Kornimate/medical-research-clean huggingface dataset:
management of frailty in older adults with turmeric and tulsi supplements

Conditions: Frail Elderly Syndrome

Summary: the aim of this study is to determine the efficacy of turmeric and tulsi polyherbal formulation in the management of frailty in the elderly population.

frailty is a wasting syndrome of old age that leaves a person vulnerable to falls, functional decline, morbidity and mortality. reducing the severity of frailty will provide large benefits for individuals, their families and for the society. it is assumed that early intervention with frail people will improve quality of life and reduce the costs of care. this trial is testing the frailty intervention with herbal medicine. if this frailty intervention is shown to be effective, there are major potential benefits to the frail older population generally in terms of decreased disability. the interventions being examined are readily transferable to routine clinical practice and can potentially be applied routinely in aged care services.

Eligibility criteria:
inclusion criteria: * subjects above the age of 65 years, providing written informed consent. * meeting three or more cardiovascular health study frailty criteria * mild or no cognitive impairment (defined as a mini-mental state examination score \>23), * able to walk without personal assistance and no other physical limitations that can limit participation and adherence, particularly to exercise intervention program exclusion criteria: people will be ineligible to participate in the trial if they: * live in a residential aged care facility * severe audio-visual impairment * progressive, degenerative neurologic disease like parkinsonism, fits/ epilepsy, etc. * rapidly progressive or terminal illness under palliative care with life expectancy less than 12 months * history of alcohol abuse or any other substance abuse * severely affect muscle/joint dysfunction resulting in disability * hospital admission in the past 3 months * regular physical training or physiotherapy or current participation in a vigorous exercise or weight-training program more than once per week * undergoing therapeutic diet incompatible with nutritional supplementation * in the opinion of research clinician, the intervention is deemed to be potentially hazardous for the subject, such as serious cardiac and pulmonary disease.
low dose chest computed tomography (ct) screening

Conditions: Hodgkin's Lymphoma

Summary: this research study is being done because patients with a history of chest radiation treatment for hodgkin's disease have been shown to be at increased risk for developing lung cancer a number of years out from treatment. the risk appears to be further increased among patients with a smoking history. in this study, the ct scans will be read and interpreted by the study radiologist, and the results recorded in a consistent manner. depending on the findings of the initial ct scan, we will then either repeat the scan in 1 year, or if indicated, send you for further scans or a biopsy. the information collected in this study will help researchers and clinicians in providing more concrete recommendations and screening guidelines for future survivors of hodgkin's disease who have had similar exposures to radiation and/or chemotherapy and smoking.


Eligibility criteria:
inclusion criteria: 1. 5 years or longer from initial hodgkin's disease diagnosis 2. current age 18 or older 3. received mediastinal irradiation and/or alkylating-agent based chemotherapy 4. smoking history of 10-pack years or more, or current smoker exclusion criteria: 1. patients with a history of lung cancer 2. patients currently receiving treatment for another cancer diagnosis (patients with another cancer, but currently disease-free and not receiving treatment are eligible) 3. patients with known diagnosis of any metastatic cancer 4. pregnant women. female patients must: be at least one year post-menopausal, have had a hysterectomy, or have a serum pregnancy test to confirm that they are not pregnant. these measures must be taken in order to avoid doing a ct scan of a pregnant woman.

Keywords: hodgkin's lymphoma lung cancer lung nodule ct scan
kefazolin versus kefazolin plus metronidazole to reduce postpartum infection

Conditions: Prevention of Postpartum Sepsis

Summary: randomised controlled trial to investigate the efficacy of adding metronidazole pre-operatively to kefazolin in reducing postpartum infection

all pregnant patients scheduled for emergency or elective caesarean section ≥18 years, willing and able to provide informed consent and not receiving antibiotics, will be eligible for recruitment. patients will be randomised into receiving kefazolin according to current standard of care administered pre-operatively intravenously with placebo (control arm), and kefazolin according to current standard of care administered pre-operatively with metronidazole 500 mg intravenously pre-operatively. outcome measures will be surgical site infection, urinary tract infection and postpartum endometritis. five hundred patients will be recruited in each arm

Eligibility criteria:
inclusion criteria: 18 years and older willing and able to provide written informed consent exclusion criteria: * women younger than 18 years women not able or willing to provide written informed consent women with or without infection already receiving antibiotics for other indications women allergic to kefazolin or metronidazole
a study of mk0663/etoricoxib for post-abdominal hysterectomy surgery pain (0663-097)(completed)

Conditions: Acute Pain Following a Total Abdominal Hysterectomy

Summary: the purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to placebo in the treatment of postoperative pain associated with total abdominal hysterectomy.


Eligibility criteria:
inclusion criteria: * patients 18 years or older in generally good health who are scheduled to have a total hysterectomy and who are willing to limit alcohol consumption exclusion criteria: * patient is allergic to the study drug, other cyclooxygenase-2 (cox-2) inhibitors/nonsteroidal anti-inflammatory drugs (nsaids), ibuprofen, morphine, or oxycodone or has hypersensitivity to aspirin or other nsaids * patient has uncontrolled high blood pressure * patient has a history of drug and/or alcohol abuse within the last 5 years * patient has taken part in another investigational study within 4 weeks of the start of study * patient is breast-feeding * patient has an active ulcer or inflammatory bowel disease
sonographic prediction of preterm delivery between 24-34 weeks of gestation

Conditions: Healthy

Summary: to evaluate if sonographic measure of short uterin cervix, sludge in amniotic fluid and abnormal doppler of the uterin artery can predict preterm labor


Eligibility criteria:
inclusion criteria: * pregnancy between 24-34 wees of gestation exclusion criteria: * lack prenatal care * fetal malformations stractural or genetical * plcenta previa * cerclage * women who underwent conization of cervix * polyhydramnious * premature rupture of membranes * induction of labor d/t medical condition preterm * women with hypertension, diabetis or preeclampsia * susp iugr * women with a chronic illness that may interupt pregnancy

Keywords: preterm delivery shory cervix amniotic fluid sludge uterine artery doppler singeltone normal amniotic fluid index without rupter of membranes 24-34 weeks of gestation
evaluation of spinelink® fixation in the treatment of degenerative spondylolisthesis and spinal instability

Conditions: Degenerative Disc Disease; Degenerative Spondylolisthesis

Summary: the purpose of this open, multi-center study is to prospectively collect outcome data on patients who are having lumbar spinal fusion surgery with implantation of the spinelink® system.

this will be an open, prospective, multi-center outcome study. this study will be conducted at up to ten centers, each of which will enroll approximately 20 patients. a maximum of 200 patients will be enrolled. this patient sample size will allow statistical comparison to historical literature and allow an inter-center comparison of outcome. enrollment into the study may include all patients who have lumbar spinal fusion performed. all spinal fusion surgery will be performed using the ebi spinelink® system.

Eligibility criteria:
inclusion criteria: 1. the patient has demonstrated grade i or grade ii degenerative spondylolisthesis exhibited by maximum slippage on flexion and extension radiographs with symptoms that include back pain and/or leg pain with spinal fusion indicated, or spinal instability as evidenced by greater than 3 mm of translational motion or greater than 10 degrees of angular motion between the involved vertebrae as evidenced by flexion-extension radiographs. 2. this surgery will be the primary fusion attempt with no more than three (3) vertebrae or 2 disc spaces involved. 3. the patient must be available for yearly follow-up in the study until completion of the 24 month evaluation. 4. the patient must be skeletally mature (epiphyses closed). 5. bone grafting material must be limited to autograft and/or bone-bank allograft. 6. the patient must be willing to comply with the treatment regimen, follow-up requirements, and have the legal ability to give informed consent. exclusion criteria: 1. patients with supplemental spinal internal fixation devices previously implanted at any other level and/or a previous fusion attempt at the involved level(s) (no interbody fusions, salvage procedures, or prior hardware). 2. patients with other pathology at the involved spinal level, e.g., osteomyelitis, paget's disease, pathologic fracture, etc. 3. patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc. 4. patients who have significant metabolic diseases including insulin dependent diabetes, renal dysfunction, etc. 5. patients involved in personal injury litigation. 6. pregnant or nursing females. 7. patient in whom unapproved biologicals (e.g. bmp-2) or bone substitute materials (e.g. grafton) would be used at the fusion site. 8. patients who are unable to understand and sign an informed consent or who, in the opinion of the investigator, would be psychologically unwilling or unable to understand or complete the protocol, especially those unwilling or unable to participate in the follow-up.

Keywords: spondylolisthesis instability
genotypic tropism testing in proviral dna to guide ccr5 antagonist treatment in subjects with undetectable hiv-1 viremia

Conditions: HIV

Summary: ccr5 antagonists might be an adequate alternative for hiv-1-infected individuals with suppressed viremia who experience antiretroviral-related toxicity. the assessment of hiv-1 tropism in proviral dna could be helpful to inform in which of these subjects ccr5 antagonists could be efficacious.

the assessment of hiv-1 tropism is needed before starting treatment with a ccr5-antagonist. several phenotypic and genotyping tropism tests have been developed in the recent years. phenotypic assays (i.e. trofiletm and es-trofiletm) have been used.in most clinical trials. genotypic tropism testing, however, is easier, cheaper and faster than phenotypic methods, and can be performed in a local hiv laboratories. viral rna amplification is difficult in subjects with hiv-1 rna levels \<500-1000 copies/ml. in these cases, the optimal source of genetic material is peripheral blood mononuclear cell (pbmc)-associated proviral dna. whereas genotypic tropism testing in proviral dna is technically feasible, it has not been validated as a tool to predict sustained virological response to ccr5-antagonist therapy in subjects with undetectable viremia. as of today, maraviroc is the only ccr5-antagonist approved for hiv treatment. it has few drug interactions and a good security profile, particularly in terms of lipid and glucose metabolism. therefore, it might be an adequate alternative for hiv-1-infected individuals with suppressed viremia who experience antiretroviral-related toxicity or metabolic problems. this study will evaluate 48-week virological outcomes in aviremic subjects with an r5 virus by proviral genotypic tropism testing who switch the "third drug" of their regimen to maraviroc.

Eligibility criteria:
inclusion criteria: 1. hiv-1 infected patients. 2. age 18 or more. 3. antiretroviral treatment containing 2 nucleoside/nucleotide reverse transcriptase inhibitors (nrtis) plus 1 non-nucleoside reverse-transcriptase inhibitor (nnrti) or 1 protease inhibitor (pi) or 1 integrase inhibitor (inin) 4. patients receiving stable antiretroviral treatment for at least 6 months. 5. viral load under 50 copies/ml in the last 6 months 6. patients with ccr5 tropism based in v3 genotyping in proviral dna using the g2p with a false positive rate of 10% interpretation method. 7. a change of treatment is needed due to toxicity / tolerability problems with the 3rd drug (pi, nnrti or inin), according to investigator criteria. 8. an antiretroviral regimen containing a ccr5-antagonist is suitable for the patient (physician criteria). 9. voluntary written informed consent. exclusion criteria: 1. pregnancy or breast-feeding. 2. patient previously treated with maraviroc. 3. patients with documented resistance to maraviroc or any other drug considered for the new arv regimen. 4. viral failure in the moment of inclusion. 5. bad adherence history or anticipated (investigator criteria).

Keywords: hiv tropism pbmc genotype 454 sequencing
predictive validity of lumbopelvic stress tests to determine those who will benefit from lumbar traction: a pilot study

Conditions: Low Back Pain

Summary: the objective in this study is to determine the predictive validity of a set of special clinical tests in identifying those who will respond to lumbar traction

the objective in this study is to determine the predictive validity of a set of special clinical tests in identifying those who will respond to lumbar traction. the central hypothesis of this pilot study is that a cluster of lumbopelvic stress tests will be able to identify a subgroup of patients with low back pain who will respond favorably to mechanical lumbar traction. if these clinical tests can identify a subgroup of patients with low back pain who respond favorably to lumbar traction, additional studies, including randomized clinical trials will be necessary to further test and validate the use of this cluster of clinical tests. the rationale for this research is to examine the connection between provocative lumbar compression testing and lumbar traction as a means of decompression

Eligibility criteria:
inclusion criteria: * complaints of low back pain with or without pain into the lower extremities * pain of at least 2/10 according to the numeric pain rating scale * score of at least 20 or greater on the oswestry disability index exclusion criteria: * medical red flags consistent with non-mechanical back pain (i.e. recent weight loss, history of cancer, night sweats, fever) * previous surgery to the lumbar spine * current pregnancy * any neurological symptoms in the lower extremities * evidence of central nervous system involvement * the inability to lie prone for 15 minutes
asc therapy for patients with severe respiratory covid-19

Conditions: Respiratory Tract Diseases

Summary: the emerging field of stem cell therapy holds promise of treating a variety of diseases. especially the mesenchymal stromal cells from bone marrow or adipose tissue (ascs) have proven their potential for regenerative therapy in patients with ischemic heart disease. both of these cell types have putative immunomodulatory properties, as they have demonstrated their ability to evade recognition and actively suppress the immune system. this knowledge is transferred into studies with covid-19 patients having severe pulmonary dysfunction, to modify the virus induced immunological and inflammatory activity involved in the progression of disease often leading to prolonged icu stay and in some occasion's death. we will conduct a clinical trial in which patients with covid-19 and severe pulmonary symptoms will be randomized to either placebo or treatment with allogeneic cscc_ascs from adipose tissue. the aim is to assess the impact of cscc_ascs on the activated immune system and clinical efficacy on pulmonary function. the perspective is that this new information can be of pivotal importance and potentially be a paradigm shift for the clinical problems and severe outcome seen in some patients with severe covid-19 and other severe diseases with acute respiratory distress syndrome.


Eligibility criteria:
inclusion criteria: * patients between 18-80 years * confirmed hcov-19 infection * temperature above 38.0o c * pulmonary symptoms and signs, at least one of the following before clinical decision for intubation and respirator treatment: 1. respiratory distress, rr ≥ 30/min; 2. oxygen saturation ≤ 93% at rest state; 3. arterial partial pressure of oxygen (pao2) / fraction of inspiration o2 (fio2) ≤ 300mmhg, 1mmhg=0.133kpa * pneumonia that is judged by chest radiograph or computed tomography * in respirator and possible for treatment within the first 24 hours exclusion criteria: * patients that have need for additional immunosuppressive treatment * patients with any past (within the past 3-5 years) or present malignancy (other than excised basal cell carcinoma). * co-infection with other infectious agent. * females capable of becoming pregnant must have a negative pregnancy test prior to treatment. after inclusion, they must use contraceptives for 2 months following the given stem cell treatment. the pill, spiral, depot injection of progesterone, sub-dermal implantation, hormonal vaginal ring and transdermal patch regarded as safe contraceptives. * patients who are participating in other clinical trials.
placebo-controlled crossover study to evaluate donepezil and mk-3134 for reversal of cognitive impairment associated with scopolamine administration (3134-005)(completed)

Conditions: Dementia

Summary: the drug, scopolamine, can result in short-term impairments of cognitive function, attention, and memory that resemble those seen in aging and alzheimer's disease. this study tested the capability of both individual and combined doses of mk-3134 and the current standard treatment: donepezil (aricept), to reverse such impairments, following a single dose of scopolamine. participants were evaluated after each of 5 different treatment periods (in a cross-over, double-dummy design): a: placebo to match both donepezil (oral \[po\]) and mk-3134 (po) followed by placebo scopolamine (subcutaneous \[sq\]); b: placebo to match both donepezil (po) and mk-3134 (po), followed by scopolamine sq; c: mk-3134 (po) followed by scopolamine sq; d: donepezil (po) followed by scopolamine sq; e: mk-3134 (po) and donepezil (po) followed by scopolamine sq. the doses of mk3134, donepezil, and scopolamine were the same over all treatment arms in which the specified drug was administered. there were 8 total visits for each treatment period, including 5 treatment visits requiring 14-day intervals between visits for study-drug washout. participants were assessed for cognitive function before and after each treatment period during the treatment visits.


Eligibility criteria:
participants were eligible for inclusion in the study who were: * male between 18 and 40 years of age. * non-smokers, in good health (as defined in protocol), and were willing to follow study-related procedures. participants were not eligible for inclusion in the study if they: * had a history of illness that, in the opinion of the study investigator or as specified in protocol, might confound the results of the study or posed an potential, additional risk to the participant if they were to participate in the study. * were taking any medication (prescription, nonprescription, vitamin supplements or herbal, illicit or legitimate) except for acetaminophen. * had a history of any significant head injury/trauma.

Keywords: dementia, cognitive impairment, neurodegeneration, alzheimer's, acetylcholine, ache
safety and immunogenicity of trivalent split influenza vaccine using the strain composition 2008/2009

Conditions: Seasonal Influenza, Vaccine

Summary: annual trial for registration influenza vaccine with the strain composition for season 2008/2009


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry * available for all the visits scheduled in the study and able to comply with all study requirements * in good health as determined by: medical history physical examination clinical judgment of the investigator exclusion criteria: * they have any serious (in the judgment of the investigator) disease, including but not limited to: cancer, except for localized skin cancer advanced congestive heart failure chronic obstructive pulmonary disease (copd) autoimmune disease (including rheumatoid arthritis) acute or progressive hepatic disease acute or progressive renal disease severe neurological or psychiatric disorder severe asthma * they have a history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein neomycin or polymyxin). * known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting for example from: receipt of immunosuppressive therapy (any parental or oral cortical steroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; receipt of immunostimulants, receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study, suspected or known hiv infection or hiv-related disease. * known or suspected history of drug or alcohol abuse. * they have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject; * women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days). * influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months * within the past 4 weeks they have received: another vaccine any investigational agent; * any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days. * they have experienced fever (i.e., axillary temperature ≥ 38°c) within the last 3 days * simultaneous participation in another clinical study. * any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives. * severely obese with body mass index (bmi) \> 35 * site personnel involved in evaluation of safety and their immediate relatives are excluded from participation.

Keywords: influenza vaccine seasonal split