Kornimate/medical-research-clean huggingface dataset:
minimally invasive versus open scarf osteotomy for hallux valgus correction: a randomized controlled trial

Conditions: Hallux Valgus and Bunion (Disorder)

Summary: the purpose of this study was to compare a minimally invasive scarf technique and the well-established open scarf technique for correction of hallux valgus deformity.

hallux valgus surgery is a common procedure being the open scarf osteotomy, one of the most studied techniques for correction of the hallux valgus. it is widely reported its capacity to reduce the angle of the first metatarso-phalangeal joint. minimally invasive scarf (mis) technique has been designed to decrease the soft tissue damage and postoperative pain. this procedure does not require ischemia, being able to do under local anesthesia and sedation. this technique is more suitable for outpatient surgery. there is a lack of studies comparing both techniques, and our purpose is to do a prospective comparative study among the two approaches of the scarf osteotomy: open vs mis.

Eligibility criteria:
inclusion criteria: - patients undergo hallux valgus surgery exclusion criteria: * intermetatarsal angle \>20º * previous hallux valgus surgery * metatarsalgia of the lesser rays that requires an osteotomy during the surgical procedure * 1st cuneometatarsal instability * infection * vascular ischemia * neuropathy

Keywords: scarf minimally invasive surgery hallux valgus
the effects of yoga training in ankylosing spondylitis patients

Conditions: Ankylosing Spondylitis; Yoga

Summary: the aim of the study is to investigate the effect of yoga training on functional level, disease activity, spinal mobility, balance, sleep quality, depression and quality of life in as patients.

yoga is an ancient indian practice, dating back several thousand years, with objective of uniting mind, body, and spirit. in western cultures, hatha yoga is most commonly practiced, and generally includes a set of physical poses(asanas), breathing techniques(pranayama) and deep relaxation(savasana).yoga has been shown to increase mobility, reduce pain, and improve quality of life in many diseases. however, there is no study examining the effects of yoga training in as patients.therefore, the aim of this study is to investigate the effects of yoga training in as patients. 60 as patients aged 20-60 years will be randomly assigned to yoga or control group. home exercises will be taught to both groups, and a brochure with home exercises will be given. the yoga group will participate in a yoga class 3 days a week, during 8 weeks. the control group will not participate in a yoga class, only will do home exercises. assessments will be done at baseline and after 8 weeks.

Eligibility criteria:
inclusion criteria: * ankylosing spondylitis(as) patients diagnosed according to modified new york criteria * to be volunteer exclusion criteria: * the presence of peripheral enthesitis, orthopedic disorders, cardiovascular disorders, neurological disorders, visual and auditory deficits, * history of surgery for spine or lower limb, * failure to complete the test

Keywords: ankylosing spondylitis yoga
a study to investigate ans03 in participants with locally advanced or metastatic solid tumors

Conditions: Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration

Summary: this is a first-in-human phase i, multi-center, open-label study of ans03 in patients with advanced solid tumors. the study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ans03 as monotherapy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * eastern cooperative oncology group (ecog) performance status: 0-2 * life expectancy ≥ 12 weeks * measurable disease per recist v1.1 * adequate organ and marrow function as defined in the protocol * with documentation of ros1 or ntrk alteration exclusion criteria: * active infection including tuberculosis and hbv, hcv or hiv * known active or untreated cns metastases * participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression * participants with serious cardiovascular or cerebrovascular diseases

Keywords: ros1/ntrk ans03
optical spectroscopy during breast cancer surgery and core needle biopsy

Conditions: Breast Cancer

Summary: the objective of the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an adjunct to core needle biopsy. for the surgery part of the study, all patients scheduled to have a mastectomy or lumpectomy for the treatment of breast cancer will be asked if they would be willing to participate in this study. for the core needle biopsy part of the study, patients with a higher pre-probability of cancer (based on mammography) will be recruited to increase the number of patients with malignant lesions and enrolled in this investigation.


Eligibility criteria:
inclusion criteria: * patients having a needle biopsy of a breast mass exclusion criteria: * none

Keywords: breast cancer breast biopsy reduction mammoplasty
expanded access to okn-007 for patients with diffuse midline glioma, h3 k27-altered

Conditions: Diffuse Midline Glioma, H3 K27M-Mutant; Diffuse Intrinsic Pontine Glioma

Summary: to provide okn-007 for compassionate use in patients with diffuse midline glioma, h3 k27-altered (dmg), including diffuse intrinsic pontine glioma (dipg), pediatric and young adult patients with high-grade diffuse midline glioma will be treated under this intermediate-sized expanded access treatment protocol.


Eligibility criteria:
inclusion criteria: 1. age from \> 12 months to ≤ 18 years of age at the time of enrollment. 2. diagnosis of diffuse midline glioma, h3 k27-altered according to the who 2021 classification of tumors of the central nervous system diagnostic criteria including diffuse intrinsic pontine glioma (dipg). in the absence of a pathologically confirmed diagnosis, a grade iv glioma involving the thalamus, hypothalamus, brainstem, cerebellum, midbrain, or spinal cord, or with a pontine epicenter and diffuse involvement of the pons. 3. patient has completed definitive radiation therapy as part of standard-of-care treatment or was unable to undergo radiation. 4. karnofsky performance status ≥ 50 for patients ≥ 16 years of age and lansky performance status ≥ 50 for patients \< 16 years of age; patients who are unable to walk because of paralysis, but who are upright in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. 5. patients must have adequate bone marrow, liver, and renal function: 6. for females of childbearing potential, negative urinary or serum pregnancy test. 7. patients must be willing to highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration. 8. toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant 9. ability to understand a written informed consent document, and the willingness to sign it. assent will be obtained when appropriate based on the patient's age. exclusion criteria: 1. patient is already participating in or qualifies for and is able to enroll in a clinical trial of okn-007 and other ongoing clinical trials. 2. patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting okn-007 treatment, whichever is shorter. 3. patients completing radiotherapy treatment less than 14 days prior to planned study treatment initiation. 4. current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with okn-007 due to safety concerns. 5. patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with okn-007. 6. known hypersensitivity to okn-007 or any component in its formulation. 7. patients taking prohibited medications as described in the current investigator's brochure. 8. patient is pregnant or actively breastfeeding.
acceptability and feasibility of human papilloma virus vaccine

Conditions: Cervical Cancer

Summary: the overall program goal is to determine the acceptability and feasibility of introducing a population based human papilloma virus (hpv) vaccination programme and understanding the key individual and community factors that would determine the potential acceptability of the vaccine.

the eligible participant will be chosen by door-door household visit. each participant will be given information regarding the study and written informed consent will be obtained from them. their participation will be entirely voluntary and no pressure or coercion will be used. our team will help them with questions that are not well understood by them or are ambiguous for them. the questionnaire is in 2 sections. section one will try and ascertain the mother's knowledge, attitude and perception regarding cervix cancer, hpv infection and hpv vaccination. section 1 will be interviewed for a period of 5-10 minutes followed by an information sheet providing details on hpv infection, its association with cervix cancer and hpv vaccination against cervix cancer. the information sheet available will be explained to them for a period of 10-15 minutes. our social workers will be available at all times to allay their misinterpretations. this will be followed by section 2 which will be a post intervention questionnaire comprising of questions regarding their attitude towards hpv vaccination and identifying barriers and motivators for these women towards vaccination. the post-intervention questionnaire would be interviewed for a period of 10-15 minutes, thus a total of 25-40 minutes will be made available to every participant for the entire session. the team is expected to cover 15 women per day totaling to 300 women per month considering the monthly holidays and time lost in certain administrative issues. patients will be recruited for 4 months which will be followed by data entry, data analysis, formulation of results and write -up. thus the entire study will last for eight months. the questionnaire consists of mostly close ended questions with options in the form of yes/no/do not know. some questions which require definitive answers have been provided with plausible options. some questions have been left open ended so as to avoid ambiguity. the questionnaire is simple, in continuity and is translated into hindi and marathi languages so as to meet the needs of the local population.

Eligibility criteria:
inclusion criteria: all married women bearing daughters of the age group 10-18 years and are conversant in either marathi, hindi or english will be included in the study. exclusion criteria: women with no children or with daughters outside the 10-18 yrs age group have been excluded.
the acute effect of physical activity on blood glucose in pregnant women

Conditions: Gestational Diabetes

Summary: the aim of the project is to investigate the acute effect of exercise on blood glucose after glucose consumption. thereby we wish to achieve knowledge that can improve prevention and treatment of gestational overweight and gestational diabetes mellitus (gdm). this will prevent serious complications during pregnancy and birth, but also long term complications like type 2 diabetes mellitus (t2dm) for both the mother and the offspring. 15 pregnant participants will perform two oral glucose tolerance tests (ogtt). one is followed by physical activity and the other is followed by inactivity and will serve as control. blood glucose will be monitored continuously during the study.

cases: 15 pregnant women recruited at the routine ultrasound scan at gestational week 19 at the department of obstetrics and gynecology, aarhus university hospital. subjects will receive both written and oral information before entering the trial. subjects with a prepregnancy bmi \> 27 and no other risk factors of diabetes will be included in the study. the women will be examined during gestational week 27-30 where the routine oral glucose tolerance test (ogtt) will take place. the routine ogtt will serve as control. intervention: the subjects will perform two ogtt separated by a minimum of two days. one - the regular ogtt will serve as control and the second ogtt will be the intervention. the two days in between will function as a "wash out period" to avoid potential carry over effect. during the ogtt subjects will consume a liquid containing 75g of glucose. the control ogtt will be followed by inactivity. the intervention ogtt will be immediately followed by 20 minutes of exercise on a bicycle ergometer with a fixed intensity. study variables: blood glucose will be monitored continuously using the ipro2 continous glucose monitor (cgm) from medtronic. a sensor is inserted into interstitial fluid and continuously generates an electrical current proportional to the glucose concentration. a recorder stores the average sensor current every 5 minutes. in both control and intervention, blood tests will be taken at time 0, 1 and 2 hours after the ogtt. blood samples will be analyzed for blood glucose, hba1c, c-peptide and insulin. data on demography, family history of diabetes, prepregnancy bmi, gestational weight gain and complications during pregnancy are collected from medical records of the patients and their offspring.

Eligibility criteria:
inclusion criteria: * prepregnancy bmi \> 27 exclusion criteria: * physical disability that affect movement
effects of trunk exercise on trunk control and balance in persons with stroke

Conditions: Cerebrovascular Accident; Balance Impairment

Summary: this study examined the effects of trunk exercise on unstable surfaces on trunk control and balance for persons in the sub-acute stage of stroke. the hypothesis was that, compared to upper limb exercises in well supported sitting position, this exercise would lead to better trunk control and sitting and standing balance. the results supported the hypothesis.

inpatients in the sub-acute stage of stroke were randomly assigned to receive upper limb range of motion exercises in well supported sitting position or trunk exercises on unstable surfaces in supine and sitting, 30 min per session, 2 sessions per week for 6 weeks, in addition to their daily conventional stroke rehabilitation. sensorimotor functions, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and fugl-meyer lower extremity motor scale, and clinical outcome assessments, including trunk impairment scale and 6-meter walk test, were conducted by a blinded assessor. biomechanical outcome measures included center of pressure area while maintaining static posture and peak displacement while leaning forward, and the average speed of the unaffected arm raising (to represent the ability to provide a stable foundation for focal movement). these measures were taken in sitting without foot support, sitting with foot support and standing to reflect trunk control, sitting balance and standing balance, respectively.

Eligibility criteria:
inclusion criteria: * age: between 20-80 years old * first time stroke * could sit without back support at least 20 seconds * could understand and follow experimental instructions exclusion criteria: * medically unstable * other neuromuscular/musculoskeletal problems that would affect balance

Keywords: stroke balance trunk exercise trunk control standing
efficacy and safety of js016 in patients with sars-cov-2 infection (covid-19)

Conditions: COVID-19; SARS-CoV-2

Summary: the human monoclonal antibody cb6 showed potent neutralization activity in vitro against sars-cov-2. cb6-lala (also called js016) has been developed for clinical use. phase i trials among healthy volunteers has demonstrated a tolerable and safe drug profile of js016. we aim to evaluate the efficacy and safety of js016 in patients hospitalized with covid-19.

as the covid-19 pandemic is emerging as a global healthcare crisis, scientists worldwide are actively developing prophylactic and therapeutic interventions. neutralizing antibody therapies are being developed for the treatment of covid-19. the human monoclonal antibody cb6 showed potent neutralization activity in vitro against sars-cov-2. the lala mutation was introduced to the fc portion of cb6 (cb6-lala) to lower the risk of fc-mediated acute lung injury in animals. cb6-lala (also called js016) has been developed for clinical use. phase i trials among healthy volunteers has demonstrated a tolerable and safe drug profile of js016. we aim to evaluate the efficacy and safety of js016 in patients hospitalized with covid-19. the data from this study will inform decisions of the clinical use of js016.

Eligibility criteria:
inclusion criteria: * severe acute respiratory syndrome coronavirus2 (sars-cov-2) infection * within 7 days from the onset of clinical symptoms or 4 days from the onset of severe symptoms * consistent with the national health committee new coronavirus pneumonia diagnosis and treatment plan (eighth edition), general or heavy diagnostic criteria. exclusion criteria: * sever covid-19 infection patients * sars-cov-2 specific antibodies (including igm and igg) were positive before included * cardiac function grade iii or iv, or left ventricular ejection fraction \< 30% * history of known or suspected active pulmonary tuberculosis or extra-pulmonary tuberculosis * chronic renal failure needs maintenance dialysis * history of solid malignant/tumor or hematological malignancy * pregnancy or lactation

Keywords: covid-19 js016 spike (s) protein sars-cov-2
comparison of unilateral or bilateral fixation in the treatment of lfs

Conditions: Lumbar Foraminal Stenosis

Summary: tlif is a popular lumbar fusion technique to perform interbody fusion. pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. conventionally, bilateral pedicle screw fixation is a standard approach. recently, studies have revealed that unilateral pedicle screw fixation provides equivalent clinical outcomes and fusion rates as compared with bilateral pedicle screw fixation in lumbar fusion. meanwhile, the unilateral approach can reduce intraoperative blood loss and operating time. to our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented tlif in lumbar degenerative diseases have been reported. the purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar foraminal stenosis using instrumented tlif with unilateral or bilateral pedicle screw fixation.


Eligibility criteria:
inclusion criteria: * signed informed consent. * patient is willing to be available for each examination scheduled over the study duration. * lumbar foraminal stenosis diagnosed by patient history, physical examination and image confirmation. * patient has symptoms referable to the stenosis level (low back pain, leg pain, tingling, numbness or weakness), which are relieved after a selective nerve root block. * has not responded to conservative treatment for a period of 3 months (e.g. bed rest, physical therapy, medication, manipulations, other). exclusion criteria: * has systemic infection, highly communicable diseases, inflammatory or autoimmune disease (e.g. osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, hiv/aids, active tuberculosis, venereal disease, active hepatitis). * has presence of active malignancy * has a history of severe allergy * has a significant medical history that, in the investigator's opinion, would not make them a good study candidate. * pregnant, or may become pregnant within follow-up period of study * has other spinal conditions that will interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease) * spondylolisthesis at the target level * has undergone previous lumbar surgery * has severe osteoporosis (t-score ≤ -3.5) * bmi \> 35kg/m2 * has a diagnosis, which requires postoperative medication that interferes with fusion, such as steroids. * has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. paget's disease, renal osteodystrophy, ehlers-danios syndrome or osteogenesis imperfecta)
postprandial ihl and imcl measured with proton magnetic resonance spectroscopy

Conditions: Postprandial IHL and IMCL Dynamics

Summary: the major research objective is to assess the potential of proton magnetic resonance spectroscopy to follow intrahepatic lipid and intramyocellular lipid dynamics after a single meal. furthermore we aim to investigate whether the addition of protein to a high fat breakfast results in a reduced postprandial accumulation of lipids when compared to a high fat breakfast alone.

fat accumulation in non-adipose tissue, such as liver and muscle, is associated with reduced insulin sensitivity and cardiovascular disease. little is known about the dietary determinants and the time course of this ectopic fat accumulation. therefore the general aim of this project is to develop and validate methodology to follow postprandial hepatic and muscular lipid retention. proton magnetic resonance spectroscopy (1h-mrs) is a well-established tool for noninvasive quantification of intrahepatic lipids (ihl) and intramyocellular lipids (imcl). previous studies have suggested a relatively rapid regulation of ihl and imcl levels, indicated by changes in these total lipid pools after high fat diets of 3 or 4 days. although ihl and imcl levels seem to change rapidly, data on ihl and imcl levels after a single meal are lacking.

Eligibility criteria:
inclusion criteria: * age 18-40 years * healthy * stable dietary habits * no use of medication * lean subjects: bmi 18-25 kg/m2 * obese subjects: bmi 30-35 kg/m2 exclusion criteria: * any medical condition requiring treatment and/or medication use * alcohol consumption of more than 20 g per day (± 2 units) * smoking * unstable body weight (weight gain or loss \> 3 kg in the past three months) * participation in another biomedical study within 1 month prior to the screening visit * contraindications for mri scan: * central nervous system aneurysm clips * implanted neural stimulator * implanted cardiac pacemaker of defibrillator * cochlear implant * iron- containing corpora aliena in the eye or brain * hearing aids and artificial (heart) valves which is contraindicated for mrs * claustrophobia