Kornimate/medical-research-clean huggingface dataset:
investigational vaccine for the prevention of disseminated tuberculosis in hiv infected people

Conditions: Tuberculosis; HIV Infections

Summary: a significant number of hiv infected patients in africa also have disseminated tuberculosis (infection throughout multiple organs). this type of tuberculosis is a significant cause of mortality in these patients. the purpose of this study is to evaluate the safety and effectiveness of a vaccine designed to prevent disseminated tuberculosis.

disseminated infection with mycobacterium tuberculosis (dmtb) has been documented in 10% to 25% of patients with hiv infection in africa. unlike pulmonary tuberculosis (pmtb), most cases of dmtb are not recognized and death ensues rapidly. therefore, dmtb may be a more important cause of hiv-associated mortality than pmtb in developing countries. mycobacterium vaccae (mv) is an investigational vaccine prepared by heat inactivation of a nontuberculous mycobacteria. mv immunization may reduce the risk of hiv-associated dmtb. the purpose of this study is to define risk factors for hiv-associated dmtb and to assess the safety and effectiveness of an mv vaccine for the prevention of hiv-associated pulmonary and disseminated tuberculosis. hiv positive patients with prior bcg immunization and hiv negative controls will be entered in a 5-year study in tanzania. participants will be randomized to receive a 5-dose series of mv or placebo over 12 months, with a repeat skin test at month 14. baseline evaluation will include medical history, chest x-ray, skin tests with purified protein derivative (ppd), and blood tests to evaluate interferon-gamma production. participants with ppd reactions greater than or equal to 5 mm will receive 6 months of prophylaxis with isoniazid. participants will be followed every 3 months for 3 to 5 years to assess new pmtb (microbiologic or clinical diagnosis) or dmtb (microbiologic diagnosis). potential risk factors for dmtb will also be assessed.

Eligibility criteria:
inclusion criteria: * hiv infection * cd4 count more than 200 cells/mm3 * bcg scar exclusion criteria: * active tuberculosis. patients will be deferred from study enrollment until they show no signs of active disease. * serious underlying disease (e.g., congestive heart failure, advanced cancer) * life expectancy of less than 2 years * pregnancy. women who are pregnant may be eligible for the study after they give birth.

Keywords: mycobacterium vaccae bcg disseminated tuberculosis srl-172 dar-901
text message support to prevent smoking relapse

Conditions: Tobacco Use Disorder

Summary: the purpose of this research is to test a text message intervention for people who are beginning an attempt to quit smoking. the intervention seeks to teach people to think about their cravings to smoke in more helpful ways. the investigators expect that participants receiving the text message craving program will be less likely to begin smoking again compared to participants in a control condition.


Eligibility criteria:
inclusion criteria: * age 18 or older * current daily smoking defined as smoking ≥5 cigarettes per day and having smoked for at least 3 months. during the first visit smoking status will be verified by a carbon monoxide level of at least 8 parts per million. * have a mobile phone and use text messaging at least monthly * be planning to quit smoking without pharmacological help. exclusion criteria: * significant cognitive impairment * current therapy or pharmacological intervention for smoking or nicotine cravings * inability to read english
cancer of the head of the pancreas: early surgery or preoperative biliary drainage?

Conditions: Pancreatic Cancer; Biliary Stasis

Summary: surgical resection is the only option for cure for patients with a resectable tumor located at the head of the pancreas. at the time of diagnosis, these patients often suffer from jaundice. studies have suggested, that jaundice might increase the risk of developing a serious postoperative complication. preoperative biliary drainage is widely used, because it is considered to improve the surgical outcome and reduce the amount of postoperative complications. there are also studies that suggest the opposite. in these studies the overall complication rate with patients who underwent preoperative biliary drainage was higher than in the patients who were operated right away. a significant amount of these complications were related to the biliary drainage process itself. however, preoperative biliary decompression is widely used in many centers as many surgical centers don't possess the needed resources to arrange early surgery. the benefits and risks of this procedure remain unclear. this multicenter trial aims to compare the surgical outcome and the rate of serious complications in patients who proceed directly to early surgery and patients who have preoperative biliary drainage.


Eligibility criteria:
inclusion criteria: * patients in this study must have a resectable tumor of the head of the pancreas, and no evidence of distant metastasis or local vascular involvement. at the beginning of the study it's not necessary to have an accurate histologic diagnosis, the tumor might be malignant or benign. the patients also have jaundice with a total serum bilirubin level of 40-250µmol/l, and are fit enough to be considered for an early surgery. exclusion criteria: * patients with ongoing cholangitis, neoadjuvant treatments or previous biliary drainage with stenting by means of ercp or ptc (percutaneous transhepatic cholangiogram) are excluded.
vtama in psoriasis patients being treated with biologics.

Conditions: Psoriasis

Summary: open label study to assess 12 weeks of add-on vtama® (tapinarof) cream, 1% qd in patients with ≥3% bsa who have received biologic therapy for at least 24 weeks.


Eligibility criteria:
inclusion criteria: 1. male or female adult ≥ 18 years of age; 2. diagnosis of chronic plaque-type 3. patient with ≥3% bsa 4. patient has been treated with biologic for a minimum of 24 weeks 5. able and willing to give written informed consent prior to performance of any study-related procedures. exclusion criteria: 1. ≤3% bsa 2. patient not receiving biologic agent, or receiving biologic agent \<24weeks
vaginal co2 laser in postmenopausal women with overactive bladder syndrome (oab)

Conditions: Overactive Bladder (OAB)

Summary: this study evaluates the clinical efficacy and symptom relief of vaginal fractional co2 laser treatment in post-menopausal women with overactive bladder syndrome(oab). post-menopausal women with oab syndrome who receive β3 adrenergic receptors (mirabegron 50mg) treatment, will be randomized in two groups. half participants will receive active co2 laser therapy, while the other half will receive placebo co2 laser therapy.


Eligibility criteria:
inclusion criteria: * postmenopausal women (≥ 12 months of amenorrhea or fsh ≥ 40 after hysterectomy with bilateral oophorectomy) who receive β3 adrenergic receptors (mirabegron 50 mg) treatment for oab * overactive bladder syndrome (oab) * ≥ 3 months symptoms of urgency, with or without urinary incontinence, and ≥ 8 micturitions / 24h * at least 3 episodes of urgent urination (3rd-4th grade) as recorded in the patient perception intensity of urgency scale (ppius) during a 3 day urination calendar , with or without urinary incontinence. exclusion criteria: * participants with: * pelvic organ prolapse (pop) \> stage ii of the pelvic organ prolapse quantitation system (pop-q) * post void residual volume \> 200 ml (measured by ultrasound) * use of moisturizers or lubricants the last month * use of vaginal estrogen in the last 6 months * use of drugs for urinary incontinence * use of psychotropic drugs * symptomatic urinary tract infection * active genital infection * kidney or liver disease * abnormal cardiac conduction, rate or rythm disorders * diabetic neuropathy * myasthenia gravis * history of malignant disease * previous radio-chemo therapy
sequential therapies after osteoanabolic treatment

Conditions: Osteoporosis, Postmenopausal

Summary: 12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics

caucasian women with severe postmenopausal osteoporosis who have completed their course with romosozumab or a pth analog will be assigned to one of the following 3 options: i) zoledronate 5mg infusion or ii) denosumab subcutaneous injections or iii) teriparatide or abaloparatide (for those previously treated with romosozumab) or romosozumab (for those previously treated with teriparatide or abaloparatide). endpoints: primary: bmd changes at the lumbar spine at 12 months. secondary: i) bmd changes at the non-dominant femoral neck and total hip at 12 and 24 months; ii) changes at levels of bone turnover markers throughout the study; iii) incident fractures: vertebral (clinical and morphometric identified on vfa scans) and non-vertebral

Eligibility criteria:
inclusion criteria: • postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide exclusion criteria: * a bone disease other than postmenopausal osteoporosis * use of medications other than romosozumab or teriparatide affecting bone metabolism during the last 12 months before entering the study * creatinine clearance \<60 ml/min/1.73 m2 * liver failure * any type of cancer * uncontrolled endocrine diseases * serum 25-hydroxy vitamin d (25-ohd) concentrations lower than 20 ng/ml (50 nmol/l) * hypersensitivity to denosumab or zoledronate or teriparatide or romosozumab or any of the excipients
evaluate the safety and effectiveness of istar medical's miniject™ implant for lowering intraocular pressure (iop) in subjects with primary open-angle glaucoma.

Conditions: Glaucoma

Summary: evaluate the safety and effectiveness of istar medical's miniject™ implant for lowering intraocular pressure (iop) in subjects with primary open-angle glaucoma.

this is a prospective, multicenter, masked clinical trial to evaluate the safety and effectiveness of istar medical's miniject™ implant for lowering intraocular pressure (iop) in subjects with primary open-angle glaucoma.

Eligibility criteria:
key inclusion criteria: * males and females, 46 years of age or older * a diagnosis of primary open-angle glaucoma, who are candidates for medical therapy, laser treatment, or glaucoma-filtering surgery * pseudophakic with prior uncomplicated cataract surgery key exclusion criteria: * angle closure, congenital, or secondary glaucoma * diagnosed degenerative visual disorders * clinically significant intraocular inflammation or infection

Keywords: glaucoma migs primary open angle glaucoma suprachoroidal space supraciliary space
the effectiveness of bottle-pep in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the effectiveness of bottle pep in patients with chronic obstructive pulmonary disease


Eligibility criteria:
inclusion criteria: * diagnosed with copd * stable disease exclusion criteria: * neuromuscular disease * recent pneumothorax * major surgery in the last 6 months
radioembolization for the advancement of y90 glass microspheres registry

Conditions: Liver Cancer

Summary: this study is a non-interventional, observational, prospective, and global participant data registry. the study will collect effectiveness and safety data from approximately 1000 participants with liver cancers treated with therasphere® in a real-life setting from multiple centers globally. the absorbed dose to tumor and normal tissue will be calculated using the simplicit90y™ software in the subgroup of hepatocellular carcinoma (hcc) participants.

this study is a non-interventional, observational, prospective and global participant data registry. approximately 1000 participants with liver cancers who are treated with therasphere® will be enrolled. data regarding participant and treatment characteristics (therasphere® and other anti-cancer treatments) will be collected within a 12-month period post therasphere® administration to: * assess treatment effectiveness and safety in a real-life administration setting * identify prognostic and predictive factors for liver cancer participants receiving therasphere® treatment data for dosimetry determination will be collected on approximately 300 hcc participants to assess: * technetium-99m macroaggregated albumin (99mtc-maa) normal tissue and tumor absorbed dose using pre-procedural single proton emission computed tomography/ computed tomography (spect/ct) * yttrium-90 and isotopes (y90) normal tissue and tumor absorbed dose using post-procedural pet/ct (or equivalent for asia) scans

Eligibility criteria:
inclusion criteria: 1. participant is ≥ 18 years of age 2. participant has confirmed liver cancer 3. participant is able to provide informed consent according to local requirements/law 4. participant has a life expectancy of ≥ 3 months 5. participant is scheduled to receive therasphere® treatment exclusion criteria: 1. participant who has previously received y90 microspheres 2. participant who has consented to participate in a btg-sponsored clinical study that includes therasphere® treatment

Keywords: registry liver cancers hcc dosimetry simplicit90y™ therasphere®
pdl1 in primary colorectal carcinoma and its prognostic impact

Conditions: PDL1- Colorectal Carcinoma

Summary: colorectal cancer (crc) is a highly heterogenous disease. it the third most commonly diagnosed cancer in the world and the second cause of death among cancer cases mortality. its incidence is rising all over the world, especially in developing countries . in egypt it is coming the seventh cancer in incidence according to world health organization (who, 2020). although there is much improvement in the diagnosis and treatment, but crc is still constituting a big impact on human life and health, so researchers are trying to find out new therapeutic targets . programmed cell death protein 1 (pd-1) is an inhibitory receptor which is expressed on the surface of t lymphocytes during activation. its role is to control t cell effector activity for various cellular responses as infections, autoimmune reactions, and cancer . cancer cells develop pd-ligand1 (pd-l1) expression which is a transmembrane molecule belonging to b7 family. its action is through pd-1/pd-l1 reaction, and causing invasion and metastasis of cancer cells by protecting it from immunosurveillance by inhibiting t cell effector function, leading to carcinogenesis and development of many cancers including colorectal cancer.


Eligibility criteria:
inclusion criteria: 1. both endoscopic and excisional biopsy specimens. 2. all the studied cases include sufficient materials for the immunohistochemical study. 3. complete clinical data exclusion criteria: 1. patients with recurrence of the primary tumor. 2. patients with a history of preoperative chemotherapy and/or radiotherapy. 3. insufficient or tiny tissue biopsies
gastric plication and banding

Conditions: Morbid Obesity

Summary: the purpose of the study is to assess the efficacy of a hybrid laparoscopic surgical procedure for treatment of morbid obesity, gastric plication (g)) and gastric banding.


Eligibility criteria:
inclusion criteria: * age 18-70 * bmi \> or = to 30 and co-morbid conditions or bmi \> or = to 40 * ability to provide informed consent * willingness to commit to long-term follow-up exclusion criteria: * inability to provide informed consent * presence of metabolic or medically correctable cause(s) for obesity, such as untreated hypothyroidism or prader-willi * contraindications to surgery such as myocardial infarction within last 6 months, end stage renal or liver disease, current infection, or other disease states contraindicative to surgery, in the principal investigator's opinion * pregnancy * plan to become pregnant within two years post-surgery * current addiction to drugs or alcohol * previous history of any type of bariatric surgery (de novo group only) * hiatal hernia \> 3 cm

Keywords: morbid obesity bariatric surgery gastric banding gastric plication
the use of an innovative device for therapeutic adherence in pediatric asthma

Conditions: Asthma

Summary: the management of chronic diseases requires a constant monitoring of treatment adherence, in order to obtain an optimal disease control. however, this is often difficult to achieve, especially in pediatric age. in this sense, for asthmatic patients treated by symbicort turbohaler, "astrazeneca" developed the "turbo+", an electronic device attached to the turbohaler, which allows to feel whether the patient does the inhalation, and to register it on a specific application. the present randomized trial aims to compare the treatment adherence between asthmatic children/adolescents aged 6-17 years treated with symbicort turbohaler plus turbo+ or symbicort turbohaler without turbo+.


Eligibility criteria:
inclusion criteria: - uncontrolled mild or moderate persistent asthma; exclusion criteria: * acute upper respiratory infections; * immunological or metabolic systemic disease; * major malformations of the upper airways; * active smokers.
brain imaging plus urodynamics to investigate the brain's control of the bladder

Conditions: Urge Urinary Incontinence

Summary: the goal of this project is to evaluate the applicability of non-invasive optical imaging for the measurement of brain function during investigation of the lower urinary tract.


Eligibility criteria:
inclusion criteria: * ambulatory women over age 60, who are incontinent at least five times weekly for 3 months despite correction of potentially reversible causes. * urinary incontinence (urge or predominantly urge) by clinical criteria. * able to accurately complete a voiding diary, to perform a 24-hour pad test under direction. exclusion criteria: * significant mental impairment \[mini mental status exam (mmse) ≤ 20) * urethral obstruction * history of bladder cancer * spinal cord lesions * multiple sclerosis * pelvic radiation * interstitial cystitis * artificial sphincter implant * expected to have changes in medications/doses during the trial * medically unstable * patients with factors that could cause transient ui \[e.g., current urinary tract infection (uti), acute confusion\] will be treated in concert with the subject's primary care provider and considered for enrollment if their ui persists. * conditions that require endocarditis prophylaxis (such as heart valve problems or bacterial endocarditis)

Keywords: urge incontinence
a crossover clinical study to evaluate the effect of chitosan mouthwash on recurrence of black stains in pediatric patients

Conditions: Black Stains

Summary: the goal of this clinical trial is to learn if chitosan mouthwash works to affect the recurrence of black stains in pediatric patients. the main questions it aims to answer are: does chitosan mouthwash lower the number of times participants need to do a scaling and polishing cleaning sessions more than normal? does chitosan mouthwash will decrease the recurrence of black stains in children and improve esthetics ? participants will: take chitosan every day for 4 months visit the clinic once every 6 weeks for checkups and data collection


Eligibility criteria:
inclusion criteria: * 1. cooperative child to be able to perform and tolerate different oral hygiene procedures 2. parents providing informed consent 3. accept 18 weeks follow up period 4. teeth showing black stains without calculus. exclusion criteria: * 1. patients with allergic reactions to food \& drugs containing derivatives from crustacean organisms. 2. taking any antibiotic drugs within 2- week period before sample collection. 3. taking any dietary supplements containing iron. 4. teeth selected should be free of caries 5. free of any developmental defects

Keywords: black stains chromogenic children pediatric recurrence
covid-19 and mental health

Conditions: COVID-19; Mental Health Disorder

Summary: the overall objective of this study is to assess the enormity of mental health outcomes among healthcare providers (nurses and physicians) exposed to covid-19 during the time of the pandemic in the united states, specifically targeting those areas most effected.

healthcare providers (nurses and physicians) on the frontlines of the covid-19 response are facing a critical situation and are subject to increased psychological distress. those directly involved in the diagnosis, treatment and care of patients with covid-19 are at significant risk of developing physical, psychological, and psychosocial distress. the data examined in this study will further clarify the mental distress experienced by healthcare workers and lead to the development of peer-support and educational initiatives to improve these findings. the central hypothesis of this research is that high levels of mental distress will be associated with caring for patients with covid-19. this study will use an observational, cross-sectional on-line survey design. participants will complete a 15 minute self-administered questionnaire. all data will be de-identified.

Eligibility criteria:
inclusion criteria: * healthcare providers (physicians and nurse) working in institutions with known or suspected covid-19. exclusion criteria: * nurses and physicians who are retired, or not currently employed or not working in an environment with known or suspected covid-19.
topical intra-oral ketoprofen for migraine prevention

Conditions: Migraine

Summary: intra-oral topical ketoprofen gel, applied to a branch of the trigeminal nerve, has been shown to prevent migraines when used once daily for 3 months in open label studies. this is a randomized, double-blind, placebo controlled phase iii prevention trial to determine safety and efficacy.

this is a 4 month trial. during the first month, a prospective headache diary is maintained. migraine frequency, severity (1-10), duration, and all headache medications are recorded. patients are then randomized to receive active gel or placebo gel in double blind fashion. gel is applied to the posterior maxilla once daily for 3 months. a daily headache diary, as outlined above, is maintained throughout the trial. patients may continue to take other migraine medications, as needed. no other new migraine therapies may be started during the trial.

Eligibility criteria:
inclusion criteria: * ihs migraine with or without aura * 18 y.o. or older * at least 4 migraines per month exclusion criteria: * pregnancy * other headache conditions * chronic daily headache * allergy or sensitivity to nsaids other severe illnesses

Keywords: migraine prevention treatment ketoprofen trigeminal nerve