Kornimate/medical-research-clean huggingface dataset:
tuberculosis diagnostic trial of cad4tb screening alone compared to cad4tb screening combined with a crp triage test, both followed by confirmatory xpert mtb/rif ultra in communities of lesotho and south africa

Conditions: Tuberculosis

Summary: according to who, about 40% of the incident tb cases in 2020 are either under-reported or under-diagnosed causing on one hand major health risks and on the other hand catastrophic financial consequences. in particular, indigent people in hard-to-reach communities with high tb/hiv burden are at high risk of missed or delayed diagnoses. hence, active case finding for tb remains an integral part of tuberculosis control in high-risk groups, such as people living with hiv (plhiv) or diabetes mellitus, people living in specific geographical locations associated with a high burden of tb and poor access to health care, miners, or prisoners. cad4tb (delft imaging, nl), a digital chest x-ray analysis software, and point-of care c-reactive protein assay (poc-crp; e.g. lumiradx, uk), which detects a cytokine induced acute phase protein, are two tests which have great potential of becoming a screening and triage test for tb as outlined in the who target product profiles. data on cad4tb and crp suggest that accuracy can be improved if thresholds are stratified by patient characteristics, such as hiv status, history of tb and tb symptoms. tb triage+ trial takes place in the communities of lesotho and south africa, which present high prevalence of subclinical tb, where a symptom-based screening would miss almost half of all infectious tb cases. tb triage+ trials conducts a direct (in the same individual) comparison of the two screening/triaging approaches which are not based on symptoms: cad4tb screening alone (approach 1) versus cad4tb screening with poc-crp triage testing (approach 2), and followed by confirmatory xpert mtb/rif ultra testing in both approaches. tb triage trial is investigates the hypothesis that a community-based active case finding strategy with cad4tb screening with poc-crp triage testing (approach 2) will be non-inferior compared to cad4tb screening alone (approach 1) with regard to yield of detected tb cases and superior with regard to cost effectiveness.


Eligibility criteria:
inclusion criteria: * willing and able to provide signed written consent or witnessed oral consent in the case of illiteracy, prior to undertaking any study-related procedure * adults (≥18 years) exclusion criteria: * any condition for which participation in the study, as judged by the investigator or a designated staff member, could compromise the well-being of the subject or prevent, limit or confound protocol specified assessments * seriously ill person who needs immediate medical care * current anti-tb treatment (preventive tb treatment permitted) * lesotho only: pregnancy (self-reported)

Keywords: lesotho south africa community-based tuberculosis active case findings cost-effectiveness cad4tb poc-crp xpert mtb/rif ultra triage screening
everolimus in combination with cyclosporine microemulsion in de novo renal transplant recipients

Conditions: Kidney Transplantation

Summary: the purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.


Eligibility criteria:
inclusion criteria: * recipients of deceased, living unrelated, or non-human leukocyte antigen (hla) identical living related donor renal transplant who actually have a viable kidney transplant at the time of randomization (within 24 hours of graft reperfusion) * the renal cold ischemic time must be \< 36 hours. * the age of the donor must be between 15 and 65 years. exclusion criteria: * patients who are recipients of multiple organ transplants, including more than one kidney * patients who have previously received an organ transplant which failed within one year * patients with current panel reactive t-cell antibody titers of 50% or more * patients who are recipients of a-b-o incompatible transplants or t-cell crossmatch positive transplant other protocol-defined exclusion criteria may apply.

Keywords: acute rejection renal function everolimus cyclosporine microemulsion
accurate clinical study of medication in patients with depression via pharmacogenomics (pgx) and therapeutic drug monitoring (tdm) of venlafaxine

Conditions: Depression

Summary: this study evaluates the efficacy of pgx-guided medication in patients with depression treated with venlafaxine and the efficacy of the combination of pgx and tdm in patients with depression treated with venlafaxine. half of participants will receive pgx-guided treatment, while the other half will receive routine treatment. after the 8th week, the pgx-guided treatment group would be randomly divided into two groups. of which, half of participants will receive the combination of pgx and tdm, and the other half will receive pgx -guided medication only.

the current clinical medication is based on "trial and error", while the traditional medication is mainly based on experience. the study mainly optimizes the treatment path from two perspectives: to help clinicians select drugs accurately through the detection of pgx; to help clinicians monitor the whole process of drug use through tdm and adjust the dosage in time to achieve better treatment. pgx tests take the information of metabolic, transporting and target genetic factors into account comprehensively. furthermore, clinical effects depend on blood concentration rather than dose concentration. tdm aims to monitor blood concentration, which is related to drug efficacy and toxicity. venlafaxine is an antidepressant drugs of the 5-hydroxytryptamine selective seratonin re-uptake inhibitors (ssris), which has been approved by fda for the treatment of depressive disorders, depressive disorders with anxiety symptoms, generalized anxiety disorders and social anxiety disorders since 1994.

Eligibility criteria:
inclusion criteria: * patients with endogenous depression, with any of the following 4 symptoms: ① interest loss; ② hypothymia; ③ early awakening; ④ serious in the morning and relieved at night; ⑤ hysteresis or agitation of movement of spirit; ⑥ appetite loss; ⑦ weight loss; ⑧ loss of libido; * scores of 17 items in hamilton depression scale (ham-d17): over 17 points; * first-episode patients or relapsed patients without taking any antidepressant drugs in the recent 3 months; * no significant abnormalities are shown in physical examination (temperature, pulse, blood pressure, head and neck, chest and abdomen). * no obvious abnormalities in laboratory examination (thyroid function). * informed patient consent. exclusion criteria: * those diagnosed with mental disorders other than major depressive disorders (with the exception of combination of anxiety disorders); non-endogenous depressive disorders; * patients with stroke, brain tumor and other brain organic diseases; * patients receiving combined drugs (but there is no need to exclude patients receving drugs against sleep disorders, such as eszopiclone, alprazolam or estazolam); * history of drug allergy; * pregnant and lying-in women; * patients with serious suicidal tendencies.

Keywords: pharmacogenomics pgx therapeutic drug monitoring tdm venlafaxine depression
post-approval study of promus element™ in china

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to compile real-world clinical outcomes data for the promus element™ and promus element™ plus everolimus-eluting coronary stent system (promus element and promus element plus stent system) in routine clinical practice in china.

everolimus-eluting stents have been studied extensively in ongoing clinical studies. the safety and effectiveness of the everolimus drug and polymer combination have been studied extensively in the spirit clinical trial program. the promus element stent is currently being studied in the platinum clinical trial program. the promus element stent is also being evaluated in promus element plus us post-approval studies and the ongoing platinum china study. this study is designed to provide post-market surveillance information on the promus element™ and promus element™ everolimus-eluting coronary stent system (promus element and promus element plus stent system) after it has been approved by sfda (state of food and drug administration) in china. the study will evaluate clinical outcomes for subjects receiving the promus element and promus element plus stents over 5 years in a real world setting according to post approval requirements from sfda.

Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age * subject understands and provides written informed consent * subject who is clinically indicated and will have an attempt of at least one promus element stent or subject who is clinically indicated and was implanted with at least one promus element stent * subject is willing to comply with all protocol-required follow-up evaluation exclusion criteria: * exclusion criteria is not required in the promus element china post-approval study which is an "all comers" study.
the effectiveness of a pressure ulcer prevention programme for older people in for-profit private nursing homes

Conditions: Prevention of Pressure Ulcers

Summary: this study aims to evaluate the effectiveness of a pu prevention programme for for-profit private nursing homes

the study will be conducted as a two-arm cluster randomized controlled trial, which will compare the efficacy of a pu prevention programme versus usual pu prevention for older people in eight for-profit private nursing homes in hong kong. for-profit private nhs recruited will be randomly assigned as experimental or control groups. the nursing homes in the experimental group will be implemented a pu prevention programme. the programme includes a training course which was tailor-made for health workers(hws) and persona care workers (pcws) and also a 16-week pu prevention protocol. the outcome measures are incidence and prevalence rate of pus as well as level of pu knowledge and skill among care staff in the nursing homes. in data analysis, survival analysis will be adopted for identifying pu incidence and prevalence rate. gee will be used to analyze the time and effect differences of pu knowledge and skills among the care staff between two groups.

Eligibility criteria:
inclusion criteria : * for-profit private nursing homes having been classified as the category a2 homes in the enhanced bought place scheme and are eager to improve current pressure ulcer prevention care; * for for-profit private nursing homes having a capacity of around 130-150 beds; * for for-profit private nursing homes having no structured pu prevention protocol, and/or programmes in place;- residents aged 60 or above * care staff including personal care workers, health workers and nurses who provide direct care to residents. exclusion criteria: * care staffs who are not speak in chinese.

Keywords: pressure ulcer nursing home
feasibility of web-based cbt-i intervention in individuals with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: forty individuals with multiple sclerosis (ms) will be randomly assigned to a 6-week web-based cognitive behavior therapy for insomnia intervention (wcbt-i) or to wcbt-i plus biweekly support meetings with research personnel via phone or video. questionnaires will be used to assess sleep quality, fatigue, and satisfaction. recruitment, retention, attrition, adherence, and safety information will also be collected. this study is significant because addressing insomnia symptoms through cbt-i could be a low-cost, low-risk, non-pharmacological options for improving sleep quality and ms symptoms in individuals with ms. this study is innovative because cbt-i has never been delivered via a web-based application to individuals with ms which may increase access to services.


Eligibility criteria:
inclusion criteria: * 18-80 years old * diagnosis of ms by physician * report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 6 months * ≥10 on insomnia severity index (isi) * english speaking * reports access to internet service and phone * has a high school diploma to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study. exclusion criteria: * known untreated sleep disorder (such as sleep apnea or restless leg syndrome) * \>3 on stop bang indicating risk of sleep apnea * increased risk of restless leg syndrome * nervous system disorder other than ms * relapse and/or corticosteroid use in past 8 weeks * score of ≥15 on the patient health questionnaire (phq-9) indicating severe depression or endorse any suicidal ideation (answer 1, 2 or 3 on #9 of the phq-9) * performs shift-work.
ketorolac intravenous regional analgesia in lower limb surgeries

Conditions: Postoperative Pain, Acute

Summary: tourniquet, a compressing device, otherwise its use in intravenous regional anesthesia, is commonly used in particular orthopedic surgeries. from the previous documented effectiveness and safety of intravenous (iv) administration of ketorolac in the circulatory-isolated limb as a part of intravenous regional anesthesia; we hypothesized that in orthopedic surgeries done with tourniquet, intravenous (iv) administration of ketorolac after tourniquet inflation, will act as intravenous regional analgesia. so, it will prolong the postoperative analgesic duration as a primary outcome.

this is a randomized controlled trial that tests the effecacy of the intravenous regional ketorolac in lower limb orthopedic surgeries with spinal anesthesia. the investigators will compare the effect of 30 mg ketorolac without local anesthetic in the injected intravenously in an isolated lower limb (with torniquet) versus intravenous 30 mg ketorolac administered 10 minutes before toniquet pressuerization on the postoperative analgesia. all patients will receive spinal anesthesia aiming for at least t12-l1 level. postoperative standard analgesia will be paracetamol and diclofenac, given for both groups.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status i or ii * elective unilateral lower limb orthopedic surgery with tourniquet under spinal anesthesia exclusion criteria: * pregnant females * body mass index ≥ 35 kg/m2 * allergy to ketorolac * had renal, asthmatic, vascular (raynaud's syndrome) disease, hematological anemias * had any history of gastrointestinal tract inflammation, bleeding, ulceration, or perforation besides * edema in the operated limb grade ≥ 3

Keywords: ketorolac randomized controlled trial intravenous regional anesthesia lower limb orthopedic surgeries
arc101 in advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of arc101 in patients with advanced cancer.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic solid tumor ovarian, testicular or other claudin 6+ cancers * measurable or evaluable disease, per recist v1.1 * eastern cooperative oncology group (ecog) performance status 0-1 * adequate organ function exclusion criteria: * active cns involvement * malignancy diagnosis other than the disease under study within 2 years prior to the first dose of study drug. * presence of uncontrolled ascites * toxicity related to prior anticancer therapy that has not returned to grade ≤1 or baseline levels * clinically significant pulmonary compromise * active autoimmune disease within 12 months prior to first dose of study drug. * female participant who is pregnant, breastfeeding, or plans to become pregnant or male participant who plans to father a child either while enrolled or within 90 days after the final administration of study drug.
efficacy of activity-based intervention on activity, participation and kinesiophobia in patients with tendon injury

Conditions: Flexor Tendon Rupture

Summary: the aim of our study is to determine the effect of activity-based intervention on the activity, participation levels and kinesiophobia (fear of movement) of the patients by evaluating the person, environment and activity using the person-environment-occupation model (peo) in the rehabilitation of hand forearm flexor tendon injuries.

our study will be carried out on housewives who were operated by pamukkale university education, application and research center directorate orthopedics and traumatology and plastic, reconstructive and aesthetic surgery services due to flexor tendon injury in the forearm or hand. patients will be evaluated at the 7th, 12th and 24th weeks post-operatively, before the start of the post-operative physiotherapy program. the data obtained from the study will be analyzed with the pasw statistics 18 release 18.0.0 program. whether the data fit the normal distribution will be determined using the shapiro-wilk test. if parametric conditions are not met, wilcoxon signed rank test and friedman analysis of variance will be used for intragroup comparisons, and mann-whitney u test will be used for intergroup comparisons. statistical significance level will be taken as p\<0.05. the physiotherapy program will start the post-operative first week for both group. activity-based therapy group will have activity exercises that is meaningful for the patients, once a week one hour addition to the physiotherapy. patients to be included in groups were randomized in a single block order using random allocation software 1.0.0.

Eligibility criteria:
inclusion criteria: * those between the ages of 18-65 * flexor tendon injury * primary tendon repair performed * a woman exclusion criteria: * presence of major nerve injury (radial, ulnar, median nerve) * presence of concomitant injuries (fracture, joint injury, ligament injury) * presence of any previous or ongoing orthopedic, neurological, rheumatological and metabolic disease or disorder in the relevant extremity
an internet-based self applied treatment program for prolonged grief disorder (pgd)

Conditions: Grief

Summary: the purpose os this study is examine the effect and feasibility (usability and satisfaction) of an icbt (grow program) for adults with pgd

the death of a loved one has physical, psychological, and social consequences. between 9.8 and 21.5% of people who lose a loved one develop prolonged grief disorder (pgd). internet- and computer-based interventions (i.e., internet-delivered cognitive-behavioral therapy, icbt) are cost-effective and scalable alternatives that make it possible to reach more people with pgd. the main goal of the present investigation was to examine the effect and feasibility (usability and satisfaction) of an icbt (grow program) for adults with pgd. a secondary objective was to detect adherence to the app (emotional monitor) used to measure daily grief symptoms. the study had a single-case multiple-baseline ab design with six participants. the grow program is organized sequentially in eight modules, and it is based on the dual-process model of coping with bereavement. evaluations included a pre-to-post treatment assessment of depression, grief symptoms, and typical grief beliefs, along with daily measures of symptom frequency and intensity on the emotional monitor app. treatment opinions and adherence to the app were also collected. efficacy data were calculated using a nonoverlap of all pairs (nap) analysis and reliable change index (rci).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * meeting diagnostic criterio for pgd * sign an informed consent * ability to understand and read spanish * abilitiy to use a computer and having access to the internet * having an e-mail address exclusion criteria: * presence of risk of suicide or self-destructive behaviors * presence of another severe mental disorder (substance abuse or dependence, pshychotic disorder, dementia o bipolar disorder) * presence of severe personality disorder * presence of a medical condition whose severity or characteristics prevent the performance of treatment * receiving other psychological treatment during the study for pgd * an increase and/or change in the medication during the study period
a study of alks 5461 for treatment refractory major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: this study will evaluate the efficacy, safety, and tolerability of adjunctive alks 5461 in adults who have treatment refractory mdd.


Eligibility criteria:
inclusion criteria: * have a major depressive disorder (mdd) primary diagnosis * have a body mass index (bmi) of 18.0 to \</= 40.0 kg/m\^2 * be willing and able to follow the study procedures and visits as outlined in the protocol (including agreeing not to enroll in any other clinical trials) * have inadequate responses to antidepressant therapy (adt) in the current major depressive episode (mde) * additional criteria may apply exclusion criteria: * has any finding that would compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements * has any other significant medical condition (eg, neurological, psychiatric, or metabolic) or clinical symptom that could unduly risk the subject or affect the interpretation of study data * has any current primary diagnosis other than mdd, where primary diagnosis is defined as the primary source of current distress and functional impairment * has experienced hallucinations, delusions, or any psychotic symptoms in the current mde * has been hospitalized for mdd within 3 months before screening * has used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days prior to screening * has received electroconvulsive therapy treatment within the last 2 years or within the current mde or failed a course of electroconvulsive treatment at any time * has a significant risk for suicide * has a positive breath alcohol test at screening * has a positive test for drugs of abuse at screening or visit 2 * is pregnant, planning to become pregnant, or is breastfeeding during the study * additional criteria may apply

Keywords: alkermes major depressive disorder treatment refractory mdd alks 5461
the effects of celecoxib on bone ingrowth

Conditions: Bone Ingrowth; Pain

Summary: the purpose of this study is to evaluate the effect of celebrex on bone growth into porous coated implants, following postoperative total knee arthroplasty administration of celebrex for pain relief.


Eligibility criteria:
inclusion criteria: * male va bilateral tka patients 18 years or older with primary oa diagnosis exclusion criteria: * patients with osteoporosis, hypersensitivity to celebrex, allergy to tetracycline, sulfonamides, patient with asthma, urticaria, or allergic-type reactions to aspirin or nsaids. * patients who have had cabg. * patients with a history of peptic ulcer disease, duodenal ulcers. * female patients and patients diagnosed with unstable hypertension or hypotensive, with serum creative levels above 1.8-2.0 or diagnosed with severe renal disease.

Keywords: celebrex, bone ingrowth, pain relief