in maintenance phase of treatment can safely perform both aerobic and resistance training . * time elapsed since the start of the maintenance phase \>20weeks. * children with muscle weakness due to chemotherapy. * the height , weight and body mass index of the child will take on standard scale. * preserved cardiac structure and function as assisted by echo-cardiogram. * the children have ability to walk. exclusion criteria: children who have one or more of the following criteria will be excluded from the study: * receiving more intensive chemotherapy. * mental disabled. * sever cardiomyopathy (ejection fraction \<40%, ecg will be used as a pretest as it might be a more sensitive tool to exclude angina pectoris). * low blood platelet levels (\< 50.000 per µl). * marked anemia (hemoglobin \< 8 g/dl). * severe cachexia (i.e., weight mass loss \> 35%). * pain in bone. * inability to walk. * sensory disturbance. * peripheral neuropathy.
mycotoxin exposure and dietary habits in colorectal cancer prevention and development among polish population

Conditions: Colorectal Cancer, Somatic (Diagnosis)

Summary: the aim of the study is the determination of the zearalenone and its metabolites (α and β) level in the blood plasma and faeces of patients at increased risk of cancer, in relation to the nutrition data (ffq) and information on the quality of life dependent on health (whoqol-bref). the study is performer within the framework of the polish colonoscopy screening program. within the study 100 volunteers between 50 and 65 years of age. while, the colonoscopies will be performed in provincial specialist hospital in olsztyn. patients with positive test result, who have been diagnosed with polyps or cancer, will be assigned to risk group. the study has been approved by a local bioethics committee.


Eligibility criteria:
inclusion criteria: * men and women aged from 50 to 65 years residing in poland. exclusion criteria: * subjects requiring long-term care due to somatic, mental retardation or other mental illness. * history of colorectal resection.

Keywords: colorectal cancer zearalenone mycotoxin gastrointestinal bacterial
tolperisone in acute muscle spasm of the back

Conditions: Back Pain; Acute Pain; Back Spasm Upper Back; Back Strain; Muscle Cramp; Muscle Spasm; Low Back Pain

Summary: this is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered as multiple doses three times a day (tid) in approximately 400 male and female subjects experiencing back pain due to or associated with muscle spasm.


Eligibility criteria:
inclusion criteria: * ambulatory * current acute back pain and/or stiffness due to acute and painful muscle spasm starting within 7 days prior to study entry and more than 8 weeks after the last episode of acute back pain. * pain of 4 or more on the subject "right now" rating of pain intensity numeric rating scale (nrs) scale of 0-10. * willing to discontinue all medication used for the treatment of pain or muscle spasm on study entry. * pain localized below the neck and above the inferior gluteal folds. * body mass index ranging between 18 and 35 kg/m². exclusion criteria: * unwillingness to stop taking pain or antispasmodic medication other than the study medication (specifically opioid use \[e.g., vicodin\], barbiturates, and cannabis). * chronic pain for the previous 3 months or longer, on more days than not. * radicular pain in the lower extremity (i.e. pain radiating below the knee), sciatica pain down the leg, or pain below the knee (indicating a lumber radiculopathy); radicular pain in the upper extremity, radiating into the forearm or hand (indicating a cervical radiculopathy). * concomitant severe pain in a region other than the back. * spinal surgery within 1 year of study entry. * back pain due to major trauma (e.g., motor vehicle accident, fracture of bone) unless resolved for more than 1 year. * treatment of back pain ongoing with non-pharmacological therapy (e.g., acupuncture, chiropractic adjustment, massage, transcutaneous electrical nerve stimulation \[tens\], physiotherapy). * subjects who test positive for alcohol by breathalyzer test. * unwilling to stop taking moderate to potent inhibitors of cytochrome p450 (cyp) isozymes cyp2d6 and cyp2c19, which are likely to cause drug interactions with tolperisone hcl (e.g., medications such as paroxetine and fluvoxamine).
investigation on failure time analysis of a new tpe material in the iceform liner

Conditions: Prosthesis Failure

Summary: durability evaluation of a new material blend in the iceform liner and iceform sleeve.

potential subjects will be identified from the customer base of a relevant clinic. if a potential participant may fit the inclusion and exclusion criteria, he/she will be contacted by a co-investigator (ci) via telephone. during the telephone call the ci will verify if they are interested in participating in a study and will initiate the enrollment procedure. if interest is expressed at this point they will answer some screening questions and if the eligibility criteria is met the subject is offered to enroll by getting a study invite through proofpilot, the eds, and an appointment to come in for initial fitting will be set up. questions relating to the duration of the study, number of clinical visits required, and the investigational device will be answered at this time. following this the subject will log into proofpilot online and go through the e-icf, if signed, the subject will answer a profile questionnaire. the next step will be an appointment, subject comes into their clinic and gets the investigational device. in some cases, the subject will get the liner shipped to their home address. this will only be done upon subjects request due to long distance from clinic. and only for very confident prosthetic users which are used to handle a new liner by themselves. potential risk of participating in the investigation will be explained to the subject at this point. the cis will communicate to the study monitors the number of users that have been identified that meet the inclusion/exclusion criteria and are willing to participate. during the clinical visit the subjects will only be fitted to the iceform investigational liner. profile and relevant contact information will already have been collected via the eds. subjects will then receive a prompt monthly, either via email, sms or smartphone notification, to fill in the eds questionnaire, and perform any tasks as applicable. if a subject reports a failure he/she will be instructed to stop using the liner, the remaining gift cards will be delivered and their participation ends. otherwise, participation will end at 6 months. the subject gets to keep the investigational device at the end of the study, therefore there is no need for an additional visit. subjects that report a failure of the tpe material may be contacted by the coordinating investigator or ci if the root cause of the failure cannot be confidently determined from the data collected with the eds system.

Eligibility criteria:
inclusion criteria: * trans-tibial amputee * uses an iceform or willow wood alpha classic (uniform profile) liner * willing and able to participate in the study and follow the protocol * confident prosthetic users for more than 3 months * older than 18 years exclusion criteria: * participating in another research study * participants of another research study during previous 2 months.
ehr nudges to improve quality of care in hf

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: the purpose of this pilot feasibility study is to test a pharmacist-facing clinical decision support tool designed to increase adherence to guideline-directed medical therapy and evaluate the tool using the reach, effectiveness, adoption, implementation, and maintenance (re-aim) evaluation framework.

heart failure (hf) is a common, morbid, and costly condition with an enormous toll on health and the health care system in the us. unlike other hf types, for patients with hfref decades of high quality, randomized controlled trials have demonstrated numerous interventions-including medications, devices, and cardiac rehabilitation-that improve quality of life, lengthen survival, and reduce hospitalizations. despite the substantial evidence, many patients with hfref do not receive optimal guideline-directed medical therapy (gdmt) as shown by several us quality registries dating back to 2009. contributors to gaps in care quality have been shown to include patient-level (i.e., illness severity, race/ethnicity, socio-economic status), clinician-level (i.e., lack of knowledge, clinical inertia), and health system-level (i.e., lack of care coordination) factors. pharmacist-led clinics in several health systems and studies have been shown to lead to high rates of gdmt intensification. this finding is consistent with decades of research in hf and other conditions in which more resources allocated to disease management can improve quality of care. yet, little data exist on adherence to optimal gdmt after completion of an intensive disease management program. northwestern medicine is a large, integrated system that operates multiple pharmacist-led clinics to optimize gdmt in patients with hfref. once patients reach the maximum level of intensification, they complete the program and are no longer actively followed by the pharmacist team. the adoption of electronic health records (ehrs) and integration of novel data sources, such as prescription fill data from third-party vendors, create the opportunity to implement strategies to monitor adherence over time and intervene when adherence declines. clinical decision support nudges in the ehr are inexpensive strategies that have been shown in clinical areas outside of hf to increase adherence to evidence-based therapies. studies that use pharmacy fill data to monitor adherence to evidence-based care are rare given some of the technical challenges of accessing these data and using them for clinical decision support tools. in this pilot feasibility study, we aim to develop and test a pharmacist-facing clinical decision support tool designed to increase adherence to gdmt and evaluate the tool using the reach, effectiveness, adoption, implementation, and maintenance (re-aim) evaluation framework.

Eligibility criteria:
inclusion criteria: * pharmacist at northwestern medicine participating in the medication adjusted to target (mat) clinic exclusion criteria: * none

Keywords: heart failure heart failure, systolic quality of health care pharmacists medication adherence
a multi-center, multi-regional observational study to test the responsiveness of the validated musiqol (multiple sclerosis international quality of life questionnaire) instrument to edss status changes in any form of multiple sclerosis (ms) in patients with or without treatment

Conditions: Multiple Sclerosis

Summary: this is a multi-center, multi-regional observational,24 month study. health-related quality of life data from the musiqol instrument and sf-36 instrument will be collected at baseline, m6, m12, m18 and m24 in patients with ms. in addition, physical health outcomes such as expanded disability status scores (edss) will be collected every 6 months.

this is a multi-center, multi-regional observational,24 month study. health-related quality of life data from the musiqol instrument and sf-36 instrument will be collected at baseline, m6, m12, m18 and m24 in patients with ms. in addition, physical health outcomes such as expanded disability status scores (edss) will be collected every 6 months.

Eligibility criteria:
inclusion criteria: 1. patient has any form of ms (confirmed by mcdonald and/or poser criteria) 2. patient is 18 years old or more (inclusive, at time of informed consent). 3. patient has an edss score lower than 7.0 (inclusive, at time of informed consent) 4. patient can be with or without treatment 5. patient has read, understood, signed and dated informed consent form 6. patient is able to fill in the questionnaire by him/herself exclusion criteria: 1. cis patient (ms not confirmed by mc donald and /or poser criteria) 2. patient receives or is planned to receive during the course of this study any investigational drug or experimental procedure 3. patient suffers from dementia in the opinion of the investigator 4. patient suffers of major medical or psychiatric illness in the opinion of the investigator

Keywords: multiple sclerosis quality of life
zanubrutinib combined with standard chemotherapy in the treatment for patients with diffuse large b cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma; CD79A Gene Mutation; CD79B Gene Mutation

Summary: this is a prospective single arm, multi-center, phase ii clinical trial to observe the efficacy and safety of zanubrutinib combined with standard chemotherapy in the treatment for patients with diffuse large b cell lymphoma and cd79a/cd79b genetic abnormality.

diffuse large b cell lymphoma (dlbcl) is the most common type of non-hodgkin's lymphoma (nhl). currently, r-chop is world-widely used in the first-line treatment for dlbcl. there are about one second of patients suffering relapse and drug resistance. abc-dlbcl mainly relies on the chronical activity of bcr signal, which can activate the downstream nf-kb pathway through btk and myd88, thereby promoting the occurrence of tumors. a study by wyndham h wilson et al. showed that 23% of abc-dlbcl patients were accompanied by acquired functional mutations of the bcr component cd79a/cd79b. zanubrutinib is a new btk inhibitor. the goal of our trial is to assess the efficacy and safety of zanubrutinib combined with standard chemotherapy in the treatment for patients with diffuse large b cell lymphoma and cd79a/cd79b genetic abnormality.

Eligibility criteria:
inclusion criteria: 1. age between 18 to 75 years old (including 18 and 75) 2. diagnosed as diffuse large b cell lymphoma 3. cd79a/cd79b genetic abnormality 4. subjects with untreated or relapsed/refractory dlbcl 5. having at least one measurable lesions 6. world health organization-eastern cooperative oncology group performance status (ecog) 0-1 7. life expectancy no less than 3 months 8. enough main organ function 9. pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study 10. agreeing to sign the written informed consents exclusion criteria: 1. diagnosed as high-grade b-cell lymphoma, including non-specified and double-strike or triple-strike 2. diagnosed as grey-zone lymphoma 3. diagnosed as primary mediastinal large b-cell lymphoma 4. diagnosed as cd20 negative diffuse large b-cell lymphoma 5. active malignant tumor need be treated at the same time 6. other malignant tumor history 7. serious surgery and trauma less than two weeks 8. systemic therapy for serious acute/chronic infection 9. congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months 10. vaccination with live attenuated vaccine less than 4 weeks 11. hiv-positive, aids patients and untreated active hepatitis 12. patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months 13. patients with a history of mental illness 14. researchers determine unsuited to participate in this trial

Keywords: diffuse large b cell lymphoma zanubrutinib cd79a/cd79b genetic abnormality
a prospective cohort study of compound nanxing zhitong ointment

Conditions: Chronic Musculoskeletal Pain

Summary: the purpose of this study is to evaluate the safety and the efficacy of compound nanxing pain relief cream in the treatment of chronic pain in the musculoskeletal system

chronic pain, especially in the musculoskeletal system, is prevalent worldwide. many studies show the burdens they impose: pain, disability, reduced quality of life (qol), marked impairment of participation in work and social activities, and heavy financial costs.the purpose of this study is to evaluate the safety and the efficacy of compound nanxing pain relief cream in the treatment of chronic pain in the musculoskeletal system. to provide a safe and effective treatment of chronic musculoskeletal pain.

Eligibility criteria:
inclusion criteria: * attendance at orthopedic, rheumatology and pain clinics for. exclusion criteria: * indication for surgery.
shp2 inhibitor bbp-398 in combination with sotorasib in patients with advanced solid tumors and a kras-g12c mutation

Conditions: Solid Tumor, Adult; Metastatic Solid Tumor; Metastatic NSCLC; Non Small Cell Lung Cancer

Summary: this is a phase 1 study of bbp-398, a shp2 inhibitor, in combination with sotorasib, a kras-g12c inhibitor (kras-g12ci), in patients with a kras-g12c mutation. the study involves 2 parts: phase 1a dose escalation and phase 1b dose expansion/optimization.

the primary objectives for phase 1a dose escalation are to evaluate safety and tolerability, and recommend a phase 1b dose (rp1bd) of the combination. the primary objectives for phase 1b dose expansion/optimization are to evaluate safety and tolerability, and the antitumor activity (defined by the orr assessed by the investigator according to recist v1.1) of bbp-398 when used in combination with sotorasib across two dose regimens in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with a kras-g12c mutation and who are kras-g12ci naïve, and recommend a phase 2 dose (rp2d) of the combination.

Eligibility criteria:
key inclusion criteria: * patients must have histologically documented, locally advanced and unresectable, or metastatic solid tumor with documentation of a kras-g12c mutation within 2 years prior to screening. * patients must have measurable disease by recist v1.1. * patients must have a minimum life expectancy of \>12 weeks after start of study treatment. * patients must have progression or disease recurrence on or after all available standard of care therapies. * patients must have an eastern cooperative oncology group (ecog) performance status (ps) 0-1. * patients must have adequate organ function. key exclusion criteria: * patients that have participated in an interventional clinical study within the last 4 weeks. * patients that have received radiotherapy or proton therapy with a limited field of radiation for palliation within 1 week of the start of study treatment, or radiation to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the start of study treatment. * patients with untreated and/or active cns metastases. * patients that have a history of allogenic bone marrow transplant.

Keywords: kras-g12c mutation shp2 mapk-pathway alterations nsclc
fetal heart rate variability

Conditions: Fetal Growth Retardation

Summary: need statement - a new way to distinguish between a healthy small fetus and a small fetus suffering from deprivation of nutrition and oxygen to prevent unnecessary induction of preterm birth and improve neonatal outcome. aim - to characterize fetal heart rate variability (fhrv) based on fetal ecg in the normal fetus and in the fetus suffering from growth retardation to evaluate its value and applicability as a supplementary tool in fetal surveillance. aim of current study - to evaluate the feasibility of ni-fecg from gestational week 20 and onwards and investigate if important factors as length and heart rate pattern affects repeatability of time domain and spectral analyses in fetuses.


Eligibility criteria:
inclusion criteria: • healthy singleton pregnancies exclusion criteria: • fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor.
a study of breath testing for small intestinal bacterial overgrowth

Conditions: Gastroesophageal Reflux; Regurgitation; Heartburn

Summary: researchers hope to determine how often small intestinal bacterial overgrowth occurs after taking proton pump inhibitors.


Eligibility criteria:
inclusion criteria: * predominant symptoms of gastroesophageal reflux disease including heartburn, regurgitation * subjects must be able to give appropriate informed consent exclusion criteria: * prior diagnosis of sibo * use of ppis or h2r-anatagonstists in the prior 3 months * major concomitant illness (renal, hepatic, rheumatologic or cardiovascular disease, or malignancy) * antibiotic therapy within one month * prior gastrointestinal surgery including esophageal, gastric, and small or large bowel surgery * previously diagnosed irritable bowel syndrome or inflammatory bowel disease * individuals who are pregnant or breast feeding * patients with plans to become pregnant * inability to take ppis, including allergy/sensitivity

Keywords: proton pump inhibitor