Kornimate/medical-research-clean huggingface dataset:
effectiveness of blood flow restriction in postoperative rehabilitation for anterior cruciate ligament injuries. a pilot study.

Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation

Summary: the goal of this clinical trial is to evaluate the effectiveness of adding blood flow restriction (bfr) therapy to a standardized rehabilitation protocol in patients undergoing postoperative rehabilitation following anterior cruciate ligament (acl) repair surgery. the main questions it aims to answer are: does combining bfr therapy with a standardized rehabilitation protocol improve functional recovery compared to rehabilitation alone? does the addition of bfr therapy enhance muscle strength and reduce recovery time in patients after acl repair surgery? participants will undergo their assigned rehabilitation protocol and will be assessed prior to and after the intervention to determine if the addition of bfr therapy to the standard rehabilitation programme significantly improves functional recovery, muscle strength, and overall rehabilitation outcomes following acl repair surgery.

anterior cruciate ligament (acl) reconstruction is a common surgical intervention following ligament rupture, particularly among athletes engaged in pivoting sports such as soccer, handball, volleyball, and skiing. despite surgical advances, up to 35% of athletes fail to return to their pre-injury level within two years post-surgery, with factors such as fear of re-injury and neuromuscular deficits playing a significant role. this randomized controlled trial evaluates the efficacy of integrating blood flow restriction (bfr) therapy into standard rehabilitation protocols after acl reconstruction. participants aged 18-45 years, recovering from acl surgery, will be randomized into two groups: a control group following the standard rehabilitation protocol and an experimental group combining bfr therapy with rehabilitation. bfr involves applying controlled vascular restriction to the proximal limb using automated devices during low-intensity resistance exercises, aiming to enhance strength and neuromuscular recovery safely. the intervention spans 12 weeks, primarily focusing on the strength and neuromuscular control phase of rehabilitation. outcomes will include measures of pain, fear of movement, functional performance, and readiness to return to sport. evaluations will be conducted at baseline and at 2, 6 and 12 weeks post-surgery. the study seeks to determine whether bfr accelerates recovery, improves functional outcomes, and facilitates a safer, more effective return to athletic activities.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 45 years. * patients who have undergone anterior cruciate ligament (acl) reconstruction surgery exclusion criteria: * cardiovascular comorbidities * severe metabolic disorders or postoperative complications * previous joint disorders requiring surgery on the affected leg * pregnancy * coagulation disorders

Keywords: physical therapy rehabilitation anterior cruciate ligament blood flow restriction randomized clinical trial
study of denosumab in subjects with giant cell tumor of bone

Conditions: Cancer; Giant Cell Tumors; Giant Cell Tumor of Bone; Benign Giant Cell Tumors

Summary: to determine how safe denosumab is in treating subjects with giant cell tumor of bone (gctb)

to determine how safe denosumab is in treating subjects with gctb

Eligibility criteria:
inclusion criteria: * pathologically confirmed gctb within 1 year before study enrollment * measurable evidence of active disease within 1 year before study enrollment * subjects with surgically unsalvageable disease (eg, sacral, spinal gctb, or multiple lesions including pulmonary metastases) or subjects whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity * karnofsky performance status equal or greater than 50% (ie, eastern cooperative oncology group status 0, 1, or 2) * adults or skeletally mature adolescents (ie, radiographic evidence of at least 1 mature long bone \[eg, humerus with closed growth epiphyseal plate\]) equal or greater than 12 years of age * skeletally mature adolescents must weigh at least 45 kg * before any study-specific procedure is performed, the appropriate written informed consent must be obtained exclusion criteria: * currently receiving other gctb specific treatment (eg, radiation, chemotherapy, or embolization) * concurrent bisphosphonate treatment * known or suspected current diagnosis of underlying malignancy including high grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma * known or suspected current diagnosis of non gctb giant cell-rich tumors * known or suspected current diagnosis of brown cell tumor of bone or paget's disease * known diagnosis of second malignancy within the past 5 years (subjects with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted) * prior history or current evidence of osteonecrosis/osteomyelitis of the jaw * active dental or jaw condition which requires oral surgery, including tooth extraction * non-healed dental/oral surgery * planned invasive dental procedure for the course of the study * subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s) * subject has known sensitivity to any of the products to be administered during dosing * unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment * subject is pregnant or breast feeding, or planning to become pregnant within 5 months after the end of treatment * female subject of child bearing potential is not willing to use two methods of highly effective contraception during treatment and for 5 months after the end of treatment * subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Keywords: giant cell tumor of bone
research study of visilizumab for treatment of acute graft versus host disease

Conditions: Graft vs Host Disease

Summary: the purpose of this phase i/ii, open-label, dose-escalation study is to evaluate an investigational monoclonal antibody administered as a first-line therapy to patients with acute, grade ii, iii, or iv graft-versus-host disease (gvhd). patients will be eligible for enrollment within 24 hours of beginning standard steroid treatment. the research is being conducted at up to 10 clinical research sites in the us.

a phase i/ii, open-label, dose-escalation pilot study designed to obtain preliminary safety, pharmacokinetic (pk) and efficacy information on visilizumab administered as a first-line therapy to patients with acute, grade ii, iii, or iv graft-versus-host disease (gvhd). it is anticipated that up to 34 patients at up to 10 study centers could be eligible for enrollment in this study. patients will be eligible for enrollment within 24 hours of beginning standard steroid treatment (2 mg/kg of methylprednisolone iv, or 10 mg/kg hydrocortisone iv, per day). steroids will be rapidly tapered over one week following visilizumab administration.

Eligibility criteria:
* patients who develop grade ii, iii, or iv acute gvhd following allogeneic hematopoietic cell transplantation * patients receiving gvhd prophylaxis including cyclosporine or tacrolimus * clinical findings: skin thickening, joint contraction, oral ulceration, diarrhea. * patients with an onset date of acute gvhd that is less than or equal to 100 days posttransplant.
early detection of barrett's esophagus in participants with reflux symptoms in primary care

Conditions: Barrett Esophagus; Esophageal Cancer

Summary: in the netherlands, the incidence of esophageal adenocarcinoma (eac) is increasing. in addition, eac has a dismal prognosis. therefore, screening for barrett's esophagus (be) has stimulated interest. although be is a known precursor of eac, a minority of patients with eac are known with a previous diagnosis of be. a non-invasive screening tool, such as breath testing, could select patients at risk for be, after which unsedated transnasal endoscopy (utne) can confirm or exclude the diagnosis. the objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by utne for be and eac.

the ongoing increasing incidence of esophageal adenocarcinoma (eac) in the netherlands during the last few decades and the still dismal prognosis has stimulated interest in screening for barrett's esophagus (be). although be is a known precursor of eac, a minority of patients with eac (\<10%) are known with a previous diagnosis of be, and hence, most cases of be are undiagnosed. screening programs to detect be followed by endoscopic surveillance and treatment of dysplasia or early neoplasia seem able to reduce the incidence of eac and improve survival. a non-invasive screening tool, such as breath testing, could select patients at risk for be, after which unsedated transnasal endoscopy (utne) can confirm or exclude the diagnosis. utne offers the possibility of a more acceptable and accurate endoscopic assessment of the esophagus with almost neglectable risks and lower costs compared to conventional endoscopy. the objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by utne for be and eac.

Eligibility criteria:
inclusion criteria: * patient aged 50 to 75 years; * recorded diagnosis of reflux symptoms \>90 days or * recorded prescriptions for acid suppressant therapy for this indication for at least 1 year in the past 5 years * written informed consent. exclusion criteria: * upper endoscopy in the previous 5 years; * a current or previous diagnosis and/or treatment of any type of malignancy (not including basal-cell skin cancer (bcc) and squamous-cell skin cancer (scc)) within the last five years; * already known with a diagnosis of barrett's esophagus or gastro-esophageal cancer; * any argument provided by a patient's own general practitioner not to include the patient; * comorbidities precluding transnasal endoscopy (e.g. inability to discontinue oral anticoagulants, history of recurrent epistaxis, allergy to lidocaine derivatives).

Keywords: barrett esophagus esophageal cancer primary care general practice screening
the health effects of blueberry anthocyanins in metabolic syndrome (the circles-study)

Conditions: Insulin Resistance; Metabolic Syndrome X

Summary: the purpose of this study is to determine the dose-dependent impact of 6 month freeze-dried blueberry powder intake on insulin sensitivity and resistance, cardiovascular disease risk factors, and lung and cognitive function in overweight and obese participants with metabolic syndrome. we will also examine acute post-prandial effects of blueberry intake (at baseline and at 6-months).


Eligibility criteria:
inclusion criteria: * men and postmenopausal women (≥ 1 year since last menstruation) * 50 to 75 years old * bmi of ≥ 25 kg/m2 * 3 characteristics of metabolic syndrome i.e: waist circumference ≥ 102 cm for men, ≥ 88 cm for women; triglycerides ≥ 1.7 mmol/l (or drug treatment for elevated triglycerides); hdl-cholesterol \< 1.0 mmol/l for men, \< 1.3 mmol/l for women (or drug treatment for low hdl-cholesterol); blood pressure ≥ 130 mm hg systolic and/or ≥ 85 mm hg diastolic blood pressure; fasting blood glucose ≥ 5.56 mmol/l * successful biochemical, haematological and urinalysis assessment at screening exclusion criteria: * current smokers, or ex-smokers ceasing \< 6 months ago * existing or significant past medical history of vascular disease or medical conditions likely to affect the study measures * fructose intolerance or known allergies to the intervention treatments * on therapeutic diets or having experienced substantial weight loss within 3 months of screening * taking flavonoid containing supplements (and unwilling to cease intake during, and 1 month preceding the trial) * planning on altering consumption of vitamin supplements / fish oil capsules during the course of the study. * prescribed hypoglycaemic, vasodilators or hrt medication. * unsatisfactory biochemical, haematological or urinary assessment at screening, or measures considered to be counter indicative for the study * \< 3 characteristics of the metabolic syndrome. nb: rec approved nosa granted to include those on anti-hypertensives (29jul2014)
vaccine therapy in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: vaccines made from a person's white blood cells and melanoma cells may make the body build an immune response and kill tumor cells. purpose: phase i trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.

objectives: i. determine the safety and tolerability of antigen pulsed dendritic cell therapy in patients with metastatic melanoma. ii. perform serial analysis of t cell and b cell function in these patients after this treatment. iii. determine objective response and response duration in these patients after this treatment. outline: patients receive filgrastim (g-csf) subcutaneously (sq) on days 1-6, then undergo leukapheresis for 2-3 days, beginning on day 6. mononuclear cells are selected for cd34+ cells in the laboratory, made into dendritic cells, and then pulsed with mart-1, gp100, tyrosinase, mage-3 peptides and flu matrix. these antigen pulsed dendritic cells (apdcs) are used for vaccinations. prior to vaccination, apdcs are mixed with mart-1, gp100, tyrosinase, mage-3, and flu matrix. patients receive this dendritic cell vaccine mixture sq every 2 weeks for 4 priming doses. patients receive 4 boost vaccinations sq at 2 months, 5 months, 9 months, and 15 months following the last priming vaccination. patients are followed monthly for 2 years. projected accrual: a total of 28 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically proven metastatic melanoma measurable disease hla-a2 01 phenotype no active cns or hepatic metastases patient characteristics: age: 18 to 80 performance status: karnofsky 80-100% life expectancy: not specified hematopoietic: normal cd4 and cd8 t cell numbers by flow cytometry lactic dehydrogenase less than 2 times normal hepatic: no viral hepatitis renal: not specified cardiovascular: no prior venous thrombosis, angina pectoris, or congestive heart failure pulmonary: no prior asthma immunologic: positive intradermal skin test for mumps, histoplasmosis, or streptokinase antigen immunoglobulin levels normal no prior autoimmune disease (lupus erythematosus, rheumatoid arthritis, or thyroiditis) no allergy to tetanus toxoid or influenza vaccine no sensitivity to e. coli drug preparations other: not pregnant or nursing fertile patients must use effective contraception hiv negative no active infection prior concurrent therapy: biologic therapy: at least 4 weeks since prior interferon at least 8 weeks since prior interleukin-2 chemotherapy: no more than 3 prior courses of cytotoxic chemotherapy at least 8 weeks since prior chemotherapy endocrine therapy: no concurrent corticosteroids radiotherapy: not specified surgery: not specified other: no other concurrent immunosuppressive agents

Keywords: stage iv melanoma recurrent melanoma
prevalence of keratoconus among patients with thyroid gland dysfunction

Conditions: Keratoconus in Thyroid Gland Dysfunction

Summary: hormonal imbalances are likely to affect the corneal metabolism and may be also associated with keratoconus. among the various endocrinologic dysfunctions assumed so far, thyroid gland dysfunction (tgd) (hypo- or hyperthyroidism; comprised as tgd) is frequently associated with eye diseases such as graves disease

aim of the work we aim to examine the prevalence of kc among patients already diagnosed by endocrinologist with tgd. materials and methods our screening for kc will include evaluation of the demographic data and complete ophthalmological examination of the patients using: va refraction k reading slit lamp examination pentacam study design epidemiological study inclusion citeria all patients diagnosed as thyroid gland dysfunction control group exclusion criteria uncooperative patients

Eligibility criteria:
inclusion criteria: * all patients diagnosed as thyroid gland dysfunction exclusion criteria: * uncooperative patients
european cardiac resynchronisation therapy survey

Conditions: Heart Failure

Summary: the european crt survey represents a joint initiative between two esc associations; the heart failure association and the european heart rhythm association. the survey will be performed in collaboration with the institute für herzinfarktforschung in ludwigshafen which will handle the data collection and data analysis.

this european crt survey was initiated by the heart failure association (hfa) and the european heart rhythm association (ehra) of the esc in order to describe current european practice and routines associated with crt-p/crt-d implantations based on sample of patients enrolled in 13 countries. the data collected following implantation provides information including clinical characteristics, diagnostic criteria, implantation routines and techniques, adverse experience, and assessment of adherence to guideline recommendations. the single follow-up visit at 1 year (9-15 months) will provide information regarding short-term clinical outcomes. the primary objective of this survey is to describe current european practice based on a broad sampling in 13 countries. the information collected will enable practice between centres and countries to be compared and permit benchmarking with national and international practice. the survey provides valuable quality assurance assessment for individual centres, permits limited economic analyses and broadly evaluates adherence to guideline recommendations. the following 13 european countries contributed patients to the survey: austria, belgium, france, germany, ireland, israel, italy, the netherlands, norway, spain, sweden, switzerland and uk. two national coordinators, one each from the fields of heart failure and electrophysiology, were selected and given the responsibility to facilitate recruitment in their respective countries. follow the link for complete list of the members of the scientific committee and national coordinators.

Eligibility criteria:
inclusion criteria: * eligible patients for crt-p or crt-d. exclusion criteria: * none

Keywords: cardiac resynchronisation therapy in heart failure
recombinant human interferon a-2b gel for hpv gynecological infections

Conditions: HPV Infection

Summary: to assess the efficacy and safety of recombinant human interferon α-2b gel (yallaferon®) for the treatment of patients with cervical high-risk hpv infections; to analyze the hpv type infections and clinical negative conversion. 285 patients with positive high risk hpv infection were randomized into interferon gel group and control group at ratio of 2:1 (203 patients in treatment group and 82 patients in control group). the patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 3 courses of treatment, whereas no treatment was conducted in control group.


Eligibility criteria:
inclusion criteria: 1. age 30 to 65 years of age the sex life of female patients; 2. , liquid-based cytology (tct) check no intraepithelial lesions and malignant cells; 3. , hpv dna typing test for high-risk hpv positive (including a single high-risk type positive, and more high-risk type of positive and high-and low-risk hybrid positive). 15 kinds of high-risk types, including hpv16, 18,31,33,35,39,45,51,52,53,56,58,59,66,68 exclusion criteria: * (1) cervical intraepithelial neoplasia (cin); (2), combined with a severe fungal, trichomonas vaginitis; (3), severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system; (4), allergies or allergy to the drug known ingredients. (5), within 30 days to accept other clinical trials of drugs or are participating in clinical trials; (6), pregnant and lactating women and to be pregnant women; (7), the researchers do not consider it appropriate clinical trials.
phase 2 study of td-9855 to treat fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study study is to determine whether td-9855 is effective in treating patients with fibromyalgia.


Eligibility criteria:
inclusion criteria: * • american college of rheumatology (acr) diagnostic criteria for fibromyalgia (fm) * informed consent * 18 to 65 years of age * discontinue therapy with adrenergic-acting drugs, and certain other medications * only acetaminophen or nsaid as rescue pain medication * no narcotic pain meds or benzodiazepines * only non-benzodiazepines as rescue hypnotics exclusion criteria: * any current psychiatric disorder, lifetime bipolar disorder, severe comorbid axis ii disorder, mental retardation, etc, as assessed by mini international neuropsychiatric interview (mini) * major depression at screening by mini when unable to be washed out of mdd meds (investigator or provider's judgment) * risk of suicide (investigator opinion and/or c-ssrs) * recent history of substance or alcohol abuse * bmi \<18 or ≥45 * concurrent disease; pain for diagnosed illness other than fm; non-compliance; history of seizures; pheochromocytoma; glaucoma; cv disease; orthostatic hypotension or orthostatic tachycardia; untreated sleep apnea * abnormal lab values (liver, kidney, thyroid, and others)

Keywords: fibromyalgia