Kornimate/medical-research-clean huggingface dataset:
biofreeze® vs. a placebo on knee osteoarthritis walking gait characteristics and pain

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to determine the effect of biofreeze® versus a placebo on walking gait characteristics and pain during walking in individuals with bilateral knee osteoarthritis (oa).

a convenience sample of 20 participants, \>40 years with previously diagnosed bilateral koa were recruited. participants must have been diagnosed with bilateral knee oa and be able to perform all study procedures. all participants reported in comfortable clothing and sneakers. after explanation of the study and consent, participants completed the demographics questionnaire, numeric pain rating scale (nprs), western ontario and mcmaster universities arthritis index (womac), and knee function survey. participants then completed a 3mph 3-minute walking baseline assessment. following the assessment, participants rated their pain and were randomly assigned to receive a blinded topical of either biofreeze® or a placebo. the dose of both gels was 5 ml per knee. the participant then waited 15 minutes, rated their pain, and repeated the 3-minute walking assessment and rated their pain once more. there was a minimum of a 24-72-hour washout period after which time the participants repeated the same protocol using the other topical.

Eligibility criteria:
inclusion criteria: * must have been diagnosed with bilateral knee osteoarthritis (oa) and be able to perform all study procedures exclusion criteria: * less than 40 years of age, pregnancy, cancer, rheumatoid arthritis, a total or partial knee replacement, and/or a corticosteroid injection within the past 4 weeks

Keywords: knee osteoarthritis topical analgesic
efficacy and significance of antiviral therapy for unresectable hepatitis b virus-related primary liver cancer

Conditions: Primary Liver Cancer

Summary: this study is working to research the efficacy and significant of the anti-virus therapy in the unresectable hepatitis b virus (hbv) related primary liver cancer(plc) so as to establish treatment standards of anti-virus therapy in plc.

primary liver cancer(plc)is one of the world's most common malignancies, especially in east-asian countries.hepatitis b virus (hbv) infection is associated with 70-90% of plc cases in china. plc can develop during any stage of the natural course of chronic hbv infection and anti-virus therapy should be considered during the management of plc. however, there is no definite guide on when or how to practice the anti-virus therapy, especially in unresectable or inoperable plc. because of these facts, research on the significant of the anti-virus therapy in the hbv-related plc is urgently needed. 200 patients will be randomly assigned to anti-virus therapy group and control gruop.the time to progression(ttp) and overall survival within two years will be used to evaluate the effect of anti-virus therapy on plc. the aim of this study is to research the efficacy and significant of the anti-virus therapy in the unresectable hbv-related plc so as to establish treatment standards of anti-virus therapy in plc.

Eligibility criteria:
inclusion criteria: 1. identify patients with plc in accordance with the clinical diagnostic criteria of plc.patients with plc shall be diagnosed with or without pathology. it is not appropriate to perform liver resection operation. 2. serum positive hbsag≥6 months. 3. criteria of liver function: child a or b level, serum total bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 10 times the upper limit of normal value. 4. hemoglobin≥8.5g/dl, pt-inr≤2.3 or pt\>6 seconds of normal value. 5. no dysfunction in major organs; blood routine, kidney function, cardiac function and lung function are basically normal. 6. patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent. exclusion criteria: 1. patients with apparent cardiac, pulmonary, cerebric and renal dysfunction, which may affect the treatment of liver cancer. 2. patients with other diseases which may affect the treatment mentioned here. 3. patients with medical history of other malignant tumors. 4. subjects participating in other clinical trials. 5. women in pregnancy and breast-feeding.

Keywords: primary liver cancer hepatitis b virus anti-virus therapy
protocol-driven hemodynamic support for patients with septic shock

Conditions: Shock, Septic; Severe Sepsis; Sepsis

Summary: this research is being done to see if a protocol (a set of orders that determine how much and how quickly a drug/fluid is given) for fluid and drugs used to increase blood pressure (vasopressors) will work better then general clinical practices to improve outcomes in patients with septic shock.

septic shock is low blood pressure caused by an infection. sepsis is the most common cause of death in non-cardiac intensive care units, and septic shock is the most severe form of sepsis. treatment for septic shock includes giving antibiotics, intravenous fluids, and medications to raise the blood pressure (vasopressors). we would like to see if a protocol-driven management strategy for septic shock can shorten time on vasopressors and limit the number of side effects. we have constructed a protocol that will allow the nurse at the bedside, in conjunction with the physician's orders, to adjust the amount of fluids and medications that raise the blood pressure (vasopressors).

Eligibility criteria:
inclusion criteria: * accp/sccm sepsis criteria * need for institution of vasopressors after adequate volume resuscitation exclusion criteria: * age\< 18 * on vasopressors for \> 24 hours prior to icu admission * other cause for shock ( cardiac tamponade, massive pulmonary embolus, cardiogenic shock) * physicians and family not committed to aggressive medical therapy ( a patient will not be excluded if he/she would receive all care except for attempts at resuscitation from cardiac arrest)

Keywords: clinical trial controlled clinical trial shock, septic
personalized blood pressure management

Conditions: Blood Pressure; Intraoperative Hypotension; Postoperative Complications

Summary: the aim of this research project is to find out whether a personalized definition of the lower blood pressure threshold based on the individual blood pressure profile by means of preoperative 24-hour blood pressure measurement can reduce organ damage (brain, kidney, heart) through reduced blood flow during surgery.


Eligibility criteria:
inclusion criteria * age ≥ 50 years * asa ii-iv (classification of the american society of anesthesiologists for the assessment of the perioperative risk depending on the underlying diseases) * duration of intervention in general anesthesia at least 90 minutes exclusion criteria: * pregnancy * emergency procedures * surgery requiring controlled hypotension (e.g., aneurysm) * cerebrovascular events in the past medical history * patients of cardiac surgery, vascular surgery, neurosurgery, and transplantation surgery * pre-existing dementia (anamnesis) * kidney transplant * dialysis-dependent renal insufficiency (kdigo criteria) * no patient consent * failure to meet the inclusion criteria * impossibility of 24-h blood pressure measurement
utilization of hepatitis c positive kidneys in negative recipients

Conditions: Kidney Transplant; Hepatitis C; HCV

Summary: to evaluate the safety and feasibility of transplanting kidneys from hepatitis c virus (hcv) infected donors into recipients without hcv infection

this will be an open label, prospective, interventional, proof of concept study to evaluate the feasibility and safety of kidney transplant from hcv positive donors into hcv negative recipients using treatment with pan-genotypic direct acting antiviral therapies (daas) for treatment of post-transplant hcv transmission

Eligibility criteria:
recipient inclusion/exclusion criteria: inclusion criteria: * adult age \>18 years able to provide consent * lack of available living donor * calculated pre-transplant reactive panel (cpra) of \<80% * estimated post-transplant survival (epts) index \>20% and \<80% * negative pre-transplant human immunodeficiency virus (hiv), hepatitis c virus (hcv), and hepatitis b virus (hbv) serology and blood hcv polymerase chain reaction (pcr) * no clinically significant pre-transplant liver disease exclusion criteria: * living donor available * dialysis time \>5 years * listing for multi-organ transplantation * active or recent history (\<6 months) of alcohol abuse or substance abuse * clinically significant liver disease as determined by principal investigator * history of hepatocarcinoma * pregnancy or lactation * refusal to accept blood transfusion * hiv infection * hcv pcr or antibody positive * hbv infection donor inclusion criteria: * positive hcv pcr at time of donation * kidney donor profile index (kdpi)\<85%
evaluation of inhaled iloprost effects using the breelib nebulizer, on clinical outcomes and physical activity of patients with advanced pulmonary arterial hypertension

Conditions: Hypertension, Pulmonary

Summary: the main aim of the observational ventastep study was to investigate the association between changes in clinical outcome measures and changes in device outcome measures in pah patients using the new breelib nebulizer in a real life setting. the study was not designed to investigate or confirm the effectiveness and safety of iloprost.


Eligibility criteria:
inclusion criteria: * ventavis-treatment naïve patients aged ≥18 years at initiation of ventavis (iloprost) therapy diagnosed with pulmonary arterial hypertension who fc iii * patients who are planned to be treated with ventavis (iloprost) and where the decision to use the breelib has been agreed by physician and patient * patients who are willing to wear a smart watch (iwatch2) over the observation period of 3 months ± 2 weeks * signed informed consent exclusion criteria: * patients allergic to nickel and methacrylates * patients participating in an investigational program with interventions outside of routine clinical practice

Keywords: pulmonary arterial hypertension pah
safety and efficacy of celecoxib versus placebo in the treatment of knee osteoarthritis in patients who were unresponsive to naproxen and ibuprofen

Conditions: Osteoarthritis, Knee

Summary: to compare the efficacy and safety of celecoxib versus placebo for the treatment of knee osteoarthritis (oa) in patients who were unresponsive to prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen


Eligibility criteria:
inclusion criteria: inclusion criteria: * diagnosed, active, and symptomatic oa of the knee in a flare state with a functional capacity class of i-iii at baseline visit * failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability, or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability exclusion criteria: exclusion criteria: * inflammatory arthritis or gout/pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded) * received acetaminophen within 24 hours of the baseline visit * use of a mobility assisting device for less than six weeks prior to study screening or use of a walker * history of gastrointestinal (gi) perforation, obstruction, or bleeding * diagnosed or treated for gi ulcer within 60 days prior to first dose of study medication * received corticosteroids or hyaluronic acid within certain timeframe before study
measurement of carboxyhemoglobin by gas chromatography as an index of hemolysis

Conditions: ABO Incompatibility; Hemolytic Disease of Newborn; Neonatal Jaundice; Neonatal Hyperbilirubinemia

Summary: the purpose of this research study is to more accurately measure the amount of true red blood cell breakdown (hemolysis) in newborn babies with potentially problematic blood type mismatch with their mothers (abo incompatibility), and to examine how the true level of red blood cell destruction relates to other laboratory tests obtained in newborns with jaundice. a better understanding of the true amount of red blood cell destruction that is caused by blood type mismatch, as well as how it relates with other laboratory tests ordered for abo incompatibility and red blood cell destruction, would help avoid unnecessary testing, treatment and prolonged hospital stays in such babies.

clinically severe jaundice due to abo incompatibility can occur when infants with blood type a or b are born to mothers with type o blood. an estimated 20 percent of pregnancies are abo incompatible, but only a very small proportion of blood type a or b babies born to o type mothers develop overt abo hemolytic disease. despite the relative rarity of abo hemolytic disease, it is common practice among pediatricians and family practice physicians to perform routine blood typing and antibody screening on all newborns born to type o mothers. a very accurate and reliable laboratory measure of red blood cell destruction is the plasma carboxyhemoglobin level (cohb). cohb levels can be determined using a minute amount of blood, obtained at the same time the newborn's heel is pierced to obtain blood for the mandatory newborn screen (performed on all newborns prior to discharge) in order to avoid an additional invasive procedure. our hope is to determine whether routine blood typing and anti-globulin testing of infants born to type o mothers is necessary, or if these tests should instead be obtained only in the context of significant visible jaundice. this would help clarify the proper management of a very common problem in the newborn, and minimize the potential for subjecting infants of type o mothers to unnecessary blood tests, unwarranted treatment, and prolonged hospitalizations.

Eligibility criteria:
inclusion criteria: * written informed consent * mother blood type o * mother rh + * healthy infants * ≥37 wks gestation * ≥ 2500 gm birth weight * apgar ≥5 at 1 and 5 minutes exclusion criteria: * major anomalies * infants evaluated for sepsis or infants with transitional respiratory problems requiring \>6 hrs observation in the nicu * significant birth trauma with continued bruising and/or sequestration of blood still evident at the time of discharge * known perinatal blood loss with hemodynamic consequences such as persistent tachycardia, need for fluid boluses or supplemental oxygen * neonatal anemia with hb\<13.5g/dl * known family history of hereditary hemolytic disease such as g6pd deficiency, hereditary spherocytosis or hereditary elliptocytosis

Keywords: abo incompatibility hemolysis jaundice hyperbilirubinemia newborn
hydrotherapy against menopausal symptoms in breast cancer survivors

Conditions: Amenorrhea; Hot Flashes

Summary: breast cancer survivors often suffer from climacteric symptoms caused by treatment or diagnosis of their disease. hormone replacement therapy is contraindicated and other pharmacological options may also include the risk of stimulating hormone receptors. hydrotherapy following the guidelines of naturopathy by s. kneipp is a non-pharmacological treatment option which may influence climacteric symptoms by affecting the regulation of body temperature. in this study, the regular self application of hydrotherapy after initial training by a professional will be evaluated for its efficacy, practicability, and compatibility.

patients should use 2-5 different treatment options per day and fulfill a diary for symptoms and adherence to self-treatment for 12 weeks.

Eligibility criteria:
inclusion criteria: * breast cancer diagnosis * menopausal complaints score \> 14 (mrs ii) * end of last chemotherapy or radiotherapy \> 2 months * expected stable disease for the next 6 months exclusion criteria: * regular intake of glucocorticoids * regular practice of hydrotherapy before inclusion * start or change of other treatments/changes of lifestyle in order to influence menopausal symptoms * psychiatric disorders with possible influence on compliance and adherence to the protocol * other severe or progressive diseases with influence on compliance and adherence to the protocol * contraindications to hydrotherapy (severe heart failure, relevant dermatological diseases, raynaud's phenomenon \[m. raynaud\], peripheral arterial occlusive disease fontaine stage iib \[vk iib\] or more, acute thrombosis, or thrombophlebitis)

Keywords: climacteric symptoms breast cancer hydrotherapy
corifollitropin alpha and ovarian response

Conditions: Infertility, Female

Summary: objective: to study whether an administration of corifollitropin alpha modifies the follicular cohort, measured by follicular output rate (fort), compared to human menopausal gonadotropin (hmg), in infertile patients undergoing in vitro fertilisation (ivf). m/m: 306 infertile patients undergoing in vitro fertilisation (ivf). ovarian stimulation protocol will be performed with a single dose of 100 μg (\<60kg) or 150 μg (≥60kg) corifollitropin alpha in group 1 (n=147), and 150-300 iu/day human menopausal gonadotropin (hmg) according to age, antimullerian hormone (amh) level and antral follicle count (afc) in group 2 (n=150). moreover, fort will be calculated as the ratio of pre-ovulatory follicle (16-22 mm in diameter) count on day of hcg×100/small antral follicle (3-8 mm) count at baseline.

patients will be allocated for convenience into two groups: those who would receive corifollitropin alpha (group 1) or hmg (group 2). ovarian stimulation protocol will be performed with a single dose of 100 μg (\ 14 mm or 3 or more follicles \>12 mm). doses will be adjusted as needed by the patient according to the ultrasound, which is performed with a 6 mhz multifrequency transvaginal probe (toshiba, japan). the criterion for hcg administration (5.000 iu choriomon, biopharma, brazil) will be at least three follicles greater than 17 mm, and then, 36 hours later, transvaginal oocyte retrieval was performed. after 3 or 5 days, one or two good-quality embryos will be transferred. it will be performed intracytoplasmic sperm injection (icsi) instead of conventional ivf when major male factor is presented. primary outcome measure is fort. secondary outcome measures include number of oocytes retrieved, mii, duration of stimulation, number of embryos, embryo quality and clinical pregnancy rate. adverse events, such as ovarian hyperstimulation syndrome (ohss) or drug-related complications are also monitored.

Eligibility criteria:
inclusion criteria: * regular menstrual cycles; * body mass index (bmi) of \<33.0 kg/m². exclusion criteria: * previous ovarian surgery; * current diagnosis of polycystic ovarian syndrome (pcos) or other endocrinopathies; * history of autoimmune or metabolic disorders.
new york blood center national cord blood program

Conditions: Leukemia; Lymphoma; Genetic Disease; Severe Aplastic Anemia; Myelodysplasia

Summary: umbilical cord blood is used as a source of hematopoietic stem cells for bone marrow reconstitution in patients who would be potential candidates for a bone marrow transplant from an unrelated marrow donor. the outcome of transplantation is obtained to assess cord blood myeloid and platelet engraftment, transplant related mortality, overall survival, graft vs. host disease and, for patients with leukemia, lymphoma or myelodysplasia, relapse.

umbilical cord blood donated to the new york blood center's national cord blood program is collect, tested, processed, cryoprotected and frozen in liquid nitrogen for possible future transplantation to anyone who needs it. the program has operated under a fda ind exemption since 1996 and is licensed as a tissue bank by the new york state department of health. candidates for transplant are patients who disease requires bone marrow transplantation but who do not have a suitable related bone marrow donor. most patients are those with high risk of refractory leukemia, lymphoma, myelodysplasia, severe aplastic anemia and certain genetic hematologic, immunologic and metabolic diseases. patients are treated at bone marrow transplant centers in the united states and in other countries with active marrow transplant programs. because the nybc program operates under ind, patients must sign an informed consent for cord blood transplantation. transplant centers report on the transplant procedure (including immediate complications) and on transplant outcome at 3, 6 and 12 months post-transplant and annually thereafter. data report to the new york blood center includes information about the patient's disease and pre-transplant conditioning regimen and post-transplant endpoints, primarily myeloid and platelet engraftment, transplant related mortality, overall survival, acute and chronic graft vs. host disease, relapse and other post-transplant complications such as infectious disease. the outcome data is used to assess safety and efficacy and will be used to apply for a license from the fda.

Eligibility criteria:
inclusion criteria: * candidates for bone marrow transplantation exclusion criteria: -

Keywords: cord blood transplantation bone marrow transplantation
clinical study of sars-cov-2 vaccine in metabolism-related fatty liver disease

Conditions: Metabolic Associated Fatty Liver Disease

Summary: the coronavirus disease 2019 (covid-19) caused by sars-cov-2 causes high morbidity and mortality worldwide. sars-cov-2 vaccination is currently the most effective means of reducing morbidity, severe illness and mortality risk. this study aimed to establish a metabolic associated fatty liver disease (mafld) cohort of sequential booster sars-cov-2 vaccination, and to identify the dynamic changes of immune response induced by sequential booster sars-cov-2 vaccination in mafld population. to investigate the effects of blood routine, liver function biochemistry and coagulation function at 28 days, 57 days and 180 days after inoculation of sars-cov-2 vaccination.

the coronavirus disease 2019 (covid-19) caused by sars-cov-2 causes high morbidity and mortality worldwide. sars-cov-2 vaccination is currently the most effective means of reducing morbidity, severe illness and mortality risk. metabolic associated fatty liver disease (mafld) has a prevalence rate of 29.63% in china, which is the most common chronic liver disease in china. this study aimed to establish a metabolic associated fatty liver disease (mafld) cohort of sequential booster sars-cov-2 vaccination, and to identify the dynamic changes of immune response induced by sequential booster sars-cov-2 vaccination in mafld population. to investigate the effects of blood routine, liver function biochemistry and coagulation function at 28 days, 57 days and 180 days after inoculation of sars-cov-2 vaccination. safety and adverse events were assessed using an electronic questionnaire at days 1, 3, 5, and 7 after enrollment. serum and peripheral blood pbmc were collected at baseline and 28, 57, and 180 days after vaccination. blood routine, liver function biochemistry, coagulation function, antibodies, peripheral blood cell subtypes and serum, and pbmc proteomics were tested to evaluate the antibody and immune response induced by sars-cov-2 vaccination.

Eligibility criteria:
inclusion criteria: 1. strengthened by the third dose of sars-cov-2 vaccination in mafdl population. 2. age ≥18 years old, gender unlimited. 3. persons who agree to participate in this clinical trial and sign informed consent voluntarily. exclusion criteria: 1. persons who failed to complete sars-cov-2 vaccination. 2. start vaccination but do not strictly follow the vaccination schedule.

Keywords: sars-cov-2 vaccination immune response