Kornimate/medical-research-clean huggingface dataset:
ofatumumab added to fludarabine-cyclophosphamide vs fludarabine-cyclophosphamide combination in relapsed subjects with chronic lymphocytic leukemia

Conditions: Leukaemia, Lymphocytic, Chronic

Summary: the purpose of this study was to evaluate the safety and efficacy of ofatumumab added to fludarabine-cyclophosphamide in patients with relapsed chronic lymphocytic leukemia (cll).

fludarabine is currently approved for treatment of relapsed chronic lymphocytic leukemia. studies have shown that drugs in combination with fludarabine have shown more effectiveness than fludarabine alone. the addition of ofatumumab to fludarabine-cyclophosphamide combination offers potentially a more effective therapy, without additional toxicity. the objective of this study was to determine the effect of ofatumumab added to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukemia who have responded previously to therapy but later develop progressive disease and require additional therapy.

Eligibility criteria:
key inclusion criteria: * confirmed and active cll requiring treatment * at least one previous treatment for cll and having achieved a complete or partial remission/response but after a period of 6 or more months, shows evidence of disease progression * fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours * age 18yrs or older * signed written informed consent key exclusion criteria: * diagnosis of refractory cll (failure to achieve a complete or partial remission/response or disease progression within 6 months of last anti-cll treatment * abnormal/inadequate blood values, liver and kidney function * certain heart problems, serious significant diseases, aiha, other current cancers or within the last 5 years * active or chronic infections * use of drugs to suppress allergic or inflammatory responses (glucocorticoids) * cll transformation * cll central nervous system involvement * current participation in other clinical study * inability to comply with the protocol activities * lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception

Keywords: relapsed oncology safety chronic lymphocytic leukemia ofatumumab efficacy
platelet-rich plasma therapy for patellar tendinopathy

Conditions: Patellar Tendinitis

Summary: the overall goal of this research is to find an effective treatment for patellar tendinopathy (pt). to achieve this, we will conduct a double-blinded randomized controlled trial to investigate if platelet-rich plasma is effective for treatment. clinical (pain and function scores) and bio-mechanical (knee strength) measures will be correlated with disease modification changes assessed using conventional and novel quantitative magnetic resonance imaging (mri) and ultrasound (us) techniques.

sixty-six patients with pt will be randomized to one of three study arms. subjects in group 1 (prp) will receive a single us-guided injection of 5 milliliters of autologous prp into the patellar tendon, subjects in group 2 (dn) will undergo ultrasound guided dry needling of the patellar tendon, and subjects in group 3 (sh) will undergo a sham control ultrasound guided dry needling in the subcutaneous tissue only (not intratendon) at the level of the patellar tendon. the efficacy of the different treatment options will be assessed by pain- and function-dependent, pt-specific victorian institute of sport assessment patella (visa-p) quality of life scores, activity level scores, knee strength measurements, and conventional and novel mri and us imaging at baseline, 16, 32, and 52 weeks post-treatment.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 39 years 2. chronic (\>3 months) pt 3. clinical examination consistent with pt 4. mri or us confirmation of pt 5. pain score of 3 or greater on a 10-point visual analogue scale 6. self-report failure of supervised physical therapy 7. self-report failure of at least 2 of the most common treatment options for pt (e.g. nsaids, relative rest, ice and bracing). exclusion criteria: 1. inability to comply with study follow-up requirements 2. history of bleeding disorders or other hematologic conditions 3. knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal tear, ligament injury or reconstruction) 4. full or partial patellar tendon tear 5. current use of anticoagulation or immunosuppressive therapy 6. prior knee trauma requiring medical attention or surgery 7. worker's compensation injury 8. daily opioid use for pain 9. contraindication to mri. 10. systemic diseases such as diabetes and connective tissue diseases. 11. prior prp or dn procedure. 12. women that are pregnant
early vitrectomy for impending macular hole

Conditions: Retinal Perforation

Summary: this study is designed to verify hypothesis that early vitrectomy may prevent impending macular hole from progression to full-thickness macular hole.

in a study conducted 15 years ago, the 'vitrectomy for prevention of macular hole study group' was not able to prove the benefits and advantages of vitrectomy for impending macular hole; however, during the interim period, notable improvements have been achieved with regard to diagnosis and efficacy of treatment. therefore, we designed this study to identify the effect of current vitreous surgery for symptomatic impending macular hole. characteristics of this study is as below * multicenter, prospective clinical trial. (early surgical intervention vs.surgical intervention when full-thickness macular hole occurs) * non-randomized study (decision was made by patients after full explanation) * after 1 year follow up, functional change(visual acuity)and anatomical change(development of full-thickness macular hole) would be evaluated

Eligibility criteria:
inclusion criteria: * male or female with impending macular hole(identified with oct) * age: over 45 years * symptom duration \< 6 months * visual acuity on trial: less than 73 letters in etdrs chart visual acuity of worsened eye: over 24 letters in etdrs chart exclusion criteria: * any vision disturbing disease other than impending macular hole * diabetic maculopathy or other retinal vascular disease * prior history of major trauma: if symptom begins after trauma * myopia over -6.5dioper or eyes with axial length \> 28mm * evidence of scar, degeneration or exudation of macula * active intraocular inflammation * history of intraocular surgery other than uncomplicated cataract extraction 3months before * uncontrolled iop \> 25mmhg

Keywords: macular hole impending macular hole stage 1 macular hole
evaluating the pharmacokinetic interactions and safety between ad-2111 and ad-2112

Conditions: Pain

Summary: a phase i clinical trial to evaluate the pharmacokinetic interactions and safety between ad-2111 and ad-2112

purpose: pharmacokinetic interactions and safety of ad-2111 and ad-2112 in healthy adult volunteers condition or disease : pain intervention/treatment drug : ad-2111(celecoxib 200mg), ad-2112(tramadol 150mg) phase : phase 1

Eligibility criteria:
inclusion criteria: * healthy adult aged 19 and more at the time of screening visit * body mass index (bmi) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit exclusion criteria: * as a result of laboratory tests, the following figures: alt or ast or total bilirubin \> 1.5 times upper limit of normal range * as a result of laboratory tests, the following figures: creatinine clearance \< 80ml/min
study to determine the efficacy and safety of a novel nicotine replacement therapy

Conditions: Tobacco Dependence

Summary: the purpose of this study is to assess the efficacy and safety of a novel nicotine product for continuous abstinence from smoking. efficacy of product will be evaluated by assessments of self-reported abstinence, verified by exhaled carbon monoxide (co) levels.


Eligibility criteria:
inclusion criteria: subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking exclusion criteria: history of cardiovascular disease, stomach ulcer or diabetes unless physician's written approval is obtained. use of other forms of tobacco/nicotine containing products other than cigarettes within 30 days before baseline visit. use of nicotine replacement therapies or other smoking cessation medicines/non-drug therapies within 30 days before the baseline visit. pregnancy or intending to become pregnant. hypersensitivity to the product, history of alcohol or substance abuse.
low-dose contrast media for low-kvp abdomen ct

Conditions: Appendicitis Acute

Summary: the purpose of this clinical study is to test the performance of low radiation dose abdominal ct combined with low dose contrast media for the diagnosis of acute appendicitis in young patients. the main questions to be answered are: 1, can low-dose contrast media paired with low-dose radiation ct of the abdomen provide acceptable diagnostic accuracy in acute appendicitis? 2. how much radiation dose can be saved by using low radiation dose abdominal ct in combination with low dose contrast media?


Eligibility criteria:
inclusion criteria: * patients in the emergency department with suspected acute appendicitis based on clinical examination * patients scheduled for contrast-enhanced ct of the abdomen and pelvis for diagnosis of suspected acute appendicitis. exclusion criteria: * patients who decline to participate * contraindications to contrast-enhanced ct (egfr \< 30 ml/min/173 m\^2 or pregnant) * bmi \>= 30.

Keywords: acute appendicitis acute abdomen ct
safety, pharmacokinetics and pharmacodynamics of nv1205 in pediatric male subjects with adrenoleukodystrophy

Conditions: X-Linked Adrenoleukodystrophy

Summary: this is a phase i/ii, open label dose escalation study of multiple dose levels of nv1205 with a long-term treatment phase.

this study is to evaluate the safety, pharmacokinetics, and efficacy of nv1205 in pediatric patients diagnosed with childhood cerebral adrenoleukodystrophy (ccald). the study consists of: * screening period: within 30 days of first dose * main treatment period of 12 weeks (part 1- from screening to week 12) * long term treatment (ltt) period (part 2- week 13 through week 96) in part 1, subjects will have an initial 4-week treatment period at the assigned dose and, if no safety concerns are noted, subjects continue for another 8 weeks of extended safety assessment. there will be several cohorts of subjects enrolled. after each cohort has completed the 4-week initial safety assessment, the safety data will be reviewed by an independent data safety monitoring board (dsmb) and, subject to dsmb recommendation, cohort 2 will be enrolled and receive the next dose level. after cohort 2 has completed 4 weeks of treatment, the dsmb will review all available safety data (cohorts 1 and 2) and, subject to dsmb recommendation, cohort 3 will be enrolled and receive the next dose level. additional cohorts may be enrolled at the recommendation of the dsmb with an incremental dose increase. in part 2, subjects will continue to receive treatment in the ltt period of the study.

Eligibility criteria:
inclusion criteria: 1. males ≥4 years and \<18 years of age 2. ccald diagnosis confirmed by genetic testing 3. loes score of \>0 and ≤15 4. patients on vlcfa lowering agents such as lorenzo's oil must stop the medication and have high vlcfa levels before enrollment exclusion criteria: * significant medical conditions such as heart, thyroid, or liver disease * hsct recipients

Keywords: x-ald
normalizing co2 in chronic hyperventilation by a novel breathing mask: a pilot study

Conditions: Hyperventilation; Chronic Idiopathic Hyperventilation; Dysfunctional Breathing; Respiratory Alkalosis

Summary: background: chronic idiopathic hyperventilation (cih) is a form of dysfunctional breathing which has proven hard to treat effectively. the investigators hypothesised that by periodically inducing normocapnia over several weeks, it would be possible to raise the normal resting level/set point of co2 and achieve a reduction of symptoms. methods: six cih patients were treated two hours a day for four weeks with a novel breathing mask. the mask was used to induce normocapnia in these chronically hypocapnic patients. capillary blood gases (pcco2, ph, standard base excess (sbe) etc.) were measured at baseline and once each week at least three hours after mask use, as well as spirometric values, breath holding tolerance and hyperventilation symptoms as per the nijmegen questionnaire (nq),.


Eligibility criteria:
inclusion criteria: chronic idiopathic hyperventilation, i.e.: * pco2 level below 4.7 kpa and * sbe value more negative than -1.0 exclusion criteria: * oxygen saturation of 95% or lower at rest

Keywords: hyperventilation chronic idiopathic hyperventilation dysfunctional breathing respiratory alkalosis respiratory acidosis
feasibility and effectiveness of a ring-type blood pressure measurement device

Conditions: Hypertension; Blood Pressure; Systolic Hypertension; Diastolic Hypertension; Essential Hypertension; Obstructive Sleep Apnea; Prehypertension

Summary: the goal of this clinical trial is to evaluate the feasibility and effectiveness of a ring-type blood pressure measurement device compared to a 24-hour ambulatory blood pressure monitoring device in patients with hypertension or suspected hypertension. the main question it aims to answer is whether the 24-hour blood pressure measurement accuracy of the ring-type blood pressure monitor is similar to that of the 24-hour ambulatory blood pressure monitor. to participate, subjects must wear a ring blood pressure monitor and an ambulatory blood pressure monitor simultaneously for 24 hours.


Eligibility criteria:
inclusion criteria: 1. patients scheduled for 24-hour ambulatory blood pressure monitoring for diagnostic purposes among those suspected of having hypertension 2. confirmed hypertensive patients scheduled for 24-hour ambulatory blood pressure monitoring for treatment purposes * either criterion 1 or 2 are planned to be selected as study participants. exclusion criteria: * participants who do not consent to the study * individuals with a body mass index of 30 or above (there's a concern of measurement errors as the standard 24-hour ambulatory blood pressure cuffs may not fit well) * pregnancy * baseline heart disease patients: individuals with a history of hospitalization due to heart failure, valvular disease, or myocardial infarction * patients diagnosed with atrial fibrillation on a 12 lead ekg within the past 6 months * end-stage renal disease (patients undergoing dialysis) * users of mobile phones that are not compatible with the test device (cart-i plus) used in the study
cross-linked cmc and silk proteins in eye disease

Conditions: Dry Eye Disease (DED)

Summary: data analyses and revision of the ded symptoms. a novel ophthalmic solution containing cross-linked cmc (cx-cmc) and silk proteins (sp) has been made available on the market. both molecules have been widely studied for their viscoelastic and hydrating, and wound healing properties. this new ophthalmic solution is the first on the market formulated with a cx-cmc and sp.


Eligibility criteria:
inclusion criteria: * subjects affected by dry eye disease exclusion criteria: * know allergies to cx-cmc * know allergies to sp
cementless one-stage revision of the chronic infected hip arthroplasty

Conditions: Infection; Hip Joint Replacement

Summary: the investigators hypothesise that cementless one-stage exchange revision surgery can be performed in patients with chronically infected hip replacement with substantial benefits for the patients, in terms of fast rehabilitation, low re-revision rates and good long term results.


Eligibility criteria:
inclusion criteria: * patient with clinical signs of infection for more than 4 weeks, arising from total hip arthroplasty (primary and revision), resurfacing hip arthroplasty or hemi-hip arthroplasty * informed oral and written consent given exclusion criteria: * life expectancy under 2 years * cognitive dysfunction * pre-operative unwillingness to receive blood * intravenous drug abuse * alcoholism * immunocompromised patients * patients receiving immunosuppressive medication * ongoing systemic inflammatory disease * poorly regulated diabetes mellitus * renal failure (requiring dialysis) * acute systemic inflammatory response syndrome with proven infection (sepsis) * signs of coexisting active long-term local infection (i.e. endocarditis) * previous two-stage revision of hip arthroplasty due to ipsilateral chronic infection (regardless of symptom free interval) or contralateral chronic infection (within the last 2 years). * \< 6 weeks since last surgery of the affected hip * if definition of infection is not fulfilled: infection defined as culture positive: ≥ 3 positive intraoperative cultures (tissue biopsies a.m. kamme-lindberg) culture negative: \< 3 positive intraoperative cultures (tissue biopsies a.m. kamme-lindberg) + chronic fistula with history of previous or existing secretion or positive cultures in pre-operatively joint fluid aspiration with other clinical signs of infection or visual pus or purulent fluid during exchange procedure with clinical signs of infection

Keywords: chronic infected hip arthroplasty fast-track one-stage cementless revision
comparison of topical analgesic with saline rinses in post extraction healing

Conditions: Periodontitis; Dental Caries; Hypertension

Summary: the aim of this study is to determine the beneficial effect of mouth rinses, both topical analgesic and saline regimens as an adjuvant therapy in the presence of standard prescription of post-operative pain killers on the progress of socket healing following routine dental extraction.

hypertension is a highly prevalent cardiovascular disease, which affects over 1 billion people worldwide. it varies with age, race, education and so forth.1 the national health survey of pakistan estimated that hypertension affects 18% of adults and 33% of adults are above 45 years old.2it is a common disease encountered in dental setting. its wide spreading, terrible consequences, and life-long treatment require an attentive approach by dentists. knowledge of hypertension is important for dentists especially for risk assessment for dental treatment. this may lead to improved monitoring and treatment. dental treatment in hypertensive patients necessitates special attention, because any stressful procedure may increase blood pressure and trigger acute complications such as cardiac arrest or stroke. extractions are usually done for teeth which are not salvageable. dentists routinely advice use of warm saline rinses to help in healing of post extraction socket. but for hypertensive patients this recommendation is potentially harmful there is no evidence based guidelines on using saline rinses for post extraction oral care among hypertensives. moreover, advantage of orally dissolved topical analgesics in addition to orally administered analgesic is questionable.

Eligibility criteria:
inclusion criteria: * healthy subjects requiring simple tooth extraction (elevator or forceps) which were either known cases of controlled hypertension under medical treatment or confirmed non hypertensives. exclusion criteria: * subjects requiring surgical tooth extraction involving bone removal and suturing, uncontrolled systemic disorders (diabetes mellitus, hypertension, blood coagulopathies, metabolic bone disorders), on platelet aggregation therapy or warfarin (anticoagulants) or bisphosphonate therapy.

Keywords: tooth extraction tooth socket healing hypertension rinses
vocational rehabilitation for the return to work of breast cancer patients: a feasibility study

Conditions: Breast Cancer; Breast Neoplasm

Summary: in italy, 50% of new breast cancer (bc) diagnosis occur in female of working age. although return to work (rtw) is strongly desired by bc patients, cancer survivors are more likely to be unemployed than healthy individuals. moreover, work difficulties may hindrance this process. since 2018, the investigators have planned a local social-healthcare pathway which provides a multidisciplinary vocational rehabilitation intervention with the aim to help cancer survivors in their rtw process. to date, the feasibility of the multidisciplinary vocational rehabilitation interventions has not been verified for bc patients.

bc is a public health burden with increasing trends in western countries. in italy, 50% of the new bc diagnosis have occurred in female of working age. even though the return to work (rtw) is strongly desired, cancer survivors are 1.4 times more likely to be unemployed than healthy individuals. furthermore, work difficulties may occur during this process. to promote the rtw, multidisciplinary interventions have shown moderate quality evidence in cancer survivors. since 2018, the investigators have planned a local social-healthcare pathway which provides a multidisciplinary vocational rehabilitation intervention with the aim to help cancer survivors in their rtw process. during the implementation of the pathway, bc patients were referred mainly by the physiotherapists of the physical medicine and rehabilitation unit (pmru). as standard care, bc patients can participate to an educational group session held by the physiotherapists after surgery. during this session, work difficulties have emerged. thus, the investigators aim to verify the feasibility of the multidisciplinary vocational rehabilitation intervention for a sample of bc patients whit work difficulties who will participate to an educational group session held by the physiotherapists.

Eligibility criteria:
inclusion criteria: * breast cancer diagnosis (regardless of stage and treatment) * breast cancer patients in working age * breast cancer patient who will participate to an educational group session held by the physiotherapists of the pmru * breast cancer patients with work difficulties exclusion criteria: * breast cancer patients with work issues that cannot be addressed by any of the interventions (e.g., patients who would like to change their job)

Keywords: cancer survivors return to work vocational rehabilitation occupational therapy
analyzing engagement trends in rhabdomyosarcoma clinical trials

Conditions: Rhabdomyosarcoma

Summary: the study seeks to delve into the firsthand experiences of patients diagnosed with rhabdomyosarcoma who partake in a separate clinical trial featuring a specific medical intervention. the primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals. the data collected from this study will help improve future outcomes for all rhabdomyosarcoma patients as well as those in under-represented demographic groups.


Eligibility criteria:
inclusion criteria: * diagnosis of rhabdomyosarcoma * considered reliable, able to understand, and willing to perform all study procedures * signed written informed consent exclusion criteria: * currently enrolled in, have completed or have discontinued from a clinical trial involving an investigational drug * is pregnant, breastfeeding or expecting to conceive within the projected duration of the study * any serious and/or unstable pre-existing medical disorders

Keywords: rhabdomyosarcoma