Kornimate/medical-research-clean huggingface dataset:
neuroendocrine dysfunction in traumatic brain injury: correlation with cognitive dysfunction and repair

Conditions: Traumatic Brain Injury

Summary: traumatic brain injury (tbi) is a neurologic disorder cuased by physical trauma to the brain. neuroendocrine abnormalities in these patients have been reported, including central hypogonadism within hours of the insult and eventual recovery of the hypothalamic-pituitary-gonadal axis with recovery of cognitive function to baseline. this pilot study will measure hormonal level of neuroendocine function at the time of tbi and various time points during recovery.


Eligibility criteria:
inclusion criteria: * male subjects having had a recent traumatic brain injury. exclusion criteria: * currently receivng sex steroids, glucocorticoids, or have an inability to complete the neurobehavioral assessment.
cart-19 cells for r/r b-cell lymphoma

Conditions: Relapsed or Refractory B-cell Lymphoma

Summary: relapsed/refractory b cell lymphoma is a challenge to be treated, however,cart-19 cells could be very promosing. this study aims to assess the safety and toxicity of cart-19 cells for patients with relapse or refractory b cell lymphoma.


Eligibility criteria:
inclusion criteria: * signed written informed consent * aged between 1-65 years * patients with relapse/refractory b-cell lymphoma * cardiac: left ventricular ejection fraction ≥ 50% * adequate renal and hepatic function * performance status: karnofsky ≥ 70% exclusion criteria: * pregnant or lactating females. * any co-morbidity precluding the administration of cart-19 cells.
diagnosis and management of inflammatory and infectious diseases

Conditions: Infection; Inflammation

Summary: this protocol is being established to cover the evaluation of patients with inflammatory and/or infectious diseases which are not covered under previously existing protocols. the purpose of such a protocol is that frequently patients are referred to us with either diagnosed or undiagnosed illnesses which would be of interest to our teaching program or which would serve as a source of patients to subsequently be entered into established, ongoing protocol studies. such patients will be admitted to the protocol and handled according to accepted medical practice of diagnosis and treatment.

study description: this protocol was established in 1978 to evaluate patients with diagnosed and undiagnosed inflammatory and/or infectious diseases that are of scientific interest. once diagnosis is made patients are referred to relevant nih protocols for follow-up. if an nih protocol does not exist for the condition, participants receive the required clinical standard of care treatment through an outside provider or through this protocol if a provider with the necessary expertise cannot be found. it is a minimal risk study. objective: to evaluate patients with possible infectious and/or inflammatory diseases in order to collect data/samples through the diagnosis of infectious and inflammatory conditions (including in terms of clinical, immunologic, and metabolic features) further characterize, and treat infectious and inflammatory conditions through the collection of clinical specimens, medical records and in-person assessments to provide a repository of information on enrolled participants to allow for hypothesis generation in future research

Eligibility criteria:
* inclusion criteria: 1. known or suspected exposure to infection, as determined by the principal investigator or presence of signs and symptoms of an infectious or inflammatory disease 2. age range: 3 years of age and older. 3. niaid/lir investigator who has an interest in the patient s illness and is willing to serve as attending physician to supervise the patient's medical care at the nih. 4. primary physician outside the nih 5. the patient or the patient's legally authorized representative is capable of informed consent and signs the consent form. the consent form will be signed by parents or guardians of patients under the age of 18 exclusion criteria: 1. pregnant. 2. presence of conditions that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study.

Keywords: inflammation infection fever natural history
prospective clinical study of intraoperative assessment of resection margin of colo-rectal cancer liver metastases

Conditions: Liver Metastasis Colon Cancer

Summary: this prospective single arm double-blind study approved by the ethics committee of the institution, will be conducted on at the oncology institute of vojvodina in sremska kamenica, serbia. patients with colo-rectal cancer liver metastases (crlm) is presented to the multi-disciplinary team (mdt).screening and enrolment is conducted after established of indication for resection. the surgeons assesses resection margin (rm) for every resected liver specimen (rls) intra-operatively by inspection and palpation. these data will be compared with pathological rm examination as a "gold standard". resection margin of 1 mm or more will be rated as negative rm (rm-) otherwise rm is positive (rm+). taking the result of the pathohistological examination as "gold standard" it is determined that rm is true positive when the pathologist and surgeon agreed that the rm is positive. false negative rm is when the surgeon assesses rm as negative and pathologist as positive. the sensitivity of the surgical assessment of rm+ is defined as the rate of rm+ which was correctly identified. true negative rm is determined when the pathologist and surgeon agreed that it is negative rm. false positive rm defined when the surgeon assessed rm as positive, but pathologist found that it was rm-. the specificity of the surgical assessment of rm is defined as the rate of rm- which is correctly identified. total accuracy represents the rate of correctly recognized positive and negative rm, relative to the total number of samples. agreement between surgeon and pathologists finding will be analyzed as well as difference between them. disease recurrence and disease-free survival (dfs) will be analyzed by rm.


Eligibility criteria:
inclusion criteria: * older than 18 years * preoperative diagnosis of liver metastases of colorectal adenocarcinoma * indication for surgical resection of liver metastases of colorectal adenocarcinoma exclusion criteria: * rm is not defined by surgeons and pathologists as positive or negative * surgical resections and application of ablative procedures at the same time * surgery for relapse of crlm, if the first crlm surgery is performed before this study start * resection was not done from any reason
schooling, income, and hiv risk in malawi

Conditions: HIV; Schooling; Conditional Cash Transfers; Unconditional Cash Transfers

Summary: this study is designed to evaluate a two-year randomized intervention in malawi that provides cash transfers to current schoolgirls (and young women who have recently dropped out of school) to stay in (and return to) school in order to understand the possible effects of such programs on the sexual behavior of the beneficiaries and their subsequent hiv risk.

motivation: education has been suggested as a "social vaccine" to prevent the spread of hiv (jukes, simmons, and bundy, 2008), but almost all of the evidence we have on the link between school attendance (or attainment) and the risk of hiv infection comes from cross-sectional studies. furthermore, the role of income (especially that of women's poverty) has been hypothesized as a significant factor in the spread of hiv in ssa, but again there is no credible evidence showing a causal link between income and hiv risk. a randomized intervention, such as the one proposed here, that provides randomly varied amounts of cash transfers to young individuals and their guardians is the perfect setting to examine the possible existence of such causal relationships. objectives: the objective of the proposed study here is to provide credible evidence on issues about which we still know very little. specifically, the main questions the study will try to answer are the following: 1. are the observed effects of a cct associated with the transfer or the conditionality imposed on the recipient? 2. do the outcomes of interest improve with increased benefit levels set by the program? 3. do cct programs for schooling have any positive health impacts, including prevention of stis such as hiv/aids among young people?

Eligibility criteria:
inclusion criteria: * female * 13-22 years old * never married
an evaluation of the long-term efficacy and safety of methylone for the treatment of ptsd

Conditions: Post Traumatic Stress Disorder

Summary: this is an extension study of participants who previously completed a transcend-sponsored clinical trial evaluating tsnd-201 as a treatment for ptsd. participants will be followed for up to 52 weeks. during the 52 week period, ptsd symptoms and safety will be assessed monthly. participants' ptsd symptoms will be assessed at each observational visit and if criteria for relapse has been met, participants may be eligible to receive a course of tsnd-201 treatment.


Eligibility criteria:
inclusion criteria: * participation in and successful completion of a prior transcend-sponsored clinical trial with tsnd-201. * agree to not participate in any other interventional clinical trials for the duration of this study. * willing and able to provide informed consent. exclusion criteria: * had significant deviation(s)/non-compliance in parent study in the opinion of the investigator which would deem them unsuitable for participation. * change or development of any physical or psychological finding that would make participant unsuitable for study.

Keywords: ptsd impact-ext methylone neuroplastogen transcend therapeutics tsnd-201
post-parotidectomy facial paresis: intraoperative and postoperative factors

Conditions: Parotid Neoplasms; Facial Paralysis

Summary: this is a protocol to govern the prospective trial of facial nerve monitoring in patients undergoing parotidectomy with an eye towards interpreting if the facial nerve monitor provides useful information to operating surgeons and if the information provided by the facial nerve monitor can predict degrees of postoperative facial nerve paresis. additionally, the study will determine if performing daily facial rehabilitation exercises provides a benefit in reducing time to recovery of temporary post-parotidectomy paresis.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * planned parotid gland surgery (superficial or total parotidectomy) * benign or malignant disease exclusion criteria: * pregnancy * preoperative facial nerve dysfunction * revision operation * history of preoperative radiation to the surgical field * entire nerve not dissected * intentional nerve sacrifice * poor signal to noise ratio during surgery * lack of access to device compatible with video conferencing software, or lack of access to broadband internet connection
identification by cytometry by mass of predictive immunological profiles of answer to treatmentby biotherapics for patients with crohn's disease

Conditions: Crohn Disease

Summary: crohn disease is an inflammatory chronic disease of the bowel the complex physiopathology of which brings in immunological, genetic and environmental factors. at present, the appeal to biotherapics anti-tnfa (infliximab and adalimumab) or anti-il-12/23 (ustekinumab) in mc represents a major therapeutic progress at the origin of a significant improvement of the symptoms, the healing of the intestinal hurts and the quality of life. considering the new immunological targets of these biotherapics, the investigators put the hypothesis that an immunological profile (impulsive person and\\or tissular) specific of the patients with one mc is associated with the answer to biotherapics. so, before beginning the treatment the patients expressing strongly the pro-inflammatory cytokine tnfa, would more may be answering machines in anti-tnfa and those with whom the immunological profile is very marked towards the way th1/th17 would more may answer favorably the ustekinumab. the identification of immunological profiles capable of predicting before treatment the answer under biotherapics could establish in mc but also in other inflammatory diseases a major step forward to guide the coverage.


Eligibility criteria:
inclusion criteria: * patient of more than 18 years old * patient presenting a mc before diagnosed according to the usual criteria * patient in relapse (score cdai \> 150) for at least 1 month * requiring patient a treatment by anti-tnf or ustekinumab according to the indications of the amm * patient compatible with the realization of endoscopic digestive biopsies * patient having signed a consent of participation exclusion criteria: -· patient with crohn disease with a cdai score \< 150 · * contraindication to anti-tnf and\\or ustekinumab · * contraindication to the realization of an iléocoloscopie ·- patient taking anti-inflammatory drugs or antibiotics · * patient presenting complications of the type intestinal sub-occlusion, fistulas or abdominal abscesses · * patient having a exclusive perianal disease or having * pregnant women · * patients having been the object of a vast intestinal resection · * patient with an ileostomy or a colostomy · * no consent of the patient · * patient under legal protection · * subject participating in another research which need a period of exclusion

Keywords: crohn immunological profile ustekinumab anti-tnf
the effect of lovastatin gel in the treatment of chronic periodontitis

Conditions: Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration

Summary: aim: dis double-blind split-mouth clinical trial study was performed to evaluate teh clinical and radiographic effect of local delivery of lovastatin gel as an adjunct to scaling and root planning (srp) in teh treatment of chronic periodontitis. method and materials: 15 patients with two mandibular molar teeth with probing depth (pd)≥3 mm, clinical attachment level (cal)≥3 mm and bone loss more than 3 mm according to parallel periapical x-ray and distance from cej to alveolar crest, were selected.totally 24 mandibular molars were selected for teh study. clinical periodontal parameters included pd, cal, bleeding index(bi), plaque index(pi) were recorded for teh selected teeth at baseline and at 1,3 and 6 months. radiographic assessments were performed at baseline and after 6 months. at one side teh pockets around randomly selected molar were injected with a blunt syringe filled with lovastatin gel 1.2%( case group=b), and on teh other side, teh pockets were filled with a placebo gel by a blunt syringe ( control group=a).two-way repeated measure anova test and t-test were used for statistic analysis spss 23.( p\<0.05) was considered significant.

statins are an important group of hypolipidemic drugs dat are able to modulate inflammation and alveolar bone loss. rosuvastatin (rsv) and atorvastatin (atv) are non to inhibit osteoclastic bone resorption and has been proposed to has osteostimulative properties.

Eligibility criteria:
inclusion criteria: 24 patients wif periodontitis chronic and temphas a 2 molar symmetrically in the lower jaw pockets of periodontal depth of at least 4 mm and cal greater than 3 mm in at least one of the surfaces of the teeth, the x-ray bars from both sides of the molar regions jaw bottom, from cej and alveolar crest was more than 3 mm, were selected exclusion criteria: 1. systemic disease 2. pregnancy or breastfeeding 3. allergy drug used 4. smoking 5. medication 6. not willing to consent to participate in the study 7-trismus 8-the type of disease periodontal (aggressive) 9. history of periodontal treatment in the previous 6 months 10-orthodontic treatment
mammosite as sole radiation therapy technique for ductal carcinoma in-situ

Conditions: DCIS

Summary: this study has been designed to compile information on the efficacy of the mammosite rts providing sole radiation therapy for patients with pure dcis.

data relevant to the evaluation of the efficacy and safety of the mammosite rts system in providing radiation therapy to patients with dcis will be collected. the mammosite is a radionuclide applicator designed to deliver internal radiation therapy (brachytherapy) in patients with breast tumors following breast tumor resection surgery (lumpectomy).

Eligibility criteria:
inclusion criteria: * pre-surgery: * unicentric pure dcis * lesions should have a greatest dimension of 3 cm or less as determined by pre-surgery mammography and mri * post-surgery: * negative histological margins confirmed prior to beginning radiation therapy. * margins are positive if there is tumor at the inked margin. * classified as low (ng1), intermediate (ng2) or high (ng3) nuclear grade dcis, using the philadelphia consensus conference guidelines are eligible * clinically node negative exclusion criteria: * distance from the balloon surface to the surface of the skin \< 5mm as determined by ct imaging. * distant metastases. * invasive or in-situ lobular carcinoma (post-surgery assessment). * nonepithelial breast malignancies such as sarcoma or lymphoma. * dcis that is multicentric in the ipsilateral breast. * pregnant or lactating. * prior non-hormonal therapy for the present breast cancer, including radiation therapy and/or chemotherapy. * collagen vascular diseases * coexisting medical conditions with life expectancy \< 2 years. * serious psychiatric or addictive disorder * previously treated contralateral breast carcinoma * synchronous bilateral breast carcinoma. * other malignancy, except non-melanoma skin cancer, \< 5 years prior to participation in the study; the disease free interval from any prior carcinoma must be continuous. * patients with diffuse disease

Keywords: mammosite dcis
subcutaneous progesterone versus vaginal progesterone gel for luteal phase support

Conditions: Infertility

Summary: it is well known that implantation of the developing blastocyst occurs during the luteal phase of the menstrual cycle when the endometrium is under the direct influence of progesterone (p).several prospective randomized controlled trials have evaluated the benefits of luteal phase p support in ovulation induction cycles and a recent review and meta-analysis demonstrated that it may be of benefit to patients undergoing ovulation induction with gonadotropins in intrauterine insemination (iui) cycles. until now, injectable p was offered only in an oil-base solution owing to the insoluble properties of the molecule, which made the im route mandatory. a recent publication, however, demonstrated the efficacy of a new p formulation that could be a game changer. the aim of the present pilot trial will be to compare the efficacy and tolerability of 25 mg/d of the new sc p with 90 mg/d of vaginal gel p for luteal phase support (lps) in coh and iui cycles.

the present randomized study will be conducted to compare the safety, effectiveness and tolerability of sc p (pleyris; ibsa institut biochimique sa) with vaginal p gel (crinone; merck serono) for lps in coh/iui cycles. the study will be conducted, recorded and reported in compliance with the principles of good clinical practice (gcp) guidelines at the department of obstetrics and gynecology of magna graecia university of catanzaro.

Eligibility criteria:
inclusion criteria: \<38 years of age with either primary or secondary infertility for at least 1 years; body mass index between 19 and 30 kg/m2; day 2 serum fsh \<15 iu/ml; normal serum prolactin level; normal uterine cavity on hysterosalpingography or hysteroscopy.- exclusion criteria: female partners with previous ovarian surgery, one ovary, polycystic ovaries on ultrasound examination, other endocrine abnormalities (i.e., polycystic ovarian syndrome, thyroid disorders, hyperprolactinemia, hypogonadotropic hypogonadism), diminished ovarian reserve (basal fsh level \>15 iu/ml), or age of \>38 years
safety and immunogenicity of v114 in healthy infants in south korea (v114-036)

Conditions: Pneumococcal Disease

Summary: the primary purpose of this phase 3, single-arm, open-label study is to evaluate the safety and immunogenicity of a 4-dose regimen of v114 administered to healthy infants in south korea.


Eligibility criteria:
inclusion criteria: * is a healthy south korean male or female who is 42 to 90 days of age at the time of signing informed consent * has a parent or legally acceptable representative who understands study procedures, alternative treatments available, and risks involved and voluntarily agrees to participate by signing informed consent exclusion criteria: * has a history of invasive pneumococcal disease or known history of other culture positive pneumococcal disease * has known hypersensitivity to pneumococcal conjugate vaccine, any licensed pediatric vaccine to be administered concomitantly, or any diphtheria toxoid-containing vaccine * has had a recent febrile illness (rectal temperature ≥38.1°c \[≥100.5°f\] or axillary temperature ≥37.8°c \[≥100.0°f\]) within 72 hours prior to receipt of study vaccine * has known or suspected impairment of immunological function * has or his/her mother has human immunodeficiency virus (hiv) infection * has or his/her mother has hepatitis b surface antigen-positive test * has known or history of functional or anatomic asplenia * has a history of autoimmune disease * has a history or suspected history of neurological disorder * has received a pneumococcal vaccine prior to study entry * has received, or is anticipated to need, corticosteroid therapy * has received a blood transfusion of immunoglobulin products * has participated in another clinical study of an investigational product
safety and efficacy of exjade in the treatment of transfusion-dependent iron overload in aplastic anemia patients

Conditions: Aplastic Anemia

Summary: evaluated exjade efficacy and safety in patients with aplastic anemia and transfusion-dependent iron overload, undergoing treatment programs of immunosuppressive treatment (cyclosporine a) , in comparison with a group of patients undergoing treatment programs of immunosuppressive treatment (cyclosporine a) without chelation therapy.

the secondary endpoints that were originally planned for this study were not analyzed as the study ended prematurely.

Eligibility criteria:
inclusion criteria: * main diagnosis: aplastic anemia * absence of severe and/or uncontrolled comorbidities * confirmed iron overload (serum ferritin ≥ 1000 mkg/l) * serum creatinine is not higher than the upper limit of normal for the given age * absence of severe proteinuria. protein/creatinine ratio should be \< 0.5 mg/mg * liver enzymes are \< 5 uln * completion of a scheduled cycle of immunosuppressive treatment program, with no severe infectious or generalized hemorrhagic complications * who (ecog) performance status ≤ 2 exclusion criteria: * no signed informed consent form * patient is under 18 years old * severe concomitant condition * severe infectious and generalized haemorrhagic complication following regular planned cycle of programmed immune suppressive treatment. * history of increased sensitivity to active substance and any other ingredient of the medicinal product. * creatinine clearance (cc) \< 60 ml/min and/or creatinine concentration in blood serum is 2 or more times higher than upper limit of age normal by results of 2 tests at visits 1 and 2. * severe liver disorders (class c by child-pugh scale). * patients with aplastic anaemia in which chelator treatment will be ineffective due to rapid progression of the disease. * significant proteinuria basing on protein creatinine ratio \> 1.0 mg/ml in urine sample from second urination at visits 1 and 2 (or as an alternative in 2 of 3 urine samples at screening); * rare hereditary disorders related to galactose intolerance, severe deficit of lactase or glucose-galactose malabsorption; * pregnancy, lactation; * level of liver enzymes higher than 5 upper limits of age normal at visits 1 and 2.

Keywords: aplastic anemia deferasirox icl670 renal function transfusion-dependent iron overload immunosuppressive treatment cyclosporine a unosuppressive treatment without chelation therapy