Kornimate/medical-research-clean huggingface dataset:
evaluation of the efficacy and safety of diclofenac hpbcd 75mg/ml in treatment of pain following dental surgery

Conditions: Dental Pain

Summary: the present study is aimed at demonstrating the therapeutic equivalence of diclofenac hpbcd 75mg/1ml s.c. with the marketed reference product, voltarol® 75mg/3ml i.m. in the treatment of acute moderate-to-severe pain after dental impaction surgery.


Eligibility criteria:
inclusion criteria: * patients undergoing surgical extraction of a single fully or partially impacted mandibular 3rd molar requiring bone removal. * patients experiencing moderate to severe post-operative pain within 6 hours from end of surgery. * pre-operative laboratory tests in the reference ranges or without clinically significant abnormalities as judged by the investigator. exclusion criteria: * surgery performed under general anaesthesia, or sedation. * complications occurring during the surgical procedure or in the period before randomisation as judged by the investigator. * acute local or systemic infection at the time of surgery that could confound the post-surgical evaluation. * patients with clinical signs of gastritis, gastro-duodenal ulcer, gi bleeding. other gi disturbances or disease that in the opinion of the investigator could be negatively affected by the administration of nsaids. * clinical signs or history of coagulation disorders that could be negatively affected by nsaids administration. * hepatic or renal impairment. * patients with significant cardiac impairment, history of cerebrovascular disease, history or peripheral arterial disease, uncontrolled hypertension. * hypersensitivity to diclofenac or other nsaids or to one of the study medication components. * patients under chronic treatment with topical or systemic analgesics/nsaids. * patients under treatment with any medication that may affect the treatment efficacy evaluation. * patients under treatment with any medication whose concomitant use may be susceptible to interactions with diclofenac or may affect safety.
reducing colorectal cancer death through mailed outreach screening

Conditions: Colorectal Cancer

Summary: the main study aim is to develop, implement and disseminate a pilot population-based mailed fit outreach screening program in the philadelphia va medical center that does not rely on having an office visit, by conducting a proof-of-concept 3-arm parallel-design pragmatic randomized trial to (1) compare the effects of usual care (uc), screening invitation + reminder (invitation-reminder), or screening invitation + mailed fit kit + reminder (mailed-fit); (2) explore whether the fit completion rate varies by age or race/ethnicity; and (3) explore barriers to use of mailed outreach screening for veterans.

this study seeks to establish the foundation to systematically study and improve the delivery and effectiveness of colorectal cancer (crc) screening in the va by developing, implementing and disseminating a pilot mailed-fit screening outreach program that does not rely on having a clinical office visit. the investigators specifically address the need to identify and remediate potential failures to identify and offer screening to eligible veterans through multilevel interventions. the investigators will also create electronic data linkages to, in future studies, enable evaluation of fit performance characteristics and help close critical evidence gaps for optimizing screening among veterans. as this is a pilot study, the focus is to assess feasibility of a population-based screening outreach approach through the development, implementation and dissemination of a mailed fit outreach program in the philadelphia va medical center that does not rely on having an office visit.

Eligibility criteria:
inclusion criteria: * the pragmatic trial will include veterans in southeastern pennsylvania and southern new jersey who, during the funding year * 50 to 75 years old * have received care at the philadelphia va medical center in the 18-48 months prior to selection for the study but who have not been seen by primary care in the past 18 months prior to selection * due for screening * are asymptomatic for crc * this includes the period during which 3-sample testing was being regularly used at the philadelphia va medical center exclusion criteria: * have any known gastrointestinal symptoms such as: * bleeding * unexplained weight loss * change in bowel habits * family history of crc * inflammatory bowel disease (ibd) * colectomy using international classification of disease (9th and 10th edition) diagnostic code or by self-report. * the investigators will also exclude veterans: * with evidence of prior colonoscopy within 10 years * sigmoidoscopy within 5 years * fecal occult blood test (fobt)/fit in the same calendar year * the information used to exclude patients will be derived from the electronic queries or chart audits.
coordinated reset deep brain stimulation

Conditions: Parkinson's Disease (PD)

Summary: the study will explore the viability of an alternative/novel programming strategy in deep brain stimulation (dbs) for patients with parkinson's disease (pd).

the study will explore the feasibility of utilizing an alternative/novel programming technique in deep brain stimulation (dbs) for patients with parkinson's disease (pd).

Eligibility criteria:
key inclusion criteria: 1. subject with pd implanted bilaterally in the stn and receiving dbs therapy for at least 3 months. 2. tolerates \> 12 hours off medication and, per clinical judgment, be able to perform all study related procedures. 3. able to understand the study requirements and the treatment procedures and must provide written informed consent before any study-specific tests or procedures are performed. key exclusion criteria: 1. exhibits significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator. 2. a female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant
targeting the neurobiology of rrb in autism using n-acetylcysteine: single-dose

Conditions: Autism Spectrum Disorder

Summary: the goal of this study is to target the neurobiology of restricted and repetitive behaviors in children with autism spectrum disorder using n-acetylcysteine (nac), a well-tolerated nutritional supplement that has shown promise for reducing symptom severity in recent small-scale trials. the findings from this research will shed light on the mechanisms of action underlying the clinical benefits of nac.


Eligibility criteria:
inclusion criteria: * children between 3 years and 12 years 11 months at the time of consent * diagnosis of autism spectrum disorder confirmed with the autism diagnostic interview-revised (adi-r) and the autism diagnostic observation schedule-2 (ados-2), or brief observation of symptoms of autism (bosa), or childhood autism rating scale- second edition (cars-2). * at least moderate restricted and repetitive behaviors severity defined by a children's yale-brown obsessive compulsive scale for children with autism spectrum disorder score ≥ 11, * physical development indicative of prepubescence as defined by the criteria for tanner stage 1, * medically stable, * passes mr safety screening (e.g., no metal in the body). exclusion criteria: * presence of known genetic abnormalities associated with autism spectrum disorder (e.g. fragile x), * current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia), * presence of significant medical problems that would interfere with participation, * the inability of at least one caregiver to speak/read english to a sufficient level to complete study requirements and materials, * individuals taking antioxidant agents and glutathione prodrugs, or * the inability/unwillingness to swallow an agent during the screening visit.

Keywords: magnetic resonance imaging n-acetylcysteine restricted and repetitive behaviors electroencephalography
cell-free dna chromatin immunoprecipitation (chip) for diagnosing cancer

Conditions: Cancer of Pancreas

Summary: the goal of this research is to use chromatin immunoprecipitation, a method used to study protein-dna interaction, as a tool to diagnose and prognose pancreatic ductal adenocarcinoma in human samples. this is a non-human subject research study. all participants are de-identified.

pancreatic ductal adenocarcinoma (pdac) is a neoplastic disease which accounts for "90% of pancreatic malignancies," and has a 5-year survival rate of only 9%. the dismal nature of the pdac diagnosis, which has a median survival time of about one year, can be attributed in part to late detection. in fact, the cancer of pancreas screening-5 study demonstrated a 73.3% survival rate in participants whose pdac was found early through surveillance via mri and endoscopic ultrasound. this eightfold increase in survival rate suggests the inherent efficacy of pdac screening, however, with the median cost of a full mri being about $2,000, there is a significant barrier to entry for pdac screening. as a result, finding a cost-effective alternative to pdac screening could improve survival rates and lower costs, both directly and indirectly. liquid biopsy could prove to be a valuable tool in the early diagnosis of pdac, as it provides a non-invasive way to detect the presence of a disease state such as pdac. chromatin immunoprecipitation (chip), a type of liquid biopsy used to study protein-dna interaction, is a promising method at the forefront of cancer research, and has been proven to be capable of detecting tumor-specific transcriptional activity. additionally, the assay has shown promise in diagnosis and prognosis of disease state. currently, few (if any) modalities of liquid biopsy in pancreatic cancer use chip, and other forms of liquid biopsy have proven to lack sensitivity and specificity. thus, the aim of this research is to utilize the chip assay as a diagnostic and prognostic tool in pdac by detecting and quantifying tumoral gene expression.

Eligibility criteria:
inclusion criteria: * 18 years old or older * pancreatic cancer patients exclusion criteria: * children may not register * persons who are unable to consent may not register

Keywords: cancer pancreas
role of ct scan for the successful recanalization of chronic total occlusion; a randomized comparison between 3d ct-guided pci vs. conventional treatment (ct-cto trial)

Conditions: Coronary Artery Obstructive Disease; Chronic Total Occlusion Lesions

Summary: the revascularization of chronic total occlusion of coronary arteries (cto) is the most challenging procedure for the coronary intervention. for the initial period for cto intervention, percutaneous coronary artery intervention (pci) of cto lesions are associated with low procedural success rates about 70%. recently, the success rate of the recanalization of ctos has been raised in several studies. coronary ct angiography (ccta) is an effective noninvasive diagnostic modality for detecting coronary artery disease. ccta can visualize the complete anatomy of coronary arteries in contrast to conventional coronary angiography, reducing the deferral rates from cto intervention. assessment of characteristics of cto lesions by pre-procedural ccta could help to determine revascularization strategy and estimate the procedure time, leading to lower procedural complications. we suggest that success rates and clinical outcome of intervention of cto lesion can be improved by pre-procedural ccta.


Eligibility criteria:
inclusion criteria: * patients (age \>19 years) with cto (timi = 0 and estimated duration of occlusion at least 3 months) * typical symptomatic angina or positive stress test in various functional studies evaluating ischemia * eligible patients for pre-procedural ct scan and coronary angiogram exclusion criteria: * cardiogenic shock or ejection fraction \< 25% * cto lesions at des restenosis or graft occlusion lesion * significant left main stenosis * retry of same cto lesion within 2 weeks * acute myocardial infarction within 48 hours * hypersensitivity to aspirin, clopidogrel, or -limus families / or contraindication to antiplatelet agents * severe hepatic dysfunction (≥3 times normal reference values) * life expectancy \< 1 years * pregnant women or women with potential childbearing

Keywords: cto ct revascularization
lurasidone hcl - a long term phase 3 study of patients with chronic schizophrenia

Conditions: Chronic Schizophrenia

Summary: lurasidone hcl is a compound being developed for the treatment of schizophrenia. this clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine xr long term among schizophrenic outpatients with chronic schizophrenia.


Eligibility criteria:
entry criteria: * screening for the present study will take place after subjects' participation in study d1050233 has been completed, and after providing informed consent. inclusion criteria: * completed all required assessments on the final study visit in study d1050233. * suitable for treatment in an outpatient setting. exclusion criteria: * any chronic organic disease of the cns (other than schizophrenia). * considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

Keywords: schizophrenia sm-13496 latuda lurasidone
topical rapamycin for fibrofolliculomas

Conditions: Birt-Hogg-Dubé Syndrome

Summary: the purpose of the study is to determine whether topical application of rapamycin can lead to reduction in size and/or number of fibrofolliculomas in bhd patients and may prevent the growth of new ones. secondary we evaluate rapamycin safety, formula acceptance and patient satisfaction.


Eligibility criteria:
inclusion criteria: * minimum age of 18 years. * at least 10 facial fibrofolliculomas, histologically confirmed. * entered in a screening program and free of malignancy as determined during screening (already had a baseline mri or ct-scan). * being able to understand instructions. * mutation status must be known. * for females: not pregnant and willing to use both oral and barrier contraceptives during the treatment period. exclusion criteria: * not capable of informed consent. * age under 18 years. * pregnancy or failure to comply with contraceptive measures. * proven or suspected malignancy of skin or other organs. * no histological confirmation. * skin lesions other than fibrofolliculoma that might worsen under sirolimus such as active infections. * not able to comprehend instructions. * no proven mutation. * less than 10 fibrofolliculomas. * planned facial surgery in the treatment period. * concomitant disease requiring systemic immunosuppressive treatment * concomitant disease requiring facial topical immunosuppressive treatment or facial topical drugs that interfere with rapamycin during trail period or in the 30 days before start trial. * tendency to form keloids or hypertrophic scars. * drug or alcohol abuse.
shiatsu for chronic non-inflammatory pain in children and adolescents

Conditions: Chronic Pain; Chronic Pain Syndrome; Chronic Pain and Comorbid Emotional Problems; Chronic Pain, Psychogenic; Chronic Pain, Widespread; Fibromyalgia; Fibromyalgia Syndrome; Functional Pain

Summary: the goal of this clinical trial is to learn if adding shiatsu therapy to standard treatment can improve quality of life in children and adolescents with chronic pain that is not caused by inflammation. the main question it aims to answer is: does shiatsu therapy help improve the quality of life in children with long-lasting pain? all participants will continue their regular treatment and will also: * receive a 30-minute shiatsu session once a week for six weeks * complete questionnaires about their quality of life and family impact before, during, and after the treatment period the study includes about 40 participants between the ages of 10 and 18, who are already being followed at the pediatric pain and rheumatology clinics at tel aviv sourasky medical center.


Eligibility criteria:
inclusion criteria: * children and adolescents aged 10-18 years * diagnosed with non-inflammatory chronic pain syndromes * actively followed by the pediatric rheumatology and/or pediatric pain clinics at tel aviv sourasky medical center (at least twice a year) * informed consent signed by at least one legal guardian (or both guardians in cases of separated parents) * if participant is 16 years or older, they must also sign the informed consent exclusion criteria: * informed consent cannot be obtained from the participant or their legal guardians * legal guardians unable to provide informed consent * patients with severe conditions (e.g., bone metastasis) * patients unable to participate in shiatsu therapy sessions * participation in shiatsu therapy within 6 months prior to study enrollment * participant or legal guardian refuses participation

Keywords: shiatsu complementary and integrative medicine pediatric chronic pain non-inflammatory pain quality of life pedsql adolescent pain manual therapy mind-body therapy pediatric rheumatology integrative medicine functional pain pain management
paroxetine vs placebo combined with aerobic exercise or relaxation in panic disorder

Conditions: Panic Disorder

Summary: efficacy and safety of a 10-weeks treatment protocol of paroxetine vs. placebo in combination with regular aerobic exercise (running) or regular relaxation training in the treatment of panic disorder.

in continuation of prior work from our group (broocks a, bandelow b, pekrun g, et al. comparison of aerobic exercise, clomipramine, and placebo in the treatment of panic disorder. am j psychiatry 1998; 155(5):603-9.) it is the purpose of this trial to test the assumed superiority of a combined therapy of paroxetine and aerobic exercise compared to placebo or unspecific relaxation training in panic disorder. participants were randomized to a 10 week treatment protocol of paroxetine 40 mg daily or placebo in combination with regular exercise or regular relaxation after having given informed consent and screening of in- and exclusion criteria.

Eligibility criteria:
inclusion criteria: * panic disorder with or without agoraphobia due to dsm-iv * written informed consent * score of 17 or more on the p\&a scale * score on the cgi of 4 or more (markedly ill) exclusion criteria: * pregnancy, lactating or insufficient contraception (pearl index \>1) * other psychiatric disorders such as psychoses, addictive disorders, dementia, etc. * clinically relevant abnormalities in physical examination or laboratory results * prior major depression or bipolar disorder * suicidality * psychotropic medication other than promethazine * current psychological treatment * unable to perform regular aerobic exercise

Keywords: panic disorder pharmacotherapy non-pharmacological treatment ssri paroxetine exercise
a phase 2 study of recombinant anti-il-17a humanized monoclonal antibody in chinese participants with moderate-to-severe plaque psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to determine the efficacy and safety of the study drug recombinant anti-il-17a humanized monoclonal antibody in chinese participants with moderate-to-severe plaque psoriasis.

study ssgj-608-pso-ii-01 is a phase 2, multicenter, randomized, double-blind, placebo-controlled, multiple-dose escalation and dose finding study to identify the doses of treatments ，and to further evaluate the effect of different dose regimens of recombinant anti-il-17a humanized monoclonal antibody versus placebo in chinese participants with moderate-to-severe plaque psoriasis during an induction dosing period with dosing for 12 weeks, followed by a randomized, double-blind, 40-week maintenance dosing period. phase ib one of three dose levels of copanlisib is assigned at registration according to the dose escalation scheme. phase ii the copanlisib dose for the phase ii part of the trial will be based on the mtd established in the phase ib part of the study.

Eligibility criteria:
inclusion criteria: * must be 18 years to 65 years, both male and female. * bmi ≥18 kg/m\^2 and ≤32 kg/m\^2 ，and male weight ≥50 kg, female weight ≥45 kg during the screening. * chronic plaque psoriasis (pso) for at least 6 months prior to the randomizationas as determined by the investigator.. * psoriasis area severity index (pasi) \>=12 and body surface area (bsa) affected by pso \>=10% and static physician global assessment (spga) score \>=3. * according to the judgment of the investigator, the subject needs to receive systemic treatment and / or phototherapy (including subjects who have used local treatment, and / or phototherapy, and / or poor control of previous systemic treatment). * subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent. exclusion criteria: * history of pustular or erythrodermic psoriasis other than plaque psoriasis at screening or baseline. * history of drug-induced psoriasis. * ongoing use of prohibited treatments. * have previously received any drug that directly targets il-17. * have concurrent or recent use of any biologic agent within washout periods or \<5 half-lives prior to randomization. * chronic infections including hiv, viral hepatitis (hepatitis b, hepatitis c), syphilis and/ or active tuberculosis. * pregnant or lactating women.
effect of doxium on high sensitivity crp and endothelin-1 serum levels in patients with diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: diabetic retinopathy (dr) is a highly specific vascular complication of type 1 and type 2 diabetes mellitus. calcium dobesilate(cd) or doxium has been tested in the treatment of diabetic retinopathy showing a slowdown of the progression of the disease after long-term oral treatment,as a potent antioxidant. endothelin-1 (et-1) besides being a very potent vasoconstrictor,acts as a mitogen on the vascular smooth muscle and play the main role in the failure of autoregulation that it is an important and often early feature of diabetic retinopathy.several studies have been confirmed that inflammation besides oxidative stress are the main mechanisms,in the pathogenesis of dr and hscrp can play a sensitive role in detecting inflammation in these patients. the aim of this study was to determine the effects of cd on decreasing et-1 and hscrp serum levels in patients with diabetic retinopathy.


Eligibility criteria:
inclusion criteria: * bs 120-200 mg/dl * age 40-70 * severe npdr(non proliferative diabetic retinopathy) or pdr(proliferative diabetic retinopathy) * type ii diabetes * no history of doxium consumption exclusion criteria: * allergy to doxium * incidence of active hepatic disease or rising of hepatic enzymes during the intervention

Keywords: endothelin-1 high sensitivity crp