Kornimate/medical-research-clean huggingface dataset:
evaluation of the safety, efficacy, and pharmacokinetics of intravenous deferiprone in hiv-positive subjects

Conditions: Asymptomatic HIV Infection

Summary: this study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in hiv-infected subjects.

this is a double-blind, placebo-controlled, randomized trial in 30 asymptomatic hiv-positive adults. there are two sequential cohorts, in which subjects will receive either one of 2 doses of deferiprone or placebo twice daily.

Eligibility criteria:
inclusion criteria: * hiv-1 positive * hiv treatment-naïve: no previous treatment with a combination anti-retroviral therapy (cart) or highly active anti-retroviral therapy (haart) regimen * hiv-1 rna \> 10,000 copies/ml * alt or ast ≤ 2.0 x upper limit of normal range, and bilirubin within normal range * body mass index (bmi) of 18.5 to 30.0 kg/m\^2 * absolute neutrophil count at baseline of ≥1.0 x 10\^9/l (black african population only) or ≥1.5 x 10\^9/l (all other races) exclusion criteria: * evidence of aids-associated illness, excluding superficial candidiasis * cd4+ t-cell count of \< 350/mm\^3 * positive for active or latent tuberculosis, as determined by the quantiferon®-tb gold test * active, serious infections (other than hiv-1 infection) within the 30 days prior to screening * positive for hepatitis b surface antigen (hbsag) and/or hepatitis virus c (hcv) antibodies * history or presence of malignancy * a serious, unstable chronic illness during the past 3 months before screening * a serious, unresolved acute illness at screening

Keywords: hiv infection antiretroviral drugs deferiprone pharmacokinetics
a journey into participation patterns among patients with hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: this study aims to uncover the factors driving patient decisions regarding enrollment, withdrawal, or re-engagement in hidradenitis suppurativa clinical trials. understanding these factors will significantly improve the relevance and effectiveness of future research endeavors. ultimately, this trial endeavors to deepen our understanding of the factors impacting hidradenitis suppurativa clinical trial participation. enhancing participation rates could accelerate the development of innovative treatments for this debilitating condition.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years old * diagnosis of hidradenitis suppurativa * able to comprehend the investigational nature of the protocol and provide informed consent exclusion criteria: * female patients who are currently pregnant or nursing * inability to perform regular electronic reporting * has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Keywords: hidradenitis suppurativa
real world data collection pediatric neuroblastoma treated with lorlatinib

Conditions: Neuroblastoma

Summary: the overall goal of this real-world data collection is to assess demographic, clinical characteristics and real-world effectiveness of pediatric neuroblastoma patients treated with lorlatinib through the expanded access program.


Eligibility criteria:
inclusion criteria: * patient receives lorlatinib through pfizer's expanded access program for treatment of alk+ neuroblastoma. * hcp documentation of at least one tumor assessment of response after patient has had at least one dose of lorlatinib * evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: * any patient who does not meet any of the inclusion criteria defined in the previous section.
relationship between thoracic hyperkyphosis and fall risk in women with fragility vertebral fractures

Conditions: Osteoporosis; Hyperkyphosis; Vertebral Body Fracture

Summary: multiple vertebral fragility fractures, one of the main complications of osteoporosis, are frequently associated with thoracic hyperkyphosis, which in turn leads to significant postural alterations. these biomechanical changes may increase fall risk, posing a critical clinical issue for elderly patients. however, the results of studies investigating the association between hyperkyphosis and fall risk are conflicting, highlighting the need for further research. this study aims to explore the correlation between the severity of thoracic kyphotic curvature and fall risk in patients with multiple fragility fractures undergoing osteoporosis treatment. additionally, the study seeks to evaluate the role of physiotherapy in improving patients' functional and postural outcomes. a retrospective observational study was conducted, supplemented by a narrative literature review to contextualize the findings. forty patients undergoing treatment at the functional recovery and rehabilitation unit (uoc) of p. giaccone university hospital in palermo were enrolled and followed up via biannual phone interviews. data were collected between may 2023 and may 2024, with a longitudinal assessment of outcomes from t0 (baseline) to t1 (12 months). the severity of the kyphotic curve was quantified using the cobb method, while fall risk was assessed through the berg balance scale. participation in physiotherapy programs was analyzed to evaluate their impact on clinical and functional outcomes.


Eligibility criteria:
inclusion criteria: * women aged ≥65 years. * presence of at least three documented vertebral fragility fractures. * diagnosis of thoracic hyperkyphosis exclusion criteria: * history of orthopedic surgeries involving the spine or lower limbs. * treatments for cerebrovascular diseases. * presence of balance disorders. * active oncological diseases. * use of walking aids

Keywords: osteoporosis hyperkyphosis vertebral body fracture rehabilitation
to assess the efficacy and safety of dual anticoagulants i.e. rivaroxaban plus aspirin and clopidogrel plus aspirin in patients suffering from an acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: direct-acting oral anticoagulants (doacs) have provided benefits to patients requiring anticoagulation for certain diseases by decreasing the burden of subcutaneous injections and the requirement for frequent monitoring through regular blood tests. doacs do not require monitoring, have a more predictable pharmacokinetic (dosing) profile and have fewer interactions with other drugs. various studies have reported the efficacy and safety of different dual-acting anticoagulants around the globe. however, there is little data available from pakistan. therefore, investigators propose this study to assess the efficiency and safety of rivaroxaban and clopidogrel along with aspirin in patients suffering from acute coronary syndrome. the objective of this study is to investigate the efficacy of dual anticoagulants i.e. aspirin plus rivaroxaban versus aspirin plus clopidogrel in patients suffering from acute coronary syndrome in terms of secondary prophylaxis. all the patient records will be documented in case report form (crf) at each visit. all data will be recorded in individual source documents. all crf information is to be filled in by site staff. if an item is not available or is not applicable, this fact should be indicated. blank spaces should not be present unless otherwise directed. the study monitor will perform source data verification of data entered into the crf. the data entered into the crf will be subject to data validation checks for consistency and completeness by the data management group. all crfs should be maintained on the system with details of any changes logged accordingly.


Eligibility criteria:
inclusion criteria: * male and female aged ≥ 18 years and above * participants able to understand the study procedures and willing to give written informed consent/assent to participate in the trial * participants willing to follow the study procedures of the study and available for the entire duration of the study. * female participants of childbearing potential must have a negative urine pregnancy test * women of childbearing potential (wocbp) must be willing to abstain from heterosexual activities or agree to use highly effective, double-barrier contraception during the study and for 90 days following the final dose of study treatment, to avoid pregnancy. (this is in line with regulatory guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals) exclusion criteria: * co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes * arrhythmias * pre-existing hepatic disease * pre-existing renal disease * already taking any drug * pregnancy * thyroid dysfunctions
embolic stroke of undetermined source, continuous electrocardiography and transthoracic echocardiography in hospitalized patients with ischemic stroke

Conditions: Embolic Stroke of Undetermined Source

Summary: transthoracic echocardiography (tte) is recommended in patients with ischemic stroke when cardiac etiology is suspected to help plan secondary stroke management. however, discrepancy for specific clinical recommendation exists between cardiologists and neurologists, and data evaluating usefulness of tte in unselected patients with cryptogenic strokes (cs) and embolic strokes of undetermined source (esus) are lacking. the investigators sought to evaluate the value of routinely performed echocardiography in consecutive cs/esus patients. the investigators will perform tte as recommended by guidelines including agitated saline contrast and speckle-tracking to investigate potential implications for secondary stroke management. in addition, the researchers aim to evaluate the effectiveness of long-term continuous electrocardiogram (cecg) monitorering with newer holter monitors to detect cardiac arrhythmia in patients with cs/esus. in this prospective study, the investigators aim to evaluate 500 consecutive patients, regardless of age, in sinus rhythm with acute is and potential cardioembolic stroke (ces) or cryptogenic stroke (cs/esus) according to trial of org 10172 in acute stroke treatment (toast) criteria. strokes are determined by magnetic resonance imaging. the researchers will perform tte as recommended by guidelines including agitated saline contrast and speckle-tracking to investigate potential implications for secondary stroke management. the investigators aim to explore underlying heart conditions and comorbidities among ces and esus patients. data will include left atrium morphology, atrial septal aneurysm, valvular disease, mural thrombus and patent foramen ovale (pfo). focus will be analysis of data on older patients, as some studies indicate that in esus patients \>60 years of age, there is a higher prevalence of pfo in patients with low atherosclerosis and cardioembolic risk. this project can potentially guide cardiologists and neurologists, on common grounds, for stroke management of potential cardioembolic origin. implications of referring all-comers with stroke of potential cardioembolic origin to echocardiography will be illustrated.


Eligibility criteria:
inclusion criteria: * hospitalized patients with verified acute ischemic stroke determined by magnetic resonance imaging (mri) and/or computed tomography (ct) of cerebrum. * patients, regardless of age, in sinus rhythm with acute is and potential cardioembolic stroke or cryptogenic stroke (cs/esus) according to trial of org 10172 in acute stroke treatment (toast) criteria. exclusion criteria: * persons not able to cooperate. * persons unable to understand and sign "informed concent."

Keywords: transthoracic echocardiography stroke strain embolism secondary prevention
fluoroquinolone associated disability

Conditions: Bronchitis; Sinusitis; Urinary Tract Infections

Summary: the purpose of this study is to: 1) describe drug utilization for fluoroquinolone(fq), azithromycin (az) and sulfamethoxazole/trimethoprim(st) in the entire truven marketscan commercial claims and encounters database (ccae) database, and specifically among individuals in the health and productivity management (hpm) during the observation period; 2) describe the rate of disability associated with 2 or more system organ class adverse events (soc aes) and exposure to fqs for several acute, uncomplicated indications; and 3) compare the rates of disability for 2 or more soc aes and exposure to fqs and az/st for the same indications.


Eligibility criteria:
inclusion criteria: * participants in the truven ccae database who were eligible for disability insurance and can be linked to the truven health and productivity management (hpm) database * study participants will be included if they have 6 months of history before the first day on fq or az/st and at least 120 days afterward exclusion criteria: * if any protocol specified medical conditions or exposure to the protocol specified medications in the 6 months preceding the first qualifying dose of fq or az/st * if participants have any disability claim in the 6 months preceding the qualifying fq or az/st dose * if participants have the protocol specified condition-specific diagnoses within the 3 months preceding the qualifying fq or az/st exposure
fame: functional assessment of a myoelectric orthosis hand orthoses

Conditions: Paresis; Stroke

Summary: the primary study objective is to compare post-stroke upper extremity (ue) movement while wearing a brace called the myopro 2 motion g versus ue movement while wearing a resting splint and no device in stroke survivors with moderate ue dysfunction. during the study, subjects will undergo general training in the operation of the emg-controlled orthosis and the comparison orthosis, and then guided through a series of standard clinical outcome measures. these outcome measures will allow the researchers to directly compare the relative benefit of the myopro 2 motion g with a resting hand splint and no device in reducing ue impairment and increasing ue dexterity and functional task performance.


Eligibility criteria:
inclusion criteria: * manual muscle test \>1/5 in the paretic biceps, triceps, finger extensors and finger flexors; * score \> 10 \< 30 on the upper extremity fugl meyer and active shoulder flexion of at least 30 degrees with device weight on affected arm; * ability to generate consistent, detectable emg signal from the bicep/tricep upper arm and distal forearm flexor and extensor sensor sites with wrist in neutral, and fingers in neutral. at rest, achieve an emg of 5 or below on myconfig (wrist and fingers in neutral and elbow extended); with gain at \< 10 and boost \<12, able to reach a threshold of 10 at both bicep and wrist flexors/extensors; * a single stroke that is the cause of arm impairment, experienced \>12 months ago; if there are additional asymptomatic lesions (as diagnosed by mri), these subjects may also be included. those with another symptomatic stroke in addition to the stroke causing arm impairment are excluded; * score \>70 on the modified mini mental status examination; * age \>18\< 85; * \> 6 months since previous functional or therapeutic use of an upper extremity myoelectric orthosis; * height \>5'0"; * weight \>110\< 250 lbs.; * forearm circumference (at widest part) \<13 in.; * bicep circumference \>9 \<15 in.; * upper arm length \>5.5 in.; * wrist thickness (anterior- posterior) \<1.75 in.; * ability to stand with minimal assistance exclusion criteria: * \> 5 on a 0-10 numeric pain rating scale for pain in the paretic hand, arm or shoulder; * \> 3 on the modified ashworth spasticity scale in the paretic elbow, \>2 at wrist or fingers; * \< 2.5 on the alexander apraxia scale; ' * history of neurological disorder other than stroke; * change in anti-spasticity medications in the last 6 months, and/or receipt of botulinum toxin in the paretic ue in the previous 4 months; * elbow contracture greater than 10 degrees; * inability to passively extend fingers while wrist is in neutral; * other conditions or physical/mental attributes that may undermine safety and/or full participation in the study; * bilateral hemiparesis.
comparing hypertension remote monitoring evaluation redesign

Conditions: Hypertension

Summary: the goal of this clinical trial is to compare the effectiveness of evidence-based, adapted, and tailored, patient-focused and clinic-focused strategies to improve blood pressure (bp) control in english- and spanish-speaking patients with hypertension (htn).


Eligibility criteria:
inclusion criteria: * 18 years or older * any sex/gender * any race or ethnicity * have hypertension or high blood pressure (bp) (bp \>=140/90 mmhg at least twice in the previous 18 months) * can read and write english or spanish * be able to provide consent exclusion criteria: • we will exclude individuals with conditions that might have severe self-management limitations due to a disability or medical condition or might complicate remote bp monitoring, such as self-reported: * pregnancy * lactating/nursing * dialysis
zimura in participants with geographic atrophy secondary to dry age-related macular degeneration

Conditions: Geographic Atrophy; Dry Age-Related Macular Degeneration

Summary: the objectives of this study were to evaluate the safety and efficacy of zimura intravitreal (ivt) administration when administered in participants with geographic atrophy (ga) secondary to dry age-related macular degeneration (amd).

participants will receive monthly intravitreal injections of zimura or sham for 18 months.

Eligibility criteria:
inclusion criteria: * participants of either gender aged ≥ 50 years * diagnosis of non-foveal ga secondary to dry amd exclusion criteria: * evidence of choroidal neovascularization (cnv) * ga secondary to any condition other than amd * any prior treatment for amd or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals * any intraocular surgery or thermal laser within three (3) months of trial entry * any prior thermal laser in the macular region, regardless of indication * any ocular or periocular infection in the twelve (12) weeks * previous therapeutic radiation in the region of the study eye * any sign of diabetic retinopathy in either eye

Keywords: geographic atrophy (ga) dry age-related macular degeneration amd zimura (previous name) anti-inflammatory complement factor c5 inhibitor arc1905 avacincaptad pegol
a study to evaluate the ability of conducting a study of oral risperidone followed by paliperidone palmitate in rwandan healthcare facilities

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the feasibility of conducting a study of oral risperidone followed by paliperidone palmitate for once monthly (pp1m) and paliperidone palmitate for every 3 months (pp3m) in rwandan healthcare facilities with mental healthcare capabilities.


Eligibility criteria:
inclusion criteria: * participants with diagnosis of schizophrenia by mini international neuropsychiatric interview (mini)- screen/ mini (module k) that requires treatment initiation or a change in treatment to better address safety or efficacy limitations of current treatment * participants at least moderately ill as measured by the clinical global impressions - severity of schizophrenia (cgi-ss) scale for schizophrenia, or experiencing poorly tolerated side effects from their current medications, or having difficulty with adequate adherence to treatment, per the investigator's judgement * participants have a primary caregiver who is willing to participate in this study (caregiver should be knowledgeable about the participant's condition and is expected to be with the participant for greater than (\>) 24 hours each week for the duration of the study) * participants able to give consent to participate in a clinical study that includes treatment with risperidone and long-acting injectable formulations of paliperidone palmitate. participants must be willing to receive injections. the participant and the caregiver participant must sign an informed consent form (icf) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study * participants must be willing and able to provide responses for all self-administered questionnaires exclusion criteria: * participants have a physical, mental, or legal incapacity that prevents a valid consent or capacity to complete about 12 months of treatment with antipsychotic medication and compliance with this study protocol * participants with history of organic brain syndromes, comorbid psychiatric and/or physical illnesses, or significant comorbid substance abuse that is likely to interfere with understanding of or compliance with study requirements * participants with known allergies, hypersensitivity, or intolerance to risperidone or paliperidone palmitate or their excipients * participants with poor prior response to risperidone * participants who received an investigational medication (including investigational vaccines) or used an invasive investigational medical device within 30 days before the planned first dose of study medication, or is currently enrolled in an investigational study
comparison of systematic surgery versus surveillance and rescue surgery in operable oesophageal cancer with a complete clinical response to radiochemotherapy

Conditions: Epidermoid Carcinoma or; Adenocarcinoma of the Thoracic Oesophagus or; Adenocarcinoma of the Oesogastric Junction (Siewert Type I or II); Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0

Summary: step 1: inclusion of eligible patients to carry out a translational search for prognostic and predictive markers of complete clinical response and pathologic complete response (using blood samples and diagnostic biopsies) and to collect data on radiochemotherapy and its toxicity. the trial will evaluate strategies after neoadjuvant treatment and not rct protocols. the rct will thus be chosen by the investigator from published effective schemes in a pre-operative setting or in patients not undergoing surgery. evaluation of the response 5 to 6 weeks after the rct. step 2: randomisation in patients with a complete clinical response: arm a: systematic surgery arm b: surveillance and rescue surgery in cases with resectable loco-regional recurrence patients not eligible for randomisation will have the possibility to participate in a specific study (information can be obtained from the sakk group (switzerland group clinical research on cancer)).


Eligibility criteria:
inclusion criteria: * epidermoid carcinoma (ec) or adenocarcinoma of the thoracic oesophagus or adenocarcinoma of the oesogastric junction (siewert type i or ii) proven histologically * stage ct2 n1-3 m0 or ct3-t4a n0 or n1-3 m0 after a full investigation * patient considered operable with a curative intent and scheduled to undergo first-line radiochemotherapy in a multidisciplinary meeting * age ≥ 18 years \< 75 years * patient with national health insurance cover and who has provided written informed consent for the clinical and biological studies. exclusion criteria: * cancer of the cervical oesophagus (15 to 19 cm from the dental arches) * weight loss \> 15% at the recruitment with no improvement after nutritional support * serious comorbidity threatening survival in the short term * contra-indication for radiochemotherapy * other uncured malignant disease in the 5 previous years (except for in situ cervical carcinoma and treated non-melanotic skin cancers) * absence of effective contraception in patients (men or women) able to procreate, pregnant or breast-feeding women * impossibility to follow the trial * legal disqualification (patients in custody or under guardianship)