Kornimate/medical-research-clean huggingface dataset:
effect of high power pain threshold ultrasound on postnatal sacroiliac joint pain

Conditions: Sacroiliac Joint Dysfunction

Summary: this study will be conducted to investigate the effect of high-power pain threshold ultrasound on postnatal sacroiliac joint pain.

sacroiliac joint pain (sij) in the pregnant and postpartum females is susceptible to dysfunction due to multiple biomechanical changes that happen over the course of gestation. this includes an increased angle of lordosis, weight gain, and structural trauma due to the physiologic process of childbirth, biomechanical changes, along with hormonal fluctuations through each trimester, particularly with increased levels of estrogen and relaxin, have been found to decrease the stability of the joint leading to sustained postpartum back pain that may necessitate surgical intervention if conservative treatment fails. pgp can result in significant physical disability and has important psychosocial implications, including extended leave from work during pregnancy and postnatal, poorer quality of life (as a result of being unable to carry out normal roles, affecting their ability to care for their children and the new baby) and predisposition to chronic pain. there are side effects to using medical treatment for pgp, such as bruising, bleeding, stomach upset (including bleeding in the stomach), peptic (stomach) ulcers, blurred vision, constipation, dry mouth, fatigue, headaches, insomnia, mood changes, nausea, urination problems, and weight gain. so, using other treatment methods, such as ultrasound therapy to treat pgp is beneficial. ultrasound therapy is a non-invasive treatment in which sound waves penetrate soft tissues, increasing blood flow; this can help relieve pain, improve circulation, and promote tissue healing. as such, ultrasound therapy is often used to treat injuries, muscle spasms, and chronic issues like neck or back pain. no previous study has investigated the effect of high-power pain ultrasound on sacroiliac pain in postpartum women. so, this study aims to investigate the effect of high-power ultrasound on postnatal sacroiliac joint pain.

Eligibility criteria:
inclusion criteria: * postpartum women diagnosed with sacroiliac joint pain and referred by an orthopedist. * their ages will range from 20 to 30 years old. * their body mass index (bmi) will range from 25 to 29.9 kg/m2. * all of them should have symptoms for at least two weeks postnatal exclusion criteria: * kidney diseases like stones or renal failure * history of ischemic heart diseases or myocardial infarction * severe vitamin d3 deficiency * severe liver diseases or hepatitis * psychological distress
a study to assess 11 beta-hydroxysteroid dehydrogenase type 1 inhibition in adipose tissue by spi-62

Conditions: Type 2 Diabetes Mellitus in Obese; Obesity; Type2Diabetes

Summary: this will be an exploratory, open-label study of 11β-hydroxysteroid dehydrogenase type 1 (hsd-1) inhibition by spi-62 in obese subjects with type 2 diabetes mellitus (t2dm)

the main objective of the study is to characterize the relationship between spi-62 plasma concentration and adipose tissue inhibition of hsd-1 in obese subjects with t2dm.additional objectives of the study are to characterize the relationship between adipose spi-62 concentration and hsd-1 inhibition, to characterize the relationship between spi-62 plasma concentration and liver inhibition of hsd-1, and to monitor the safety and tolerability of spi-62, in obese subjects with t2dm. this will be a phase i, open-label study in male and non-menstruating female subjects. potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. subjects will receive spi-62 daily for up to 14 days. subjects will also receive cortisone-d8, a mass-labeled hsd-1 substrate, by infusion during one or two confined study visits during the period of spi-62 administration. subjects may also receive cortisone-d8 during one to four additional confined study visits after cessation of spi-62. subjects will receive a follow-up call approximately 30 days after the last dose of study drug (spi-62 or cortisone-d8). results of population pharmacokinetic-pharmacodynamic modeling of data from this trial combined with those of prior trials will be reported separately from the clinical study report.

Eligibility criteria:
inclusion criteria: * male or non-menstruating female * 18 to 65 years of age * bmi 30.0 to 45.0 kg/m2 * diagnosis of t2dm for at least 3 months prior to the first dose of study drug. exclusion criteria: * uncontrolled t2dm with glycated hemoglobin ≥9.5%. * any other current or prior medical condition expected to interfere with the conduct of the trial or the evaluation of its results. * any clinically significant abnormal laboratory value which cannot be explained by a known and permitted clinical condition. * positive urine drug screen (except tetrahydrocannabinol) or positive alcohol breath test result. * participation in a clinical trial involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives, whichever is longer, or 90 days for a biological, prior to the first dose of study drug. * use of, or intent to use, any medications/products (prescription or over-the-counter) or herbal supplements within 4 weeks prior to the first dose of study drug, except those specifically allowed in the protocol.
tiva admnistration and autologous fat transfer in breast reconstruction

Conditions: Breast Cancer

Summary: the aim of the present study is to investigate the effect of intravenous anesthetics versus the administration of volatile anesthetics on stress and pain levels during autologous fat transfer for breast reconstruction in a day care center.

the sample of the study will be patients who will have autologous fat transfer for breast reconstruction. patients will be divided into 2 groups. the tiva group (n = 23) will be administrated intravenous anesthesia (propofol-remifentanil), while the des group (n = 23) volatile anesthetics (desflurane-remifentanil). specifically, the tiva group will include patients over 50 years of age with high risk of nausea / vomiting and postoperative delirium, as well as suspicion of malignant hyperthermia. patients with cardiac and respiratory problems will be included in the des group. the following data will be collected in the data sheet: patient demographics (gender, age), body mass index (body height- body weight). simultaneously, the pain levels will be evaluated by vas optical analogue scale of vas 0-10 in pacu, preoperatively and postoperatively, and perioperative pain levels will be assessed with cpot scale (values 0-8). stress levels will be evaluated with 3 nas questions: a. how sad do you feel right now? b. how anxious do you feel right now? and c. how optimistic do you feel right now?. the 3 nas questions will also be given preoperatively and postoperatively to the ward. the sedation levels will be assessed by rass scale (values +4 to -5) and the bispectral index (bis). the level of patient's awareness will be assessed by gcs scale (3 (indicating deep unconsciousness) and either 14 (original scale) or 15 (more widely used modified or revised scale)). the presence or absence of nausea / vomiting and the appearance of immediate postoperative complications will be examined. finally, post-operative stress will be examined with stress biomarkers, salivary acth hormone and salivary cortisol hormone.

Eligibility criteria:
inclusion criteria: tiva group * patients with american society of anesthesiologists (asa) physicalstatus classification system i-iii * age \>50 years * high risk of nausea / vomiting * high risk of postoperative delirium * suspicion of malignant hyperthermia. volatile anesthesia * patients with american society of anesthesiologists (asa) physicalstatus classification system i-iii * 20-70 years * patients with cardiac problems * patients with respiratory problems exclusion criteria •in both groups, the exclusion criteria are the opposite of the inclusion criteria

Keywords: admnistration fat transfer autologous fat transfer breast reconstruction tiva volatile anesthesia stress levels pain levels
pre-phase treatment before r-chop chemotherapy in elderly patients with newly diagnosed dlbcl

Conditions: Diffuse Large B Cell Lymphoma

Summary: a phase 2 trial of pre-phase treatment before r-chop chemotherapy in elderly patients with newly diagnosed dlbcl

r-chop chemotherapy cataract treatment with anterior steroids phenotypic effects evaluate the felony associated with the procedure for the primary purpose. this study evaluated efficacy, treatment outcome and safety for all patients.

Eligibility criteria:
inclusion criteria: 1. histologically the first large-scaled b-cell lymphoma patient 2. diagnosis time 65 years old or older 3. patients planning r-chop chemotherapy 4. ann arbor stage 2 (bulky ≥ diameter of 7cm), stage 3 or stage 4 5. the international prognostic index (ipi) is a high intermediate or high risk 6. patients without prior history of lymphoma 7. the decision to participate voluntarily in this study and the written consent of the patient exclusion criteria: 1. histologic subtypes other than cd20 positive broad-band macro-b cell lymphoma 2. large b-cell lymphoma involving the central nervous system 3. inadequate systemic disease a. patients with clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia) or myocardial infarction within the past 6 months b. serious neurological and psychiatric illness c. serious active infection d. other medical illnesses other than clinical trials 4. if the drug used in this study is allergic 5. if you do not agree to participate in the study
cement excess at single implant crowns malmö/lund

Conditions: Gingivitis and Periodontal Diseases; Tooth Loss

Summary: abstract aim: the primary aim of this study is to test whether or not cement residues in the submucosal environment of implants lead to a change in the microbiota and induce inflammation of the periimplant tissues. material and methods: 24 patients in need of a single tooth replacement will be enrolled in this cross-over controlled clinical study. all patients will receive a two-piece dental implant, which will be restored with both a cemented and a screw-retained single crown. at the time of impression taking, patients will be randomized into two groups. patients in group a will receive a screw-retained crown. every 8 weeks microbiological samples using sterile paper points will be collected and analyzed for bacterial content by real-time pcr. additionally, two host markers (mmp8, il-1ß) will be determined by elisa. following this first period of 16 weeks, the screw-retained crown will be replaced by a new intraorally cemented crown. cement removal will be preformed according to best clinical procedure. these crowns will again be left for another period of 16 weeks and followed up for the harvesting of microbiological samples every 8 weeks. after the second 16-week the crowns will be removed to evaluate any excess cement. all patients will be fitted with the original screw-retained crown. clinical parameters for inflammation and probing depths will be obtained after each 16 week-period. in group b the crowns will be incorporated in a reverse pattern. during the first 16 weeks any possible cement residues will be removed according to best clinical procedure, while for the second period of 16 weeks patients will be fitted with a screw-retained single crown. again, microbiological and clinical parameters will be obtained at the same intervals as in group a. after the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. patients will be followed up for another 16-week period.


Eligibility criteria:
inclusion criteria: * - patient older than 18 years * systemically healthy subject * periodontally healthy individuals * absence of peri-implantitis * no bone loss * good oral hygiene (pcr ≤ 20%) * healthy periodontal tissues (bop≤ 20%) * patients with a single tooth gap in the posterior area of either jaw (premolars and molars) * at least 8mm in mandible; at least 6mm in maxilla (summers technique) exclusion criteria: * - ongoing periodontal disease * bruxism * unwilling to comply with study procedures * heavy smokers (≥10 cig/d) * ongoing periodontitis/implantitis

Keywords: cement dental implant implant prosthodontics
hkt-500 in adult patients with osteoarthritis (oa) knee pain

Conditions: Osteoarthritis of the Knee

Summary: ketoprofen in a topical patch formulation has been demonstrated to be effective for treating mild to moderate pain caused by various musculoskeletal disorders.

the objective of this study is to demonstrate the short-term multiple dose efficacy and safety of hkt-500 in subjects with pain caused by mild to moderate osteoarthritis of the knee. the goal of the study is to gather additional information about the analgesic efficacy and safety of repeated, 24-hour applications of 2 hkt-500 patches per knee for a total of 28 days in subjects with pain caused by mild to moderate osteoarthritis of the knee.

Eligibility criteria:
inclusion criteria: * man or woman ≥45 years of age. * clinical diagnosis of unilateral or bilateral oa of the knee * taking an nsaid or acetaminophen on a regular basis and has a history of knee pain amelioration with nsaid or acetaminophen use. * mild to moderate oa of the knee at the screening visit * subject exhibits an arthritis "flare" in the target knee within 7 days day of withdrawing from a nsaid or acetaminophen. * subject understands that treatment will be administered on an inpatient basis. * subject is capable of understanding and complying with the protocol and has signed the informed consent document. exclusion criteria: * subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile * subject has symptoms that are attributable to primary inflammatory diseases of the joint * subject has unstable knees including a history of the knee catching or giving way or physical examination evidence of instability * subject has arthropathies that occur in conjunction with systemic diseases * subject has a chronic pain condition * subject is grossly obese * subject has a history of knee surgery within the past 12 months or arthroscopy within the past 6 months. * subject has a history of osteotomies. * subject is not willing to discontinue the use of nsaids, acetaminophen or other prohibited treatments * subject used opioids for oa pain within 1 month

Keywords: pain knee arthritis knee pain
a phase ii study of ssgj-707 monotherapy in first-line pd-l1 positive advanced nsclc patients

Conditions: NSCLC

Summary: this study includes two cohorts, cohort a is for non-squamous nsclc and cohort b is for squamous nsclc.

this study is a study of ssgj-707 monotherapy in first-line pd-l1 positive advanced nsclc patients. this study includes two cohorts, cohort a is for non-squamous nsclc and cohort b is for squamous nsclc. each cohort will assess the efficacy and safety of the preset several dose levels of ssgj-707 in advanced nsclc patients.

Eligibility criteria:
inclusion criteria: 1. males and/or females over age 18 2. histologically and/or cytologically documented local advanced or metastatic nsclc . 3. eastern cooperative oncology group (ecog) performance status of 0-1. 4. expected survival \>=3 months. 5. signed informed consent form. exclusion criteria: 1. known uncontrolled or symptomatic central nervous system metastatic disease. 2. adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (national cancer institute common terminology criteria \[nci ctcae\] v.5.0). 3. inadequate organ or bone marrow function. 4. pregnant or breast-feeding woman. 5. known allergies, hypersensitivity, or intolerance to ssgj-707. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
evaluation of compumedics "somfit" device

Conditions: Sleep Apnea

Summary: to study whether somfit is substantially equivalent to an existing approved device (i.e. compumedic's grael system) to assist in elucidating sleep disorders.

sleep is recognized as one of the three pillars of health (i.e. nutrition, exercise and sleep). poor quality and fragmented sleep leads to an increase in the risk for development of chronic health conditions. given the importance of good quality sleep and its critical role in overall well-being, there is a need for regular monitoring and assessment of sleep quality in individuals. however, current technologies will only allow for this to be performed in sleep clinics and with the help of full polysomnography (psg) systems which require the patients to spend a night at the clinic with several wired electrodes connected to their scalp. this will cause discomfort for the patients in a long run. to solve this problem, compumedics has recently developed a miniaturized, portable and affordable sleep monitoring system with code name of "somfit" which can be used in the comfort of patients' home. the aim of this study is to validate somfit for home based sleep studies.

Eligibility criteria:
inclusion criteria: * individuals age between 18 to 75 * be able to give informed consent * individuals with diagnosed obstructive sleep apnoea (osa) exclusion criteria: * less than 18 years of age * greater than 75 years of age * unable or not willing to provide informed consent * need for nursing care * currently working nightshift
long-term treatment with rhigf-1 in ghis

Conditions: Growth Hormone Insensitivity Syndrome

Summary: the objective of this study was to evaluate the long-term safety and effectiveness of mecasermin (the study drug) in children with growth failure due to severe primary insulin-like growth factor-1 deficiency (primary igfd).


Eligibility criteria:
inclusion criteria: * height \<-2sd for age and gender * igf-1 \<-2sd for age and gender * evidence of gh resistance exclusion criteria: * closed epiphyses * prior active malignancy * major organ disfunction * treatment with medications that would diminish growth * clinically significant cardiac abnormalities

Keywords: growth insulin like growth factor laron syndrome
role of circulating cytotoxic lymphocytes in endothelial cell injury in systemic sclerosis

Conditions: Scleroderma, Systemic

Summary: systemic sclerosis (ssc) is an auto-immune systemic disease characterized by vascular damage, cutaneous and visceral fibrosis and a dysimmune condition. therapies in this disease remain insufficient and the complications resulting from organs involvement lead to strong morbi-mortality.the dermic infiltrate of the patients includes a strong proportion of tcells. t cells and natural killer (nk) cells are potentially involved in the vascular damage of the ssc. however mechanisms at the onset of this endothelial cytotoxicity and its impact on the capacities of regeneration of the endothelial tissue remain poorly understood. fractalkine is at the same time an endothelial membrane-bound adhesion molecule and a chemokine which is able to bind cx3cr1 expressed by the immune populations. the purpose of the project is to define the role displayed by cytotoxic, circulating immune populations of ssc patients in endothelial cytotoxicity as well as the role of the axis fractalkine / cx3cr1 in mediating the interactions between the immune cytotoxic cells and the endothelium.


Eligibility criteria:
inclusion criteria: * patients affected by ssc of more than 18 years * healthy patients exclusion criteria: * impossibility to take some blood * current infection * ongoing cancer * chemotherapy or a current radiotherapy * pregnant or breast-feeding women
is milk associated with glycemia in the nicu

Conditions: Premature Birth

Summary: the purpose of this study is to determine if concentrations of hormones in prepared human milk (hm) feeds are associated with metabolic disturbances in the recipient premature infant. to do so, prospectively 100 infants receiving hm-derived fortifiers as part of clinical care will be studied, saving aliquots of daily prepared feeds until any fortification ceases.

the purpose of this study is to determine if concentrations of these hormones in prepared hm feeds are associated with metabolic disturbances in the recipient infant. a prospectively study 100 infants receiving hm-derived fortifiers as part of clinical care, saving aliquots of daily prepared feeds until any fortification ceases. insulin and pthrp will be compared in feeds from matched days when metabolic disturbances were documented vs not; each infant serving as a control. hypothesis 1 feed dose of insulin and pthrp will be higher from days when hypoglycemia and hypercalcemia are observed, respectively, vs control days when metabolic disturbances are not observed. hypothesis 2: over time, daily feed dose of insulin will correlate with average daily blood glucose in infants receiving hm products.

Eligibility criteria:
inclusion criteria: * infants eligible to receive human milk (hm)-derived fortifiers. to qualify for these fortifiers, infants must be born \<30 weeks gestation and/or weigh \<1250g at birth. enteral or oral feeding modes both qualify for participation. additional supplementation to feeds beyond hm-derived fortifier (such as medium-chain triglycerides) is acceptable. * infants initially on intravenous nutrition will still be eligible for consent. feed sample collections from these infants will commence once they advance to consume hm-based feeds once hm-derived fortifier is prescribed. exclusion criteria: * infants diagnosed with congenital disorders that impact glucose or calcium metabolism will be excluded. * infants with conditions necessitating specialized diets (ex: chylothorax) will also be excluded. * non-english speaking subjects will be excluded as the team of study personnel includes those that speak english only.
values of the immune activation markers cd38 and hla-dr and the ratio cd4/cd8 according to the delay of combined antiretroviral therapy (c-art) initiation in primary hiv-infected patients (primimmuno)

Conditions: HIV-infected Patients

Summary: the objective was to identify factors associated with the normalization of the cd4/cd8 ratio (\>=1) in patients with a history of primary hiv infection (phi) and long-term combined antiretroviral therapy (cart).


Eligibility criteria:
inclusion criteria: all hiv patients with a known history of phi and a minimum of 2 years of effective cart (\< 200 copies/ml) without interruption or virological failure exclusion criteria: patients with hepatitis c or b virus co-infection or with a history of neoplasia or immunosuppressive therapy after the date of pih

Keywords: hiv-infected patients cart immune restoration markers