Kornimate/medical-research-clean huggingface dataset:
high dose versus standard dose of ribavirin in patients with chronic hepatitis c, genotype 3

Conditions: Chronic Hepatitis C

Summary: the rate of sustained virological response (svr) in patients with chronic hepatitis c, genotype 3, high viral load and without rapid virological response (rna-hcv negative at week 4) is low. standard of care of these patients include treatment with weekly peginterferon plus 800 mg/day of ribavirin (rbv). extended treatment to 48 weeks does not provide more clinical benefit than the standard duration. the main hypothesis is that higher dose of ribavirin may be better in terms of svr than the standard dose.

aims: 1. efficacy 1.1) rate of rna-hcv negative at week 4 and 24 in each arm. 1.2) rate of svr in each arm. 2. safety 2.1) rate of adverse effects in each arm. design: randomized controlled trial. patients will be randomly allocated into three arms: arm a : peginterferon α-2a (180 μg/week)sc. plus ribavirin (800 mg/day) p.o. over 24 weeks. arm b: peginterferon α-2a (180 μg/week) plus ribavirin (1600 mg/day) with support of epoetin β (450 iu/kg/week) sc over 4 weeks: b1.- if rna-hcv undetectable at week 4, standard of care will be continued (peginterferon α-2a, 180 μg/wee plus ribavirin (800 mg/day) over 20 additional weeks). b2.- if rna-hcv were detectable at week 4, treatment will be continued with peginterferon α-2a (180 μg/week) plus rbv(1,600 mg/day) plus epoetin β (450 ui/kg/week) over 20 additional weeks. sample size: 111 patients. to increase the svr from 50% to 75%. beta: 0.1; alfa: 0.05; loss: 15%. randomization will be 1:2, 37 patients in group a and 74 patients in group b.

Eligibility criteria:
inclusion criteria: * hcv genotype 3 * rna-hcv \> \> 600.000 iu/ml. * compromise to use contraceptive measures on treatment until 6 months after the end of treatment. exclusion criteria: * pregnant or breastfeeding females. * concurrent treatment with antineoplastic or immunomodulatory agents, including corticosteroids or radiation therapy over the last 6 months before starting the trial * treatment with investigational drugs \< 6 weeks before starting the trial * chronic liver disease other than hepatitis c. * evidence of hepatocellular carcinoma. * evidence of carcinoma hepatocellular * decompensated liver disease * baseline neutrophil count \< 1500/cc; or platelet count \< 90,000/cc * baseline hemoglobin \<12 g/dl in females o \<13 g/dl in males. * increased risk of anemia(eg, thalassemia, spherocytosis..). * ischemic heart disease or cerebrovascular disease. * serum creatinine \>1.5 times upper limit of normality. * history of severe psychiatric conditions (major antidepressives or neuroleptic drugs required for major depression or psychosis), suicide attempts or psychiatric disability . * history of convulsive disorders. * immunological conditions. * chronic obstructive lung disease with limited functionality * severe heart disease or congestive cardiac insufficiency cardiopathy grave. * advanced atherosclerosis * solid organ or bone marrow transplant.

Keywords: chronic hepatitis c genotype 3 high viral load
vitamin d replacement in statin-induced myopathy

Conditions: HMG COA Reductase Inhibitor Adverse Reaction

Summary: pretreating people with replacement doses of vitamin d will allow them to tolerate statin medications that have caused muscle pain for them in the past.

patients who have been unable to tolerate statin medications due to muscle pain will be randomly assigned to receive vitamin d or placebo for 6 weeks before reintroducing their statin medication. the investigators will judge whether vitamin d in the manner administered in the study reduces the myalgia with statins and allows patients to remain on these important medications.

Eligibility criteria:
inclusion criteria: * male and female adults * identified by their physician as having myalgia with their statin medication. exclusion criteria: * unexplained ck \> 4x upper limit of normal, at study entry, or on a statin medication in the past. * severe myositis * consumption in excess of 14 alcoholic beverages per week * situations which will cause difficulty in interpreting the vitamin d and / or pth. examples: * present consumption of vitamin d supplements \> 1000 iu daily * renal impairment (estimated creatinine clearance \< 70 ± 14 ml/min/m2 in males; and \< 60 ± 10 ml/min/m2 in females) * chronic liver disease or impaired liver function * any contraindication for statin re-challenge example: rhabdomyolysis or allergy to statins

Keywords: statin hmg coa reductase inhibitor myalgia vitamin d
development and evaluation of a hormone replacement therapy decision-aid

Conditions: Menopause; Hormone Replacement Therapy

Summary: the decision regarding the use of post-menopausal estrogen hormone replacement therapy (ht) is complex because patients must balance the short and long-term risks and benefits. information from new and important clinical trials must also be considered. the purpose of this research is to develop and evaluate the efficacy of a ht cd-rom decision-aid in improving the decision making process for women considering the use of estrogen ht.

background: the decision regarding the use of post-menopausal estrogen hormone replacement therapy (ht) is complex because patients must balance the short and long-term risks and benefits. information from new and important clinical trials must also be considered. the purpose of this research is to develop and evaluate the efficacy of a ht cd-rom decision-aid in improving the decision making process for women considering the use of estrogen ht. objectives: the objectives of the study are to: 1) develop a model of the decision-making process for postmenopausal women considering hormone (ht), based on multi-attribute utility theory (maut); 2) produce an interactive cd-rom decision-aid for ht; 3) evaluate the effect of the interactive cd-rom decision-aid on patient satisfaction with decision (swd) and knowledge about menopause and ht; and 4) test the effect of the interactive cd-rom decision-aid on women�s decisions regarding use of ht. methods: phase i (completed) used structured interviews and surveys in the development of a decision model for ht. in phase ii, an interactive cd-rom decision-aid was developed and a randomized controlled trial (rct) of its effect on decision processes was conducted. postmenopausal women, aged 45-74 were recruited from the primary care clinics of the four participating veterans affairs hospitals: milwaukee, madison, chicago-hines, and chicago-westside. the primary hypothesis was that women who use the cd-rom decision-aid would demonstrate increased satisfaction with their decision regarding hormone replacement therapy use compared to women receiving the control intervention. status: enrollment and follow-up assessments have been completed. the study is in the analysis phase. the study was presented to the va hsr\&d combined monitoring board on february 5, 2003 and the committee voted unanimously to recommend continuation of the trial. the study has had one publication and several scientific abstract presentations.

Eligibility criteria:
inclusion criteria: - postmenopausal as defined by: amenorrhea for 12 months or fsh greater than or equal to 25 exclusion criteria: * unable to speak english * are assessed not to have capacity for making medical decisions for their own care * had alcohol or drug abuse issues in past 6 months before baseline visit * personal history of breast cancer, active liver disease, active vascular thrombosis, and/or active unexplained vaginal bleeding
clinical trial to assess the efficacy and safety of easydew md regen cream containing neopop-s.

Conditions: Laser-Induced Scar

Summary: the purpose of this clinical study is to evaluate the effect on skin regeneration after applying easydew md regen cream containing neopep-s, a regeneration factor, to patients who have undergone picosure picosure laser skin treatment as needed.

this clinical study is a researcher-led randomized control group comparative clinical study that is conducted prospectively for one month after applying medical devices for clinical research. the subjects are those who have undergone a picosure laser procedure for therapeutic purposes on the skin tissue of the face or body, and a screening test is conducted after the subject (and/or legal representative) agrees in writing to participate in the clinical study. the screening test results are evaluated, and subjects who meet the selection criteria and do not meet the exclusion criteria are registered in clinical research. participating subjects are randomly assigned to the control group and the study group using a random number table at a 5:5 ratio. * control group: 10 people without treatment * study group: 10 people applying easydu regen md cream clinical study subjects are randomly assigned to control and study groups. in the case of the study group, the easy dew regen md cream provided through prescription is applied twice a day (morning and evening) to the skin of the area where the picosure laser treatment has been performed and absorbed well. the control group is the non-chalant group. however, general moisturizers that were used at home rather than medical devices for one month after the procedure can be used, and they are applied twice a day (morning and evening) to the skin of the area where the laser treatment has been performed and absorbed well. one month of clinical research medical device application will be observed, and subjects will regularly visit the research institution to evaluate its validity and safety during screening visits (visit1), treatment (visit2), 2 weeks after treatment (visit3), and 1 month after treatment (visit3) you will receive it.

Eligibility criteria:
inclusion criteria: * those aged 19 to 65 who have undergone picosure laser treatment on facial and body skin tissues * decided to participate in this clinical study and signed a written informed consent the subject exclusion criteria: * subjects with uncontrolled diabetes * subjects with uncontrolled hypertension and cardiovascular disease * subjects with hemorrhagic diseases such as hemophilia * immunosuppressants, corticosteroids, cytotoxic agents, and anticoagulants can affect the results subjects who are or are scheduled to receive medication for an extended period of time * acute or chronic skin disease causes stage progression or active bacteria in the application area who has a virus infection * when the researcher's judgment determines that participation in the study is inappropriate (e.g. keloid constitution)
clinical value of the mri combined with scc-ag for the diagnosis of hsil (cin 2/3)

Conditions: Magnetic Resonance Imaging Examination

Summary: the study aimed to identify the clinical value of magnetic resonance imaging examination (mri)combined with serum squamous cells carcinoma antigen (scc-ag) in women with high-grade squamous intraepithelial lesion (cervical intraepithelial neoplasia grades 2-3 (cin 2-3)).

186 female patients with the hsil(cin2-3) were included in this study and followed up from the time of admission. all patients underwent colposcopy examination, mri, scc-ag, loop electrosurgical excision procedure (leep), extrafascial hysterectomy, or radical hysterectomy. pathological findings of the patient's tissues were used as the final diagnostic criteria. on the one hand, we compared the sensitivity, specificity, positive predictive value (ppv), and negative predictive value (npv) of mri+scc-ag, leep of the menopausal group, and non-menopausal group. on the other hand, evaluating the accuracy of mri combined with scc-ag examination in diagnosing hsil(cin2-3) by receiver-operating characteristic curve (roc)．

Eligibility criteria:
inclusion criteria: * no previous history of cervical lesions * tct and hpv test results suspected cervical lesions * further colposcopy showed hsil or cin 2-3 * all selected patients underwent mri, serological tests for scc-ag levels, leep, or radical hysterectomy exclusion criteria: * patients with receiving cold knife conization * patients with skin squamous cell carcinoma or previous history of cancer * pregnant women * patients with serious heart, liver, kidney, blood system and autoimmune diseases
effect of intermittent oro-esophageal tube vs. nasogastric tube on feeding amount in stroke patients

Conditions: Ischemic Stroke

Summary: the goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using intermittent oro-esophageal tube and nasogastric tube. patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. on this basis, the observation group will use intermittent oro esophageal tube for enteral nutrition support, while the control group will use nasogastric tube. researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if intermittent oro-esophageal tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to nasogastric tube

the study will last 15 days for each participant. the goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using intermittent oro-esophageal tube and nasogastric tube. patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. on this basis, the observation group will use intermittent oro esophageal tube for enteral nutrition support, while the control group will use nasogastric tube. researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if intermittent oro-esophageal tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to nasogastric tube

Eligibility criteria:
inclusion criteria: * age\>18 years. * meeting the diagnostic criteria for ischemic stroke . * dysphagia confirmed by videofluoroscopic swallowing study. * clear consciousness. * no history of prior stroke. * stable vital signs. exclusion criteria: * dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc. * complicated with severe liver and kidney failure, tumors, or hematological disorders. * simultaneously in need to undergo other therapy that might affect the outcomes of this study. * pregnant or nursing females.
study of effectiveness of adding the health promotion and rehabilitation for treatment for alcohol and drug abusers

Conditions: Alcoholism; Substance-Related Disorders; Smoking; Chronic Disease; Malnutrition

Summary: the purpose of this study is to evaluate the effect of adding the health promotion activities and rehabilitation to the usual alcohol and drug interventions on the outcome for alcohol and drug abusers compared to the usual intervention alone.

background: alcohol and drug abuse are followed by tremendous physical, psychological and social problems as well as early death. heavy smoking, poor nutrition, physical inactivity and chronic diseases (co-morbidity) are often part of these problems and illnesses. there seems to be a large potential for a better outcome by including smoking cessation, physical training, diet and nutrition as well as co-morbidity in a multi-disciplinary setting - a potential not used yet. this very integrated program (vip) is inspired from the rehabilitation offered to patients with chronic diseases and surgical patients having a likewise unhealthy lifestyle and similar co-morbidity. aim: to evaluate the effect of adding the vip program to the usual alcohol and drug intervention on the outcome for alcohol and drug abusers compared to the usual intervention alone. the vip project consists of 3 steps: 1. to map the health status and estimate the potential improvement for 400 alcohol and drug abusers 2. to pilot test the vip program 3. to evaluate it compared to the daily routines for 260 alcohol and drug abusers with a poor health status in a randomised controlled trial. main outcome: change from abuser to non-abuser. secondary outcomes are health status; quality of life, use of health services, time return to work (or similar activity level), harm reduction, and cost-effectiveness.

Eligibility criteria:
inclusion criteria: * alcohol or drug dependency exclusion criteria: * withdrawal of informed consent * missing competence to give informed consent * pregnant or nursing women

Keywords: drinking behavior harm reduction tobacco use cessation smoking cessation rehabilitation health promotion nutrition therapy feeding behavior exercise
photobiomodulation for concussions: the use of the impact® test as an assessment tool

Conditions: Mild Traumatic Brain Injury

Summary: brain photobiomodulation (pbm) therapy is an innovative modality for the stimulation of neural activity in order to improve brain function and is currently under investigation as a treatment for several diverse neurological disorders. our emphasis on this study is to review the use of pbm as a treatment modality for concussions and the use of impact® (immediate post-concussion assessment and cognitive testing) test to assess improvement in cognition and symptomatology in patients with post-concussion syndrome (pcs) treated with pbm.

* this will be a retrospective, single arm, unmasked, clinical study. * data scores will be collected for patients who initially underwent the workplace post-injury 1 test of the impact® test system prior to pbm treatment. * patients were treated with photobiomodulation using the bioflex® duo+ system that utilized a 180 bulb light emitting diode (led) array followed by laser probes. both delivery methods were applied to the cervical spine and the cranium, and both entailed the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. treatment is provided three times per week on alternating days with weekends off for 4 weeks for a total of 12 treatments utilizing health canada approved device specific protocol guidelines for treatment of the cervical spine. * data scores will be collected for a second impact® test using the workplace post-injury 2 test. * results of the post-injury 1 test and the post-injury 2 test will be compared.

Eligibility criteria:
inclusion criteria: * patients between the ages of 15-65 years clinically diagnosed with a mild traumatic brain injury by a health professional and currently not undergoing any treatment during a 1 year period from january 2018 to december 2018. * documentation of the history of a qualifying mild traumatic brain injury within 3 months of traumatic incident and/or diagnosis with persistent symptomatology after 3 months. for reference, international classification of diseases, tenth revision (icd-10) clinical criteria require a history of tbi and the presence of three or more of the following eight symptoms: 1) headache, 2) dizziness, 3) fatigue, 4) irritability, 5) insomnia, 6) concentration or 7) memory difficulty, and 8) intolerance of stress, emotion, or alcohol4. exclusion criteria: * any positive findings on imaging studies * a diagnosis of or a family history of neuropsychiatric co-morbidity. * any additional diagnoses compounding the diagnosis of a concussion or mild traumatic brain injury (tbi) * currently undergoing any type of therapy

Keywords: concussion, photobiomodulation, impact
weightbearing after high tibial osteotomy

Conditions: Osteoarthritis, Knee

Summary: in this project we want investigate the clinical results after different rehabilitation regimens(limited or unlimited weightbearing after surgery) in open-wedge high tibial osteotomies. the hypothesis is that unlimited weightbearing is beneficial for the healing and rehabilitation.

in the treatment of osteoarthritis of the medial compartment of the knee, open wedge high tibial osteotomy is a good choice of treatment for the young and active patient. however it leaves an open gap which has to be filled with a bone substitute and requires stable fixation. different rehabilitation-regimens are described, many advocating a period of partial weight-bearing for a period after surgery. results from biomechanical studies suggest that immediate full weight-bearing is safe, enabling earlier mobilisation without compromising safe solid healing. the aim of the present study is to evaluate whether there is any difference in clinical outcome, correction, stability and healing in open-wedge osteotomies (osteosynthesis with the dynafix® system (ebi)) after 2 different rehabilitation regimens: limited weight-bearing (20 kg) for 6 weeks, and unrestricted weight-bearing. the investigation is performed as a randomised prospective clinical trial including 20 patients with a planned 2 years follow-up period. clinical outcome is evaluated with: hospital of special surgery score, koos, sf 12 and lysholm score. routine standing x-rays is performed. stability of the osteotomy is assessed with roentgen stereophotogrammetric analysis (rsa) that provides the opportunity of exact 3-dimensional measuring of eventual loss of correction.

Eligibility criteria:
inclusion criteria: * signed informed consent * osteoarthritis of medial compartment of the knee, ahlbäck gr. 1-2 * varus deformity exclusion criteria: * prednisolone treatment. * nsaid treatment. * bmi \> or = 35. * previous surgery in lateral knee compartment. * secondary arthrosis following fracture(s) of the tibial condyle(s). * lack of informed consent. * correction \>12,5 mm * peroperative displaced fracture of lateral bony hinge.

Keywords: osteoarthritis, knee osteotomy healing rehabilitation roentgen stereometric analysis
epigenetic integrity of spermatozoa in patients with germinal testicular tumours

Conditions: Seminomas

Summary: recent data suggest that sperm cells carry an epigenetic message during spermatogenesis and that this message is crucial for the future development of the embryo. this epigenetic signature is notably represented by methylation of genes subjected to imprinting (gsi) and the methylation of transposable elements (te). data on the maintenance of the imprint and of the control of te accompanying human gametogenesis in a context of adult germinal testicular cancers, seminomas, are extremely fragmentary for tumour tissues and inexistent for gametes. the aim of this study is to determine whether patients with seminomas in comparison with fertile men carry a higher risk of presenting epigenetic alterations affecting their gametes. this study is based on the use of an existing collection of biological samples. 90 samples will be selected and split into 3 groups: * group 1: 30 sperm samples from patients with seminomatous testicular tumours * group 2: 30 sperm samples from fertile patients * group 3: 30 sperm samples from infertile patients after treatment of the samples (thawing, cell sorting and removal of cryoprotectants), they will be analysed.


Eligibility criteria:
inclusion criteria: * biological samples from persons who have provided written consent * biological samples of patients over 18 years old * with testicular tumours/fertile/infertile * matched for age with patients suffering from testicular tumours exclusion criteria: * biological samples of persons without national health insurance cover * biological samples from patients with chronic hepatitis b or c or hiv infection