Kornimate/medical-research-clean huggingface dataset:
naviscore pmcf study ( repic04f )

Conditions: Coronary Artery Disease; Ischemic Heart Disease

Summary: multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study to confirm and support the clinical safety and performance of naviscore scoring balloon to meet eu medical device regulation (mdr) requirements in all the consecutive patients treated with naviscore.

the objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study is to confirm and support the clinical safety and performance of the naviscore scoring balloon in a non-selected, real world population under daily clinical practice when used as intended by the manufacturer to meet eu medical device regulation requirements for post-market clinical follow-up.

Eligibility criteria:
inclusion criteria: * patient treated with naviscore according to routine hospital practice and following instructions for use * informed consent signed exclusion criteria: • not meet inclusion criteria

Keywords: mdr (medical device regulations) pmcf (post-market clinical follow-up) coronary balloon dilatation catheter
lidocaine for pain control during intrauterine device insertion

Conditions: IUD Insertion Complication

Summary: despite being the most common method of contraception, the use of intrauterine devices (iuds) is limited by the associated pain during insertion. many pharmacologic interventions had been studied for their efficacy to reduce iud insertion pain, of them, lidocaine was found to be superior over nsaids or other local anesthetics. this work aims at comparing the safety and efficacy of different lidocaine formulations to optimize selection in reduction of iud associated pain.


Eligibility criteria:
inclusion criteria: 1. multiparous women. 2. over 18 years of age and eligible for iud insertion. 3. application of iud will be done in postmenstrual period. exclusion criteria: null parity. 2. history of failed intrauterine device insertion (uterine perforation, acute expulsion). 3. copper allergy. 4. uterine anomaly. 5. post-partum endometritis or septic abortion in the past three months. 6. untreated cervicitis/vaginitis, including bacterial vaginosis. 7. immunosuppression. 8. history of lidocaine ,prilocaine allergy. 9. analgesic or anxiolytic use within the last 24 hours before the procedure. 10. wilson's disease. 11. suspicion of pregnancy. 12. untreated abnormal uterine bleeding.

Keywords: lidocaine dosage forms pain scores
pharmacokinetics of leo 43204 gel in actinic keratosis administered under maximal use conditions

Conditions: Actinic Keratosis

Summary: this is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. the trial includes three active treatment groups. to be eligible for inclusion in this trial, subjects must have at least 15 clinically typical, visible, and discrete actinic keratosis (aks) on the face, scalp or on the arm within a contiguous area of approximately 250 cm2 of sun-damaged skin. there will be 3 treatment groups: (1) once daily application of leo43204 gel 0.018% on the full face for three consecutive days, (2) once daily application of leo43204 gel 0.1% on the arm on a treatment area of approximately 250 cm2 for three consecutive days and , (3) once daily application of leo43204 gel 0.037 % on the scalp for three consecutive days.


Eligibility criteria:
inclusion criteria: 1. subjects with 15 or more clinically typical, visible and discrete aks on either: * full face (corresponding to a treatment area of at least 250 cm2). if subjects have a beard they must shave no later than the day before the first drug application. * a contiguous area of approximately 250 cm2 on the arm between wrist and shoulder. * balding scalp (corresponding to a treatment area of approximately 250 cm2). subjects with sparse hair on the scalp can be enrolled as long as lsr and ak assessments are not compromised. 2. subject at least 18 years of age. 3. female subjects of childbearing potential\* must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment. 4. female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion. exclusion criteria: 1. location of the treatment area (full face, full balding scalp, chest, trunk or extremities) * within 5 cm of an incompletely healed wound. * within 5 cm of a suspected basal cell carcinoma (bcc) or scc. 2. previously assigned treatment in this clinical trial or previously participated in a clinical trial in the leo 43204 programme. 3. lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horns)and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
the optimal timing of a second autologous peripheral blood stem cell transplantation in patients (<61 years) with multiple myeloma

Conditions: Multiple Myeloma

Summary: autologous peripheral blood stem cell (pbsc) transplantation is now considered standard therapy in patients (\< 65 ans) with multiple myeloma. the intergroupe francophone du myelome conducted a randomised trial of the treatment of multiple myeloma with high dose chemotherapy followed by either one or two successive autologous stem cell transplantation. the probabilities of event-free-survival and overall survival were doubled with a double transplant. the benefits were greatest among patients who had not had a very good partial response to the first transplant. the aim of this multicenter randomised trial in previously untreated patients with multiple myelome (stage ii, iii ds)is to assess the optimal timing of a second autologous stem-cell transplant.after a first-line therapy with thalidomide-dexamethasone followed by a pbsc collection, patients are randomly assigned to receive two autologous pbsc transplants (arm a)or one autologous pbsc transplant followed by a consolidation therapy with thalidomide-dexamethasone (arm b). patients included in the arm b will receive a second transplant in case of disease progression on consolidation therapy, or in case of relapse in responders.


Eligibility criteria:
inclusion criteria: * patients less than 61 years of age * durie salmon stage ii or iii * written and informed consent exclusion criteria: * prior treatment for myeloma * ecog performance score of 4 * positive hiv test * chronic respiratory disease (dlco \< 60%) * systolic ejection fraction \< 50% * pregnant or nursing women
special drug use investigation for valtrex (valaciclovir) (suppression prophylaxis)

Conditions: Genital Herpes

Summary: the purpose of this study is to collect and assess information on proper use of valaciclovir regarding safety and efficacy of long-term use in suppressive therapy for subjects with recurrent genital herpes.


Eligibility criteria:
inclusion criteria: * subjects who started suppressive therapy for recurrent genital herpes for the first time exclusion criteria: * subjects with a history of hypersensitivity to the ingredients of valtrex or aciclovir
the efficacy of estrogen therapy against adhesion reformation after hysteroscopic adhesiolysis

Conditions: Intrauterine Adhesion

Summary: asherman's syndrome is characterized by the presence of intrauterine adhesions (iua) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. the gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. the recurrence of intrauterine adhesions is a major challenge in clinical practice. intrauterine balloon has been used for the prevention of intrauterine adhesions. it has been reported that dried biological amnion graft was used to prevent adhesion after the operation of intrauterine adhesions. estrogen is also used for postoperative prevention of intrauterine adhesions. intrauterine balloon can reduce the recurrence of adhesions after operation. disposable balloon uterine stent，which is an innovative intrauterine balloon，is specially designed to fit into the cavity of the uterus. does disposable balloon uterine stent and amniotic products combine estrogen therapy improve clinical outcomes? therefore, this study was conducted.

allocation: randomized endpoint classification: efficacy study intervention model: parallel assignment masking: double (participant and outcomes assessor) primary purpose: prevention

Eligibility criteria:
inclusion criteria: * age 20-40 years； * previously diagnostic hysteroscopy confirmed adhesion score \>5， according to the american fertility society （afs）classification of iua； * complains of menstruation disorder and reproductive dysfunction； * informed consent. exclusion criteria: * premature menopause, * presence of other intrauterine lesions (e.g. polyps, myoma, septa), and * presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases), * adhesions limited to the lower uterine cavity or the cervical canal.

Keywords: asherman syndrome hysteroscopy uterine stent estrogen amnion hysteroscopic adhesiolysis
tango for neuropathy among breast cancer survivors

Conditions: Cancer, Breast; Neuropathy

Summary: group dance classes have been found to improve markers of quality of life and physical health (i.e., balance) among some populations engaged in rehabilitation, such as the elderly and individuals with parkinson disease. however, such interventions have yet to be studied among cancer survivors despite the relevance of quality of life and physical health within cancer survivorship. group dance classes are a promising avenue in that they deliver activity-based medicine in a social context, thus potentially improving physical as well as psychosocial aspects of health. to further this avenue of inquiry, we propose to study the effect of dance-based interventions for cancer survivors.

participants will be randomized (1:1) to one of two activity intervention arms: argentine tango dance or home exercise. information about neuropathy symptoms, motion, falls incidence, and participant feedback about the interventions will be collected. aim1: to evaluate change in postural control over 16 sessions of tango (exp) vs hex (control) (n=26 per group) as primary endpoint. as secondary measures, to assess: balance function (i.e., tug) and patient-reported outcomes (pros) (i.e., symptoms, pain, fatigue, mood, quality of life) monthly including 1 month post-intervention completion; postural control and symptoms within-session; and falls incidence weekly for 6 months following intervention completion. hypothesis: at primary endpoint, participants in the experimental group will show more improvement than participants in the control group in measures sensitive to neuropathy disease state (i.e., sway variability and area). aim2: to evaluate change in gait variability after 16 sessions of tango (exp) vs hex (control) (n=26 per group; 1:1 randomization). as secondary measures, to analyze local and orbital dynamic stability (pre, post, and 1mo post-intervention), pros (monthly), and falls incidence (weekly) following intervention completion. hypothesis: at primary endpoint, participants in the experimental group will show more improvement than participants in the control group in measures of gait variability (i.e., stride-to-stride variability in speed).

Eligibility criteria:
inclusion criteria: * breast cancer survivor stage i-iii * symptomatic for neuropathy * postural control outside 70% ci for adults who are middle-aged without neurotrauma * having completed taxane-based chemotherapy treatment at least 3 months ago; * able to understand and comply with directions associated with testing and study treatments. exclusion criteria: * pre-existing vestibular deficit; * poorly controlled diabetes (hga1c \> 8); * non-ambulatory or lower extremity amputation (assistive devices allowed); * use of cytotoxic or immunotherapy during study (endocrine therapy allowed); * participation in physical therapy during the study; * contraindication to participate in tango due to orthopedic issue (e.g., herniated vertebral disc);
plasma hydrogen sulfide, nitric oxide and stress hyperglycemia in acute myocardial infarction

Conditions: Myocardial Infarction

Summary: acute myocardial infarction (ami) can cause heart failure, an irregular heartbeat, cardiogenic shock, or cardiac arrest. it is the major cause of morbidity and mortality in the general population. the diagnosis of ami is complex basing on the clinical history, physical examination, cardiac markers, and a chest radiograph. besides, considering that the mechanisms linking activation of inflammation and acs are complex as well, progress in diagnosis and therapy improves little

the world health organization (who) indexed cardiovascular disease (cvd) as a leading foundation for human death in developing as well as developed countries. ischemic necrosis of the myocardium is called myocar¬dial infarction. despite improvements in medical and interventional therapies in recent years, acute myocar¬dial infarction is still an important cause of mortal¬ity and morbidity. hydrogen sulfide (h2s) is a colorless, water-soluble gas and is an endogenously produced labile diffusible mediator with multiple roles in the cardiovascular system in health and disease. h2s is endogenously generated, and cystathionine-β-synthase (cbs), cystathionine-γ-lyase (cse), and 3-mercaptopyruvate sulfurtransferase (3-mst) are key enzymes involved in its biological production. once interacting with carbon monoxide and nitric oxide, h2s will initiate a unique gaseous signaling net¬work and participate in the regulation of multiple patho¬physiological processes. plasma h2s levels negatively correlated with hba1c, duration of diabetes, and systolic and diastolic blood pressures.

Eligibility criteria:
inclusion criteria: * patients with confirmed diagnosis of ami- * patients of age 18 years or more who are willing to participate in the study and give their consent for same. exclusion criteria: * patients with congenital heart diseases, alcoholics with a past history of liver disease, pulmonary embolus, sepsis, chest trauma, and renal failure were excluded from the study.

Keywords: hydrogen sulfide nitric oxide stress hyperglycemia acute coronary syndrome
sildenafil in heart failure with reactive pulmonary hypertension

Conditions: Heart Failure With Reactive Pulmonary Hypertension

Summary: the purpose of this study is to determine whether sildenafil 20mg taken three times a day is effective in the treatment of heart failure with reactive pulmonary hypertension. this is a double-blind, placebo controlled trial.

patients will be screened at the time of a diagnositic right heart catheterization. patients will be selected based on pressures measured during this procedure, current medications, and current symptoms. at baseline a 6 minute walk test and quality of life questionnaire will be administered. medical records will be reviewed and results of recent testing will be recorded. qualifying participants will be randomized to receive 90 days of either placebo or sildenafil 20 mg three times a day. randomized patients will be followed for safety and efficacy by phone and as otherwise clinically indicated. at the end of the 90 day treatment period, patients will be evaluated via 6 minute walk, quality of life questionnaire, and other diagnostic tests as clinically indicated. primary outcome will be change in the 6 minute walk distance. secondary outcomes will be based on clinically available results such as change in heart pressures measured by right heart catheterization and echocardiogram. at the end of the treatment period, providers and patients will be unblinded in order to optimize further treatment. to achieve statistical significance, 64 patients will be enrolled and randomized.

Eligibility criteria:
inclusion criteria: * known chronic heart failure appropriately treated with angiotensin converting enzyme (ace) inhibitors and beta blockers, unless contraindicated or poorly tolerated * indication for right heart catheterization * pulmonary artery mean pressure \>25 mmhg * pulmonary capillary wedge pressure \> 15 mmhg * pulmonary vascular resistance \> 3 wood units exclusion criteria: * hypersensitivity, allergy, or intolerable side effect to sildenafil * history of primary pulmonary hypertension, connective tissue disorder, severe chronic obstructive pulmonary disorder (copd), pulmonary embolism, or left to right shunt * co-morbidities, limited exercise intolerance: * morbid obesity (bmi \>40) * copd with oxygen dependence * severe peripheral vascular disease with intermittent claudication * status post amputation of lower extremity at any level * severe degenerative joint disease preventing normal walking
the role of genetic factors in the development of breast cancer in the kazakh population

Conditions: Breast Cancer

Summary: this is a gwas study that aims to identify possible candidate genes associate to breast cancer by exploring single nucleotide polymorphism (snp) in a group of breast cancer, in the kazakh population. the investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find snp significantly associate with breast cancer

a genome-wide association study (gwas) is an approach used in genetics research to associate specific genetic variations with particular diseases. the method involves scanning the genomes from many different people and looking for genetic markers that can be used to predict the presence of a disease. once such genetic markers are identified, they can be used to understand how genes contribute to the disease and develop better prevention and treatment strategies.

Eligibility criteria:
inclusion criteria: * persons with a histologically confirmed diagnosis of breast cancer. * the age of patients is from 18 to 60 years; * persons of kazakh nationality, whose paternal and maternal grandparents are kazakhs. * persons who are able and willing to provide written informed consent; * persons capable and willing to comply with the research protocol; exclusion criteria: * persons under 18 and over 60 years old; * persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent; * pregnant or lactating women; * tuberculosis of any localization in the active phase and in history; * severe and decompensated diseases of the liver and kidneys, cardiovascular system; * severe and decompensated course of endocrine diseases; * lack of histological verification of breast tumor

Keywords: gwas
second open label extension to bridging study ctbm100c2303

Conditions: Pulmonary Infections; Pseudomonas Aeruginosa

Summary: this was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in ctbm100c2303 and extension study one ctbm100c2303e1 (all visits), who were proven infected with pseudomonas aeruginosa at enrollment into ctbm100c2303.


Eligibility criteria:
inclusion criteria: * completed all visits in study ctbm100c2303 and ctbm100c2303e1, and visit 11 of study ctbm100c2303e1 took place not more than 5 days before enrollment into this study. * confirmed diagnosis of cystic fibrosis participants with p. aeruginosa infection. * forced expiratory volume in one second (fev1) at screening (at start of study ctbm100c2303) must be between 25% and 80% of normal predicted values. exclusion criteria: * any use of inhaled anti-pseudomonal antibiotics between the termination of the trial ctmb100c2303e1 and the enrollment into this study. * known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

Keywords: tobramycin inhalation powder cystic fibrosis lung diseases anti-bacterial agents treatment of pulmonary infections with p. aeruginosa in cystic fibrosis participants
relieving pain and improving sleep: evaluating topical pain relief and sleep patches

Conditions: Pain, Back; Pain, Acute; Sleep Disorder; Sleep Disorders, Circadian Rhythm; Sleep; Sleep Deprivation; Insomnia

Summary: this minimal risk, randomized, double-blind, placebo controlled institutional review board (irb)-approved study with functional measurements, will evaluate pain relief and sleep improvement after use of a drug- free, non-invasive patch (freedom or rem patch; the super patch company inc.); using validated scales and functional measurement tools along with crossover and control groups within the same subject group not receiving an 'active' patch.

emerging technologies that use haptic (skin pressure) technology have been studied and have shown positive improvements in stress levels, balance, sleep, and pain. the freedom and rem patch (superpatch company, toronto, canada and florida, usa) that also incorporates this technology has shown promise to improve relieve pain and improve sleep. this irb-approved, randomized controlled trial (rct) will measure effectiveness of the pain and sleep patches through assessment of validated scales and functional measurements such as the brief pain inventory (bpi), the schober test, the bubble inclinometer measurement, and the flexion finger-floor measurement for the pain patch, and pittsburgh sleep quality index (psqi), the insomnia severity index (isi), and a sleep wearable monitor for the sleep patch.

Eligibility criteria:
inclusion criteria: * ages 18-64 * ability to provide informed consent * received a study patch (active or sham) from their treating clinician (randomized) for back, shoulder, and other musculoskeletal pain. * has been diagnosed with an acute, moderate pain condition * agrees to wear an adhesive study patch during the study period exclusion criteria: * patients who are beneficiaries of a government-funded healthcare program * use of drugs of abuse (illicit or prescription) * have an implanted device, or wears, or adheres any electrical device to the body during the study, other than a hearing aid.

Keywords: musculoskeletal pain sleep disorder insomnia back pain acute pain sleep