Kornimate/medical-research-clean huggingface dataset:
clinical trial of gammora® plus antiretroviral treatment for hiv

Conditions: HIV Seropositivity

Summary: the goal of this phase ii, open-label, randomized, controlled clinical trial is to evaluate the impact of gammora®, a 16-mer hiv integrase-derived peptide associated with a boosted darunavir antiretroviral regimen compared gammora® arm) to a boosted darunavir antiretroviral regimen only (control arm) in the estimated hiv reservoir among antiretroviral naïve people living with hiv. the main questions it aims to answer are: 1. will the proviral (total) hiv-1 dna decrease rapidly in the gammora® arm compared to the control arm? 2. will the apoptosis markers evaluated in the cd4+ t cell by flow cytometry increase in the gammora® arm compared to the control arm? forty antiretroviral naïve viremic people with hiv with cd4+ t cell counts \>350 cells/ml will be randomized to receive 20 mg of gammora® in 2ml sc solution plus tenofovir/3tc and darunavir 800mg+ritonavir 100mg (gammora® arm) or antiretroviral only (control arm). in the gammora® arm, participants had a 2-week gammora® monotherapy lead-in period with gammora® given daily before antiretroviral treatment is started, followed by 12 weeks of antiretroviral therapy plus gammora® given every other day. the first two weeks of the trial (lead-in period for the gammora® arm) were labeled w-2 and w-1 for both groups, and blood samples were collected for both groups. w0 denotes the week art was started in both arms.


Eligibility criteria:
inclusion criteria: 1. confirmed hiv infection; 2. antiretroviral naive; 3. hiv viral load \> 1.000; 4. cd4+ t cell counts \>350 cells/mm3; 5. body weight \> 50 kg; 6. signed informed consent form. exclusion criteria: 1. bmi \< 18.5 kg/m2 at screening; 2. coinfection with hbv (hbsag +) or hcv; 3. any significant acute illness within one week before the first visit. 4. use of any immunomodulatory therapy (including interferon), systemic steroids, or systemic chemotherapy within four weeks before screening; 5. active malignancy or malignancy in follow-up. 6. changes in safety tests: neutrophil count \ 1.5 mg/dl, direct bilirubin \> 85 μmol/l, ast or alt \> 2.5 x unl; 7. potential allergy or hypersensitivity to the components of the gammora® formulation. 8. participation in another clinical trial within 12 months before screening. 9. any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the investigator's discretion.

Keywords: hiv cure integrase peptide proviral hiv dna apoptosis antiretroviral therapy
lux lung special access scheme australia named patient use (npu)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the program will provide early access to the investigational drug bibw 2992 to treat patients with advanced nsclc who have failed at least 12 weeks on erlotinib or gefitinib. the compassionate use programme will also provide additional safety and efficacy information on bibw 2992 use. named patient use (npu)


Eligibility criteria:
inclusion criteria: * patients with pathologic confirmation of adenocarcinoma of the lung stage iiib with pleural effusion or stage iv exclusion criteria: * brain metastases which are symptomatic; patients with treated, asymptomatic brain metastases are eligible with stable brain disease for at least four 4 weeks without the requirement for steroids or anti epileptic therapy * significant or recent acute gastrointestinal disorders with diarrhea as a major symptom as judged by the investigator. * patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug * history of cardiac disease that is clinically significant, as judged by the investigator or uncontrolled cardiac disease (including congestive heart failure, angina, myocardial infarction, arrhythmia, including new york heart association (nyha) functional classification of 3) * cardiac left ventricular function with resting ejection fraction of less than 50% * bilirubin 1.5 mg / dl (26 mol / l, si unit equivalent) * aspartate amino transferase (ast) or alanine amino transferase (alt) three times the upper limit of normal (if related to liver metastases five times the upper limit of normal) * serum creatinine 1.5 times of the upper normal limit or calculated/measured creatine clearance 45ml/min * women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial * pregnancy or breast feeding * patients unable to comply with the protocol * patients with known hiv, active hepatitis b or active hepatitis c * pre-existing interstitial lung disease (ild) * requirement for treatment with any of the prohibited concomitant medications listed in section 4.2.2.1. * patients already pre-treated with bibw 2992
fractional nonablative 1540 nm laser resurfacing for burn scars- a randomised controlled trial

Conditions: Burn Scar Patients

Summary: the objective was to evaluate the efficacy of 1540 nm fractional laser treatment of mature burn scars.


Eligibility criteria:
inclusion criteria: * burn scars with and without previous skin grafting. exclusion criteria: * a tendency to produce hypertrophic scars or keloids, * previous treatment with dermabrasio, chemical peel, filler, laser treatment or intense pulsed light (ipl) of study areas, * photosensitivity, * pregnancy or lactation, * current anticoagulative medication, * oral retinoid drugs within the past 6 months, * pigmentation after recent exposure to sun or solarium, * patients not considered to be able to follow the treatment protocol.
night-time compression systems for breast cancer related lymphedema

Conditions: Breast Neoplasms; Lymphedema

Summary: women who have undergone breast cancer surgery may develop swelling of the arm on the side the breast cancer occurred. if the swelling becomes chronic it is called lymphedema. this study will examine night-time compression system garments for lymphedema. our objective is to determine if breast cancer survivors are willing and able to use the garment overnight to help control their lymphedema. thirty breast cancer survivors from alberta will be enrolled in the 24-week long study. measurements will be taken of each arm to assess the extent of lymphedema and to measure changes over the study period. we will also examine other outcomes such as the impact of the night-time compression system garment on sleep. the study will provide important information on the feasibility of night-time compression system garments as a self-management strategy for lymphedema.


Eligibility criteria:
inclusion criteria: 1. women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 10% and maximum 40% increase in arm volume over the unaffected arm (mild to moderate lymphedema). 2. patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization. 3. patients must have their own fitted compression garment for daytime maintenance. 4. no past or current use of a night-time compression system for maintenance. those patients who have trialed a night-time compression system in the past year must observe a six-month washout period before entering the trial. exclusion criteria: 1. clinical or radiological evidence of active disease, either local or metastatic. 2. history of contralateral breast cancer and axillary surgery. 3. serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow-up. 4. patients for whom compression is contraindicated. 5. psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol. 6. unable to comply with the protocol, measurement and follow-up schedule.

Keywords: breast cancer arm lymphedema compression therapy
self-breathe rct for chronic breathlessness

Conditions: Cancer; COPD; Asthma; Bronchiectasis Adult; Interstitial Lung Disease; Cystic Fibrosis; Chronic Heart Failure; Sickle Cell Disease; Renal Failure; Liver Failure; Post COVID-19; Dyspnea

Summary: a feasibility rct comprising two groups: 1. intervention (self-breathe in addition to standard nhs care) 2. control group (standard / currently available nhs care)


Eligibility criteria:
inclusion criteria: * adults ≥ 18 years of age, with the ability to read and type in english * access to a computer, or tablet or smart phone, with internet access and the ability to email * chronic breathlessness (cb) defined as; breathlessness that persists (\>3months) despite optimal pharmacological treatment of the underlying disease including cancer, chronic obstructive pulmonary disease (copd),asthma, interstitial lung disease (ild), bronchiectasis, cystic fibrosis (cf) chronic heart failure (chf), sickle cell disease, chronic renal/ liver failure or post covid-19 * chronic breathlessness at rest or on exertion; mrc dysponea score \>2 * willing to engage with short-term self-guided internet-based breathlessness intervention (self-breathe) * able to provide informed consent exclusion criteria: * breathlessness of unknown cause * a primary diagnosis of chronic hyperventilation syndrome * currently participating in a rehabilitation programme, e.g. pulmonary/cardiac rehabilitation
study of mirna-155 in acute leukemia

Conditions: Acute Leukemia

Summary: the leukaemias are a heterogeneous group of blood cancers, acute leukaemia (al) is caused by malignant proliferation of blood cells arrested at an immature stage of development, they are very aggressive diseases that run a rapidly fatal course if not promptly diagnosed and appropriately treated. misdiagnosis is very common with delay in diagnosis and prompt treatment being the causes of high morbidity and mortality in acute leukaemias. although with the continuous improvement of clinical and laboratory diagnosis and treatment methods, the prognosis of aml has been significantly improved, but there are still about 70% of patients who cannot survive more than 5 years after diagnosis the activity of mirnas in tumors is regulated by the same alterations affecting protein-coding genes, such as chromosomal rearrangements, genomic amplifications or deletions or mutations, abnormal transcriptional control, dysregulation of epigenetic changes and defects in the biogenesis machinery a typical chromosomal rearrangement is a chromosomal translocation, especially in hematological malignancies, in which it promotes tumor development and progression by the promoter exchange or by the creation of chimeric genes translated as fusion proteins. in acute myeloid leukemia (aml) patients with myeloid/lymphoid leukemia gene (or mixed-lineage leukemia, mll) rearrangement, by large-scale genome-wide microarray analysis, it was demonstrated that among 48 selected mirnas, 47 of them are increased


Eligibility criteria:
inclusion criteria: * approval to sign an informed written consent, patient with newly diagnosed al. exclusion criteria: * refusal to sign an informed written consent, cases with chronic leukemias, lymphoma or leukemic phase of lymphoma or patients on chemotherapy.
the feasibility of the painreportit guided relaxation intervention-inpatient

Conditions: Sickle Cell Disease; Stress; Pain

Summary: the goal of this research study is to improve the self-management of pain, stress, and cognitive/affective symptoms that may result in adult inpatients with sickle cell disease (scd) by determining the feasibility of a self-management guided relaxation (gr) stress reduction intervention using a tablet-based mobile device. currently, opioid analgesics are primarily used to treat scd pain while self-managed behavioral modalities such as gr, are rarely used, particularly, in inpatient settings. little is known about the effects or mechanisms of gr on pain, stress, and cognitive/affective symptoms in adults with scd hospitalized with pain. emerging evidence from the hypothalamic pituitary adrenal (hpa) axis theory offer insights for understanding the mechanisms. adding gr as a supplement to analgesic therapies will address the dearth of self-management strategies for controlling pain in scd. gr is a simple and cost-effective non-drug intervention that could reduce pain and stress in inpatients with scd. gr is an intervention where inpatients with scd are directed to listen to and view audio-visual recordings while they visualize themselves being immersed in that scenario.

the purpose of this research study is to see if a new computerized stress reduction program, called painreportit guided relaxation intervention, can be used to teach people who have sickle cell disease (scd) how to track their stress and pain daily and use guided audio-visual relaxation exercises to help them reduce their stress and pain. to obtain preliminary data for a larger trial, 30 adult inpatients with scd admitted with scd pain will be recruited. the investigators will stratify patients on worst pain intensity (\ 5) and randomly assign 15 adults to attention control (12-min scd experience discussion on day 1 and daily stress/pain tracking on days 2-4) and 15 adults to experimental (12-min gr video clip on day 1 and daily stress/pain tracking and gr on days 2-4) groups. immediate effects on pain, stress, and relaxation responses after the 12-min session will be examined. patients will continue the trial for additional 4 days, with self-management on days 2-4 and posttest on day 5 while hospitalized to test short-term effects. during days 2-4, the experimental group will choose and watch any of six video clips (2 min, 5 min, 8 min, 10 min, 15 min, and 20 min lengths) at least once a day; and at stress onset and as often as they need. we will investigate mechanisms by which gr produces its effects in adult inpatients with scd.

Eligibility criteria:
inclusion criteria: * has scd diagnosis; * reports pain 3 or greater in the previous 24 hours (0-10 scale) * admitted to university of florida (uf) health for pain crisis * speaks and reads english * 18 years of age or older * self-identifies as being of african descent or hispanic exclusion criteria: * legally blind * physically or cognitively unable to complete study measures
post discharge after surgery virtual care with remote automated monitoring technology-2 (pvc-ram-2) trial

Conditions: Surgery; Perioperative Complication

Summary: the post discharge after surgery virtual care with remote automated monitoring technology-2 (pvc-ram-2) trial is a multicentre, parallel group, superiority, randomized controlled trial to determine the effect of virtual care with remote automated monitoring (ram) technology compared to standard care on acute-hospital care during the 45-day follow up after randomization, in adults who have undergone semi-urgent (e.g., oncology), urgent (e.g., hip fracture), or emergency (e.g., ruptured abdominal aortic aneurysm) surgery. secondary outcomes at 45 days after randomization include 1) days in hospital; 2) index length of hospital stay; 3) hospital re-admission; 4) emergency department visit; 5) medication error detection; 6) medication error correction; and 7) surgical site infection. additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 15 and 45 days. we will also assess optimal management of long-term health by evaluating among self-reported current smokers and those with atherosclerotic disease, whether patients are taking classes of efficacious medications at 45 days post randomization.


Eligibility criteria:
inclusion criteria: 1. are ≥40 years of age; 2. will undergo or have undergone semi-urgent, urgent, or emergency surgery requiring expected hospital stay of ≥2 days; and 3. provide informed consent to participate. exclusion criteria: 1. planned transfer to a rehabilitation or convalescent facility, or repatriation from trial hospital site to local community hospital following surgery; 2. are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to a language barrier or a cognitive, visual, or hearing impairment; or 3. reside in an area without cellular network coverage.

Keywords: virtual care remote monitoring acute hospital care
volontary inspiratory muscles measures compared with phrenic nerves magnetic stimulations measures

Conditions: Neuromuscular Diseases; Respiratory Failure

Summary: respiratory failure is the main death cause in neuromuscular diseases. non-invasive and volitional measures of inspiratory muscles strength include the nasal pressure with an occluded nostril (psnip) and the maximal inspiratory pressure (pimax). unfortunately, volitional maneuvers depend of patient effort. the aim of this research is to validate a non-invasive and non-volitional technique to evaluate diaphragm strength at neuromuscular diseases patients. the methodology consists to add to pimax and psnip measures 5 phrenic nerves magnetical stimulation maneuvers (pstim).stimulations will be realize at 3 inspiratory pression levels (0, -1 cm h2o and -5 cm h2o).


Eligibility criteria:
inclusion criteria: * 18 years old and more men or women * neuromuscular diseases * pimax and snip evaluation indication exclusion criteria: * pregnant women * usual contre-indications for nuclear magnetic resonance
master protocol to study treatment patterns, medication adherence, health and economic outcomes and unmet needs in rcc

Conditions: Renal Cell Carcinoma (RCC)

Summary: the study aims to assess treatment patterns and outcomes in advanced rcc patients in real world clinical practices across various real world databases. four databases will be evaluated


Eligibility criteria:
inclusion criteria: * age 20 years or older in the year of the index first line therapy prescription. * 2 or more rcc diagnoses (icd-9: 189.0; icd-10: c64.1, c64.2, c64.9) at least 30 days apart, in the 1 year prior to the index date until 30 days post index date. * 2 or more code for secondary malignancy codes indicating possible diagnoses for metastatic disease at least 30 days apart, in the 1 year prior to the index date until 30 days post index date. (icd-9: xx-199.xx; icd-10: c77-c79, except icd9: 198.0 secondary malignant neoplasm of the kidney and icd10: c79.0 secondary malignant neoplasm of the kidney and renal pelvis.) * exploratory sensitivity analyses were performed to review patients with 1 or more diagnosis codes for advanced or metastatic rcc 12 months prior to the index date and 1 or more secondary malignancy codes around the rcc diagnosis dates. * continuous enrollment from 12 months prior to the index date. patients will be required to have continuous enrollment from their index date until the end of the available data. this will allow for sub-analysis of cohorts with 3 months, 6 months and 12 months of available data exclusion criteria: * received advanced treatment prior to the study index date. * prescription records with negative days of supply will be excluded from all the analyses except in cost variable calculation. the day of supply for claims with missing or 0 days will be imputed. * only one rcc diagnosis in the 12 months prior or one mont post index date. * patients with data for analysis (\< 3 months post index date)
prosthetic arthroplasties in weight-bearing shoulders

Conditions: Prosthetic Arthroplasties

Summary: repeated transfers and wheelchair propulsion in patients with neurological deficit of the lower limbs leads to a major mechanical overload of the upper limbs, especially on shoulders, the "weight-bearing" shoulder. under these conditions, arthroplasty is subject to significant constraints; such an indication in this condition is always discussed. the objective of this study was to evaluate the medium-term clinical and functional outcomes of anatomical and reverse arthroplasty on the weight-bearing shoulder in individuals with long-term wheelchair use.


Eligibility criteria:
inclusion criteria: * patients not walking or rarely walking, long-term users of a wheelchair before the intervention, and surgery on at least one shoulder by anatomical or reverse prosthesis exclusion criteria: * patient walking without aid * shoulder surgery other than arthroplasty

Keywords: paraplegia shoulder prosthesis spinal cord injury wheelchair
skin sterility after ethyl-chloride spray

Conditions: Skin Sterility After Use of Ethyl-chloride Spray.

Summary: the aim of this study is to investigate sterility of ethyl-chloride topical anesthetic spray when used prior to an injection. the hypothesis is that the spray does not change the sterility of the injection site after skin is prepped.

this is an irb-approved, prospective, blinded, controlled study. in the first set of experiments, skin sterility is assessed. healthy adult subjects are prepared for mock injections of shoulders and knees. no injection is performed. each site has a set of 3 skin cultures: 1) prior to the alcohol prep (pre-prep), 2) post-alcohol prep (pre-spray), and 3) after ethyl-chloride was sprayed on the site (post-spray). in the second set of experiments, sterility of ethyl chloride is tested directly by culturing the liquid from the spray bottles.

Eligibility criteria:
inclusion criteria: * age -- 18-85 * healthy skin at shoulder and knee area exclusion criteria: * allergy to ethyl-chloride * skin lesions at shoulder or knee

Keywords: topical skin sterility ethylchloride ethyl chloride spray
structural and intermediary social determinants of oral health among egyptian women

Conditions: Oral Health

Summary: globally, there is substantial evidence indicating that low household income, lack of education, poor living conditions and inadequate psycho-social social support are potential risk factors for morbidity and premature death. despite that, worldwide, there is scarcity in evidence on potential social determinants of oral health among different population groups.the study aims to identify the potential social determinants with an influence on oral health status of egyptian women.

statement of problem globally, there is substantial evidence indicating that low household income, lack of education, poor living conditions and inadequate psychosocial social support are potential risk factors for morbidity and premature death. despite that, worldwide, there is scarcity in evidence on potential social determinants of oral health among different population groups. aim of study to identify the potential social determinants with an influence on oral health status of egyptian women. materials and methods a total of 300 egyptian women in childbearing age (18-49 years) will be recruited from 4 primary healthcare units in qalyubia governorate in egypt. four trained investigators will conduct a face-to face interview with study participants to gather data on potential structural and intermediary social determinants of health using a questionnaire. the questionnaire is based upon the commission on social determinants of health (csdh) conceptual framework which was set up by the world health organization in 2005. this tool includes questions on socioeconomic position, material factors and living conditions, psychosocial factors and behavioral factors. caries experience and gingival health of participants will be determined using dmft, dmfs and cpitn indices respectively.

Eligibility criteria:
inclusion criteria: * egyptian women in child bearing age (18-49 years) attending one of the governmental primary healthcare units. exclusion criteria: * women who recently moved from one place of residence to another. * women attending the dental clinic at one of the primary health units selected for the survey. * pregnant women. * completely edentulous women. * women with mental or psychological issues.

Keywords: social determinants oral health women egypt