Kornimate/medical-research-clean huggingface dataset:
trial of pde4 inhibition with roflumilast (arq-154) foam 0.3% for the management of seborrheic dermatitis (stratum)

Conditions: Seborrheic Dermatitis

Summary: this phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (arq-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis.


Eligibility criteria:
key inclusion criteria: * participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws. * males and females ages 9 years and older at the time of consent. * clinical diagnosis of seborrheic dermatitis of at least 3 months duration at screening as determined by the investigator. stable disease for the past 4 weeks. * seborrheic dermatitis up to 20% bsa involvement. involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas. * an investigator global assessment (iga) disease severity of at least moderate ('3') at baseline. * overall assessment of erythema and overall assessment of scaling scores of at least moderate ('2') at baseline. * females of childbearing potential (focbp) must have a negative serum pregnancy test at screening (visit 1) and a negative urine pregnancy test at baseline (visit 2). * females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization. * subjects in good health as judged by the investigator. * subjects are considered reliable and capable of adhering to the protocol and visit schedule according to the investigator judgment. key exclusion criteria: * subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the baseline visit and during the study. * planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other led. * previous treatment with arq-154 or arq-151. * subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the investigator. * females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. * subjects with a history of chronic alcohol or drug abuse within 6 months prior to screening. * subjects, parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). * subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members living in the same house of enrolled subjects.
the effect of dystonia severity on participation in daily living activities and caregivers in children of cerebral palsy with secondary dystonia

Conditions: Secondary Dystonia; Cerebral Palsy, Mixed

Summary: dystonia is the most common movement disorder in the pediatric population after spasticity. it can affect normal motor development and cause significant motor retardation. the presence of dystonia may affect motor function, pain, and ease of care in cp. additionally, it can cause serious difficulties in daily living activities and social participation and long-term joint deformity. the increase in the severity of dystonia in cp children with secondary dystonia may affect the quality of life, activity and participation of the children, as well as the caregiver. the importance of caregivers is an undeniable fact, especially in these patient groups. this study aims to investigate the burden of dystonia severity on the participation in daily living activities and caregivers of children with cp with secondary dystonia.

it's an observational study. purpose of the study: investigating the burden of dystonia severity on the participation in daily living activities and caregivers of children with cp with secondary dystonia. * does dystonia severity affect participation in daily life activities in cp children with secondary dystonia? * does the severity of dystonia in children with cp with secondary dystonia affect the burden on the caregiver? * are the participation in daily living activities and caregiver burden of children with cp with secondary dystonia related to each other? total of 20 cp cases with secondary dystonia who applied to acıbadem university department of pediatric neurosurgery will be included in the study. dystonia severity of these cases will be evaluated with the barry-albright dystonia scale (bads). children's participation in daily living activities will be evaluated with the caregiver priorities and child health index of life with disabilities (cpchild), and the burden on the caregiver will be evaluated with the care and comfort hypertonicity questionnaire (cchq).

Eligibility criteria:
inclusion criteria: * total of 20 cases cp with secondary dystonia, aged between 3-15 years were included in the study. * obtaining voluntary consent from the family. exclusion criteria: * having a surgical operation procedure on the musculoskeletal system. * receiving bont-a in the last 6 months.

Keywords: dystonia participation caregiver burden
ph iia study (soc +/- ns5b)

Conditions: Hepatitis C Virus

Summary: at least 1 dose of bms-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegifnα-2a)/ribavirin (rbv) for the treatment of treatment-naïve, chronically-infected hepatitis c virus (hcv) genotype 1 subjects


Eligibility criteria:
inclusion criteria: * subjects chronically infected with hcv genotype 1 as documented by: positive for anti-hcv antibody, hcv rna, or a positive hcv genotype test at least 6 months prior to screening, and positive for hcv rna and anti-hcv antibody at screening * hcv rna ≥ 10\*5\* iu/ml at screening * less than 4 weeks total prior therapy with an ifn formulation (ie, ifnα, pegifnα-2a), or rbv and no exposure to ifn or rbv within 24 weeks of randomization * results of a biopsy obtained ≤ 24 months prior to randomization showing no evidence of cirrhosis * body mass index (bmi) of 18 to 35 kg/m², inclusive. bmi = weight (kg)/ \[height (m)\]² at screening exclusion criteria: * liver transplant recipients * documented or suspected hcc by imaging or liver biopsy * evidence of a medical condition associated with chronic liver disease other than hcv (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) * history of chronic hepatitis b virus (hbv) as documented by hbv serologies (eg. hbsag-seropositive). patients with resolved hbv infection may participate (eg. hbsab-seropositive) * current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
telomeres evaluation in endometriosis

Conditions: Endometriosis

Summary: the purpose of the study is to assess the telomere array of different endometriosis tissue and endometrium from women with endometriosis compared to healthy women. our hypothesis is that telomere shortening and high telomerase activity will be found in tissues from women with endometriosis.

the purpose of the study is to assess the telomere array of different endometriosis tissue and endometrium from women with endometriosis compared to healthy women. our hypothesis is that telomere shortening and high telomerase activity will be found in tissues from women with endometriosis, compared to women without endometriosis. a prospective study that compares telomeres and telomerase levels in different lesions of endometriosis and endometrial tissue of women with endometriosis and healthy women without endometriosis. the study group will consist of women with suspected endometriosis facing surgical treatment and the control group will consist of healthy women facing gynecologic surgery for different indication. we will sample endometrial tissue in both groups. in the study group we additionally will sample endometriosis lesion. the samples collected will test for histological diagnosis of endometriosis and verification tests will be done to characterize the telomeres array and telomerase levels and other characteristics for genomic instability such as spontaneous aneuploidy. expect telomere shortening and high telomerase activity in endometrial tissue and in endometriosis tissue sample, that won't characterize samples from women without endometriosis.

Eligibility criteria:
inclusion criteria: * women with suspected endometriosis facing surgical treatment exclusion criteria: * no endometriosis on histology * malignant finding on histology

Keywords: endometriosis telomere telomerase
a study of pf-05212384 in combination with other anti-tumor agents and in combination with cisplatin in patients with triple negative breast cancer in an expansion arm (tnbc)

Conditions: Neoplasm

Summary: this study will evaluate pf-05212384 (gedatolisib) pi3k/mtor inhibitor)) in combination with either docetaxel, cisplatin or dacomitinib in select advanced solid tumors. the study will assess the safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer in order to determine the maximum tolerated dose in each combination. the cisplatin combination expansion portion will evaluate the anti tumor activity of pf 05212384 plus cisplatin in patients with tnbc in 2 separate arms (arm 1 and arm 2).


Eligibility criteria:
inclusion criteria: cisplatin combination expansion: arm 1:patients with tnbc with no prior cytotoxic chemotherapy therapy in the metastatic setting; arm 2: patients with tnbc and one or two prior cytotoxic therapies in the metastatic setting. * arm a: castrate resistant prostate cancer, advanced breast cancer, or non-small cell lunch cancer that are candidates for treatment with a docetaxel-based combination. * arm b: urothelial transitional cell cancer, triple negative breast cancer, ovarian cancer or non small cell lunch cancer that are candidates for a cisplatin-based combination. * arm c: her2+ breast cancer refractory to prior herceptin or lapatinib, her2+ esophagal-gastric cancer, head and neck squamous cell cancer, or non small cell lunch cancer that are candidates for treatment with a dacomitinib-based combination. * availability of archival tumor biopsy sample or willing to provide fresh biopsy if not available. * eastern cooperative oncology group \[ecog\] performance must be 0 or 1. * adequate bone marrow, renal and liver function. exclusion criteria: * prior therapy for cisplatin combination expansion: * prior platinum (carboplatin or cisplatin) in either the adjuvant or metastatic setting; * prior radiation to \>25% bone marrow as estimated by the investigator. * patients with known symptomatic brain metastases. * chemotherapy, radiotherapy, biologics or investigational agent within 4 weeks of the lead-in dose. * major surgery within 4 weeks of the baseline disease assessments. * \>2 prior regimens containing cytotoxic chemotherapy in the metastatic setting. * active bacterial, fungal or viral infection. * uncontrolled or significant cardiovascular disease.

Keywords: advanced cancer solid tumors pi3k mtor pi3k/mtor metastatic triple negative breast cancer (tnbc)
advance dbs-f in patients with mild probable alzheimer's disease

Conditions: Alzheimer Disease

Summary: the primary objective of this feasibility study is to evaluate the safety of dbs-f in patients with mild alzheimer's disease by assessing all device and/or therapy related adverse events. the secondary objective is to preliminarily estimate the treatment effect size on the outcomes of interest at 12 months post-randomization. the objectives do not involve formal tests of hypotheses.


Eligibility criteria:
inclusion criteria: 1. 45-85 years of age (inclusive) 2. probable alzheimer's disease according to the national institute of aging alzheimer's disease association criteria. 3. must meet certain criteria on cognitive and behavioral rating scales 4. if female, subjects who are post-menopausal or surgically sterile or willing to use birth control methods for the duration of the study. 5. an available caregiver willing to participate. 6. subject is living at home and likely to remain at home for the study duration. 7. the subject is currently taking a stable dose of cholinesterase inhibitor (achei) medication for at least 60 days exclusion criteria: 1. must meet certain criteria on cognitive and behavioral rating scales 2. current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit 3. history of head trauma in the 2 years prior to signing the consent to participate in the study 4. history of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on ct or mri 5. active psychiatric disorder 6. mental retardation 7. current alcohol or substance abuse as defined by diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) 8. contraindications for pet scanning (e.g., insulin dependent diabetes) 9. contraindications for mri scanning, including implanted metallic devices (e.g. non-mri-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces. 10. abnormal lab results that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study. 11. abnormal cardiovascular or neurovascular disorder that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study. 12. unstable doses of any medication prescribed for the treatment of memory loss or alzheimer's disease. 13. currently prescribed any non-ad medications that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study. 14. is unable or unwilling to comply with protocol follow-up requirements. 15. has a life expectancy of \< 1 year. 16. is actively enrolled in another concurrent clinical trial.

Keywords: mild probable alzheimer's disease
pots net mrna functional correlation with net activity

Conditions: Postural Tachycardia Syndrome

Summary: dna acetylation can be responsible for significant down-regulation of transcription of the norepinephrine transporter (net). net is an important clearance transporter that removes norepinephrine (ne) from sympathetic neuronal synapses. very low levels of net can "cause" postural tachycardia syndrome (pots) or make these patients more susceptible to certain medications. quantified net messenger rna (mrna) levels from a peripheral blood sample may be able to assess net availability, which is simpler than older methods. this has not been validated against net function. in this protocol, the investigators seek to assess whether these net mrna levels correlate with net function. the investigators will assess the dhpg (net dependent ne metabolite):ne ratio in pots patients and control subjects from both plasma and urine samples.

work from the baker institute in melbourne, australia has shown that there can be significant epigenetic modification of the norepinephrine transporter (net). dna acetylation can be responsible for significant down-regulation of transcription. net is an important clearance transporter that removes norepinephrine (ne) from sympathetic neuronal synapses.very low levels of net can produce a hyperadrenergic phenotype and can "cause" postural tachycardia syndrome (pots). the baker institute researchers have started using quantified net mrna levels from a peripheral blood sample to assess net availability. this is a huge advance due to its simplicity, in contrast to a prior method which involved a vein biopsy to look at the level of protein expression. in this protocol, the investigators seek to assess whether these net messenger rna (mrna) levels correlate with net function. when net transports ne back into presynaptic neurons, a high percentage gets converted to a metabolite (dhpg) and then released into the blood stream. therefore, the ratio of dhpg:ne ratio is decreased with reduced net activity. the investigators will assess this dhpg:ne ratio in pots patients and control subjects from both plasma and urine samples.

Eligibility criteria:
inclusion criteria: * • postural tachycardia syndrome * previously diagnosed with pots • control subjects * not diagnosed with pots * age between 13-80 years * male and female subjects are eligible. * able and willing to provide informed consent (if ≥18 years) or assent with parental consent (if age 13-17 years) exclusion criteria: * • inability to give, or withdrawal of, informed consent * use of serotonin-norepinephrine reuptake inhibitors (snri) or net inhibitors within 1 month o these drugs pharmacologically block net activity * use of tricyclic antidepressants within 1 week o many tricyclic antidepressants pharmacologically block net activity * other factors which in the investigator's opinion would prevent the subject from completing the protocol.

Keywords: norepinephrine norepinephrine transporter
multi-center prospective study determining the sustainability of pain relief and psychosocial and functional responses when utilizing a multiple waveform enabled neurostimulator

Conditions: Chronic Pain; Intractable Pain

Summary: the triumph study is a post-market, international, multicenter, interventional, prospective, single-arm study intended to evaluate the sustainability of pain control and psychosocial and functional responses utilizing a multiple-waveform enabled neurostimulator in subjects with chronic, intractable pain of the trunk and/or limbs.

triumph study will utilize the multiprogram trial stimulator or invisible trial system with burstdr for the trial evaluation period and the prodigy or proclaim elite family of neurostimulators with tonic or burstdr waveform at permanent implant and follow-up for pain control and improvement of psychosocial function. the follow-up visits will be scheduled at 3, 6, 12, 18, and 24 months post permanent implant

Eligibility criteria:
inclusion criteria: 1. subject has chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain. 2. subject has a score of 6 or higher on the numeric rating scale (nrs) for average pain specific to the area(s) of chronic pain being treated over the past 24 hours at the baseline visit. 3. subject is considered by the investigator as a candidate for implantation of a spinal cord stimulator system according to the system instructions for use. 4. subject is 18 years of age or older at the time of enrollment. 5. subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits. 6. subject has signed and received a copy of the ethics committee/institutional review board (ec/irb) approved informed consent. exclusion criteria: 1. subject currently has a spinal cord stimulation system implanted. 2. subject has previously failed spinal cord stimulation (scs) therapy (either trial system evaluation or permanent implant). 3. subject has a primary diagnosis of peripheral vascular disease (pvd), angina pectoris, or chronic migraine. 4. subject has or plans to have a peripheral nerve stimulation system (pns), peripheral nerve field stimulation system (pnfs), dorsal root ganglion system (drg), or implantable infusion pump. 5. subject is currently participating in another clinical investigation with an active treatment arm. 6. subject unable to read and/or write.

Keywords: proclaim elite 5 proclaim elite 7 prodigy prodigy mri burstdr stimulation tonic stimulation multiprogram trial stimulator invisible trial system
effect of bra use during radiotherapy for breast cancer radiotherapy

Conditions: Breast Cancer; Radiation Therapy

Summary: this prospective randomized study investigated the reproducibility of breast shape, radiation dose irradiated to the lungs, heart, dose distribution, patient satisfaction, and treatment toxicity when wearing and not wearing a bra during radiotherapy for patients with breast cancer.

post-surgery radiotherapy to the breast is standard treatment after breast-conserving surgery in patients with breast cancer. in order to apply the latest radiation therapy technologies, such as intensity-modulated radiotherapy, it is important to maintain the correct posture. however, due to the nature of the breast made of soft tissue, it is difficult to maintain the same breast shape during each treatment. this is especially difficult for large, ptotic breasts. accordingly, we developed a bra for breast cancer patients in order to perform accurate radiotherapy. it was designed to fix the breast using bands in various directions so that its shape and position can be fixed during radiation treatment. this is a prospective, randomized controlled study to evaluate the effects of using a bra for breast cancer patients on the reproducibility of breast shape, radiation dose irradiated to the lungs, heart, dose distribution, patient satisfaction, and treatment toxicity.

Eligibility criteria:
inclusion criteria: 1. patients with histologically confirmed invasive breast cancer or ductal carcinoma in situ 2. patients eligible for whole breast irradiation after partial mastectomy 3. adults over 20 years old 4. patients with good overall performance (ecog ps 0-1) exclusion criteria: 1. recurrent breast cancer patients 2. patients who have previously received radiation therapy to the ipsilateral breast 3. patients who underwent breast reconstruction 4. bilateral breast cancer 5. patients with skin diseases such as contact dermatitis
detection of tumor dna through cervical smear and liquid biopsy in endometrial cancer patients and evaluation of prognostic and predictive values of tumor dna assay

Conditions: Endometrial Cancer

Summary: circulating tumor dna (ctdna) may help detect and prognosis-stratify patients with endometrial cancer. both cervical swab-based genomic dna (gdna) and whole blood-based ctdna can be utilized for this goal. our objective is to utilize cervical swab and whole blood samples to analyze tumor-derived ctdna from patients with endometrial cancer. these samples will be collected prospectively, and prior to staging operation. samples from patients without cancer, who undergo hysterectomy for benign gynecological cause, will be utilized as controls. variants called by next generation sequencing were classified into four-tiers based on asco/amp system. these initially captured samples will be used to compare performance in terms of detection rate and to stratify patients based on the mutational profile. additionally, in patients with advanced disease, we plan to collect whole blood samples every 3 months to assess any changes in mutational landscape. clinical data including age, cormorbidities, treatment methods, date of diagnosis and recurrence, response evaluation for chemotherapy or radiotherapy, survival data will be used to contextualize our findings.


Eligibility criteria:
inclusion criteria: 1. female, over 19 years of age 2. patients with endometrial cancer or benign gynecological diseases exclusion criteria: 1. patients in pregnancy 2. patients being treated for cancer of other organs, including gynecological cancer. 3. patients who has difficulty reading and understanding korean. 4. the tester's determination that the patient will not be able to comply with the clinical trial procedures. 5. patients with severe infections or other serious medical problems that have resulted in impairment of the patient's function, making it difficult to the trial.