Kornimate/medical-research-clean huggingface dataset:
the effect of bacille calmette guerin (bcg) vaccination on immune responses in hiv-exposed and unexposed infants

Conditions: HIV Infections

Summary: background: each year, more than half a million babies are infected with hiv by mother-to child transmission in developing countries. many of these babies get sick and develop hiv disease (aids) at a very young age. exposure to other infectious diseases may influence this early progression to aids. bcg is a live tuberculosis vaccine made from cow tuberculosis. it is routinely given at birth to most babies, also to babies born to hiv-positive mothers. bcg can cause disease (bcgosis) in hiv-infected babies. more importantly, bcg may also trigger immune responses in the body that lead to the spread of the hiv virus and early progression to aids. objective(s) and hypothesis: the researchers will investigate whether bcg causes progression of hiv by doing a clinical trial: babies born to hiv-positive mothers will be randomly allocated to get the bcg vaccine at birth or at 14 weeks of age. in these 2 groups of babies, the researchers will compare: * the percentage of babies who progress to hiv disease * blood markers of hiv disease (the amount of virus and protective white blood cells in the body) * the body's immune response to bcg vaccine and other childhood vaccines * the percentage of children who develop bcg scarring, bcg vaccine complications and tuberculosis. potential impact: bcg is the most widely given vaccine worldwide and is routinely given to babies born to hiv-positive mothers in developing countries. any effect that bcg has on hiv progression in babies will have a significant public health impact in settings with a high burden of hiv disease.


Eligibility criteria:
inclusion criteria: * maternal hiv status verified * study consent * uncomplicated singleton pregnancy with delivery planned at local health facility * resident in study area exclusion criteria: * active tuberculosis or tuberculosis contact in mother * no consent * planning to move out of study area * not planning on delivering at local maternal obstetric unit * not planning on attending local baby clinic

Keywords: bcg hiv immune responses delayed vaccination infant morbidity nutritional status morbidity mortality
statins: a new therapeutic option for treatment of patients with endometriosis

Conditions: Endometriosis

Summary: endometriosis is a chronic inflammatory disorder leading to painful periods, pain with intercourse and infertility. the available treatment options to alleviate pain involve mainly hormonal treatments and surgery. all current hormonal treatments are effective but disrupt the normal variations in reproductive hormones which prevent ovulation, and thus pregnancy. statins, a group of cholesterol lowering drugs, have anti-inflammatory properties which may be helpful also for the pain related to endometriosis. the investigators plan to undertake a pilot study of 10 patients with endometriosis who will take pravastatin sodium together with coq10, which is inhibited by statins, for a period of 3 months. if this pilot study shows that the statin treatment may decrease pain symptoms in endometriosis, then the investigators plan to undertake a larger study to further investigate this matter.

* initial grading of pain by a linear analogue scale (las) from 1-10 * initial blood biochemistry including liver function test, lipid profile, creatine/bun, creatine kinase * 3 months of treatment with statins (pravastatin) in a dose of 40mg daily * supplementation with coq10 (200mg) daily for 3 months

Eligibility criteria:
inclusion criteria: * female patients of reproductive age group (18-38 years) with a clinical or surgical diagnosis of endometriosis with pain symptoms exclusion criteria: * use of hormonal suppression for pain control (ocp, gnrha) within 6-months * history of surgery for endometriosis within 6- months * current renal or hepatic active disease * current or history of myopathic disease * medication that may interact with statins (erythromycin, gemfibrosil, antifungals, antiretrovirals, other cholesterol lowering drugs)

Keywords: endometriosis pain fertility
expanded access program of neladalkib (nvl-655) for patients with advanced alk+ nsclc

Conditions: Non Small Cell Lung Cancer; ALK-positive Non-small Cell Lung Cancer (NSCLC)

Summary: the expanded access program will provide an alternate mechanism for patients, who lack satisfactory therapeutic alternatives and cannot participate in a neladalkib clinical trial, to access investigational neladalkib.

the purpose of this expanded access program is to provide investigational alk inhibitor, neladalkib (nvl-655), for eligible patients with alk-positive locally advanced or metastatic nsclc (alk+ nsclc) who have previously received lorlatinib or a second-generation alk tyrosine kinase inhibitor (tki) and lack satisfactory therapeutic alternatives and are unable to access neladalkib through a clinical trial.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years. 2. histologically or cytologically confirmed locally advanced or metastatic nsclc with a documented alk rearrangement or activating alk mutation. 3. previously received lorlatinib or received at least one second-generation alk tki and is either not eligible for or does not have access to lorlatinib, with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician. 4. enrollment in a clinical trial of neladalkib is not possible. 5. adequate organ function and bone marrow reserve. exclusion criteria: 1. prior receipt of neladalkib. 2. previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol. 3. ongoing anti-cancer therapy.
evaluation of apathy using attentional reaction test in neurodegenerative diseases

Conditions: Alzheimer Disease

Summary: apathy, defined as a lack of motivation in behaviour, cognition and affect, is common in neurodegenerative diseases. specific scales are available for the evaluation of apathy but it lacks objective evaluation methods. the aim of this study is to evaluate the changes in reaction time task according to the presence or absence of reward stimulation and to assess the relation between these performances and apathy scales.

material: 13 patients with mild cognitive impairment (mci), 15 patients with alzheimer's disease (ad) and 91 elderly healthy subjects were enrolled. a computerized test using the experiment software e-prime® was designed to assess reaction times (in ms) in different experimental conditions after a training trial (neutral, stimulation, stress, stimulation after stress, extinction) and relation between the performances to the test and the apathy inventory (ai) scores (lack of initiative, lack of interest, emotional blunting) were observed. method: using a computerized test, each patient is asked to press a button (mouse of the computer) each time the screen of the computer becomes completely white. after pressing the button, a randomized colorized geometric figure appears on the screen, and disappears automatically after a few seconds, replaced by a new white screen. reaction time (in ms) between a white screen and a press of the button is analysed. after a training trial, reaction times are analysed in different experimental conditions: neutral - stimulation1 (patient gets points when pressing the button) - stress (alarm) - stimulation2 (patient gets points when pressing, after the stress trial) - extinction (similar to neutral condition).

Eligibility criteria:
inclusion criteria: * elderly patients with diagnosis of alzheimer's disease according to dsm-iv criteria * mmse \>20 exclusion criteria: * none * motor or psychiatric disorders
omega-3 supplementation for pediatric migraine

Conditions: Migraine

Summary: the purpose of the study is to assess the biochemical and clinical effects of omega-3 polyunsaturated fatty acid (pufa) supplementation in youth suffering from migraine, including its effects on migraine disability, psychological distress, and overall quality of life. this study duration 12 weeks.

omega-3 polyunsaturated fatty acids (pufas), particularly eicosapentaenoic acid (epa) and docosahexaenoic acid (dha), hold potential therapeutic benefit for pediatric migraine due to their potent anti-inflammatory, anti-nociceptive, and neuromodulatory properties, which impact the pathophysiology of migraine. dietary alteration and supplementation of omega-3 pufas have been shown to decrease the frequency, duration, and severity of headaches in adults with migraine, yet no rigorous clinical studies on omega-3 pufa supplementation have been conducted in children and/or adolescents suffering from migraine. this study will establish feasibility of the intervention of omega-3 pufa supplementation for pediatric migraine (i.e., provide proof-of-concept that the intervention raises omega-3 index levels compared to placebo). the investigators will enroll 80 children and adolescents (ages 10-17 years) with a diagnosis of migraine and randomize participants 1:1 to receive an omega-3 pufa dietary supplement intervention or placebo daily for 12 weeks, with assessments conducts at baseline and at 12 weeks.

Eligibility criteria:
inclusion criteria: * males and females between the ages of 10 and 17 years * parent consent and subject assent * diagnosis of migraine based on the third edition of the international classification of headache disorders (ichd-3) criteria exclusion criteria: * known allergy to fish or seafood * current use of an omega-3 dietary supplement * significant neurological or psychiatric disorders or developmental delays * non-english speaking * allergy to coconut * pregnancy
up-down determination of the ed90 of metaraminol to treat hypotension during cesarean section

Conditions: Hypotension

Summary: the purpose of this study is to find the best dose of metaraminol to be used in patients during elective cesarean sections.

the purpose of this study is to determine the effective dose 90% (ed90) of metaraminol to treat hypotension after spinal anesthesia in elective cesarean sections (cs). it is a double-blind study that uses the biased-coin up-down sequential allocation method to determine the ed90 of metaraminol. baseline systolic blood pressure (sbp) will be determined by three automated measures 3 minutes apart just before cs. during the period from induction of spinal anesthesia to fetal delivery sbp will be monitored every minute and metaraminol will be administered every time it is lower than baseline value. if sbp falls below 80% of baseline value, the treatment will be considered a failure. an adequate response will be defined as the absence of hypotension during the study period.

Eligibility criteria:
inclusion criteria: * elective cs under spinal anesthesia * normal singleton pregnancy beyond 36 weeks gestation * asa physical status i/ii * age over 18 years exclusion criteria: * patient refusal * allergy to metaraminol * preexisting or pregnancy-induced hypertension * cardiovascular or cerebrovascular disease * fetal abnormalities

Keywords: cesarean section hypotension metaraminol vasoconstrictor agents adult female pregnancy anesthesia, obstetrical/adverse effects anesthesia,spinal blood pressure/drug effects nausea vomiting
trial of 1 cycle of adjuvant bep chemotherapy in high risk, stage 1 non-seminomatous germ cell testis tumours

Conditions: Stage I Testicular Non-Seminomatous Germ Cell Tumor

Summary: high-risk stage 1 nsgctts are curable with careful surveillance followed by 3 cycles of bep (bleomycin, etoposide, cisplatin with 500mg/m2 of etoposide per cycle) chemotherapy for the 40-50% of cases experiencing recurrence. alternatively, adjuvant chemotherapy with 2 cycles of bep(at a lower dose than that used for advanced disease - etoposide 360mg/m2) for these patients achieves the same outcome and avoids intensive surveillance, but delivers 33% more chemotherapy cycles on a population basis. if a single cycle of bep at the dose used in advanced disease had a similar high rate of relapse-free survival (cure) to that seen with two lower dose cycles, this would reduce the overall burden of chemotherapy and healthcare resource usage and would be likely to lead to a change in practice globally.


Eligibility criteria:
inclusion criteria: * histologically proven non-seminomatous germ cell tumour of combined gct (nsgct + seminoma)of the testis * histologically proven vascular invasion of the primary tumour into the testicular veins or lymphatics * clinical stage 1 patients (normal afp and hcg, or optimum marker decline approaching normal levels after orchidectomy and no evidence of metastases on ct of chest, abdomen and pelvis) * men aged 16 years or over * creatinine clearance \> 50 ml/min * no previous chemotherapy * wbc \> 1.5 x 10\^9/l and platelets 100 x 10\^9/l * fit to receive chemotherapy * able to start bep(500) chemotherapy as part of 111 study within 6\* weeks of orchidectomy * written informed consent \*if there are unavoidable delays this timescale can be extended to 8 weeks exclusion criteria: * all patients with pure seminoma * all patients with non-seminoma or combined nsgct + seminoma \> stage 1 * all patients with no vascular invasion * previous chemotherapy * patients with second malignancy except contralateral tin and contralateral germ cell tumour treated by orchidectomy and subsequent surveillance of more than 3 years * co-morbidity precluding the safe administration of bep(500) chemotherapy * patients with renal function impairment (bilirubin \>1.25 x uln and/or ast \>2 x uln) * patients with pre-existing neuropathy * patients with pulmonary fibrosis * patients with serious illness or medical conditions incompatible with the protocol
combination of anti-cd137 & ipilimumab in patients with melanoma

Conditions: Melanoma

Summary: the purpose of this study is to determine if bms-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed malignant melanoma * stage iii (unresectable) or stage iv disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens * willing to undergo up to 3 biopsies of an accessible lesion exclusion criteria: * active/symptomatic brain metastases * primary ocular melanoma or primary tumor of unknown origin * concurrent autoimmune disease * previous treatment with a cd137 agonist or ctla-4 inhibitor
a new method for detection of bacteria in the bloodstream

Conditions: Burns; Wounds

Summary: the primary aim is to determine if this new technique will detect and identify bacteria in the blood sooner than standard blood cultures or identify patients who may be septic without growing bacteria in their cultures. these will be correlated with the data collected from medical records on presumed sepsis. these results will be linked to data concerning infection that will be available as part of routine care including blood counts and other laboratory values that would be part of the routine medical care such as a white blood cell count. the earlier the bacteria are identified and the appropriate antimicrobials are administered the better the patient outcome.

this study will involve additional blood samples to be taken during the routine clinical blood draw, while the subject is being treated for their burn/wounds. the additional research samples will be examined for bacteria. a second blood draw will be performed at approximately 24 hours of initial blood collection. the blood is being collected and then correlate with results of routine medical care blood cultures and clinical status of the subject (diagnosis of sepsis, hemodynamic instability). data that will be abstracted from the current electronic medical record includes whether there is any type of catheter indwelling (brand name and type), insertion methods including place of insertion (intensive care unit, operating room, emergency department), adherence to bundle, complications during insertion, colonization of the subject with bacteria (mrsa), and culture results obtained as part of clinical care. demographics (subject's age) and diagnoses will also be captured as some studies have shown a higher risk of infection with certain processes (burns) and percentage of burn.

Eligibility criteria:
inclusion criteria: * burn patient with ≥20 % total body surface area burns or non-burned wound care patient requiring wound care in the burn intensive care unit. * must weigh ≥ 50 kilograms exclusion criteria: * pregnant or lactating women * prisoners
hydrocortisone use during peri-operation for pituitary adenomas

Conditions: Pituitary Adenoma; Adrenal Insufficiency; Surgery

Summary: the investigators hypothesize that withholding hydrocortisone during the peri-operation in patients with pituitary adenomas whose hypothalamus pituitary adrenal axis are intact are safe.

pituitary is the headquarters of the endocrine system of the body, secreting several hormones maintaining the normal function of the endocrine organs. after surgery, pituitary dysfunction is seen in a small proportion of patients, even in some patients resulting in severe consequence, i.e. adrenal insufficiency or pituitary crisis. therefore, patients undergoing pituitary surgery have been usually given "stress dose" steroids whether their hypothalamus pituitary adrenal (hpa) axis are deficient or preserved. results of several retrospective studies showed that there was no significantly increase in postoperative adrenal insufficiency in no supplementation (of hydrocortisone) group than in supplementation group. given the considerable side effects of using steroids, whether hydrocortisone administration is necessary for all patients with pituitary adenomas during peri-operation needs to be discussed. for chinese patients with pituitary adenomas except for those of cushing's disease, hydrocortisone administration during the peri-operation is a routine practice. peking union medical college hospital is the china pituitary disease registry center. here, the investigators aim to launch a single-center prospective randomized controlled trial to verify the hypothesis that withholding hydrocortisone during the peri-operation in patients with pituitary adenomas whose hpa axis are intact are safe.

Eligibility criteria:
inclusion criteria: * patients with pituitary adenomas that need surgical resection of the tumor, whose hypothalamus-pituitary-adrenal axis are intact * patients of either gender aged from 18 years to 70 years exclusion criteria: * patients with cushing's disease * patients with pituitary adenomas who have already developed secondary adrenal insufficiency before surgery * patients with pituitary apoplexy or other acute pituitary conditions that need emergency surgery * the postoperative pathology result indicates that the tumor is not a pituitary adenoma * patients that refuse to participate in the study or those who ask to quit after enrollment

Keywords: pituitary adenomas peri-operation hydrocortisone adrenal insufficiency
safety and efficacy of kpi-121 in subjects with dry eye disease

Conditions: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Summary: the primary purpose of this study is to determine the efficacy and safety of kpi-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. the product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (qid).

this is a phase 3, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of kpi-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.

Eligibility criteria:
inclusion criteria: * have a documented clinical diagnosis of dry eye disease in both eyes exclusion criteria: * known hypersensitivity or contraindication to the investigational product(s) or components * history of glaucoma, intraocular pressure (iop) \>21 mmhg at the screening or randomization visits, or being treated for glaucoma in either eye. * diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within 30 days prior to screening. * in the opinion of the investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

Keywords: ocular discomfort pain corticosteroid hyperemia dry eye
phase iii study of kx-826 with adult male patients with aga

Conditions: Androgenetic Alopecia

Summary: this is a phase iii, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of kx-826 for topical use in chinese adult male patients with androgenetic alopecia (aga).

in this study, around 740 adult male subjects with aga (rating iiiv, iv and v on hamilton-norwood scale) were to be enrolled. all subjects would be evaluated with 1:1 randomized to receive active drug or placebo in a double-blind fashion (370 subjects in each group), and would be treated for 24 weeks at the specified dose and frequency of each group. during the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation.

Eligibility criteria:
inclusion criteria: 1. agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study, and sign the icf in writing; 2. male, ≥ 18 old; 3. clinically diagnosed as androgenetic alopecia; 4. rating iiiv, iv and v on hamilton-norwood scale; exclusion criteria: 1. have used androgen replacement therapy, immunosuppressants, corticosteroids and other drugs that may affect the efficacy evaluation within 3 months prior to screening; 2. have used minoxidil within 6 months prior to screening; 3. have used finasteride or dutasteride within 12 months prior to screening; 4. had used topical drugs for alopecia sites within 3 months prior to screening; 5. have received scalp radiation and/or laser or surgical therapy within 12 months prior to screening; 6. those who, in the opinion of the investigator, have other conditions that may affect compliance or are not suitable for participation in this study.

Keywords: kx-826 aga