Kornimate/medical-research-clean huggingface dataset:
measuring the hiv-1 reservoir during cure interventions studies (merci)

Conditions: Hiv

Summary: the aim of this study is the gain new insights into hiv latency before and after cure intervention studies through extensive blood and tissue sampling (lymph node and colon biopsies) from 30 individuals.


Eligibility criteria:
inclusion criteria: * meets the inclusion criteria of the cure intervention study exclusion criteria: * current history of opportunistic infection (aids defining events as defined in category c of the cdc clinical classification), consisting of chronic hiv-1 infection. * evidence of active hbv infection (hepatitis b surface antigen positive or hbv viral load positive in the past and no evidence of subsequent seroconversion (=hbv antigen or viral load negative and positive hbv surface antibody)). * evidence of active hcv infection (hcv antibody positive result within 60 days prior to study entry with positive hcv viral load or, if the hcv antibody result is negative, a positive hcv rna result within 60 days prior to study entry). * current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease. * current history of cancer. * history of hiv-related thrombocytopenia. * pregnancy or breastfeeding. * any condition, including preexisting psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant. * abnormal results of standard of care laboratory tests: 1. confirmed haemoglobin \<11g/dl for women and \<12 g/dl for men 2. confirmed platelet count \<100 000/µl \* 3. confirmed neutrophil count \<1000/μl 4. confirmed ast and/or alt \>10xuln * active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 60 days prior to entry. * the following treatment will be prohibited three months before screening and during the study: 1. immunosuppressive drugs (inclusive corticosteroids) except for drugs used for topical use. 2. immunomodulatory drugs including but not limited to granulocyte-colony stimulating factors, granulocyte-monocyte colony-stimulating factor, interleukin 2, 7 \& 15.

Keywords: hiv latency
edessy icsi outcome embryo score (eios) efficacy

Conditions: Infertility

Summary: purpose of this study is to detect outcome of intracytoplasmic sperm injection (icsi) according to eios

a total of 243 infertile couples underwent long gnrh agonist protocol in the art unit, international islamic center for population studies and research (iicpsr), al-azhar university. embryos which reached the two cell stage at 25-27 hr were classified as ec, and the remaining as non early cleavage embryos (nec). embryos were assessed again at 64-68 hours post-icsi for day three embryo morphology score (loi et al.,2008). the best two or three embryos, according to day 3 embryo morphology were transferred. each patient was given a score according to eios (female age, number of retrieved oocytes, number of ec embryos, number of good quality embryos and number of embryos transferred).

Eligibility criteria:
inclusion criteria: * age ≤ 40 years old. bmi \>25 - 30 kg/m2. have two ovaries. regular cycles. 1st icsi cycle. long midluteal gnrh protocol exclusion criteria: uterine factor as a cause of female factor infertility. pelvic masses or diseases (e.g: endometriosis, fibroids, hydro- salpnix, ...). history of medical disorders (e.g: hypertension, d.m, thyroid dysfunction, liver diseases, renal diseases,...). azoospermia as a cause of male factor infertility.

Keywords: icsi outcome
irinotecan plus carmustine in treating patients with recurrent primary malignant glioma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of irinotecan plus carmustine in treating patients who have recurrent primary malignant glioma.

objectives: i. determine the maximum tolerated dose of irinotecan administered in combination with a fixed dose of carmustine in patients with recurrent primary malignant glioma. ii. determine the toxic effects of irinotecan and carmustine in these patients. outline: this is a dose escalation study of irinotecan. patients receive irinotecan iv over 90 minutes weekly on weeks 1-4 and carmustine iv over 1 hour on weeks 1-6. treatment continues in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities. projected accrual: approximately 18-36 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically proven recurrent primary malignant glioma measurable recurrent or residual primary central nervous system neoplasm confirmed by mri patient characteristics: age: 18 and over performance status: karnofsky 60-100% hematopoietic: hematocrit greater than 29% absolute neutrophil count greater than 1,500/mm3 platelet count greater than 125,000/mm3 hepatic: sgot less than 1.5 times upper limit of normal (uln) bilirubin less than 1.5 times uln renal: creatinine less than 1.5 mg/dl bun less than 25 mg/dl pulmonary: dlco at least 60% other: not pregnant fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 6 weeks since prior chemotherapy no prior irinotecan or carmustine treatment failure no more than 1 prior chemotherapy regimen endocrine therapy: patients taking corticosteroids must be on a stable dose for at least 1 week prior to study and the dose should not escalate over entry dose level radiotherapy: at least 6 weeks since prior radiotherapy surgery: at least 3 weeks since prior surgical resection other: no concurrent medication that may interfere with study results

Keywords: recurrent adult brain tumor
bone strength after spinal cord injury

Conditions: Spinal Cord Injury

Summary: background: after a traumatic spinal cord injury, a severe bone loss in the paralyzed extremities is observed. this leads to a osteoporosis which is connected to a high fracture risk. aims: to compare the two measurement methods dexa and pqct concerning optimal diagnostics and assessment of fracture risk in subjects with spinal cord injury. subjects: 250 women and 250 men (age≥18, any ais-classification) with an acute or chronic spinal cord injury will be recruited for this study. for a reference group, 500 able-bodied persons will be measured analogously. methods: using dexa-osteodensitometry, bone parameters of the lumbar vertebral column, proximal femur, distal radius, distal tibia and knee area will be assessed. additionally, geometric bone parameters of the tibia will be measured by using pqct. all measurements will be done unilaterally. for the assessment of potential risk factors for reduced bone stiffness after spinal cord injury a questionnaire will be used.


Eligibility criteria:
inclusion criteria: * spinal cord injury * mobilized patients * written informed consent exclusion criteria: * current fracture * limited mobility * contractures of the lower limbs * decubitus ulcer * pregnancy

Keywords: osteoporosis bmd sci dxa pqct
ultrasound prescan vs conventional landmark-guided technique in spinal anesthesia in orthopedic obese patients

Conditions: Ultrasonography; Anesthesia, Spinal; Body Mass Index; Obesity

Summary: the study is aimed at evaluating whether ultrasound pre-procedural scan with accuro may reduce needle redirections when performing spinal injection in patients with bmi = or \> 30 in orthopedic surgery

this is a open-label randomised controlled study. 90 patients will be recruited and divided into two groups of 45 patients per group. patient recruitment will be performed by patient visit and checking inclusions and exclusion criteria. after written informed consent, every single patient will be allocated in one of the two groups following a computer generated randomization list. patients in both groups will undergo: * standard monitoring with non invasive blood pressure (nibp) cuff, three-lead electrocardiography (ecg) and pulse-oximetry (spo2). * peripheral intravenous access * sedation (as prescribed by the or anesthesiologist) * spinal anesthesia performed by anesthesiologists skilled in both techniques (conventional landmark technique or accuro guided) at the l3-l4, l4-l5 or l5-s1 level, with a 25 or 27 gauge needle, with the surgical side declive or proclive according to the baricity of the local anesthetic used (sitting position, when needed, will be reported in the crf) in both groups an observer will monitor and register spinal procedure duration (starting point: anesthesiologist wearing sterile gloves, ending point: end of local anesthetic injection). control group (landmark technique): the anesthesiologist will identify lumbar spinous processes with traditional landmark palpation. once the correct interspinous level and the mid-line will be identified, the anesthesiologist will proceed with needle insertion and spinal injection. treatment group (ultrasound pre-procedural scan with accuro): by using accuro us probe the anesthesiologist will perform a pre-procedural lumbar spine scan to detect the needle entry site. after image optimization, the accuro probe will be aligned with the spine mid-line, as indicated by a dashed red-line on the screen. after that the interlaminar space at the desired intervertebral level will be detected, as indicated by orange overlay in the screen. the depth and the device angle used to detect the interlaminar space will be annotated. the anesthesiologist will then disengage the accuro locator needle guide and press gently against the skin. then the probe will be removed and the spinal injection will be performed.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * bmi ≥ 30 kg/m2 * american society of anesthesiologists' (asa) classification i-iii * orthopedic surgery to be performed under spinal anesthesia * able to understand and to sign informed consent exclusion criteria: * local anaesthetic allergy * serious spine deformities * previous spine surgery * inability to express informed consent * contraindications to spinal anaesthesia * pregnancy
combination of conditioned medium and umbilical cord-mesenchymal stem cells therapy for acute stroke infarct

Conditions: Ischemic Stroke

Summary: the purpose of this study was to determine the effectiveness of a combination of intranasal conditioned medium (cm) with intraparenchymal umbilical cord mesenchymal stem cells (uc-mscs) transplantation in acute stroke patients to induce neurogenesis.

this study has 3 arms namely cm and uc-mscs treatment, uc-mscs treatment only, and control. the investigator hypothesized that group of cm and uc-mscs combination is the optimal treatment to induce neurogenesis in stroke patients.

Eligibility criteria:
inclusion criteria: * male or female aged 25-60 years diagnosed with ischemic stroke acute phase * the patient has had a ct scan/mri of the brain to assess ischemic territory * the patient must have an nih stroke score of 8-20 * the patient or legal assistant has obtained detailed informed consent regarding the study protocol and agreeing to participate in the study * patients with the glasgow coma scale (gcs) score \> 8 * patients with pt-aptt values within normal limits exclusion criteria: * patients with recurrent stroke in the 6 months preceding the episode current stroke * ct or mri images show midline shift and bleeding transformation * participate in similar studies using cm and/or uc-msc * patients who are immunocompromised and/or who are receiving therapy immunosuppressive * patients who cannot have a ct or mri examination due to their condition * patients with impaired renal and hepatic function after the onset of ischemic stroke: serum glutamic oxaloacetic transaminase (sgot) and serum glutamic pyruvic transaminase (sgpt) \> 5x the upper limit of normal values and a significant increase in urea-creatinine values * patients with a history of malignant tumors or other severe neurologic conditions.

Keywords: ischemic stroke mesenchymal stem cells conditioned medium secretome
kinesio taping compared to exercise intervention for round shoulder subjects with impingement syndrome

Conditions: Shoulder Impingement Syndrome (SIS); Round Shoulder Posture (RSP)

Summary: to compare the effect between the exercise intervention (strengthening exercise and stretching exercise) and exercise intervention with taping on decreasing round shoulder posture and improving symptoms in subjects with shoulder impingement syndrome/round shoulder syndrome.

background: poor posture and abnormal scapular kinematics have been suggested as possible primary factors in developing shoulder impingement syndrome (sis) and also as secondary observed phenomena of sis. round shoulder posture (rsp) is major and common posture contributing to increase the potential for subacromial impingement or exaggerate the symptoms of sis. objective: to compare the effect between the exercise intervention (strengthening exercise and stretching exercise) and exercise intervention with taping on decreasing rsp and improving symptoms in subjects with sis/rsp. methods: forty subjects with impingement age between 20 and 75 are recruited and measured on acromial distance, pectoralis minor index (pmi), posterior and anterior shoulder tightness, distance of scapular medial border, pain score and flexilevel scale of shoulder function (flex-sf). clinical significance: shoulder impingement syndrome (sis) have been identified as the majority of reported shoulder complaints. the project will provide an effective intervention for subjects with sis/rsp.

Eligibility criteria:
inclusion criteria: 1. subjects age between 20 and 75 2. diagnosed with shoulder impingement syndrome 3. at least three positive of five tests, including neer's test, hawkin's test, empty can test, tenderness in tendon of rotator cuff exclusion criteria: 1. shoulder pain onset due to trauma 2. a history of shoulder fractures or dislocation 3. cervical radiculopathy 4. degenerative joint disease of the shoulder 5. surgical interventions on the shoulder 6. inflammatory arthropathy

Keywords: shoulder impingement syndrome kinesio tape round shoulder posture
high-risk breast lesions: a multicenter retrospective study

Conditions: Premalignant Lesion

Summary: in this multicenter study, the goal was to document the excisional biopsy or follow-up results of high risk lesions diagnosed on image guided cnb/vab, and evaluate the clinical, imaging and histologic features for associated malignancy risk. the possibility of upgrade related to histologic subtype, tissue sampling and other variables was also evaluated.

this is a retrospective multicentric study that include 1345 patients from 30 centers. patients who had a diagnosis of high risk lesions (hrl) on image guided core biopsy (tru-cut/vacuum biopsy) were reviewed in a 12 year period (between 2008 and 2020). the lesions included were adh, ln (alh/lcis), papilloma (without or with atypia), rs, and fea. the patients who managed with an excisional biopsy or having at least 1 year follow-up documentation following the diagnosis of borderline lesion were included in the study. radiological findings, diameter of lesion (\>15 vs \ 4 vs \<4) were documented. ibm spss version 25.0 statistical package program was used for analysis.

Eligibility criteria:
study population: the women with diagnosis of atypical ductal hyperplasia, lobular neoplasia, flat epithelial atypia, papilloma and radial scar on image guided core needle biopsy were studied sampling method: non-probability sample minimum age: 12 maximum age: 86 sex: female gender based: no accepts healthy volunteers: no criteria: inclusion criteria: * image guided needle biopsy diagnosis * atypical ductal hyperplasia * lobular neoplasia * flat epithelial atypia * papilloma * radial scar * diagnosed on image guided needle biopsy exclusion criteria: * fibroepithelial tumors * mucocele like tumors * diagnosed on surgical biopsy
an efficacy and safety study of argx-113 in patients with myasthenia gravis who have generalized muscle weakness

Conditions: Generalized Myasthenia Gravis

Summary: a randomized, double-blind, placebo controlled, multicenter phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of argx-113 in patients with gmg.


Eligibility criteria:
inclusion criteria: 1. patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures. 2. male or female patients aged ≥ 18 years. 3. diagnosis of mg with generalized muscle weakness meeting the clinical criteria for diagnosis of mg as defined by the myasthenia gravis foundation of america (mgfa) class ii, iii, iva and ivb. other, more specific inclusion criteria are defined in the protocol exclusion criteria: 1. pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing. 2. male patients who are sexually active and do not intend to use effective methods of contraception during the trial or within 90 days after the last dosing or male patients who plan to donate sperm during the trial or within 90 days after the last dosing. 3. mgfa class i and v patients. 4. patients with worsening muscle weakness secondary to concurrent infections or medications. 5. patients with known seropositivity or who test positive for an active viral infection at screening with: * hepatitis b virus (hbv) (except patients who are seropositive because of hbv vaccination) * hepatitis c virus (hcv) * human immunodeficiency virus (hiv) other, more specific exclusion criteria are further defined in the protocol.
new oral direct anticoagulants in patients 80 years old and over : a population pharmacokinetics study

Conditions: Atrial Fibrillation

Summary: several new oral direct anticoagulants have been recently marketed. however, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. this study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. the investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. the method employed is a population pharmacokinetic/pharmacodynamic study.

several new oral direct anticoagulants have been recently marketed. a main indication for taking these drugs is atrial fibrillation and, in everyday practice, most patients with atrial fibrillation are older people. however, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. furthermore, this limited data strongly suggests that, in older patients, mean concentrations, overall exposition and half-live of these drugs are increased, as compared with younger people. this study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. the investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. the method employed is a population pharmacokinetic/pharmacodynamic study. this is, many people (projected 225 patients) will have a few blood samples each and all data will be pooled using statistical methods specific to this kind of studies. each patient will have one to five blood samples, taken at te same time that routine blood analysis, to determine plasma concentrations of the studied drug. in addition, patients will be followed for thrombotic and haemorrhagic events at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * age 80 years or older * under treatment with dabigatran, rivaroxaban or apixaban * for non-valvular atrial fibrillation exclusion criteria: * mechanical (non-biological) heart valve * any severe condition leading to a short estimated life expectance (a few months)

Keywords: anticoagulants factor xa inhibitors antithrombins pharmacokinetics aged, 80 years and older
theatre in adolescents with chronic medical conditions (cmcs)

Conditions: Chronic Disease

Summary: investigators are building a program that uses improvisation to teach kids and teens with medical issues healthy ways to cope. medical issues have been linked to anxiety and depression. doing theatre can prevent these complications. participants will meet in groups of about ten for ten weeks to do improvisation that is fun and supportive. participants will meet with a study team member before the program starts, after the program ends, six months after the program ends, and twelve months after the program ends. at these visits, participants will be screened for anxiety, depression, quality of life, and will be given a short interview.

adolescents with chronic medical conditions are at increased risk for anxiety and depression compared to other people their age. therapies that use role-play prevent anxiety and depression. however, often these studies do not have an underlying psychological framework, or there is not enough information to replicate the program. investigators designed an intervention using role-play based on integrative community therapy, developed in the 1980s by dr. adalberto barreto. this program will help adolescents with chronic medical conditions explore their feelings about issues related to having a chronic condition, learn new coping strategies, and help one another find support among peers. this treatment will take place once a week for 10 weeks and investigators will compare the effects to those derived from improvisational theatre alone. to evaluate this new treatment, the study team will screen participants for anxiety, depression, quality of life, and will give a short qualitative interview. this will occur before and after the intervention, 6 months after the intervention, and 1 year after the intervention.

Eligibility criteria:
inclusion criteria: * identify as having a cmc * in grades kindergarten to 12th grade during the year recruited for the study * 5 years of age and ≤ 19 years of age at the start of the intervention * able and willing to participate in improvisational theatre in spoken english * able to understand and answer standard questionnaires used for evaluation in english (with or without accommodation) exclusion criteria: * none