Kornimate/medical-research-clean huggingface dataset:
ac-1204 long-term efficacy response trial (alert protocol)

Conditions: Alzheimer's Disease

Summary: the study will evaluate the safety \& efficacy of ac-1204, a ketogenic compound, administered orally on a daily basis for 6 months. following the 6 month double-blind phase of the study, subjects may enroll in an optional 6 month open-label extension phase. efficacy will be evaluated by standard tests of memory and cognition, along with other measurements of activities of daily living and quality of life. safety will be assessed by frequency of adverse events and changes in laboratory test results. subjects will be stratified and outcomes will be separately analyzed based on apolipoprotein e4 genotype (apoe4).

two primary outcome measures will be assessed in apoe4(-) patients: 1. differences from baseline between ac-1204 and placebo groups' adas-cog scores at 6 months 2. differences from baseline between ac-1204 and placebo groups' cibic+ scores at 6 months secondary endpoints will include differences between ac-1204 \& placebo groups' scores for these same instruments at 3 months.

Eligibility criteria:
inclusion criteria: * males/females between age of 55 -85 years * mmse scores between 16-26 * probable mild to moderate ad exclusion criteria: * presence of other cns disorders as alternative causes of dementia * type 1 or type 2 diabetes * significant renal/hepatic disease

Keywords: alzheimer's disease ad ac-1204 ketogenic ketosis
fludarabine or observation in treating patients with stage 0, stage i, or stage ii chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: rationale: drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. sometimes, the cancer may not need treatment until it progresses. in this case, observation may be sufficient. it is not yet known whether fludarabine is more effective than observation in treating chronic lymphocytic leukemia. purpose: this randomized phase iii trial is studying fludarabine to see how well it works compared to observation only in treating patients with stage 0, stage i, or stage ii b-cell chronic lymphocytic leukemia.

objectives: * identify prognostic factors that predict a short survival in patients with stage 0-ii b-cell chronic lymphocytic leukemia treated with fludarabine or observation only. outline: this is a randomized study. patients are stratified according to risk (high risk vs low risk). patients in the low-risk group undergo observation only. patients in the high-risk group are randomized to 1 of 2 treatment arms. * arm i: patients receive fludarabine. * arm ii: patients undergo observation only. projected accrual: a total of 880 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * confirmed diagnosis of b-cell chronic lymphocytic leukemia * rai stage 0-ii (binet stage a) disease * meets 1 of the following criteria: * high-risk disease, as defined by the following: * serum thymidine kinase level \> 7.0 u/l * elevated β2-microglobulin level * presence of non-nodular bone marrow infiltration * short lymphocyte doubling time * low-risk disease * meets none of the criteria (as listed above) for high-risk disease patient characteristics: performance status * not specified life expectancy * more than 6 months hematopoietic * no autoimmune hemolytic anemia * no thrombocytopenia hepatic * not specified renal * not specified other * no severe organ dysfunction * no other prior or concurrent malignancy prior concurrent therapy: chemotherapy * no prior chemotherapy * no other concurrent chemotherapy

Keywords: b-cell chronic lymphocytic leukemia stage 0 chronic lymphocytic leukemia stage i chronic lymphocytic leukemia stage ii chronic lymphocytic leukemia
prospective randomised study of a new an uncemented stem.

Conditions: Hip Osteoarthritis

Summary: patients will be randomised to either operation with a corail stem or a sp-cl stem. the groups are examined with rsa, conventional x-rays, prom-data and dxa. first evaluation will be done at two years.


Eligibility criteria:
inclusion criteria: * primary osteoartritis secondary osteoartritis exclusion criteria: * ongoing treatment with corticoid steroids, active cancer disease, previously known osteoporosis or osteomalacia, inflammatory arthritis, unsuitable anatomy, difficulties to speak or understand the swedish language.

Keywords: hip arthroplasty joint replacement uncemented stem anatomical stem
sex-differential health interventions in low-birth-weight infants

Conditions: Mortality; Morbidity; Growth; Neonatal Mortality

Summary: our group has consistently found that the major interventions to reduce morbidity and mortality in low-income countries have sex-differential effects. these interventions include bcg vaccine, oral polio vaccination (opv), and vitamin a supplementation (vas). low-birth-weight (lbw) children constitute the largest high-risk group in low-income countries. according to current policy, they receive opv at birth. current evidence suggests that a policy of providing bcg with opv for girls and vas instead of opv for boys at birth may improve survival in lbw neonates. this will be tested in a large randomized trial. we experienced an unexpected cluster of deaths among boys in the vas arm, which could be due to chance, but we decided to stop randomizing boys to opv or vas. very recent evidence has suggested that low-birth-weight boys may benefit from bcg at birth as well. hence, we have obtained ethical permission to continue the trial with randomization of boys to opv or opv plus bcg.


Eligibility criteria:
inclusion criteria: * low-birth-weight infants (\<2500 g) exclusion criteria: * already received bcg/opv * overtly sick or have malformations at the time of enrolment * clinical signs of vitamin a deficiency (very unlikely)

Keywords: bcg vaccine oral polio vaccine vitamin a supplementation low-birth-weigth sex-differential prevention immunological parameters
a safety and immunogenicity trial with an adjuvanted tb subunit vaccine (ag85b-esat-6 + ic31)

Conditions: Tuberculosis

Summary: the study has the following objectives: primary objective to evaluate the safety profile of an adjuvanted tb subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months secondary objective to determine the immunogenicity profile of an adjuvanted tb subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months.

number of trial subjects=48 investigational product=ag85b - esat-6 + ic31 dosage group 1: tst negative, 50 µg antigen group 2: tst negative, 50 µg antigen + fixed adjuvant group 3: bcg vaccinated, 50 µg antigen + fixed adjuvant group 4 : latent tb, 50 µg antigen + fixed adjuvant dosage volume 0.5 ml administration intramuscularly into deltoid muscle, alternate arms at day 0 (right) and day 56 (left).

Eligibility criteria:
inclusion criteria: * male between 18 and 40 years old * tst negative groups: tst- and negative quantiferon-tb gold in tube test * bcg group: known to be bcg-vaccinated \> 2 years before(scar, vaccination card), tst+ (\> 6 or any documented value \> 6 mm on medical file in the past), with no active, chronic or past tb disease as confirmed by chest x ray, negative quantiferon-tb gold in tube test and negative 6-day lymphocyte tests. * infection group: latent tb, tst+ ( = or \> 10 mm or documented = or \> 10 mm positive on medical file in the past), previously tb infected but with no active disease confirmed by chest x ray, may have received chemoprophylaxis but with no tb treatment/chemoprophylaxis within the preceding 2 years, positive quantiferon-tb gold in tube test and/or positive 6-day lymphocyte test. * healthy based on medical examination/history at the inclusion * signed informed consent * prepared to grant authorized persons access to the medical records * the volunteer is likely to comply with instructions exclusion criteria: * confirmed active tb based on clinical evaluation(history, physical findings and investigations) * vaccinated with any vaccine 3 months before first vaccination * administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) * hbv, hcv or hiv sero-positive * participation in other clinical trials * known hypersensitivity to any of the vaccine components * laboratory parameters outside of normal range considered clinically relevant

Keywords: safety immunogenicity adjuvanted tb subunit vaccine
homeless youth study - stepping stone project

Conditions: Mental Health

Summary: homelessness is associated with a multitude of negative consequences including an increased risk for mental health problems. once homeless, these individuals face significant barriers to mental health care and are therefore less likely to receive the treatment they need. mobile technology may offer a novel platform for increasing access to mental health care in this population. thus, the primary goals of this pilot study are to (1) establish the feasibility and acceptability of delivering a brief cognitive-behavioral intervention to homeless youth via smartphone technology, (2) examine the extent to which brief cognitive-behavioral interventions delivered via mobile technology improve mental health and trauma-related psychological symptoms in homeless youth, and (3) establish smartphone usage patterns among homeless youth to inform future interventions.


Eligibility criteria:
inclusion criteria: * english-speaking * homeless as defined by lacking "a fixed, regular, and adequate nighttime residence," (department of education) including youth who temporarily share the housing of others due to financial hardship * currently sleeping in a chicago-based shelter (at least 50% of nights in the past week) * willingness and ability to comply with requirements of the study protocol exclusion criteria: * involvement in risky behaviors that could interfere with the ability to fully engage in the study, as determined by the principal investigator * current involvement in legal proceedings * mental retardation or significant cognitive impairment * significant suicidal ideation indicated by a bdi-ii item 9 score ≥ 2 or enacted suicidal behaviors within 6 months prior to eligibility * any concurrent psychotherapy of any duration * inability to understand study procedures and participate in the informed consent process
reactogenicity, safety, and immunogenicity of covid-19 vaccine booster

Conditions: Covid19

Summary: preliminary data suggest that inactivated vaccine-induced neutralizing antibodies against sars-cov-2 decrease at six months after vaccination. observational, unpublished data also indicate that vaccine effectiveness against covid-19 wanes over time. thus, the investigators aimed to determine the reactogenicity, safety, and immunogenicity of a homologous or heterologous booster of sars-cov-2 vaccines among people already immunized with an inactivated sars-cov-2 vaccine. the study focuses on the elderly population and healthcare workers.


Eligibility criteria:
inclusion criteria: * full immunization with coronavac (2 doses; 0,28) prior to april 15, 2021 * being a resident of any of the eligible nursing homes (located in the metropolitan region of chile) * healthcare workers of one of the eligible nursing homes. * healthcare workers of hospital de urgencia asistencia publica (huap, santiago, chile) exclusion criteria: * prior history of covid-19 * not able to consent

Keywords: covid-19 inactivated vaccine booster chile
effects of dietary fiber on gastrointestinal function

Conditions: Gastrointestinal Health

Summary: the purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in healthy, adult volunteers.

the study is a blinded, cross-over design with subjects completing three, two-week treatment periods, separated by two, two-week washouts. volunteers will consume a dietary fiber for two of the treatment periods at two dose levels. the fiber will be added to foods and dispensed to subjects to be consumed twice a day during each treatment period. during the control period, subjects will receive the same study foods, but with no added fiber. major outcomes will include fecal weight, and responses to questionnaires that assess fecal characteristics, bowel habits and gastrointestinal tolerability.

Eligibility criteria:
inclusion criteria: * healthy men and women * age 18 - 54 years * bmi \< 30 kg/m2 exclusion criteria: * presence of gi or other serious diseases known to affect gi function * recent use of antibiotics * very high fiber intake * use of medications known to affect gi function * presence of allergies to study foods

Keywords: dietary fiber gastrointestinal toleration fecal weight
oral nsai versus acetaminophen or placebo as a discharge treatment of non complicated renal colics

Conditions: Renal Colic

Summary: treatment with nsai in renal colics has not been well investigated and there is no clear recommendations regarding this subject. the aim of this study is to determine if an oral nsai treatment is beneficial in patients discharged for the emergency department after the first line treatment of a renal colic investigating the reccurence of pain, the reconsultation rates and the admissions.

renal colic (rc) are a frequent cause of consultation in the emergency departement (ed). it counts for approximatively 20 % of patients presenting to the ed with severe acute onset abdominal pain. the first line treatment of renal colics is based on nsai drugs associated with antalgics and is further investigated in the nsai vs morphine study (nct02156596) but there is no clear recommendations regarding the outpatient treatment of renal colics. oral nsai are still widely used as a second line medicine for this condition and variety of molecules were tried with non solid scientific arguments. piroxicam, a non-selective cox inhibitor drug appared to the oxicam class of nsai, is widely used to treat rhumatoid and inflammatory disesases, and often prescribed in tunisia as a second line treatment of rc. in this study, the investigators aimed to investigate the efficiency and safety of the use of oral nsai drugs (piroxicam) compared to acetaminophen or placebo as a second line treatment of renal colics

Eligibility criteria:
inclusion criteria: * over 18 years old * consenting to participate in the study * patients treated in the ed for rc * no contraindications of nsai or paracetamol treatment exclusion criteria: * contraindication of nsai treatment * patients non reachable by telephone call * patients that did not receive or use the treatment

Keywords: renal colic nsai acetaminophen
botulinum toxin injections for thoracic outlet syndrome

Conditions: Thoracic Outlet Syndrome

Summary: botulinum toxin type a injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with tos. this will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo.

to assess the effect of botulinum toxin type a (btx-a) injections into the scalene muscles on pain, paresthesias and function in subjects with tos. hypothesis: btx-a injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with tos. this will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo. study design: double-blind, randomized, placebo-controlled parallel groups effectiveness trial evaluating changes in pain, paresthesias and function before, at six weeks and four months following injection. study population: sixty subjects at least eighteen years of age with a clinical diagnosis of tos of at least three months duration but less than one year, referred to our practice for management of tos. intervention: each subject will receive an injection under emg guidance into the anterior and middle scalene muscles of either 100 units of btx-a (experimental group), or normal saline (control group). outcome measures: the primary outcome measure will be pain as measured on a ten point numeric rating scale with a two point reduction considered significant. secondary outcomes will be paresthesias as measured on a numeric rating scale, function measured on the disabilities of the arm, shoulder and hand (dash) questionnaire.

Eligibility criteria:
inclusion criteria: * age at least 19 years * medically stable * able to give informed consent * meets criteria for clinical diagnosis of tos * symptoms of tos present for at least three months and less than two year * have had emg studies and a ct or mri scan of the cervical spine exclusion criteria: * prior treatment with btx-a * allergy to btx-a * history of botulinum toxicity * prior scalenectomy * surgery for tos planned within four months * use of blood thinners, i.e., warfarin; unfractionated or low molecular weight heparin * history of myasthenia gravis, eaton-lambert syndrome or shy-drager syndrome * unable to complete follow-up assessments at 6 weeks and 4 months * any abnormalities on emg, ct or mri studies suggesting an alternate diagnosis * pregnancy or planned pregnancy within six months

Keywords: botulinum toxin type a thoracic outlet syndrome
alzheimers disease and neuromarkers in patients with acute hip fractures

Conditions: Alzheimers Disease; Inflammation; Hip Fracture

Summary: the investigators explore the presence of ad factors beta-amyloid and tau in csf and plasma to verify ad diagnosis in patients with acute hip fracture. clinical dementia test is performed prior to operation. blood samples and csf samples are collected at surgery and blood samples are collected postoperatively at intervals. mortality is assessed at 30 days, 3 months and 1 year. morbidity is assessed at , 3 months and \>1 year. neuromarkers specifically addressing the inflammatory component are to be analyzed and correlated to outcome together with ad markers, as above.

the hypotheses explored in this investigation is that patients being pre-ad or having ad have worse prognosis following an acute hip fracture. this has been demonstrated in retrospective studies. in this study we admit all patients with a hip fracture planned tro receive a spinal anesthesia. our golden standard of anesthesia in this patient cohort. preoperatively clinical dementia score is assessed after study inclosure. at the performance of the spinal dosage is standardized. prior to giving this 5 ml of csf is collected and blood is collected. blood is then collected at intervals up until day 3 postoperatively. we plan to analyze beta-amyloid and tau in csf and plasma to verify ad diagnosis in patients with acute hip fracture. mortality is assessed at 30 days, 3 months and 1 year. morbidity is assessed at, 3 months and \>1 year. neuromarkers specifically addressing the inflammatory component are to be analyzed and correlated to outcome together with ad markers, as above.

Eligibility criteria:
inclusion criteria: * hip fracture with a planed spinal anesthesia exclusion criteria: * not receiving a spinal anesthesia i.e. no csf is available
an exploratory study of the effects of nivolumab combined with ipilimumab in patients with treatment-naive stage iv or recurrent non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with stage iv or recurrent non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * histologically confirmed, stage iv or recurrent non-small cell lung cancer with no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease * measurable disease by ct or mri * must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work exclusion criteria: * participants with untreated central nervous system metastases * participants with active, known or suspected autoimmune disease * prior treatment with any drug that targets t cell co-stimulations pathways (such as checkpoint inhibitors) other protocol defined inclusion/exclusion criteria apply
asymmetric subthalamic deep brain stimulation for axial motor dysfunction in parkinson's disease

Conditions: Parkinson Disease

Summary: this single-center, randomized, quadruple-blinded, double-crossover comparative efficacy trial will study the effects of unilateral 50% voltage reduction in axial motor dysfunction for patients with parkinson's disease that develop treatment-resistant postural stability gait dysfunction after bilateral subthalamic nucleus deep brain stimulation surgery.


Eligibility criteria:
inclusion criteria: * patients with parkinson's disease (pd) (previously diagnosed according to the uk brain bank criteria) who develop treatment-resistant postural instability gait dysfunction (pigd) more than 6 months but less than 5 years after bilateral subthalamic nucleus deep brain stimulation (stn-dbs). * treatment-resistant pigd will be defined as freezing of gait and updrs or mds-updrs pigd subscales of more than 6 points despite optimization of medications and bilateral stn-dbs programming. exclusion criteria: * treatment-resistant pigd less than 6 months or more than 5 years after stn-dbs surgery. * pigd responsive to optimization of medications and/or bilateral stn-dbs programming. * cognitive impairment or psychiatric comorbidities (including substance abuse) that would interfere with the informed consent process, study adherence or outcome assessments. * advanced pd or any other neurological, cardiovascular or musculoskeletal co-morbidities that would preclude or require assistance to complete the 10-meter walking test. * patients not able to comply with 4-week interval evaluations following their potential enrollment due to personal reasons. * serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically-stable on therapy, in the opinion of the site investigator, for at least 30 days prior to study entry. * inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Keywords: parkinson's disease axial motor dysfunction asymmetric neuromodulation subthalamic nucleus deep brain stimulation
a phase 3 clinical trial to evaluate the efficacy and safety of hgp0412 and hip1402 in patients with bph

Conditions: Benign Prostate Hyperplasia

Summary: the main objective of this study is to evaluate efficacy and safety of (tamsulosin) hgp0412 and hip1402 in patients with benign prostatic hyperplasia

a multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of (tamsulosin) hgp0412 and hip1402 in patients with benign prostatic hyperplasia

Eligibility criteria:
inclusion criteria: * age\>=45, male, diagnosed on bph, total ipss\>=13 exclusion criteria: * hypersensitivity to investigational products or components * psa\>=4ng/ml