Kornimate/medical-research-clean huggingface dataset:
the impact of involving informal health providers for tuberculosis control in sudan

Conditions: Tuberculosis

Summary: training and engaging of unpaid informal providers (such as tea-sellers, women's groups, youth clubs, small traders and religious groups) from poorer localities in tb disease recognition, referral and community awareness raising will increase the access of tb patients to formal health facilities and decrease their delay in initiating tb treatment.

barriers to accessing health services faced by poor and vulnerable populations are numerous in developing countries. these include; geography, income poverty, lack of trust in the quality of public health services, and lack of empowerment of women and adolescent girls (as patients and carers) to mobilize adequate and timely resources to access these services. the project aims to test if tb case detection can be increased by engaging informal health care providers in active case finding. in one urban district of khartoum, these providers will be trained to work as first point of entry to the health system using a comprehensive package that includes disease recognition, health communication, and patient referral. in a comparator urban district of khartoum, no attempts will be made to engage informal providers. by comparing data of tb patients and lab registers between the intervention and comparator districts in khartoum, this project aims to test if, and to what extent, these expected effects can be realized. overall this is a trial of a health policy so individual patients will not be recruited or randomized to one intervention or the other. rather the policy is being applied in one district while the other district is being used as a comparator.

Eligibility criteria:
inclusion criteria: * access point for health seeking by the poor and vulnerable * active and well known in community * intervention activities can be confined to intervention area * based in community/locality * longevity; long standing * present in control and intervention areas * able and willing to complete the training to be triage-plus providers (ie giving formal consent) exclusion criteria: * formal health providers, e.g. clinics, labs, hospitals (moh, ngo or private) * internationally funded organizations, e.g. international ngos * civil servants e.g. teachers

Keywords: tuberculosis informal providers informal carers barriers to health system
study evaluating the tolerance of conjugate meningococcal c vaccine in infants

Conditions: Meningitis, Meningococcal

Summary: infant phase: to determine the safety of and production of antibodies by a group c meningococcal conjugate vaccine (mncc), when given at 2, 3, and 4 months of age with routine vaccines. booster phase: to compare the safety of and production of antibodies by mncc with and without mmr and to compare the antibody response to that produced by a low dose of plain polysaccharide vaccine as a way of investigating immune memory


Eligibility criteria:
inclusion criteria: * healthy infants 7-10 weeks of age eligible to receive routine immunization

Keywords: infant conjugate vaccine meningococcal antibody immune memory health meningococcal vaccines
open-label multi-site extension trial in subjects who completed the delta 1 or delta 2 trials

Conditions: Chronic Hand Eczema

Summary: the purpose of this extension trial is to evaluate the long-term safety of delgocitinib. subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until week 36. a final follow-up phone call is planned on week 38.

subject who completed 16 weeks of treatment with delgocitinib cream 20 mg/g or vehicle cream twice daily in trials delta 1 or delta 2 will be offered to roll-over to this extension trial. subjects will be treated with delgocitinib cream 20 mg/g twice daily only if they need it to control their chronic hand eczema. in the periods when the disease is controlled, no treatment will be administered. clinic visits every 4 weeks are planned (with the possibility of unscheduled visits) to investigate safety and efficacy of treatment, as well as its effect on patient-reported outcomes (pros).

Eligibility criteria:
inclusion criteria: * participants must have met eligibility criteria at screening and baseline in the parent trial (delta 1 or delta 2). * participants must have completed the treatment period in the parent trial (to be assessed at baseline visit in this extension trial). * participants must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator. * a woman of childbearing potential must use an acceptable method of birth control throughout the trial up until the end-of-treatment/early termination visit. exclusion criteria: * participants who prematurely discontinued treatment with imp or initiated rescue medication in the parent trial. * participants who experienced any adverse event (ae) during participation in the parent trial, which precludes further treatment with delgocitinib cream 20 mg/g in the judgement of the investigator. * any medical or psychiatric condition that could put the participant at undue risk by participating in the trial, or which, by the investigator's judgment, makes the participant inappropriate for the trial.
essential oils following iud insertion

Conditions: Pain, Muscle; IUD

Summary: this study will measure the effects of topical application of sweet marjoram essential oil + grapeseed oil with massage on uterine cramping/pain post-iud insertion/placement. the intention is to conduct a pilot study that could give a first look at the data to determine whether this line of research is worth pursuing with more time, effort, and resources. the results of this pilot study will provide adequate data (e.g., variance estimates) needed for obtaining reasonably reliable sample size estimates if larger studies are warranted in the future.

patients will be consented and randomized to one of three methods by a member of the study team on the day of their iud insertion. several variables of interest will be collected via the electronic medical record and via questionnaire.

Eligibility criteria:
inclusion criteria: * 18 years of age or older at time of iud insertion * english speaking * subject has signed study-specific consent form * subject has taken clinic recommended nsaid at least 30 minutes prior to iud insertion exclusion criteria: * subject is in post-partum period * known allergies to sweet marjoram essential oil or grapeseed oil * broken or irritated skin on lower abdomen * diagnosis of ibs/ibd
pilot project of adaptive thoracic radiotherapy for small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: this study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. the investigators hypothesize that an adaptive radiotherapy (rt) planning strategy for small cell lung cancer (sclc) patients with chest-confined disease will allow for safe delivery of higher doses of chest rt than a non-adaptive rt planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.


Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically proven newly diagnosed small cell lung cancer * chest-confined disease (including bulky intrathoracic disease) * adequate pulmonary function tests (fev-1\>1.0 l, dlco\>50%) * patients of childbearing potential must practice adequate contraception * age \> or = 18 years * karnofsky performance status \> or = 70 * eligible for concurrent chemoradiotherapy exclusion criteria: * patients who have undergone complete or subtotal tumour resection * evidence of non-small cell histology * prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years * prior rt to the thorax or neck * compromised lung function with inadequate pulmonary function tests (fev-1\<1.0,dlco\<50%) * pregnant women

Keywords: small cell lung cancer adaptive radiotherapy thoracic radiotherapy
bendamustine, gemcitabine and vinorelbine (begev) as induction therapy in relapsed/refractory hodgkin's lymphoma patients

Conditions: Hodgkin's Lymphoma

Summary: test of bendamustine in combination with gemcitabine and vinorelbine could contribute to a higher response rate with the reduction of toxic side effects

the aim of this study is to evaluate bendamustine, gemcitabine and vinorelbine (begev) scheme efficacy as induction therapy to high dose chemotherapy with allogeneic hematopoietic stem-cell transplantation (ahsct) for patients with relapsed/refractory hodglin's lymphoma (hl). four begev courses repeated every 3 weeks in the absence of any reasons listed in the paragraph 7.5; whenever an objective response is observed at disease evaluation performed after iv cycle patients undergo to high dose chemotherapy with ahsct (conditioning regimens based on preference of each centre).

Eligibility criteria:
inclusion criteria: * relapsed/refractory disease after receiving one line of standard chemotherapy * history of classical hodgkin's lymphoma (hl) * eastern cooperative oncology group (ecog) performance status of ≤ 2 * at least one site of measurable nodal disease at baseline ≥ 1.5 cm * absolute neutrophils count (anc) ≥ 1.5 x 109/l; platelets count ≥ 75 x 109/l exclusion criteria: * diagnosis of nodular lymphocyte predominant hodgkin's lymphoma (nlphl) * prior radiation therapy ≤ 3 weeks prior to start of study treatment * any concurrent anti-cancer therapy * evidence of another malignancy not in remission or history of such a malignancy within the last 2 years. * aspartate aminotransferase (ast/sgot) and/or alanine aminotransferase (alt/sgpt) ≥ 2.5 x upper limit of normal (uln) or ≥ 5.0 x uln if the transaminase elevation is due to disease involvement * known history of human immunodeficiency virus (hiv)seropositivity * hepatitis b virus (hbv) or hepatitis b virus (hcv)active hepatitis

Keywords: hodgkin lymphoma refractory relapsed
single-arm trial to evaluate the biodistribution and shedding of talimogene laherparepvec

Conditions: Melanoma

Summary: the primary objective was to estimate the proportion of participants with detectable talimogene laherparepvec deoxyribonucleic acid (dna) in the blood and urine at any time after administration of talimogene laherparepvec within the first 3 cycles.


Eligibility criteria:
key inclusion criteria: male or female age ≥ 18 years with histologically confirmed diagnosis of melanoma and unresected stage iiib, iiic, ivm1a, ivm1b, or ivm1c regardless of prior line of therapy. subject is candidate for intralesional therapy administration into cutaneous, subcutaneous, or nodal disease and must also have measurable disease, serum lactate dehydrogenase ≤ 1.5 x upper limit of normal, and eastern cooperative oncology group (ecog) performance status of 0 or 1, and adequate hematologic, hepatic, and renal organ function. key exclusion criteria: subject must not have clinically active cerebral metastases, greater than 3 visceral metastases (this does not include lung metastases or any nodal metastases associated with visceral organs) or any bone metastases melanoma, primary ocular or mucosal melanoma, history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or symptomatic autoimmune disease, or evidence of immunosuppression for any reason. subject known to have acute or chronic active hepatitis b or hepatitis c infection, or human immunodeficiency virus infection will also be excluded. subject who has active herpetic skin lesions or prior complications of herpes simplex virus type 1 ( hsv-1) infection (eg, herpetic keratitis or encephalitis), and/or requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use will also be excuded. subject must not have received previous treatment with talimogene laherparepvec.
diagnosis of bladder pain syndrome / interstitial cystitis

Conditions: Bladder Pain Syndrome; Interstitial Cystitis; Overactive Bladder

Summary: to identify new, simple and reliable biomarkers for bladder pain syndrome/interstitial cystitis (bps/ic) for diagnosis of this disease.

collection and analyses of bladder biopsies, bladder washings, blood and urine samples of patients with bladder pain syndrome/interstitial cystitis (bps/ic), overactive bladder syndrome (oab) and bladder-healthy controls. analyses include elisa, rt-qpcr, dna sequencing, and immunohistochemistry techniques. differences between patient groups are statistically evaluated.

Eligibility criteria:
inclusion criteria: * patient with diagnosed bps/ic, oab or healthy controls * included healthy controls must have another pelvic surgery planned (e.g. hysterectomy) * being able to act and judge exclusion criteria: * unstable endocrinological situation * severe illness

Keywords: bps/ic oab
new preservative-free combination of trehalose, sodium hyaluronate and n-acetyl-aspartyl-glutamate (naaga) in dry eye

Conditions: Dry Eye Disease (DED)

Summary: the goal of this prospective, non-randomized, non-comparative, monocentric pmcf study is to assess the performance of a new preservative-free combination of trehalose, sodium hyaluronate and naaga on ded at 6 months in 30 patients having dry eye disease. the main questions it aims to answer are: * to assess the performance and safety of t2769 at 3 months and 6 months. * to assess patient compliance to therapy. * to assess the occurrence of dry eye flares. participants will be asked to use t2769 on a daily basis and complete a self-questionnaire throughout the study.


Eligibility criteria:
inclusion criteria: * men and women aged over 18 years, * able to give written informed consent prior the initiation of any procedure, * history of dry eye syndrome for at least 3 months, * osdi ≥13, * never been treated with artificial tears or with no artificial tears at least 1 month before the enrolment, or not satisfied with current artificial tears. exclusion criteria: systemic/non ophthalmic exclusion criteria * known or suspected hypersensitivity to one of the components of the imd, * history of or active relevant systemic condition incompatible with the investigation or likely to interfere with the investigation results or the patient safety according to investigator judgment. specific exclusion criteria regarding childbearing potential women * pregnant or breast-feeding women, * childbearing potential women neither surgically sterilised nor using an adequate contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch) . exclusion criteria related to general conditions * alcohol addiction and heavy smoker according to investigator's judgement, * unable to understand the investigation procedures or to give informed consent, * non-compliant (e.g., not willing to attend a visit or completing the self-questionnaire; way of life interfering with compliance), * participant in this investigation at the same time as another clinical investigation/study, * participant in this investigation within the exclusion period of a previous study/investigation with a minimum of one month, * participant being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee or family member of the investigation sites or of the sponsor's company. exclusion criteria related to previous and concomitant treatments (medications/non-medicinal therapies/procedures) • participant with previous, current or anticipated prohibited listed treatment (or prohibited modification of treatment regimen).
auricular transcutaneous electrical nerve stimulation treatment of autism

Conditions: Autism Spectrum Disorder

Summary: in this study, investigators will examine the treatment effects of transcutaneous electrical nerve stimulation with different stimulation frequencies on individuals with autism.

in this study, investigators will examine the treatment effect of transcutaneous electrical nerve stimulation at auricular area with vagus nerve distribution on high-functioning individuals with autism. specifically, investigators will choose two ear acupoints: heart and shenmen. participants will be randomized to either 1 hz or 20 hz tvns group (up to 5 times per week) for three weeks.

Eligibility criteria:
inclusion criteria: 1. autism diagnosed based on dsm-v classification criteria 2. 18-60 year old high functioning adult autism patients (e.g. asperger's, iq equal or greater than 80) 3. subjects who do not show aggressive behaviors based on neuro/psychiatric evaluations as determined by a licensed study physician. exclusion criteria: 1. a history of chronic serious infection, any current infection, any type of cancer or autoimmune disease or other severe diseases; 2. subjects taking any medications that confound the study results
brief group psychotherapy for anxiety and depression

Conditions: Affective Disorder

Summary: the present work aims to develop a randomized clinical trial with a sample of 100 patients diagnosed with anxiety and depression in primary care. all participants are tested by several self-reports related to emotional disorders in a repeated measures design, pre and post treatment. it is our aim this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment in primary care. in addition, emotional regulation will be assessed and examined as a key factor in the clinical improvement.


Eligibility criteria:
inclusion criteria: * anxiety * depression exclusion criteria: * severe mental disroders * drug abuse * suicidal ideation/severe depression
randomized controlled trial of calcitriol vs. placebo among critically-ill patients with sepsis

Conditions: Severe Sepsis or Septic Shock

Summary: observational studies among critically ill patients have shown strong associations between vitamin d deficiency and adverse outcomes, including increased length of stay, infection, and mortality. it is unknown whether vitamin d deficiency contributes directly to adverse outcomes or whether it is simply a biomarker of severity of illness or overall health status. however, vitamin d plays a key role in host defense, largely by stimulating production of the anti-microbial peptide cathelicidin (ll-37). we will test the hypothesis that administration of activated vitamin d (calcitriol) will increase serum levels of cathelicidin.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * severe sepsis or septic shock * central venous catheter (for blood drawing) exclusion criteria: * serum calcium ≥ 10.0 mg/dl or phosphate ≥ 6.0 mg/dl, assessed within previous 48 hours * current or recent therapy (within previous 7 days) with nutritional vitamin d at doses \>1,000 i.u. per day or activated vitamin d at any dose * history of solid organ or bone marrow transplant, primary parathyroid disease, metabolic bone disease, or sarcoidosis * expected to die or leave the icu within 48 hours * history of hypersensitivity or any allergic reaction to calcitriol * end stage renal disease * acute kidney injury receiving intermittent renal replacement therapy * enrolled in a competing study * pregnancy
correlation between objective skin pigment measurement and fitzpatrick skin type

Conditions: Skin Pigment

Summary: the purpose of this study is to correlate subjective skin pigment measurements as reported by patient-responses to the fitzpatrick skin type scale versus objective classification of skin pigment utilizing individual typology angle (ita) measurements.

the fitzpatrick scale is a numerical classification for human skin color developed in 1975 as a way to estimate the response of different types of skin to uv light. it is used by dermatologists to classify skin tone and assess the risk of skin cancer. the fitzpatrick scale encompasses six gradings, from i to vi. however, this does not include all skin tones, as there are significantly more not encompassed within the scale. the aim of this study is to incorporate objective measurements when identifying a patient's fitzpatrick skin type.

Eligibility criteria:
inclusion criteria: * male and females that are 18 years of age and older * subjects with all fitzpatrick skin types i-vi one-third of subjects will be fitzpatrick i or ii skin types, one-third of subjects will be iii or iv, and one-third will have v and vi. exclusion criteria: * individuals who are pregnant or breastfeeding. * prisoners * adults unable to consent * individuals with open wounds on the nondominant upper inner arm * individuals with fibrotic skin disease or other skin conditions or hair growth on the nondominant upper inner arm that could affect skin measurements in the opinion of the investigator * individuals with tattoos that cover the site on the nondominant upper inner arm * individuals with post-inflammatory hypopigmentation or hyperpigmentation * individuals with vitiligo * individuals who have used self-tanning products or tanning beds in the last two weeks.
assessment of the axone micro quadripolar lead for enhanced cardiac resynchronization therapy

Conditions: Heart Failure; Cardiac Resynchronization Therapy

Summary: the primary objective of this study is to assess the chronic safety and performance of the axone left ventricular (lv) micro-lead.

this is a interventional, pivotal, prospective, single arm, open label, multicenter, international trial. the device under investigation is the axone system, consisting of: * axone 4lv: an ultrathin, lumenless, quadripolar, is4-compatible lead designed for left ventricular pacing for cardiac resynchronization therapy (crt). * axone µguide: a dedicated, permanently implantable micro catheter designed for implantation of the axone 4lv lead. the primary endpoint data will be used to support ce marking of the axone system. the primary endpoints will be evaluated at 6 months post-implantation. subjects will be followed-up at 6 weeks, 3 months, 6 months, 12 months post-implantation, then yearly until 4 years post-implantation.

Eligibility criteria:
inclusion criteria: * indication for cardiac resynchronization therapy-defibrillator (crt-d) device implant according to the latest esc (european society of cardiology) guidelines * de-novo implant of a platinium 4lv crt-d device (or any newer 4lv crt-d model manufactured by microport crm) * reviewed, signed and dated informed consent form exclusion criteria: * lv lead previous implant attempt * upgrade to crt from a previously implanted pacemaker or implantable cardioverter-defibrillator (icd), or crt device replacement * known allergy to contrast media used for imaging during cardiac catheterization * tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue) * severe renal failure (creatinine clearance according to the modification of diet in renal disease (mdrd) formula \< 30ml/min/m²) * active myocarditis * stroke, myocardial infarction or cardiac revascularization within 40 days prior to implant * previous heart transplant or currently on heart transplant list * life expectancy less than 1 year * already included in another clinical study that could confound the results of this study * pre-menopausal women / women in childbearing age, including pregnant and breastfeeding women * less than 18 years old or under guardianship * incapacitated subject, inability to understand the purpose of the study, or to meet follow-up visits at the implanting site as defined in the protocol * diagnosis of drug addiction (substance use disorder)

Keywords: left ventricular lead