Kornimate/medical-research-clean huggingface dataset:
cyclical sighing for pain

Conditions: Pain

Summary: this is a single-site, two-arm, parallel-group randomized clinical trial (rct). the clinical effects of a 4-minute audio-recorded cyclical sighing intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.


Eligibility criteria:
inclusion criteria: * age ≥18 * seeking treatment at the tallahassee orthopedic clinic exclusion criteria: * cognitive impairment preventing completion of study procedures. * other unstable illness judged by medical staff to interfere with study involvement.
efficacy of pulmonary vein isolation alone in patients with persistent atrial fibrillation

Conditions: Atrial Fibrillation; Catheter Ablation; Recurrence

Summary: this study examines non-inferiority of pulmonary vein isolation (pvi) for persistent atrial fibrillation (af) to extensive ablation; and reveals the effect of the presence or origin of af trigger on outcomes of catheter ablation.

study design the earnest-pvi trial is a prospective, multicenter, randomized, open-label non-inferiority trial in which patients with persistent af will undergo ablation. after providing written informed consent at each hospital, patients who are eligible for the trial will be randomized to either pvi alone or pvi plus additional ablation. left atrial dimensions will be the only adjustment factor considered in dynamic allocation to avoid bias. patients randomized to the pvi alone group will be treated with pvi, while patients randomized to the pvi plus additional ablation group will receive additional complex fractionated atrial electrogram or linear ablation after pvi. ablation for af triggers from non-pv foci, the cavotricuspid isthmus, clinical coexisting tachyarrhythmia such as atrial flutter (afl), atrial tachycardia (at), and supraventricular tachycardia will be allowed in both groups. patients will be followed up 1, 3, 6, 9, and 12 months after the procedure. the primary endpoint of the study is the recurrence of af documented by scheduled or symptom-driven ecg during 1 year after the procedure. "recurrence of af" is defined as the documentation of any atrial arrhythmia including af, afl, and/or at lasting ≥ 30 seconds by ecg or other appropriate tests. the sample size and randomization are specified based on the concept of non-inferiority to achieve the primary objective. the recurrence rate of af was assumed to be 40% in both groups and a non-inferiority margin of 10% was calculated by referring to the previous studies. therefore, a sample size of 256 subjects in each group is required with a power of 80% and significance level of 5% considering some dropouts. the statistical evaluation will be carried out according to the intention-to-treat principle.

Eligibility criteria:
inclusion criteria: * patients undergoing a first-time ablation procedure for persistent af exclusion criteria: * patients with long-standing persistent af lasting ≥ 5 years * patients with left atrial dimension ≥ 50 mm by 2-dimensional echocardiography * patients with valvular af (defined as the presence of mitral or aortic stenosis or regurgitation with a history of rheumatic fever or implantation of artificial heart valves) * patients who underwent prior cardiac surgery * patients receiving hemodialysis * patients with heart failure (left ventricular ejection fraction \< 30% and nyha class ≥ iii) * patients receiving antiarrhythmic agents before the ablation procedure (within 60 days for amiodarone, or 5 half-lives for other drugs) * patients who are not considered to be suitable candidates by the attending physician

Keywords: persistent atrial fibrillation non-inferiority trial
a study to evaluate the use of placenta protein 13 (pp13) in the first trimester of pregnancy as a diagnostic aiding tool in the assessment of the risk for developing preeclampsia in women with low and unknown risk

Conditions: Preeclampsia

Summary: the purpose of this study is to evaluate whether it is possible to detect changes in the concentration of pp13 in the blood of pregnant women who may go on to develop the complication of preeclampsia later on in the pregnancy, and if these changes can be detected early enough to allow early diagnosis and treatment for prevention of these complications and reduce their damage. this study will test if the pp13 biomarker during the first trimester of pregnancy has the ability to provide assessment of risk for the development of preeclampsia that necessitates delivery before 37 weeks gestation or can predict preeclampsia before 34 weeks gestation.

after obtaining informed consent maternal demographics, vital signs, height, weight, medical history, pregnancy dating, dipstick for urine protein, previous lab results, nuchal translucency results and uterine artery doppler results (if done) will be obtained. blood for pp13 will be obtained at 7-13 weeks and optionally at 21-23 weeks. hospitalization and delivery information will be obtained via a chart review for evidence of preeclampsia.

Eligibility criteria:
inclusion criteria: * healthy, pregnant females * singleton fetus at 7 0/7 to 13 6/7 weeks gestation exclusion criteria: * multi-fetal pregnancy * mental retardation * known fetal anomaly or demise * bmi \> 35, serious medical condition
pentax airway scope (aws) intubation

Conditions: Obesity

Summary: this study will compare the macintosh laryngoscope with the pentax. the pentax aws is a novel airway management device that is designed to facilitate laryngoscopy and endotracheal intubation.

100 obese patients (bmi 30 to 50) requiring orotracheal intubation for elective surgery will be randomly allocated to intubation with either a conventional macintosh laryngoscope or with the pentax aws. our study hypothesis is that use of pentax aws will make tracheal intubation easier to perform in the obese surgical patient (bmi 30 to 50), as evidenced by the time to complete the intubation process as well as an "ease of use" visual analog score (vas) measure.

Eligibility criteria:
inclusion criteria: * subject is at least 18 years old * bmi between 30 and 50 * scheduled for elective surgery requiring orotracheal intubation exclusion criteria: * a known difficult airway * loose teeth * subject pregnancy * rapid sequence induction required * subject is unable to give consent * anesthesiologist considered use of the pentax aws to be contraindicated * special endotracheal tube (ett) is needed for the case.

Keywords: intubation obese
feasibility of the ic-flow device for fluorescent perfusion evaluation during feasibility of the ic-flow device

Conditions: Skin Flap Necrosis; Perfusion; Complications

Summary: 1. primary objective: demonstrate that the ic-flow imaging device with indocyanine green (icg) is a feasible technique when visualizing and identifying perfusion of organs when compared to the karl storz vitom ii icg system during open reconstructive surgical procedures 2. secondary objective: 1. evaluate the mean assessment of handling properties using the ic- flow versus the vitom ii. 2. evaluate the mean surgeon preference level using the ic- flow tower, the ic-flow hand-held device versus the vitom ii.

currently, there is no literature that supports the clinical application of the ic-flow. however, we intend to perform this pilot study to determine safety and feasibility of said device in comparison to its homologue, fda-approved vitom ii icg system. the device named the karl storz vitom ii icg system is an imaging system used in capturing and viewing fluorescent images. the system is fda approved for all the indications that are going to be used in our study as well as the specialties involved it is composed of an open field multidirectional imaging arm and head, a light guide and a video processor/illuminator (fda 510 (k) k171238, may 25, 2017). as indicated by the department of health and human services from the fda, the indications for use are the following: "the system is used in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures." and "the system is intended to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal procedures." based on the information provided by the fda, the device has no direct nor indirect effect on patients. furthermore, the device predicts a safe use and it's intended to provide imagery feedback alone. there is few clinical trials which broadly exemplify the alternate applications of icg fluorescence as a diagnostic tool for intraoperative anatomical identification, in terms of structure, perfusion, and tissue viability. no significant increase of risks or dye-associated complications had been reported.

Eligibility criteria:
inclusion criteria: 1. patients of both genders 2. minimum age: 18 years old 3. spoken and written command of the language spoken in the country's center 4. ability to understand and follow the study procedures and sign the informed consent 5. open surgical porcedures exclusion criteria: 1. known allergies to iodides 2. known history of coagulopathy 3. women who are pregnant or breastfeeding, or for whom possibility of pregnancy was not ruled out

Keywords: organ perfusion fluorescence icg
elotuzumab safety surveillance in japanese patients with relapse or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: bms will conduct a regulatory postmarketing surveillance (pms) to evaluate the safety of elotuzumab in clinical practice in japan.


Eligibility criteria:
inclusion criteria: * all patients with relapsed or refractory multiple myeloma who are beginning to receive elotuzumab at the selected sites will be included in this surveillance study exclusion criteria: * not applicable
long-term study in patients under anti-retroviral combination therapy switching to viramune®

Conditions: HIV Infections

Summary: collecting data on maintaining anti-retroviral activity (quantitative hiv rna determination) and immunological activity (cd4 cells) after switching from protease inhibitor or nnrti to nevirapine (viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.


Eligibility criteria:
inclusion criteria: * adult male and female out-patients with hiv type 1 infection who have achieved a viral load below detection limit (50 copies/ml) for more than 6 months under a previous combination therapy with protease-inhibitors (pi) or non-nucleoside reverse transcriptase inhibitors (nnrti) * women can only be included, if a test has excluded pregnancy * only women can be included, who use a reliable means of contraception during the observational study exclusion criteria: * known sensitivity to viramune or one of its excipients * clinically relevant changes in lab findings (e.g. increase in aspartate aminotransferase (ast) or alanine aminotransferase (alt) by more than five-fold of upper limit normal) * patient is not able to abstain from treatment with ketoconazole, oral contraceptives, and other medication cyp3a metabolism * for females: * pregnancy * breast-feeding * insufficient or unreliable contraception
safety and efficacy of nbi-98854 in pediatric subjects with tourette syndrome

Conditions: Tourette Syndrome

Summary: this is a phase 2, double-blind, placebo-controlled, randomized withdrawal study to evaluate the safety and maintenance of efficacy of an optimized once-daily (qd) dose of nbi-98854 in pediatric subjects with ts.


Eligibility criteria:
inclusion criteria: 1. have a clinical diagnosis of tourette syndrome (ts) 2. have at least moderate tic severity 3. have ts symptoms that impair school, occupational, and/or social function 4. if using maintenance medication(s) for ts or ts spectrum diagnoses (e.g. obsessive-compulsive disorder \[ocd\], attention-deficit hyperactivity disorder \[adhd\]), be on stable doses 5. be in good general health 6. adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen 7. subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study exclusion criteria: 1. have an active, clinically significant unstable medical condition within 1 month prior to screening 2. have a known history of long qt syndrome or cardiac arrhythmia 3. have a known history of neuroleptic malignant syndrome 4. have a cancer diagnosis within 3 years prior to screening (some exceptions allowed) 5. have an allergy, hypersensitivity, or intolerance to vmat2 inhibitors 6. have a blood loss ≥250 ml or donated blood within 30 days prior to screening 7. have a known history of substance dependence, substance (drug) or alcohol abuse 8. have a significant risk of suicidal or violent behavior 9. have initiated comprehensive behavioral intervention for tics (cbit) during the screening period or at baseline or plan to initiate cbit during the study 10. have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than nbi-98854) during the study 11. have previously participated in an nbi-98854 clinical study, except for nbi-98854-1403 or nbi-98854-1501. 12. have hiv, hepatitis b, or hepatitis c
the role of ampligen in strategic therapeutic intervention (sti) of haart

Conditions: HIV Seropositivity; HIV Infection

Summary: this is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding ampligen to a strategic therapeutic intervention (sti) of haart in patients with plasma hiv rna \ 400.


Eligibility criteria:
1. adults at least 18 years of age. 2. cd4 cell count of \> 400 cells. 3. plasma hiv-1 rna \< 50 copies/ml on two occasions: one within the six weeks prior to starting baseline and the other during baseline. 4. history of virologic success with suppression of hiv rna level \< 50 copies/ml during the last nine months documented a minimum of two times during the last ten months or a minimum of three times during the last fifteen months while patient is receiving a haart regiment. during the four months prior to starting baseline, continuing through baseline and the 64 week study period, the haart regimen must remain unchanged and contain at least one of the following ten anti-retroviral drugs: * abacavir (ziagen) * zidovudine (retrovir) azt * zalcitabine (hivid) ddc * didanosine (videx) ddl * stavudine (zerit) d4t * efavirenz (sustiva) * indinavir (crixivan) * ritonavir (norvir) * nelfinavir (viracept) * amprenavir (agenerase) only one hiv plasma rna level \> 50, but \< 100 copies/ml is permitted during the four month period immediately prior to starting baseline. 5. karnofsky performance status of at least 70. 6. the following laboratory parameters within 21 days prior to treatment: * hemoglobin \> 9.2 g/dl for men and \> 8.9 g/dl for women; * neutrophil count \> 1000; * platelet count \> 75,000; * ast/alt \< 4.0 x upper limit of normal (uln); * serum creatinine \ 50 ml/min. 7. ability and willingness to give written informed consent. 8. for females with child bearing potential: a negative serum pregnancy test within 14 days prior to randomization. females of child bearing potential agree to use an effective means of contraception. 9. the patient must have completed any elective routine immunizations (including influenza vaccination) eight or more weeks prior to first dose of study drug.

Keywords: treatment interruption hiv infections
examination of efficacy and safety of other anti-resorption drugs after 2-year-denosumab therapy in japanese osteoporosis patients

Conditions: Osteoporosis

Summary: the aim of this study is to examine the efficacy and adverse events in the following 3 groups in japanese osteoporosis patients after 2-year-denosumab therapy: serm and eldecalcitol treatment for 24 months bisphosphonates and eldecalcitol treatment for 24 months eldecalcitol treatment for 24 months


Eligibility criteria:
inclusion criteria: * osteoporosis patients exclusion criteria: * not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant
study of at-101 in combination with topotecan in relapsed/refractory small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: this is an open label, multicenter phase i/ii study to evaluate the safety and efficacy of at-101 in combination with topotecan in relapsed/refractory small cell lung cancer

further study details provided by ascenta:

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed small cell lung cancer (sclc). mixed histology will not be eligible. * progression of disease after only one prior platinum containing chemotherapy regimen. prior regimen must not have contained irinotecan * all patients must have measurable disease. * patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities. * ecog performance status 0-1 * adequate hematologic function * adequate liver and renal function * ability to swallow oral medication exclusion criteria: * patients with more than one prior regimen of chemotherapy or prior regimen that did not contain a platinum agent. note: patient who stopped prior therapy due to toxicity or had less than 2 cycles of platinum based therapy would not be eligible for the phase ii portion of this study. * prior chemotherapy regimen containing irinotecan. * active secondary malignancy. * unstable or progressive brain metastases. * prior history of radiation therapy to \> 25% of the bone marrow. * uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (chf), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements. * failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).

Keywords: at101 at-101 cancer lung small-cell topotecan
study assessing complete wound healing by comparing surgenex® pellograft in treating dfu and sanograft® in treating vlu to soc

Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer

Summary: the purpose of this study is to compare pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, and to compare sanograft to standard of care in treating venous leg ulcers. the study will demonstrate wound healing outcomes with comparators including time to wound epithelialization, decrease in wound size, and total number of study product applications towards healing outcome. this information is important to the centers for medicare and medicaid services (cms) and other payors in determining coverage policy and reimbursement for this product category.


Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years of age 2. subject has diagnosed type 1 or type 2 diabetes 3. subject's wound is located on foot or ankle (dfu) or leg (vlu) 4. subject has diabetic foot ulcer \> 1.0 cm2 and ≤ 25 cm2 or venous leg ulcer \> 1.0 cm2 and ≤ 50 cm2 5. subject has adequate circulation to affected extremity with tcpo2 results of ≥ 40 mm hg on the dorsum of the affected foot or abi results ≥ 0.7 and≤ 1.2 or great toe pressure ≥ 50 mmhg 6. subject is willing and able to comply with all protocol requirements 7. subject is willing and able to provide informed consent or obtain consent from legal authorized representative (lar) exclusion criteria: 1. subject is pregnant 2. subject has hba1c \> 12 within 3 months prior to randomization 3. subject has \> 30% reduction in wound size after 2-week run-in period 4. subject has active infection, undrained abscess, or critical colonization of the wound with bacteria 5. subject has osteomyelitis or exposed bones, probes to bone or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or mri 6. subject is on parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during 30 days before screening. chronic oral steroid use is not excluded if dose \< 10 mg per day of prednisone 7. subject is currently undergoing cancer treatment 8. subject has used biologic skin substitutes within 14 days of enrollment 9. subject has an allergy to suture material 10. subject has life expectancy less than six-months as assessed by the investigator 11. subject is participating in another clinical research study prior to this study completion
investigation of the effects of different exercise programs in patients with restless legs syndrome.

Conditions: Restless Legs Syndrome; Anxiety; Sleep

Summary: restless leg syndrome (rls) is a very common neurological condition characterized by an uncontrollable desire to move the legs. due to the traumatic effect of rls on morbidity, the patient is negatively affected in many different directions. the duration and quality of sleep of the patients decrease, and their cognitive functions change. the prevalence or risk of anxiety and depression increases in this population. at the same time, the quality of life of patients is significantly reduced. among the different pharmacological agents used in rls, dopamine agonists are the most widely used. however, the reporting of serious and common side effects related to this treatment has led to non-pharmacological approaches in the treatment of rls and the effectiveness of many different approaches has been investigated. the exercise approach, which is determined to be effective in the treatment of the disease, is a subject that has been little studied. the type, duration and frequency of optimal exercise could not be standardized. in addition, the effect of exercise on rls patients has been investigated in limited subjects. for this reason, the aim of our study is to examine the effect of different exercise programs on symptoms, sleep, cognitive functions, quality of life, psychological status and fatigue in patients with rls.


Eligibility criteria:
inclusion criteria: * having been diagnosed with rls according to the international restless legs syndrome study group 2014 criteria * being over the age of 18 * being literate * not having received any treatment for rls, discontinuing treatment, or continuing symptoms despite current treatment. exclusion criteria: * having any of musculoskeletal disorders that prevent physical activity * history of ischemic heart disease (recent myocardial infarction or unstable angina, uncontrolled hypertension) * liver dysfunction * kidney dysfunction * anemia * diagnosis of another sleep disorder * diagnosis of gastrointestinal disease (irritable bowel syndrome, crohn's disease, ulcerative colitis etc.) * pregnancy * history of psychiatric, psychoactive, antidepressant medication use * history of malignancy