Kornimate/medical-research-clean huggingface dataset:
effect of lumbar proprioception training on primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: the aim of this study will be to investigate the effect of lumbar proprioception training on primary dysmenorrhea.

although previous studies reported the effect of physiotherapy practices through therapeutic exercises on primary dysmenorrhea as core muscles strengthening, core stability exercises, connective tissue massage and classical massage, relaxation, strengthening, stretching, aerobic exercises, pelvic floor muscle strengthening exercises, yoga and pilates. none of them have investigated the effect of lumbar proprioception training on primary dysmenorrhea. therefore, this study will be the first one which aims to investigate the effect of lumbar proprioception training on primary dysmenorrhea. this trial will include 2 groups; group a composed of 20 females that will receive hot packs and pelvic rocking exercises for 4 weeks and group b also composed of 20 females that will receive hot packs and pelvic rocking exercises in addition to lumbar proprioception training for 4 weeks.

Eligibility criteria:
inclusion criteria: * all females will have moderate to severe primary dysmenorrhea (as determined by walidd scale). * their ages will range from 18 to 22 years old. * all females will be virginal and non-smokers. * their bmi will be range from 20-25 kg/m2 * they have regular menstrual cycle with menstrual cycle length of 28-30 days. * they have persistent primary dysmenorrhea of more than 6 months exclusion criteria: * they shouldn't have musculoskeletal or neurological disorders, chronic lbp or sacroiliac dysfunction, diabetes, pelvic pathology or any gynecological disease. * they shouldn't experience a stressful event in the last 6 month. * attending regular exercise training in the last 6 months. * taking medications or vitamin and mineral supplements due to other medical conditions.

Keywords: lumbar proprioception training pelvic rocking exercises primary dysmenorrhea
safety study of a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-ipv2 hd) in infants early in life

Conditions: Polio

Summary: phase ii, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and impact on intestinal shedding of a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-ipv2 hd) or a single dose of standard trivalent inactivated poliovirus vaccine (t-ipv) when given concomitantly with the third dose of bivalent oral poliovirus vaccine (b-opv) to infants early in life


Eligibility criteria:
inclusion criteria: 1. age: 6 weeks (-7 to +14 days). 2. healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination. 3. written informed consent obtained from 1 or 2 parents or legal guardian as per panama regulations. exclusion criteria: 1. previous vaccination against poliovirus. 2. low birth weight (bw \<2,500 gm). 3. any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (hiv) infection. 4. family history of congenital or hereditary immunodeficiency. 5. major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine). 6. known allergy to any component of the study vaccines. 7. uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections. 8. administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. 9. acute severe febrile illness at day of vaccination deemed by the investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met.). 10. member of the subject's household (living in the same house or apartment unit) has received opv in the last 3 months. 11. subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
prospective observational study evaluating treatment decision impact of prosigna® in early stage breast cancer patients

Conditions: Breast Cancer

Summary: this multicenter, prospectively designed study examines whether the prosigna score influences physician and patient adjuvant treatment selection over and above currently used prognostic factors. this study also examines the impact of the test results on patients' reported outcomes, including their decisional conflict status and anxiety levels.

the primary objective of this study is to assess the extent to which the prosigna test results affect the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early stage breast cancer conventionally considered candidates for genomic testing based on current treatment guidelines. the oncologist's initial recommendations will be based on the utilization of tools or algorithms based on clinical and pathologic factors. no genomic tools will be used in the initial assessment. changes in recommendation after availability of prosigna test results will include (1) hormonal therapy alone or (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the test.

Eligibility criteria:
inclusion criteria: * surgically resected node-negative, estrogen receptor-positive, her2-negative early-stage invasive breast cancer (t1-t2, n0, pn0 (i+), pn0 (mol+), m0) 1. estrogen receptor status will be evaluated by immunohistochemistry (ihc) and more than 1% of stained tumor cells will be considered positive. 2. her2 status will be evaluated by ihc and/or by in-situ fluorescence hybridization (0 or 1+, or 2+ will be considered negative in the absence of in-situ fluorescence hybridization). * postmenopausal females, which is defined as: 1. natural amenorrhea \> 12 months, regardless of age 2. bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study) 3. radiological castration with amenorrhea \> 3 months, regardless of age 4. hysterectomy and postmenopausal blood levels of fsh/lh * able to give informed consent * eligible for treatment of breast cancer with adjuvant chemotherapy, as determined by the treating physician * ecog performance status of 0 or 1 exclusion criteria: * tumor specimen from core needle biopsy (cnb) * tumor stage t3-t4 * non-invasive breast cancer (e.g., paget's disease, dcis) * tumors with nodes that are not n0, pn0 (i+), or pn0 (mol+) * tumors that are estrogen receptor (er) negative or her2-positive * have metastatic disease * have received another genomic test for prognosis of early breast cancer (i.e., oncotype dx, mammaprint, or bci) * unable to give informed consent * unable to complete patient reported outcome surveys * have contraindications for adjuvant chemotherapy, as determined by the treating physician o age, performance status, significant comorbidities, etc. * ecog performance status \> 1

Keywords: prosigna estrogen receptor positive node negative her2 negative
radiofrequency for chronic knee pain post-arthroplasty

Conditions: Chronic Knee Pain; Osteoarthritis, Knee

Summary: chronic knee osteoarthritis (oa) is one of the most common diseases with increasing prevalence in advanced age. knee oa results in movement restriction, sleep disturbance, and disability. total knee arthroplasty (tka) is employed often in the symptomatic treatment of knee oa. it has been estimated that 3.4 million tkas will be performed in the year 2030 in the united states alone. many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty. the purpose of this study is to evaluate whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain.

chronic knee osteoarthritis (oa) is one of the most common diseases with increasing prevalence in advanced age. knee oa results in movement restriction, sleep disturbance, and disability. total knee arthroplasty (tka) is employed often in the symptomatic treatment of knee oa. it has been estimated that 3.4 million tkas will be performed in the year 2030 in the united states alone. many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty. as the prevalence of knee arthroplasty increases, so does the frequency of revisions. it has been found that 20% of patients reporting painful knee arthroplasties were not able to be diagnosed with a specific cause and were therefore referred to a pain specialist. pharmacologic therapy and non-surgical interventions are often employed with minimal benefit to the patient's level of disability as indicated by clinical evidence. genicular radiofrequency ablation seems to be a safe, effective and minimally invasive therapy for chronic knee oa patients who have had a positive diagnostic block. no study has determined whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain. the investigators propose to examine the effect of genicular radiofrequency ablation in chronic post-arthroplasty knee pain in patients who respond positively to diagnostic nerve blocks.

Eligibility criteria:
inclusion criteria: * study candidate must provide written informed consent. * must be ≥ 50 years of age at the time of consent * chronic knee pain despite total knee arthroplasty at least 6 months prior to consent * orthopedic evaluation indicating no further surgery is warranted * stable pain medication regimen for 30 days prior to baseline visit * knee pain is primary pain complaint exclusion criteria: * acute knee pain * connective tissue disorders affecting the knee * serious neurologic or psychiatric disorders that would affect the outcome of the study as determined by the principal investigator * steroid or hyaluronic acid injections into the affected knee in the past 3 months * confounding pain conditions of the index leg that may affect medication requirements or study outcomes

Keywords: genicular radiofrequency ablation knee arthroplasty, total
compare the efficacy and safety of 48-week treatment with clevudine 30mg versus lamivudine 100mg for chb infection

Conditions: Hepatitis B

Summary: the purpose of this study is to compare the efficacy and safety of 48-week treatment with clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis b infection.


Eligibility criteria:
inclusion criteria: 1. patient is between 18 and 60, inclusive. 2. patient is hbv dna positive with dna levels at screening \>= 3 x 1,000,000 copies/ml. 3. patient is documented to be hbsag positive for \> 6 months and hbeag positive. 4. patient has ast and alt levels which are \>= 1 times and \<= 10 times the upper limit of normal (x uln). 5. patient has bilirubin levels \ 1.5 x uln with diagnosis of gilbert's disease and conjugated bilirubin within normal limits. 6. women of childbearing age must have a negative urine (b-hcg) pregnancy test before start of trial treatment. 7. patient is able to give written informed consent prior to study start and to comply with the study requirements. exclusion criteria: 1. patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy. 2. patients previously treated with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for hbv infection. 3. previous treatment with interferon must have ended at least 6 months prior to the screening visit. 4. patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy. 5. patient is co-infected with hcv or hiv. 6. patient has evidence of decompensated cirrhosis or hepatocellular carcinoma (alpha fetoprotein). 7. patient is pregnant or breast-feeding. 8. patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases. for males, condoms should be used. females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal, or using at least a medically acceptable barrier method of contraception (i.e., iud, barrier methods with spermicide or abstinence). 9. patient has a clinically relevant history of abuse of alcohol or drugs. 10. patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease. 11. subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening visit. 12. subjects who are taking any traditional chinese medication, or has been taking any traditional chinese medication within the last 2 weeks prior to screening visit. 13. any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
thiol/disulphide homeostasis and vascular endothelial growth factor levels in diabetic children

Conditions: Periodontal Diseases

Summary: the aim of this study to evaluate the vascular endothelial growth factor level and thiol/disulphide homeostasis in saliva of diabetic children with gingivitis.

eighty children (44 with type 1 diabetes mellitus and 44 systemically healthy) will be recruited for the study. the children will be divided into four subgroups based on their periodontal and systemic condition: 1) systemically and periodontally healthy children, 2) systemically healthy children with gingivitis, 3) periodontally healthy children with t1dm, and 4) children with t1dm and gingivitis. the plaque index, gingival index, probing pocket depth, will recorded. the vascular endothelial growth factor level determined by elisa. native thiol, total thiol and disulphide levels will be measured in saliva.

Eligibility criteria:
inclusion criteria: * children diagnosed as type 1 diabetes mellitus * age between 7-14 years exclusion criteria: * having another systemic problem except type 1 diabetes mellitus * children carrying orthodontic appliances

Keywords: type 1 diabetes mellitus
oncological safety of oncoplastic breast surgery in multicentric breast cancer

Conditions: Safety of Breast Coservative Multicenteric Breast Cancer; Breast Neoplasms; Breast Cancer; Multicentric

Summary: the purpose of the study is to evaluate oncological safety of oncoplastic breast surgery in multicentric breast cancer

breast cancer is the most prevalent cancer in women worldwide, accounting for about 23.8%. multifocal and multicentric breast tumors are defined as two or more neoplasms separated in one breast. in multifocal tumors, a quarter of the breast is involved while in multicentric tumors, two quarters or more are involved. there is no exact radiological definition, but the distance between the multifocal tumors is less than or equal to 5 cm, whereas the distance between multicentric tumors is 5 cm, or more. due to increasingly use of more developed imaging methods such as tomosynthesis, magnetic resonance imaging (mri) in these patients, we face more mf/mc breast cancer cases. it is seen that mf/mc breast cancer incidence ranges from 6% to 75% in different series. breast-conserving surgery (bcs) and radiotherapy have been adopted as the main treatment methods for early breast cancer. however, there are some studies stating that bcs carries risks for local recurrence in patients with mf/mc breast cancer. oncoplastic breast conservation (obc) relies on applying plastic surgery principles within the context of sound oncological resection. volume-reducing or volume- replacing methods are utilised to optimise postoperative appearances whilst prioritizing negative margin resection, supported by prompt adjuvant therapy. in fact, it is agreed that in cases where more than 20% of the breast tissue must be excised for oncological margin clearance, oncoplastic surgery is likely to require more complex techniques.this may allow larger specimens to be resected than in traditional breast conservation surgery, but with comparable histopathological properties to those who would be offered mastectomy. previous work has suggested that as such, obc should be regarded as a separate entity from breast conservation therapy, and that direct comparison with mastectomy outcomes should be performed to inform decision-making amongst clinicians and with patients when planning for surgery.

Eligibility criteria:
inclusion criteria: * female patients with multicentric breast cancer * female patient aged from 18 to 65 years old * patients who are fit for general anesthesia. * patients who provide a written informed consent. * patient who agree to provide short term outcome data and agree to provide contact information to provide contact information exclusion criteria: * female patients less than 20 years old * stage 4 breast cancer * patients who are contraindicated for radiotherapy * pregnant patients in first trimester * patient with inflammatory carcinoma

Keywords: breast conservative surgery
dose escalation study to evaluate the safety and antiviral activity of val-mcyd in adults with chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: this study was conducted to determine the safety, tolerance, pharmacokinetics and antiviral activity of val-mcyd at doses ranging from 50 mg to 800 mg per day.


Eligibility criteria:
inclusion criteria: * documented clinical history of chronic hepatitis c and compensated liver disease * no antiviral treatment for hepatitis c in the 6 months prior to the screening visit other protocol-defined inclusion criteria may apply. exclusion criteria: * patient is pregnant or breastfeeding * patient is co-infected with hbv or hiv other protocol-defined exclusion criteria may apply.
cediranib (azd2171, recentin™) in addition to chemotherapy in patients with untreated metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to determine if cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: * written informed consent * carcinoma of the colon or rectum * one or more measurable lesions exclusion criteria: * adjuvant/neoadjuvant therapy within 6-12 months of study entry * untreated unstable brain or meningeal metastases * specific laboratory ranges * specific cardiovascular problems * participation in other trials within 30 days

Keywords: colorectal cancer cediranib recentin
predictors of inhaled nitric oxide responsiveness in patients with pphn

Conditions: PPHN; Hypoxic Respiratory Failure

Summary: to identify biochemical, clinical, or genetic biomarkers that may predict responsiveness to ino in neonates with pphn/hrf. the primary outcome will be identification of any biomarker(s) associated with response to ino therapy. we will evaluate related biomarkers at various time-points during disease progression and in response to therapy, including single nucleotide polymorphisms in the cyclic adenosine monophosphate/cyclic guanosine monophosphate-phosphodiesterase (pde) pathway, indicators of metabolic dysregulation and inflammation, as well as biochemical markers of heart strain. we will perform targeted neonatal echocardiograms to evaluate severity of pphn and heart function both as an added clinical biomarker and to follow disease progression.

a single-center, prospective observational cohort study evaluating potential biochemical, clinical, and/or genetic biomarkers in neonates admitted with a diagnosis of pphn that may predict ino response. thus, it is important to collect data prior to the initiation of ino to be able to identify biomarkers that can predict response. for patients who meet the screening criteria and when consent is not attainable prior to initiation of the potential life-saving ino therapy, then samples will be obtained with deferred written informed parental consent obtained within the first 4 hours after enrollment. these patients will have one sample of blood, urine, and tracheal aspirate (if available) collected. if the patient meets the inclusion and exclusion criteria, the patient will be recruited for study participation. to ensure no delay in care or in the initiation of the only fda-approved vasodilator for this population, ino, a deferred written informed parental consent is requested to allow for the collection of blood, urine, tracheal aspirate specimens (if available) prior to the initiation of ino. only one sample of blood and tracheal aspirate specimens will be collected prior to the deferred consent. samples are often collected during the routine collections that are obtain from patients who are critically ill such as in our study participants, therefore, no additional discomfort will be expected from this study. urine collection will be from cotton ball collection that would normally be discarded and is noninvasive. all data and biospecimens obtained from eligible infants whose parent(s) decline consent or do not qualify for the study will be discarded.

Eligibility criteria:
inclusion criteria: 1. greater than 34 weeks gestational age. 2. less than or equal to 10 postnatal days of age. 3. echocardiographic evidence of pphn (right-to-left or bidirectional shunt at the foramen ovale or the ductus arteriosus and/or severe tricuspid regurgitation) exclusion criteria: 1. lethal congenital anomalies, obvious syndromic or chromosomal disorders. 2. congenital diaphragmatic hernia. 3. congenital heart defect (except a small atrial septal defect, ventricular septal defect, and/or pda).
knee nerve cryoneurolysis and impact on pain after prosthetic surgery

Conditions: Knee Injuries

Summary: interventional, comparative, randomized, controlled study versus standard treatment, in 3 parallel groups, monocentric, aiming to demonstrate the superiority of preoperative cryoneurolysis versus no procedure, in patients operated on for knee arthroplasty and receiving standard analgesia.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and ≤ 80 years; * patient to undergo prosthetic knee surgery; * patient in good health (asa score 1 to 3); * patient able to understand the information related to the study, read the information leaflet and agree to sign the consent form. exclusion criteria: * known intolerance to any of the products administered during surgery or cryoneurolysis; * patient with an electric implant; * patient with a contraindication to cryoanalgesia (coagulation disorders, infections, nerve damage); * drug addict patient; * intervention on septic bone; * chronic renal failure (creatinine clearance \<30 ml / min); * history of cryoglobulinemia, cold urticaria or raynaud's syndrome; * pregnant or breastfeeding woman; * patient under guardianship or curatorship, or under a regime of deprivation of liberty; * patient participating in another clinical trial, or in a period of exclusion from another clinical trial; * patient not beneficiary of a social security scheme.