Kornimate/medical-research-clean huggingface dataset:
treatment of multiple gingival recession defects using a new xenogenic collagen membrane compared to connective tissue graft: a randomized controlled split-mouth clinical study

Conditions: Gingival Recession

Summary: limitation of donor site and significant postoperative morbidity are often described in connective tissue graft. we want to show if mucogain matrix used in tunnel technique to recover rti cairo recessions defects could be an alternative to connective tissue graft


Eligibility criteria:
inclusion criteria: * patient with 3 contiguous, symmetrical and bilateral rti cairo gingival recessions (miller class 1) (i.e. 6 recessions) * patient non-smoker * patient affiliated to social security * patient signed informed consent. exclusion criteria: * patient with or having presented an acute or chronic severe cardiovascular, kidney, liver, gastrointestinal, allergic, endocrine, neuropsychiatric pathology, developed cancer of the upper aero digestive tract treated with radiotherapy * patient with severe hemorrhinopathy * patient treated with oral retinoids, bisphosphonates, oral or anticonvulsants * patient who has taken steroidal or non-steroidal anti-inflammatory therapy, anti-cancer or immunosuppressive chemotherapy within the last 6 months. * patient with contraindication to necessary and pre-, per- or post-operative treatments * follow-up of the patient seemed difficult by the investigator * patient with insufficient oral hygiene incompatible with oral surgery
a study on the safety of tak-279 and whether it can reduce inflammation in the bowel of participants with moderately to severely active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the main aim of this study is to learn if tak-279 reduces bowel inflammation and symptoms compared to placebo. another aim is to compare any medical problems that participants have when they take tak-279 or placebo and how well the participants tolerate any problems. the participants will take capsules of either tak-279 or placebo for up to 3 months (12 weeks). then all the participants will receive tak-279 for the rest of the treatment part of the study (1 year or 52 weeks). during the study, participants will visit their study clinic several times.

study tak-279-uc-2001 is a multicenter, randomized, placebo-controlled, study with a 12-week double-blinded induction treatment period, a 40-week open-label treatment period (52 total weeks of treatment), and a 4-week safety follow-up period. an approximate total of eligible 207 participants will be randomized to one of the three treatment groups - 1. tak-279 dose 1 2. tak-279 dose 2 3. placebo the maximum study duration per participant is approximately 60 weeks, including up to 30 days for the screening period, a 12-week randomized and double-blinded induction treatment period, a 40-week open-label treatment period, and a 4-week safety follow-up period.

Eligibility criteria:
inclusion criteria: 1. male or female aged 18-75 years old with diagnosis of uc for at least 30 days. in south korea, the age requirement for adult participants is ≥19 years of age. 2. confirmed diagnosis of moderately to severely active uc assessed by mms and es. 3. participants with a history of inadequate response to, loss of response to, or intolerance to one or more of conventional, biologic or advance therapies for uc. 4. participants must meet the contraception recommendations. exclusion criteria: 1. participants with indeterminate/unclassified inflammatory bowel disease (ibd), microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of crohn's disease (cd). 2. participants with complications of uc such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study. 3. participants with a current ileostomy or colostomy. participants who had a j-pouch are excluded, as a j-pouch could result in a stoma. 4. participants who have failed 3 or more classes of advanced therapies.

Keywords: drug therapy latitude uc, latitude research program
assess incidence of deep vein thrombosis(dvt)following administration of recombinant human antithrombin (rhat) to hereditary antithrombin(at) deficient patients in high risk situations.

Conditions: Antithrombin Deficiency, Congenital

Summary: patients with hereditary antithrombin (at) deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. the trial is focusing on patients with confirmed hereditary antithrombin deficiency who are undergoing a surgical procedure or induced/spontaneous labor and delivery. the study will test the safety and efficacy of recombinant human antithrombin (rhat) by infusing rhat prior to, during and following the period of risk or surgical procedure.

objectives : 1. assess the safety of recombinant antithrombin (rhat) in hereditary antithrombin (at) deficient patients. 2. assess the incidence of acute deep venous thrombosis(dvt) alone in patients with hereditary antithrombin (at) deficiency in situations usually associated with a high risk for thromboembolic events after increasing and targeting functional at activity at \>80% and \< 120% of normal by prophylactic iv administration of rhat. 3. clinically assess and determine the relevance of thromboembolic events other than acute dvt to rhat administration.

Eligibility criteria:
inclusion criteria: * have congenital at deficiency with a personal or family history of venous thrombotic events. * have a history of congenital at deficiency that includes 2 or more plasma at activity levels of ≤ 60% normal. * are scheduled to have an elective procedure known to be associated with a high risk for occurrence of deep venous thrombosis (dvt). this will include surgical patients or pregnant patients scheduled for cesarean section or delivery induction. in addition, hospitalized pregnant hd patients in active labor will be allowed into the study. * are at least 18 years of age, not exceeding 70 years of age. * have signed an informed consent form. * have a negative serum pregnancy test at screening and negative urine pregnancy test at baseline. this only applies to female surgical patients (not scheduled for cesarean section) of childbearing potential. * are able to comply with the requirements of the study protocol. exclusion criteria: * patients who have a diagnosis of hereditary apc resistance, factor v leiden, protein s or c deficiency, prothrombin gene mutation (g20210a), or acquired (lupus anticoagulant) thrombophilic disorder. * patients who are scheduled for a neurosurgical procedure or open-heart surgery. * patients who have an underlying medical condition, which in the opinion of the investigator, could complicate the assessment of the incidence of dvt. * patients who have a known allergy to goats or goat products. * patients who have participated in a study employing an investigational drug within 30 days of the start of their participation in the current trial. * patients using fondaparinux sodium, or are expected to be treated with fondaparinux sodium during the study period.

Keywords: antithrombin deficiency, congenital antithrombin iii deficiency
spot-check noninvasive hemoglobin (sphb) clinical validation

Conditions: Anemia; Healthy; Pediatric ALL

Summary: the purpose study is to report on the accuracy of noninvasive hemoglobin (sphb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.

the primary objective of this clinical investigation is to report on the accuracy of the rad-67 and dci mini sensor to measure sphb as compared to hemoglobin measurements obtained from a manual hicn analytical method and automated beckman coulter laboratory hematology analyzers.

Eligibility criteria:
inclusion criteria: * age: greater than one month * weight: greater than or equal to 3kg * the subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study exclusion criteria: * subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (dfu) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc. * subjects deemed not suitable for the study at the discretion of the investigator * subjects unlikely to be able to refrain from excessive motion during data collection. excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc. * decision-impaired adult and pediatric subjects who are unable to give consent and assent
susceptibility-guided therapy for helicobacter pylori infection treatment

Conditions: Helicobacter Pylori Infection

Summary: this multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on hp drug resistance mutation gene detection (multiple pcr method), individualized regimens based on hp traditional drug sensitivity testing (e-test method) and empirical regimens in the helicobacter pylori treatment.

this multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on hp drug resistance mutation gene detection (multiple pcr method), individualized regimens based on hp traditional drug sensitivity testing (e-test method) and empirical regimens in the treatment of helicobacter pylori in patients with chronic gastritis. this study will compare the efficacy of individualized and empirical drug sensitivity regimens, and conduct cost-effectiveness analysis to provide pharmacoeconomic guidance for clinical decision-making. at the same time, it will provide reference for the reasonable pricing of h.pylori drug sensitivity test and considering the health benefits brought by its inclusion in medical insurance.

Eligibility criteria:
inclusion criteria: * participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (icf). * 18-75 years old on the day of signing the icf. * helicobacter pylori infection confirmed by 13c-urea breath test or rapid urease test. exclusion criteria: * patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases. * subjects or guardians refused to participate in the trial. * alcohol and/or drugs abuse (addiction or dependence) or poor compliance with doctor's judgment. * have taken antibiotics, bismuth, proton pump inhibitors or chinese traditional medicine 4 weeks before treatment. * pregnant or lactating women. * active peptic ulcer. * allergic to drugs used in the trial. * any other circumstances that are not suitable for recruitment.
comparison study of letrozole alone or letrozole with zoledronic acid in early breast cancer, neoadjuvant therapy

Conditions: Breast Cancer

Summary: this study is to measure the extent of tumor shrinkage when letrozole and zoledronic acid are given before surgery to newly diagnosed post-menopausal women with early breast cancer


Eligibility criteria:
inclusion criteria * postmenopausal women * newly diagnosed with non metastatic breast cancer * candidate for mastectomy or breast-conserving surgery exclusion criteria * patients with invasive tumors * patients receiving anti-cancer treatment * patients who have undergone surgery other protocol-defined exclusion criteria may apply.

Keywords: neoadjuvant, postmenopausal women, breast cancer, hormonal therapy, bisphosphonate
identification of metabolic phenotypes associated with melanoma metastasis

Conditions: Melanoma (Skin)

Summary: the goal of this study is to observe metabolic features associated with human melanoma tumors.

this is a single center, correlative study designed to assess metabolic features of melanoma tumors in patients. the study will involve the collection of melanoma tissue at the time of surgical biopsy or excision. all samples will be assessed by mass spectrometry for metabolomic analysis. a subset of patients will have received \[u-13c\]glucose infusions which will be utilized for isotope tracing metabolic analysis. relevant clinical data (eg survival, metastasis) will be correlated with metabolic findings.

Eligibility criteria:
inclusion criteria: * patients with known or probable malignant melanoma lesions requiring surgical biopsy or excision. * subjects of all races and ethnic origins over age 18. exclusion criteria: * not a surgical candidate * poorly controlled diabetes
a comparative study of an innovative 3-lead wireless water resistant holter system and a conventional holter system

Conditions: Cardiac Arrhythmia

Summary: holter monitoring is one of the most widely used diagnostic methods to detect cardiac arrhythmias. newer holter monitors may provide some advantages over the more traditional ones. this study will compare the findings of a holter exam using an innovative 3-lead wireless water resistant device with a conventional device.

the 24-hour ambulatory electrocardiography, commonly known as holter monitoring, is a diagnostic method to correlate clinical symptoms with cardiac arrhythmias. the holter monitor records electrical signals from the heart using electrodes attached to the chest, which are connected via cables to a digital recorder. in addition to the device to record the cardiac electrical signals, the holter system also has a software for review and analysis of the record. the software of the holter system has an integrated automatic analysis process to detect different sorts of heart beats, rhythms, etc, which are then validated by a technician and a physician. the success of the automatic analysis depends of the quality of the captured electrical signals, which are dependent on the appropriate attachment of the electrodes/cables to the patient body. therefore, inappropriately attached electrodes/cables can result in electromagnetic disturbance that can interfere with the ecg signal, resulting in a very noisy record that is hard to be analysed. newer holter systems that eliminate the cables and attach the recorder directly to the electrodes positioned in the patient´s chest might reduce the electromagnetic disturbance in the ecg signal capture and, therefore, improve the quality of the exam. this study will compare the findings of a holter exam using an innovative 3-lead wireless water resistant device with a conventional device.

Eligibility criteria:
inclusion criteria: * any individual who has an indication of 24 hours holter monitoring and is referred to the arrhythmia clinic of the instituto dante pazzanese de cardiologia exclusion criteria: * refusal to provide written informed consent
evaluation of efficacy of botulinum toxin a plus oral tadalafil 5 mg in diabetic men with erectile dysfunction

Conditions: Erectile Dysfunction With Diabetes Mellitus

Summary: study is aiming to evaluate safety, efficacy and durability of intracavernosal injection (ici) of botulinum toxin a plus oral tadalafil in controlled diabetic men with refractory erectile dysfunction.

total of (32) male patients will be included in this study and will be recruited from the andrology, sexology \& stds outpatient clinics- faculty of medicine -cairo and aswan universities. all those patients are complaining of erectile dysfunction unresponsive to approved pharmacological treatments. each patient will have an informed consent obtained prior to conducting the study. all patients will be subjected to the following: * history taking. * clinical examination (general and local genital examination). * international index of erectile function (iief-5) before and after treatment (rosen et al., 2002). * erection hardness score (ehs) before and after treatment (mulhall et al., 2006). * global assessment questionnaire after treatment (giuliano et al., 2007). * all patients will be examined by duplex doppler ultrasonography in the basal condition and after the induction of penile erection with the assistance of an intracavernous injection of alprostadil 20 μg/ml. * all patients will receive single dose of ici of 100u of (btxa) combined with 5mg oral tadalafil once daily for 3 months. * the subjects will be re-examined and international index of erectile function (iief-5), erection hardness score (ehs)and penile color doppler ultrasound with pge-1 injection will be done at 6 and 12 weeks from the start of therapy in addition to global assessment questionnaire will be done at 12 weeks from the start of therapy \* procedure * the patients will lied down in supine position. after cleansing the skin with alcohol, intracavernosal injection of single dose 100u (btx-a) diluted in isotonic saline 2cm proximal to coronal margin at right and left sides will be performed and the injection site will be pressed directly for two minutes. to prevent systemic toxicity, a veno-occlusive ring will be used at the base of the penis at the time of injection and will be kept in place for 15 minutes after injection.

Eligibility criteria:
inclusion criteria: * adult controlled diabetic married men who proved to be vasculogenic ed by penile duplex. * men who had shown an insufficient response for at least 3 months to the registered pde5-is at the highest approved dose, either on-demand or daily, or to pge1 icis. * severe erectile dysfunction (erection hardness score ≤ e3 after intracavernosal injection of pge-1). exclusion criteria: * men who had cardiovascular disease interfering with sexual activity. * men with history of an unstable psychiatric conditions * presence of penile anatomical abnormalities that would significantly impair erectile function. * history of spinal or pelvic radical surgery.
multicenter comparison of interictal hfo as a predictor of seizure freedom

Conditions: Epilepsy Intractable

Summary: in drug-resistant focal epilepsy, interictal high frequency oscillations (hfo) recorded from intracranial eeg (ieeg) may provide clinical information for delineating epileptogenic brain tissue. the ieeg electrode contacts that contain hfo are hypothesized to delineate the epileptogenic zone; their resection should then lead to postsurgical seizure freedom. we test whether our prospective definition of clinically relevant hfo is in agreement with postsurgical seizure outcome. the algorithm is fully automated and is equally applied to all datasets. the aim is to assess the reliability of the proposed detector and analysis approach.

we use an automated data-independent prospective definition of clinically relevant hfo that has been validated in data from two independent epilepsy centers. in this study, we combine retrospectively collected datasets from 9 independent epilepsy centers. the analysis is blinded to clinical outcome. we use ieeg recordings during nrem sleep with a minimum of 12 epochs of 5 minutes of nrem sleep. we automatically detect hfo in the ripple (80-250 hz) and in the fast ripple (250-500 hz) band. there is no manual rejection of events in this fully automated algorithm. the type of hfo that we consider clinically relevant is defined as the simultaneous occurrence of a fast-ripple and a ripple. we calculate the temporal consistency of each patient's hfo rates over several data epochs within and between nights. patients with temporal consistency \< 50% are excluded from further analysis. we determine whether all electrode contacts with high hfo rate are included in the resection volume and whether seizure freedom (ilae 1) was achieved at ≥2 y follow-up. applying a previously validated algorithm to a large cohort from several independent epilepsy centers may advance the clinical relevance and the generalizability of hfo analysis as essential next step for use of hfo in clinical practice.

Eligibility criteria:
data as provided from the participating center
to compare efficacy and safety of ct-p39 and eu-approved xolair in patients with chronic spontaneous urticaria

Conditions: Chronic Spontaneous Urticaria

Summary: a double-blind, randomized, active-controlled, parallel group, phase 3 study to compare efficacy and safety of ct-p39 and xolair in patients with chronic spontaneous urticaria who remain symptomatic despite h1 antihistamine treatment

ct-p39, containing the active ingredient omalizumab, is a recombinant humanized monoclonal antibody that is being developed and manufactured as a proposed biosimilar to xolair (omalizumab) by the sponsor. ct-p39 is identical to xolair with respect to concentration and presentation. the 150 mg of drug product (ct-p39) will have the same pharmaceutical form and strength as 150 mg xolair (in a prefilled syringe \[pfs\] for subcutaneous injection) and is intended to have a similar quality profile compared with xolair.

Eligibility criteria:
inclusion criteria: * diagnosed with csu * diagnosed as csu refractory to h1-antihistamine exclusion criteria: * chronic urticaria with clearly defined underlying etiology * clinically significant allergic reaction and/or hypersensitivity to any component of omalizumab * history of anaphylactic shock * history of and/or concomitant immune complex disease (including type iii hypersensitivity) * parasitic diseases or colonization on stool evaluation for ova and parasites * unable to receive background therapy with protocol-defined antihistamines or contraindicated to epinephrine

Keywords: chronic spontaneous urticaria
the effect of agomelatine or fluoxentine on heart rate variability in patients with major depressive disorder

Conditions: Depressive Disorder, Major

Summary: phase advance of hrv will be anticipated in agomelatine group. it is anticipated that both agomelatine and floxentine will increase hrv at the end of the treatment.

phase advance of hrv will be anticipated in agomelatine group. it is anticipated that both agomelatine and floxentine will have equal efficacy in improvement of depressive symptoms and increasement of hrv at the end of the treatment.

Eligibility criteria:
inclusion criteria: * asian patients * male or female * 18 to 65 years outpatients * dsm-iv-tr criteria for major depressive disorder exclusion criteria: * patients with cardiac conditions and other physical conditions contraindicated for drug study * shift worker * patients known to be non-responders to fluoxetine treatment * pregnancy, or breastfeeding

Keywords: agomelatin prozac heart rate variability major depression sleep depressive symptoms
a pilot trial of acute n-acetylcysteine effects on working memory and other cognitive functions in schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the effects of the amino acid supplement n-acetylcysteine versus placebo on working memory and other cognitive functions in persons with a diagnosis of schizophrenia.

working memory impairment in schizophrenia is produced by deficiencies of feedback inhibition of glutamate release, due to low cysteine-glutamate antiporter activity. because of this mechanism, we are interested in whether acute administration of n-acetylcysteine will improve performance of patients with schizophrenia on a battery of cognitive tasks utilized to test working memory and other cognitive domains, versus placebo. this pilot study will utilize a randomized, double blind, placebo controlled, crossover design.

Eligibility criteria:
inclusion criteria: * subjects will be between 18-60 * meet diagnostic and statistical manual-iv (dsm) criteria for schizophrenia * be on a stable dose of antipsychotic medication for at least 1 month * be deemed clinically stable for 3 months by the regular clinical staff exclusion criteria: * current substance or alcohol abuse * pregnancy * clozapine treatment * known sensitivity to sulphur containing compounds * previous diagnosis of mental retardation * nitroglycerin use * asthma diagnosis, verified and treated by a primary care doctor * use of any other medication that may interact with the study medication

Keywords: schizophrenia working memory n-acetylcysteine