Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of cryoablation for abdominal pain associated with pancreatic cancer

Conditions: Pain; Pancreatic Cancer

Summary: cuc10-pan09 will evaluate the safety and efficacy of cryoablation therapy on the relief of epigastric/abdominal pain associated with pancreatic cancer.

cuc10-pan09 is a supportive care, phase 1 multicenter, prospective, single arm study with subjects serving as their own control. this study is to enroll patients who will undergo cryoablation of the celiac plexus. subjects will be followed for 3 months post their cryoablation procedure. cryoablation is the process of destroying tissue by the application of extremely cold temperatures. galil medical cryoablation systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), ears-nose-throat (ent), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney).

Eligibility criteria:
inclusion criteria: * subject must be at least 18 years old * subject has unresectable or inoperable pancreatic carcinoma as determined by ct or mri * subject's epigastric/abdominal 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) on the bpi despite pharmaceutical pain management * ecog of 0-3 * platelet count \>50,000 * inr \<1.5 exclusion criteria: * subject's life expectancy is \<3 months * subject has current neutropenia (anc \<1000) * subject unable to undergo ct or mri * subject had previous etoh neurolytic block for pancreatic cancer-related pain less than 2 weeks from screening * subject had surgery \<4 weeks from screening

Keywords: cryoablation cryotherapy cryosurgery pancreas pancreatic cancer celiac plexus pain abdominal pain
glycan attachment specificity, toward rotavirus vaccine improvement gastrovimc (clinical investigation)

Conditions: Gastroenteritis; Acute Gastroenteritis

Summary: the gastrovim research explores the links between individual genetic susceptibility, genetic variability of rotavirus strains and effectiveness of immunization with the rotavirus vaccination: a clinical investigation to assess glycan attachment specificity, toward rotavirus vaccine improvement.

the work will be carried out in france and in a tropical area of population with diverse geographical origins: the guyana populated with native americans, people of european descent, people of asian (hmong) and a large source population african. the first aim of the project will be to characterize the specificity of the vp8 \* hbga of rotateq and rotarix vaccines in order to ensure their binding characteristics glycans are similar to those of recent p8 clinical strains circulating in france and were maintained in the culture passages. the second objective will be to validate the impact of recently described polymorphisms hbgas on susceptibility to infection by rva through gastrovimc prospective clinical research. the third objective will be to determine the relative role of recognition and hbgas ganglioside in the initial attachment and viral entry. the expression of hbgas and ganglioside by permissive cell lines in culture human stem rva be manipulated to define the role of glycans in attachment and infection.

Eligibility criteria:
inclusion criteria: * 0 to 16. * giving consent to participate if applicable (\>6yo) * parents informed and written consent obtained * admitted in paediatric emergency for wether an acute gastroenteritis (case group) or anything else than an infection or gastroenteritis (control group) exclusion criteria: * case group: rotavirus rapid screen test negative; viral gastroenteritis other than rotavirus; bacterial gastroenteritis * control group: family and / or patient unable to full informed consent to research; infectious pathology context in general.

Keywords: vaccine polymorphism
to demonstrate the relative bioavailability of alprazolam tablets, 2 mg

Conditions: Anxiety

Summary: to demonstrate the relative bioavailability of alprazolam tablets, 2 mg.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.
geriatric-oncological study on quality of life and independence after radiotherapy

Conditions: Cancer; Age <70

Summary: elderly patients \* with multiple comorbidities are underrepresented in most radio-oncology studies. in times of individualized therapy and when weighing up oncological over- or under-therapy, this observational study is a step towards the implementation of established geriatric instruments and concepts in radiation oncology. as part of the initial outpatient consultation on radiotherapy, the quality of life of patients older than 70 years before the start of therapy is assessed using the eortc qlq-c30 and eld14 questionnaires. furthermore, a geriatric screening is carried out using the g8 questionnaire. the geriatric screening carried out in routine clinical practice with little effort is used to filter out patients with no risk of increased vulnerability - these participants do not require any further examinations.

vulnerable patients with deficits (g8 score \<15 pts) receive a geriatric assessment (comprehensive geriatric assessment (cga)) consisting of abbreviated comprehensive geriatric assessment (acga), appetite (mini nutritional assessment (short form = mna-sf)) at the beginning and end of radiotherapy ), physical functionality (short physical performance battery) and measurement of hand strength. in addition, these patients receive an individualized inpatient geriatric-oncological complex treatment, which is already implemented analogous to the palliative complex treatment. the patients receive targeted support from trained nursing staff, social services, physiotherapy, nutritional advice, hospital pharmacies and psycho-oncology. at the end of the oncological therapy and for the first aftercare after the end of therapy, the questionnaires on quality of life are filled out again in order to analyze changes. initially, 20 patients are to be treated in a first phase (feasibility) in this concept of geriatric-oncological complex treatment in order to build up and expand the necessary structures for an interdisciplinary complex treatment and to set parameters for adherence to the therapy concept and maintaining quality of life and independence in the activities of the daily life for this collective of patients. as part of a follow-up study, vulnerable patients are then to be stratified and randomized using these parameters so that a more detailed analysis is possible.

Eligibility criteria:
inclusion criteria: * age from 75 years * g8-screening \<15pkt * potentially curative radiotherapy exclusion criteria: * no written informed consent * life expectancy\< 6 month

Keywords: quality of life after radiotherapy independence after radiotherapy
the effect of manipulating hydration status during cycling in the heat on acute kidney injury biomarkers

Conditions: Hypohydrated; Euhydrated

Summary: acute kidney injury (aki) is common in prolonged endurance events. risk factors for exercise-associated aki include: the exercise itself, heat, hypohydration, muscle breakdown and non-steroidal anti-inflammatory drug (nsaid) use. prior research from our laboratory showed the hypohydration during high-intensity running increased a biomarker of aki (urine osmolality-corrected kidney injury molecule 1). therefore, the current study will now investigate the effect of manipulating hydration status during cycling on biomarkers of aki.


Eligibility criteria:
inclusion criteria: * healthy * recreationally active exclusion criteria: * smoker/vaper * regular use of anti-inflammatory medications (e.g. ibuprofen) * history of kidney disease or diabetes
safety and efficacy study of pf-06835375 in primary immune thrombocytopenia

Conditions: Primary Immune Thrombocytopenia

Summary: this is a phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of pf-06835375 in adult participants with primary immune thrombocytopenia (itp). this study will focus on participants with persistent (\>3 months and ≤12 months), or chronic (\>12 months) itp

this study is designed to elucidate the effects of pf-06835375 on platelet counts in participants with moderate to severe primary itp. based on the experience with other b-cells depleting agents, it is expected that the platelet counts will increase following a standard treatment. each participant in cohort 1 will receive 1 subcutaneous injection of dose 1 every month for 3 months during the 12-week treatment period. and each participant in cohorts 2 and 3 will receive 1 subcutaneous injection of dose 2 or 3 every month for 4 months during the 16-week treatment period. this should provide sufficient levels of exposure and depletion of cxcr5 positive cells to sustain the effects of pf-06835375 during the treatment period. additional depletion of tfh cells may provide sustained increase in platelet count following the last treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of primary itp. ongoing itp (platelet counts \ 12 months exclusion criteria: * bleeding event according to the who grading scale ≥2 occurring ≤4 weeks prior to screen or a current bleeding event that, in the opinion of the investigator, requires treatment with standard of care therapy or require blood or blood products during screening * splenectomy within 3 months of randomization or planned during the study duration.

Keywords: itp platelets
efficacy and safety of profile halotm mixed fractional laser on treating of facial and neck photoaging.

Conditions: Photoaging

Summary: 1. fractional laser has become an important laser modality in management of a number of skin conditions and photoaging. fractional photothermolysis is the fractional emission of light into microscopic treatment zones, creating small columns of injury to the skin in a pixilated fashion. epidermal and dermal disruptions occur in these focal zones of thermal injury, stimulating dermal collagen production and elastic tissue formation. fractional laser has been used successfully to treat photodamage and overall dyschromia in the caucasian population. however, there is not much improvement in asian population. 2. photoaging refers to the skin caused by intense and chronic exposure to sunlight. the visible effects of photoaging are fine wrinkles, mottling, pigmentation and roughness of the skin. these changes are usually associated with chronologic aging. however, photoaging is not a good indicator of chronologic age. it just makes a person look older than his or her chronologic age. skin ageing may be divided into two processes: intrinsic ageing and extrinsic ageing (or photoageing). both are accompanied by changes in the morphological and biomechanical properties of skin. 3. profile halotm dual-wavelength fusion fractional laser is the first hand tool in the world that integrates ablative and non-ablative fractional lasers. it includes a non-ablative fractional laser with a wavelength of 1470nm and an ablative fractional laser with a wavelength of 2940nm. a day after treatment, new epithelial tissue began to appear, and the necrotic epidermis formed microepidermal necrotic debris (mends). mends were surrounded by keratin 2-7 days after treatment, and collagen sequence in mtzs was changed 7 days later. the 2940 ablative fractional laser can be added with 20-100 micron lattice stripping, ensuring safety while enabling mends to be peeled off 2 days earlier and reducing the risk of side effects. this makes the laser safe and effective compared with the single fractional laser and reduces the downtime.


Eligibility criteria:
inclusion criteria: * subjects must be clinically diagnosed by the investigator to facial photoaging dover 2-4 and cervical stripe fitzpatrick 1-2.5 * no other treatment was performed for the skin lesions for half a year before the treatment * patients with a "no" in any of the above criteria are not eligible for inclusion exclusion criteria: * subjects with a recent history of exposure to sunlight; * subjects allergic to topical anesthesia; * subjects with scar constitution; * subjects with skin malignant tumors or precancerous lesions; .subjects with diabetes, heart disease, epilepsy, connective tissue disease, etc. * subjects who pregnant or breast feeding; * subjects with recent skin infections (such as viruses, bacteria, etc.); * ther methods are being used to treat subjects with similar diseases; * subject who have taken isotretinoin a in the past year; .subject with facial dermatitis.

Keywords: fractional laser photoaging treatment halo
topical absorption of glutathione-cyclodextrin complex in healthy human subjects improves immune response against mycobacterium infection

Conditions: Glutathione-cyclodextrin Complex Absorption

Summary: the proposed clinical trial will confirm the therapeutic absorption of glutathione following topical glutaryl application in increasing blood gsh levels without an invasive procedure. goal: confirm therapeutic level of glutathione following topical transdermal application. hypothesis: the hypothesis of the proposed study is that the glutathione administration will increase rbc levels of glutathione above 80%. aim: determine a non-invasive way to increase glutathione levels in the plasma and blood cells. this aim will be accomplished as follows: step 1: we will recruit eligible healthy participants in the two study groups who are not currently taking any glutathione or n-acetyl cysteine (nac) supplementation. step 2: determine baseline levels of gsh, free radicals and cytokines through analysis of venipuncture blood draws. step 3: study subjects will be asked to spray themselves with either placebo or glutaryl four times twice a day for three days on the ventral part of the abdomen. measure the levels of gsh, free radicals and cytokines after 1 hour, 4 hour and 72 hours.


Eligibility criteria:
inclusion criteria: * group 1 (control group) will include 15 healthy volunteers with the age group between 21-65. participants belonging to group 1 will be recruited from the local area. group 1 will serve as controls for group 2. group 2 (glutathione group) will include 15 healthy volunteers that are not allergic to any components of glutaryltm who will be sprayed four times twice a day for three days with topical glutathione complex (glutaryltm) formulation on their skin on their ventral part of the abdomen. components of glutaryl: main ingredients of glutaryl are glutathione, ascorbic acid and cyclodextrin. the preservative system used is potassium sorbate and radish root extracts. exclusion criteria: * pregnant and breastfeeding women. anyone below age of 21 or above age of 65. patients with active cancer. patients with known liver disease, hepatitis, covd-19, hiv, or aids. patients taking some form of glutathione. subjects who have previously fainted following venipuncture will also be excluded. by interviewing the subjects we will determine whether or not the subject will be excluded from the study based on their previous phlebotomy experiences.
retrospective study of viral reactivation across all bone marrow transplant protocols since 2010

Conditions: Viral Infections

Summary: background: some blood and immune disorders can be helped with hsct. this is allogeneic hematopoietic stem cell transplantation. the person who gets the stem cells has their immune system suppressed. this is done to help prevent their body from rejecting the transplant. during this time, the person is at a high risk to get viral infections. researchers want to study the records of people who had transplants a few years ago. they want to look at how often certain viral complications happened. objective: to study how often certain viral complications occurred after hsct and what risks factors were involved. eligibility: records will be reviewed. no participants will be contacted. design: researchers will review medical records from the nih clinical center. the records will be from people who had hsct between 2010 and 2015 when they were between 4 and 85 years old. they already gave consent for their data to be studied. data collected will include: vital statistics like age and sex viral status of the recipient and donor reason for transplant transplant details how the immune system recovered after transplant if the recipient got graft versus host disease any infections overall survival

this protocol is a retrospective chart review of patients who have underwent hematopoietic stem cell transplantation (hsct) at the nih clinical center. if this proposal is approved, btris will identify and populate the patients in these protocols, and btris identified reports will be used going forward. btris identified reports will be used to review patient progress notes, all aspects of the transplant platform, as well as viral titers over the course of each patient s follow-up, supplemented by review of paper or cris electronic medical records as needed. the study will involve review of patient records and will not use specimens or participant contact. the participants whose records will be reviewed in this protocol were enrolled in nih protocols between 2010 and december 1, 2020. btris policy requires approval from principal investigators on certain protocols. these principal investigators have been contacted via email for permission to conduct this study and have verified that none of the original protocols or informed consent documents precludes such a review of clinical data.

Eligibility criteria:
* eligibility criteria: subjects will not be recruited for this study.

Keywords: reactivation or proliferation of latent viral infections. viral infection lymphoproliferation natural history
safety, tolerability and immunogenicity study of different vaccine regimens of trivalent ad26.mos.hiv or tetravalent ad26.mos4.hiv along with clade c glycoprotein (gp)140 in healthy human immunodeficiency virus (hiv)-uninfected adults

Conditions: Healthy

Summary: the purpose of this study is to assess the safety/tolerability of the 2 different vaccine regimens of priming with trivalent ad26.mos.hiv and boosting with trivalent ad26.mos.hiv and clade c gp140 plus adjuvant or priming with tetravalent ad26.mos4.hiv and boosting with ad26.mos4.hiv and clade c glycoprotein (gp)140 plus adjuvant. immune responses of the different vaccine schedules will be assessed.


Eligibility criteria:
inclusion criteria: * are negative for human immunodeficiency virus (hiv) infection at screening * is healthy on the basis of physical examination, medical history, electrocardiogram (ecg), and vital signs measurement performed at screening * are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures * female participants of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin \[beta hcg\]) at the screening visit, and a negative urine pregnancy test pre-dose on day 1 * are assessed by the clinic staff as being at low risk for hiv infection exclusion criteria: * has chronic hepatitis b (measured by hepatitis b surface antigen test) or active hepatitis c (measured by hepatitis c virus \[hcv\] ab test; if positive, hcv ribonucleic acid \[rna\] pcr test will be used to confirm active versus past hcv infection), active syphilis infection, chlamydia, gonorrhea, or trichomonas . active syphilis documented by serology unless positive serology is due to past treated infection * has had a thyroidectomy or active thyroid disease requiring medication during the last 12 months (not excluded: a stable thyroid supplementation) * has had major psychiatric illness and/or substance abuse problems during the past 12 months (including hospitalization or periods of work disability) that in the opinion of the investigator would preclude participation * has been in receipt of any licensed vaccine within 14 days prior to the first dose of study vaccine/placebo, plans to receive within 14 days after the first study vaccination, or plans to receive within 14 days before or after the second, third or fourth vaccination * is a recipient of a prophylactic or therapeutic hiv vaccine candidate at any time, or a recipient of other experimental vaccine(s) within the last 12 months prior to the day 1 visit (vaccination 1). for participants who received an experimental vaccine (except hiv vaccine) more than 12 months prior to the day 1 visit (vaccination 1), documentation of the identity of the experimental vaccine must be provided to the sponsor, who will determine eligibility on a case-by-case basis
blue light cystoscopy with cysview® registry

Conditions: Bladder Cancer

Summary: registry study to gather more information on the current use of blue light cystoscopy with cysview (blcc) in urologists' practices.

data will be captured on specific patient types undergoing blue light cystoscopy with cysview for known or suspected non-muscle invasive bladder cancer. specific clinical questions will be asked. 1. what is the incremental detection rate with blue light cystoscopy with cysview over conventional white light cystoscopy in each of the seven (7) patient populations? does this translate into lower recurrence/progression rate? 2. how do the six (6) tumor variables used in the european association of urology (eau) risk tables (primary/secondary, recurrence rate, size, multifocality, grade, and history of carcinoma in situ (cis))6 affect this incremental rate? 3. how does an abnormal cytology or positive or negative fluorescent in situ hybridization (fish) affect the likelihood that blue light cystoscopy with cysview will detect more cancers than white light? 4. what are the performance characteristics of blue light cystoscopy with cysview within eight (8) weeks of bacillus calmette-guérin (bcg) with respect to improved tumor detection and false positive rate compared to conventional white light cystoscopy? 5. what is the incremental blue light cystoscopy with cysview detection rate over random bladder biopsies alone in patients being evaluated for routine three month restaging (group 4) or occult disease (group 5)? 6. what are the performance characteristics of blue light cystoscopy with cysview after repeated blue light cystoscopy with cysview evaluations with respect to improved tumor detection, false positive rate and safety compared to conventional white light? 7. does an abnormal urinalysis help identify patients with inflammation more likely to have false positive blue light cystoscopy with cysview results? 8. what is the practical learning curve for becoming "proficient" with blue light cystoscopy with cysview? 9. what is the overall false positive rate with blue light cystoscopy with cysview? 10. can blue light cystoscopy with cysview make the resection more complete? if yes, is this due to improved margins and/or additional tumors seen under blue light? the blue light cystoscopy with cysview registry is a web-based program supported by global vision technologies. data will be captured longitudinally over five (5) years on patients from each enrolled site. each center will enter their respective site's patient data electronically.

Eligibility criteria:
inclusion criteria: * adult \>18 years old * suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy exclusion criteria: * porphyria * gross hematuria * known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives

Keywords: cysview hexaminolevulinate hexvix nmibc blcc blue light cystoscopy with cysview cystoscopy turbt tur fluorescent cystoscopy non-muscle invasive bladder cancer (nmibc) transurethral resection (tur)