Kornimate/medical-research-clean huggingface dataset:
senile osteoporotic fractures cohort study（sofcs）

Conditions: Osteoporotic Fractures

Summary: osteoporotic fracture is one of the main causes of disability and death in elderly patients. specific disease cohort study is an important basis for accurate prevention and treatment of senile osteoporotic fractures. investigators plan to collect and manage the baseline and clinical information of more than 2000 elderly patients with osteoporotic fractures after surgery through the platform of special disease collaborative prevention and treatment system and medical record database of suzhou municipal hospital in two years, and carry out short-term and long-term follow-up observation.

osteoporotic fracture is one of the main causes of disability and death in elderly patients. compared with patients with no history of fractures, the risk of a second fracture after an initial fracture doubled, with a fatality rate of up to 34.8%. there has been a lot of progress in the diagnosis and treatment of osteoporotic fractures in the elderly. however, there are few reports on the diagnosis and treatment of osteoporotic fractures in the elderly after surgery. based on previous studies, it is found that the re-fracture after operation of osteoporotic fracture in the elderly is not only directly caused by the fall, but also caused by the interaction of multiple risk factors including environmental factors, physiological factors and neuroskeletal musculoskeletal system. therefore, it is of great significance to break the traditional diagnosis and treatment mode, improve the diagnosis and treatment effect, and save medical resources to carry out research on the disease characteristics, rules and risk warning after senile osteoporotic fracture operation. specific disease cohort study is an important basis for accurate prevention and treatment of senile osteoporotic fractures. investigators plan to collect and manage the baseline and clinical information of more than 2000 elderly patients with osteoporotic fractures after surgery through the platform of special disease collaborative prevention and treatment system and medical record database of suzhou municipal hospital in two years, and carry out short-term and long-term follow-up observation.

Eligibility criteria:
inclusion criteria: 1. patients ≥65 years old 2. patients with osteoporosis 3. no gender limitation exclusion criteria: 1. \< 65 years old; 2. non-osteoporotic fracture; 3. alzheimer's disease; 4. bone tumors.

Keywords: senile osteoporotic fracture,cohort study,mechanism,outcome
short-term safety, efficacy and mode of action of apremilast in moderate suppurative hidradenitis

Conditions: Hidradenitis Suppurativa

Summary: study design: a double-blind randomised placebo-controlled trial intervention: randomized placebo controlled treatment of 20 hs patients of which fifteen patients will be randomized to apremilast and five patients to placebo. the total duration of the treatment period per subject is 16 weeks. primary objectives: to evaluate the expression profile of inflammatory cytokines in hs lesional skin at week four (t=4) and week sixteen (t=16): * of patients receiving apremilast compared to placebo; * within both groups relative to baseline (t=0). secondary objectives: * to prospectively evaluate the clinical efficacy of apremilast. * to assess the effect of apremilast on patient reported outcomes measures. * to assess the short-term safety and tolerability of apremilast in patients with hidradenitis suppurativa.

rationale: hidradenitis suppurativa (hs) is a chronic, inflammatory, recurrent, debilitating skin disease. it is characterized by painful, deep-seated, inflamed boils in the inverse areas of the body, most commonly the axillae, inguinal and anogenital regions. systemic therapy with immunosuppressive agents (systemic corticosteroids, dapsone, cyclosporin) has been investigated in the past decades and has shown limited efficacy. the use of the selective immunosuppressant apremilast has not yet been evaluated in hs. the investigators hypothesize a beneficial effect of apremilast in hs patients, similar to the efficacy of apremilast in psoriasis patients. namely, it has been shown that the immune dysregulation in the pathogenesis of hs shows many similarities with that of psoriasis. moreover, the tnf-α blocker adalimumab was registered for hs after approval for the treatment in patients with psoriasis.

Eligibility criteria:
key inclusion criteria: * adult (≥ 18 years of age) male or female patients with moderate hs according to a pga of 3 on the 5-point hs-physician global assessment (hs-pga); * hs of more than 6 months duration; have lesions in at least two anatomical locations. key exclusion criteria: * contra-indication for apremilast; previous use of apremilast; have any current and/or recurrent clinically significant skin condition in the treatment area other than hs; * presence of other uncontrolled major disease; * pregnant or lactating women.

Keywords: acne inversa
prospective, multicenter study of the efficacy and tolerance of tacrolimus on refractory nephrotic syndrome (rns)

Conditions: Kidney Diseases; Nephrotic Syndrome; Tacrolimus

Summary: exploring the efficacy and safety of tacrolimus on refractory nephrotic syndrome ; acquiring the experience of tacrolimus on the treatment of refractory nephrotic syndrome in chinese patients.


Eligibility criteria:
inclusion criteria: 1. subjects of either sex, 14-65 years of age; 2. diagnosis of nephrotic syndrome with hypoalbuminemia (\ 3.5g/24hr); 3. provision of written informed consent by subject or guardian; 4. refractory nephrotic syndrome: steroid resistant: persistence of proteinuria despite prednisone therapy 1mg/kg/d for 16 weeks; steroid dependent: ns recurs when steroid dosage decease.twice within 6 months, and 3 times within 1 year. exclusion criteria: 1. inability or unwillingness to provide written informed consent ; 2. known hypersensitivity or contraindication to tacrolimus, cyclophosphamide, azathioprine, corticosteroids; 3. usage of immunosuppression therapy (mmf, ctx, cysa, mtx ect) for more than 1 week within 1 month prior to first randomization; 4. pregnancy, nursing or use of a non-reliable method of contraception; 5. continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks; 6. previous kidney transplant or planted transplant; 7. scr \> 4mg/dl (353umol/l); 8. active hepatitis, with liver dysfunction; 9. diagnosed dm; 10. participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .

Keywords: refractory nephrotic syndrome tacrolimus
study of cc-93269, a bcma x cd3 t cell engaging antibody, in participants with relapsed and refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: study cc-93269-mm-001 is an open-label, phase 1, dose escalation (part a and c) and expansion (parts b and d), first-in-human clinical study of cc-93269 in subjects with relapsed and refractory multiple myeloma.

the dose escalation parts (part a with cc-93269 administered intravenous (iv) and part c subcutaneous (sc)) of the study will evaluate the safety and tolerability of escalating doses of cc-93269, administered iv or sc, to determine the maximum tolerated dose (mtd) and non-tolerated dose (ntd) of cc-93269. the expansion parts (part b and d) will further evaluate the safety and efficacy of cc-93269 administered iv or sc at or below the mtd in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the recommended phase 2 dose (rp2d).one or more dosing regimens may be selected for cohort expansion. all treatments will be administered in 28-day cycles for up to 5 years for subjects maintaining clinical benefit, or until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.

Eligibility criteria:
inclusion criteria: * history of multiple myeloma with relapsed and refractory disease * eastern cooperative oncology group performance status of 0 or 1 * must have measurable disease as determined by the central laboratory exclusion criteria: * symptomatic central nervous system involvement of multiple myeloma * prior autologous stem cell transplant ≤ 3 months prior * prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior * history of concurrent second cancers requiring active, ongoing systemic treatment other protocol-defined inclusion/exclusion criteria apply

Keywords: multiple myeloma bcma x cd3 t cell antibody cc-93269 relapsed and refractory
measuring adherence to medication for depression and attention-deficit hyperactivity disorder

Conditions: Major Depressive Disorder; Attention-deficit Hyperactivity Disorder (ADHD)

Summary: poor adherence is a common reason for treatment failure in many fields of medicine, and likely affects common psychiatric treatments as well. members of the present study team have used medication event monitoring system (mems®) caps effectively to objectively monitor adherence in skin disease, and have shown that they provide a much more accurate measure of adherence behavior than self-reports, pill counts, or serum drug concentrations. the present study will use mems® caps to measure adherence in 10 patients with depression and 10 patients with attention-deficit hyperactivity disorder (adhd) from a student clinic population. the aims will be to show the usefulness of mems® caps in measuring adherence to psychiatric treatment, and gather data on typical adherence rates for depression and adhd patients on typical treatment regimens. the data obtained will be used to inform future studies that use an intervention to improve adherence behavior and ultimately disease outcomes.


Eligibility criteria:
inclusion criteria: * any male or female, at least 18 years of age, using the student health clinic, with a diagnosis of depression or adhd. * written consent of participation must be given by the subject. exclusion criteria: * subject is less than 18 years of age. * inability to complete all study-related visits. * introduction of any other prescription medication while participating in the study. (patients who are on a stable dose of non-study-related prescription medications for at least 4 weeks prior to the study, and throughout the study period, are not excluded.) * female patients whose medications may be harmful during pregnancy must be on an acceptable form of birth control, otherwise they will not be eligible for participation.

Keywords: adherence
non-contrast magnetic resonance angiography assessment of patients referred for transcatheter aortic valve implantation

Conditions: Aortic Valve Stenosis

Summary: the overall objective of this proposal is to examine the feasibility and accuracy of non-contrast magnetic resonance angiography (mra) to comprehensively evaluate individuals referred for transcatheter aortic valve implantation (tavi).


Eligibility criteria:
inclusion criteria: * adults with severe aortic stenosis referred for possible transcatheter aortic valve implantation with clinically indicated computed tomography imaging exclusion criteria: * inability or unwillingness to consent * inability to complete magnetic resonance imaging (mri) study * contraindication to mri * participation in another research study * non-diagnostic computed tomography scan
self-propelled versus standard percutaneous endoscopic gastrojejunostomy(peg-j); rct

Conditions: Feeding Tube

Summary: our main hypothesis is that self-propelled percutaneous endoscopic gastrojejunostomy tube (peg-j) that has a balloon on it's tip is associated with lower j-tube retrograde migration rate, and lower rates of short- and long-term complications when compared to standard pegj feeding tubes.


Eligibility criteria:
inclusion criteria: * consecutive adult patients (18-80 years of age) with need for post-pyloric feeding (patients unable to eat due to stroke, intubated patients with respiratory failure, patients with acute pancreatitis, etc). * ability to give informed consent. exclusion criteria: * unable to give informed consent * pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing) * acute gastrointestinal bleeding * coagulopathy defined by prothrombin time \ 50 sec, or inr \> 1.5), on chronic anticoagulation, or platelet count \<50,000 * inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy * cirrhosis with portal hypertension, varices, and/or ascites * allergy to egg

Keywords: pegj peg-j percutaneous endoscopic gastrostomy feeding tube gastroparesis acute pancreatitis stroke respiratory failure gerd balloon self-propelled
validation of the clinical and antimicrobial effectiveness of a clorexidine and sodium dna based mouthwash in patients with stage iii and iv periodontitis

Conditions: Periodontitis

Summary: sodium dna has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. the aim of this rct study is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing chlorhexidine 0.12% + sodium dna and chlorhexidine 0.20% at two weeks, compared with a placebo, on patients with stage iii or iv periodontitis.

sodium dna has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. the aim of this rctstudy is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing chlorhexidine 0.12% + sodium dna and chlorhexidine 0.20% at two weeks, compared with a placebo, on patients with stage iii or iv periodontitis. the study was designed as a double-blind randomized controlled trial (rct) with three parallel groups of individuals.

Eligibility criteria:
inclusion criteria: • clinically diagnosed with stage iii or iv periodontitis according to the efp/aap 2017 criteria. exclusion criteria: * periodontal treatment, antibiotics, nsaids, immunosuppressants during the last 6 months. * pregnancy. * systemic diseases.
effects of tdcs and vns on postoperative analgesia

Conditions: Acute Postoperative Pain

Summary: this study seeks to evaluate the efficacy of transcranial direct current stimulation (tdcs) and afferent vagus nerve simulation (vns) in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery. study outcomes will include changes in pain levels and vital signs. for patients who are admitted after surgery, opioid consumption in the 24 hours after surgery and time from surgery to discharge are recorded as secondary outcomes. patients will be divided in the following comparison groups: * group +/+ will receive ten minutes of active tdcs followed by ten minutes of active vns. * group +/- will receive ten minutes of active tdcs followed by ten minutes of sham vns. * group -/+ will receive ten minutes of sham tdcs followed by ten minutes of active vns. * group -/- will receive ten minutes of sham tdcs followed by ten minutes of sham vns.

two nonpharmacologic interventions have shown promise in treatment of chronic pain. afferent vagus nerve simulation (vns) can modulate nociception, even though the exact mechanism is unclear. clinically, it has found uses in chronic pain as well as early evidence of potential use in postoperative pain. alternatively, transcranial direct current stimulation (tdcs) is a form of non-invasive and polarity-specific technique of modulating neuronal circuitry using a weak electric current delivered by a battery. tdcs has also been shown to modulate chronic pain and has been shown to produce eeg signatures similar to those seen in states of adequate intraoperative analgesia. this study seeks to evaluate the efficacy of tdcs and vns in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery by randomizing 200 subjects in 4 groups: * group +/+ will receive ten minutes of active tdcs followed by ten minutes of active vns. * group +/- will receive ten minutes of active tdcs followed by ten minutes of sham vns. * group -/+ will receive ten minutes of sham tdcs followed by ten minutes of active vns. * group -/- will receive ten minutes of sham tdcs followed by ten minutes of sham vns. patient's vital signs and pain level will be obtained before the procedure and after. patients that have to stay in hospital will also be evaluated by opioid consumption and time from surgery to discharge.

Eligibility criteria:
inclusion criteria: * adults aged 18 years or above with the capacity to provide informed consent who are undergoing an elective surgery requiring general anesthesia exclusion criteria: * cardiac bradyarrhythmia: taking beta-blockers; * patients with metal implants around the chest, neck, or head (e.g. implantable pacemakers and defibrillators, deep brain stimulation devices); * pregnancy * history of epilepsy or seizures. * patients undergoing surgical procedures involving the head, neck or spine, or those requiring the use of cardiopulmonary bypass

Keywords: postoperative pain chronic pain transcranial direct current stimulation vagus nerve stimulation
supporting peer interactions to expand access to digital cognitive behavioral therapy for spanish-speaking patients

Conditions: Depression, Anxiety

Summary: investigators will evaluate the implementation of an evidence-based, spanish-language, digital, cognitive-behavioral therapy intervention (silvercloud) in primary care settings for latino patients with depression and/or anxiety. 426 participants will be enrolled in a two-armed trial comparing self-guided vs. supported dcbt (silvercloud). at the provider level, investigators will compare the efficacy of provider referrals with the use of a clinic patient registry to identify candidates who could benefit from a digital mental health intervention.

the investigators will evaluate the implementation of an evidence-based, spanish language, digital cognitive-behavioral therapy (dcbt) intervention (silvercloud) in safety-net primary care clinics for limited english proficiency (lep) latinx patients with depression and/or anxiety. an effectiveness-implementation hybrid trial (type 2) design with both provider and patient-level randomization will be conducted. at the provider-level the investigators will compare outreach (using the clinic patient registry) with inreach (traditional provider referral), at the patient-level two modes of delivery of the dcbt platform - supported and unsupported will be compared.

Eligibility criteria:
inclusion criteria: 1. phq-9 ≥ 10 or gad-7 ≥ 8 2. has access to the internet via smartphone and/or broadband at home, and basic level of technological literacy or willingness to undergo a brief technology use training 3. ≥18 years of age 4. preference for receiving medical care in spanish 5. not in concurrent psychotherapy 6. if currently taking an antidepressant medication, patient must have been on a stable dose for at least 6 weeks, and have no plans to change the dose. we will permit patients on antidepressants to enter the study, as this will increase generalizability. antidepressant status will be monitored at each assessment to control for those effects, if necessary. exclusion criteria: 1. currently receiving psychotherapy, as this treatment will be offered as a frontline treatment for depression and anxiety, however, patients are allowed to be referred to treatment while participating in this study and initiation of treatment will be monitored and considered in analyses 2. visual, hearing, voice, or motor impairment or illiteracy that would prevent completion of study procedures 3. diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, or substance use disorder 4. severe suicidality (as assessed by expressing suicidal ideation, plan, and intent). although procedures with back-up plans are in place for patients who develop suicidality (see human subjects section), patients assessed with severe suicidality will be referred to more-intensive treatment resources.

Keywords: digital health intervention mobile health digital cognitive-behavioral therapy peer supporter
long term effects of an inpatient pulmonary rehabilitation program in patients with pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: there is evidence that an inpatient pulmonary rehabilitation of 3 weeks improves exercise capacity and quality of life in patients with idiopathic pulmonary fibrosis. however, there are no data available regarding long-term effects of this multimodal program. the aim of this study is to investigate the long-term impact of a rehabilitation program 3 month after finishing on exercise capacity and physical activity.


Eligibility criteria:
inclusion criteria: * want to start a rehabilitation program in "schoen klinik berchtesgadener land" * patients with idiopathic pulmonary fibrosis (vital capacity \> 50% pred.) exclusion criteria: * exacerbation in the last 4 weeks

Keywords: pulmonary fibrosis interstitial lung disease pulmonary rehabilitation exercise capacity physical activity quality of life
assessment of the safety and efficacy of pramipexole extended release in patients with parkinson's disease in routine clinical practice

Conditions: Parkinson's Disease

Summary: the general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with parkinson's disease in routine clinical practice.


Eligibility criteria:
inclusion criteria: * early and advanced idiopathic parkinson's disease * male and female patients over 18 years of age * indication for treatment with pramipexole er according to summary of product characteristics (smpc) exclusion criteria: * ongoing treatment with pramipexole er * exclusion criteria in line with the pramipexole er smpc: in particular hypersensitivity to pramipexole or to any of the excipients and pregnancy and lactation as stated in the smpc.
efficacy, safety, and pk of m5717 in combination with pyronaridine as chemoprevention in adults and adolescents with asymptomatic plasmodium falciparum infection (capture-2)

Conditions: Malaria Infection

Summary: this study will evaluate the efficacy and safety of a single dose of m5717 plus pyronaridine tetraphosphate in clearing current plasmodium falciparum infection and protecting against recurrent infections in asymptomatic adults and adolescents. the study will also assess the duration of protection provided by different doses of m5717 plus pyronaridine and the additional contribution of m5717 to the duration of protection using external study data.


Eligibility criteria:
inclusion criteria: * participants with asymptomatic plasmodium falciparum malaria with no fever or other sign of acute uncomplicated malaria and, with microscopic confirmation using giemsa-stained thick film, and a parasitemia of \>= 40 to \<= 10,000 asexual parasites/microliter (μl) of blood. * axillary temperature \< 37.0 degree celcius (ºc) or oral/tympanic/rectal temperature\< 37.5ºc; without history of fever during the previous 48 hours. * have a body weight \>= 45 kilogram (kg) * participants capable of giving signed informed consent which includes compliance with the requirements and restriction listed in the informed consent form * other protocol defined inclusion criteria could apply exclusion criteria: * participants with any disease requiring chronic treatment * participants with any preplanned surgery during the study * participants with any previous treatment with pyronaridine as part of a combination therapy during the last 3 months * participants with any adequate hematological, hepatic, and renal function as defined in the protocol * other protocol defined exclusion criteria could apply

Keywords: plasmodium falciparum chemoprevention malaria plasmodium eukaryotic translation elongation factor 2 (peef2) exposure response adults adolescents asymptomatic infection