cyrilzakka/clinical-trials huggingface dataset:
Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan

The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in postoperative supraventricular tachyarrhythmias.


Eligibility Criteria:
Inclusion Criteria:

1. 20 years or older
2. Postoperative supraventricular tachyarrhythmias
3. Within 7 days postoperatively
4. Other inclusion criteria as specified in the protocol

Exclusion Criteria:

1. Acute myocardial infarction (within 1 month after onset)
2. Severe heart failure \[New York Heart Association (NYHA) functional class III or higher\]
3. Atrioventricular block (grade II or higher), or sick sinus syndrome
4. Other exclusion criteria as specified in the protocol
Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion

The ureteral access sheath (UAS) is an ancillary device widely used by urologists to facilitate fast, repeatable, and safe access to ureters and collecting systems; improve visibility; reduce the risk of infection by reducing intrarenal pressure; and protect ureters and scopes when extracting multiple stones during surgery.

Insertion of ureteric access sheath may be difficult due to tight ureter, so sometimes preoperative stenting might be needed. Silodosin is an α1A adrenoceptor with high affinity and selectivity for the ureteric muscle, which may reduce ureteral spasm.

Oral a1-blockers can reduce intraureteral pressure, and may reduce maximal ureteral access sheath insertion force.¹ Preoperative silodosin protects against significant ureteral injury related to UAS insertion during fURS and decreases postoperative pain level. Silodosin premedication might be an effective and safe technique to replace prestenting.²


Eligibility Criteria:
Inclusion Criteria:

* All patients with renal stones who will undergo flexible ureteroscopy and planned for using ureteral access sheath

Exclusion Criteria:

* Paediatric age group (less than 18 year)
Study on the Dose-response Relationship of Pharmacodynamic Parameters in Patients With Hemophilia With Inhibitors

Randomized, double-blind, single-dose, 5 ways crossover, exploratory clinical trial evaluating four different doses of AryoSeven (eptacog alfa, activated) and NovoSeven on selected pharmacodynamic parameters in patients with hemophilia with inhibitors.

Randomized, double-blind, single dose, 5 ways crossover, clinical trial evaluating four different doses (10 µg/kg, 30 µg/kg, 90 µg/kg, and 270 µg/kg) of AryoSeven (recombinant human FVII activated or eptacog alfa, activated) and one dose of NovoSeven (30 µg/kg) on selected pharmacodynamic parameters (PD) \[Primary: Thrombin Generation Assay (TGA)\] in male adult and adolescent (\>12 years) patients with hemophilia A or B, with an inhibitors titer \>5 Bethesda Units \[BU\] and not in bleeding status. This will be an exploratory study to evaluate dose-response relationship of PD markers as surrogate efficacy endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of congenital haemophilia A or B with inhibitors to FVIII or FIX titer \>5 Bethesda Units \[BU\]
* with \> 2 episodes of bleeding/year requiring treatment with FVII infusions, not in bleeding episode
* Male adults and adolescents (\>12 years)
* Patient informed consent has been obtained \[Patients to be enrolled must also provide voluntary written informed consent to the protocol prior to screening to be eligible for the study. For adolescents, parent/legal guardian must provide consent and, wherever possible, patient assent will also be obtained. For compromised patients, their designated proxy must provide informed consent\].
* Patients willing and able to be hospitalized prior to time of study medication administration for plasma sampling (5 times during the study).

Exclusion Criteria:

* Any other type of congenital or acquired coagulopathy, such as: liver disease (hepatitis), vitamin k deficiency, uremia, malignancy.
* Antibodies against Factor VII
* Ongoing bleeding prophylaxis regimens with AryoSeven/NovoSeven or planned to occur during the trial
* Platelet count less than 100.000 platelets/mcL (at screening visit)
* Any clinical sign or known history of arterial thrombotic event or deep venous- thrombosis or pulmonary embolism
* HIV positive with current CD4+ count of less than 200/µL
* Liver cirrhosis
* Factor VIII/IX immune tolerance induction regimen planned to occur during the trial
* Known hypersensitivity to the study medication
* Parallel participation in another experimental drug trial.
* Parallel participation in another marketed drug trial that may affect the primary end-point of the study.
* Concomitant diseases and/or medications, or any other conditions, that render the patient unsuitable for inclusion into the study in the judgement of the investigator.
Autologous Bone Marrow Stem Cells in Cirrhosis Patients

Liver cirrhosis (LC) is the end stage of chronic liver disease. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it's serious problems. The potential for stem cells in bone marrow (BM) to differentiate into hepatocytes cells was recently confirmed. Moreover, BMC transplantation has been performed to treat hematological diseases, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study we will evaluate safety and feasibility of autologous bone marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell transplantation through the portal vein in patients with decompensate cirrhosis.

BM (200 ml) will be harvested from the iliac crest according to standard procedures under general anesthesia and is collected in plastic bags containing anti coagulant. After precipitation of red blood cells, Low density mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For CD133+ cells separation the CliniMACS instrument will be used. Cells are injected via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 4 weeks, and laboratory data are analyzed for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Liver biopsy showing histological Cirrhosis, grade B or C (Child-Pugh score)
* Alkaline phosphatase between 2 X to 3X normal value
* liver Cirrhosis in Sonography study
* Incomplete response to UDCA after 6 months of treatment.
* Negative pregnancy test (female patients in fertile age)
* written consent

Exclusion Criteria:

* Presence of active hepatic encephalopathy
* Refractory ascites
* Evidences of active autoimmune liver disease (e.g. gamma globulin of more than 2 times of upper limit of normal, and ALT \> 3 times normal in patients with autoimmune hepatitis)
* Hepatocellular carcinoma or other malignancies
* sepsis
* Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
* HIV, HBV or HCV infection
* Cardiac, renal or respiratory failure
* Active thrombosis of the portal or hepatic veins
* INR\>2
Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)

This study aims to demonstrate non-inferiority of Pidogrel ® compared to Plavix ® in patients with coronary disease:

* Primary Outcome Measures: measure of platelet reactivity by VerifyNow assay after 600 mg loading dose or after the last maintenance dose (75 mg).
* Secondary Outcome Measures: Time to first occurrence of major cardio-vascular events (MACE).
* Safety Criteria: severe bleeding (GUSTO scale).

after randomization of patients in both groups (Plavix or Pidogrel), the measure of platelet activity by the VerifyNow assay, 4 to 12 hours after the loading dose of 600mg or after the last dose of clopidogrel for patients on maintenance dose. The VerifyNow assay will determine: - The PRU:-P2Y12 Reaction Units-

-% Of platelet inhibition It will be considered low responder or clopidogrel resistant patient with PRU\> 235 or %inhibition \<15%.

Monitoring of patients included in the study will take place over a period of 12 months, MACE will be notified and dated. MACE criteria are: angina, myocardial infarction, coronary angioplasty, coronary artery bypass graft, and stroke.

Each hemorrhagic event will be notified and classified according to the GUSTO scale.

Eligibility Criteria:
Inclusion Criteria:

* Male or female,
* Old (e) over 20 years
* Patients hospitalized for acute coronary syndrome (Whatever the T and troponin)
* Patients with proven coronary candidates for treatment with clopidogrel (who received a loading dose of 600mg over 2 hours and treated with 75mg / d of clopidogrel for longer than 7 days)

Exclusion Criteria:

* Patients unwilling.
* Patient participating in another study.
* Patients with cardiogenic shock
* Patient on anti GpIIbIIIa or stopped less than 72 hours before the test aggregability
* Patients scheduled for surgery in less than 6 months.
* Patients candidates for coronary angioplasty
* Patients who underwent TAC + / - bare stent fewer than 30 days.
* Patients who underwent stenting with ATC active there is less than 12 months.
* ischemic stroke older than 6 weeks.
* History of hemorrhagic stroke (any time)
* Patients on warfarin or candidates
* Patients with a different anti ADP (ticlopidine, prasugrel)
* Patients with indication for clopidogrel-cons (side effects, bleeding ...)
* Thrombocytopenia \<100000/mm3
* anemia (Ht \<30%)
* Thrombocythaemia (Ht\> 52%)
* Patients seeking treatment for an elective forms of Clopidogrel.
* Pregnancy
Tympanoseal Clinical Study

The purpose of this investigational study is to assess the ability of Tympanoseal (sodium/calcium alginate), an investigational device, to act as a scaffold during healing of the tympanic membrane. Tympanoseal is intended for use following removal or extrusion of indwelling tympanostomy tubes or traumatic injury of the tympanic membrane.

This study will provide data on the safety and the ability of sodium/calcium alginate gels to act as a scaffold capable of occluding a tympanic membrane perforation over the duration of complete healing. Tympanoseal could be used in cases where cartilage or fat graft tympanoplasty would be indicated.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients over 2 years of age at enrollment
2. Documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane.
3. Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian and ability for subject to comply with the requirements of the study

Exclusion Criteria:

1. Active otorrhea or otitis media
2. Otorrhea or otitis media within 4 weeks prior to the operation
3. History of cholesteatoma
4. Perforations on the edge of the tympanic membrane
5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
6. Subject is taking systemic/oral corticosteroids
7. Subject will require the continued use of any type of topical otic medication to the ear(s) with Tympanoseal
The Effect of Patient Cost-Sharing on Antidepressant and Adjunctive Therapy Use

The primary objective of this study is to measure the effects of patient cost-sharing on the initiation of adjunctive treatment and subsequent healthcare utilization and expenditures among a population of commercially insured adults on antidepressant therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged 18-64) will be selected from the MarketScan Commercial Database between January 1, 2004, and September 30, 2008, if they have at least two medical claims with a diagnosis of depression and at least one prescription fill for an antidepressant medication.

Exclusion Criteria:

* Patients who have any claim with a diagnosis of dementia, schizophrenia, delusional disorder, psychoses, pervasive development disorder, mental retardation, cerebral degenerations, Parkinson's disease, senility, manic depression, bipolar disorder, or major depressive disorder with psychotic symptoms.
The Impact of Different Relaxation Techniques on Psoriasis Patients With an Elevated Psychological Stress Level

Two mind-relaxing techniques will be applied to psoriasis patients with an elevated psychological stress profile at baseline


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of psoriasis
* adequate psychological stress profile
* access to a personal computer/ laptop/ smartphone with internet connection
* agreement to the informed consent form

Exclusion Criteria:

* other dermatological conditions which impair the life quality
* psychological disorders under psychiatric treatment
* hearing impairment
* other on-going medical studies
* pregnancy
* aliteracy
Adverse Drug Reactions With Fatal Outcome

The purpose of this study is to determine the incidence of drug-related deaths in a university hospital during the year 2015

The investigators aimed to determine the incidence of drug-related mortality of admitted patients in a university hospital during the year 2015

Eligibility Criteria:
Inclusion Criteria:

* inpatients deaths and drug-related deaths.

Exclusion Criteria:

* death patients in the emergency room, patients with a death diagnosis not available, and dead patients due to other causes non-drug related.
Preventing Maternal Depression In Head Start

Maternal depression disproportionately affects low-income and minority women, and has profound negative impacts on their children. The investigators are conducting a randomized trial of a systems approach to identify mothers at risk for depression in Head Start - a federally funded early learning program for children of low-income families - and to provide an on-site intervention to prevent or alleviate depressive symptoms; improve functioning; and, where appropriate, proactively link mothers to more definitive mental health services.

This study is one component of a series of studies that aims to develop a comprehensive system of maternal depression prevention and management within Head Start. In our March 2014 review of the CT.gov protocol, we synchronized it with our institution's IRB protocol, which had been modified based on how the individual studies within this series relate to one another. Specifically, the original IRB protocol combined two studies into one: a 'main' depression prevention trial (n=230, R01MH091871), and a small adjunct pilot aimed at referring those with symptoms of major depression to further care (n=60). Thus, the original CT.gov protocol included subjects both at risk for depression and with symptoms consistent with major depression. When the latter pilot study subsequently received external funding, we separated the two studies into two IRB protocols, and thus have adjusted our CT.gov protocol to the appropriate sample size of 230, and indicated symptoms of major depression as an exclusion criterion for the prevention trial. Because Major Depressive Episode was inadvertently listed as a primary outcome measure for the prevention trial (and PTSD and Anxiety as secondary outcome measures), we have removed them as such and listed it under 'other' outcomes, thereby aligning the CT.gov protocol with the statistical analysis plan of the original grant application and IRB protocol. Lastly, we corrected administrative errors in the study's projected end date and masking design.

Eligibility Criteria:
Inclusion Criteria:

* Family enrolled in Head Start, and child expected to attend Head Start activities for at least 6 months of the 12-month follow-up period.
* Family without imminent plans to relocate
* Mother is comfortable in English or Spanish.
* Parent/guardian who has a child that attends Head Start
* Child attending Head Start and is between the ages 0-5
* Screen positive to 2-question depression screener (PHQ2), or have a past history of depression
* Ability to provide informed consent.
* Not suicidal

Exclusion Criteria:

* High suicidal ideation
* Cognitive limitation
* Psychosis
* No known risks for depression
* Symptoms reflecting major depressive episode
Evaluating the Efficacy of a 60-day Emotion Regulation Journal

Participants randomized to the intervention group will receive a physical copy of the 60-day emotion regulation journal during the baseline meeting. Participants will also be introduced the purpose of the journal and its intended usage (i.e., daily journaling). Intervention participants will not be offered guidance or feedback on the journal after these initial instructions, in order to emulate an ad libitum usage. Control group participants will not receive any contact with the researchers outside of the planned questionnaires and to receive their journal at the two-month timepoint.


Eligibility Criteria:
Inclusion Criteria:

* (1) being 18+ years old (2) being fluent in English, (3) currently living in the Greater Victoria area, (4) self-reporting no previously diagnosed mental illness or psychiatric conditions, and (5) scoring a mean of \<4.6 on the Cognitive Reappraisal, and mean of \>3.14 on the Expressive Suppression subscales of the Emotion Regulation Questionnaire (based on previous mean data)

Exclusion Criteria:

* Scoring a mean of ≥4.6 on the Cognitive Reappraisal or a mean of ≤3.14 on the Expressive Suppression subscales of the Emotion Regulation Questionnaire, currently receiving or seeking therapy for a mental illness, a current or previous diagnosis of mental illness, or self-identifying as neurodivergent.
The Contraceptive Efficacy and Safety of an Intravaginal Acetic Acid Thermoreversible Gel on Chinese Women.

The study aims to explore the efficacy and safety of an intravaginal acetic acid thermoreversible gel in Chinese women of reproductive age, comparing it with nonoxinol gel by assessing the six-month Pearl Index and the incidence of any side effects.

Despite significant increases in the availability and effectiveness of contraceptives globally, there are few female-led devices that combine contraception and STI prevention. Previous studies suggested that acetic acid thermoreversible gel, a female targeted contraception, can regulate intravaginal ph, killing sperm and STI pathogens and protecting intravaginal probiotics. Therefore, we have developed a contraceptive gel containing 11.23 mg/g of poloxamer 407-acetic acid. To determine its contraceptive effectiveness and safety compared with the widely used nonoxinol gel, we will recruit about 240 reproductive-aged women in four centers in China and randomly allocate into two groups. During a six-month follow-up, we will compared their pregnant rates and incidence of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* 1) Aged between 20 and 45 years old;
* 2) Regular menstrual cycles (cycle length 25-35 days, menstruation lasting up to 7 days);
* 3) Have a history of pregnancy with the current partner at least once;
* 4) Currently engaging in regular sexual activity and planning to do so in the next six months (at least once a week);
* 5) Have not used hormonal contraceptive methods in the past 3 months;
* 6) Normal menstrual cycles have resumed after the removal of an intrauterine device;
* 7) Normal menstrual cycles have resumed after a previous miscarriage;
* 8) Breastfeeding women with normal menstrual cycles resumed;
* 9) No apparent gynecological abnormalities confirmed through examination, and normal cervical cytology (Pap smear grade I according to the Bethesda system);
* 10) Reliance on the investigational drug as the sole contraceptive method during the study period;
* 11) Willing to participate in this study, adhere to required follow-up visits, and voluntarily sign the informed consent form.

Exclusion Criteria:

* 1) Amenorrhoea for more than 1 month, suspected pregnancy;
* 2) Moderate to severe erosive changes in the cervix;
* 3) Vaginal cleanliness grade III or above;
* 4) Trichomonas, fungal vaginitis, and bacterial vaginosis, among other conditions, have not been cured;
* 5) Uterine prolapse of degree II or above and severe protrusion of the anterior and posterior vaginal walls;
* 6) Unexplained vaginal bleeding;
* 7) Genital tract deformities;
* 8) Malignant tumors of the genital tract;
* 9) Moderate or severe urinary incontinence;
* 10) Recurrent urinary tract infections;
* 11) History of allergy to acetic acid and/or nonoxinol.
Glycemic Stability During the Intraoperative Period Among Patients With DM Undergoing CABG Surgery

Objectives: Intraoperative glycemic stability and control among patients with diabetes mellitus (DM) undergoing coronary artery bypass grafting (CABG) surgery remains a significant concern. In this study, the intraoperative glycemic stability among diabetic patients undergoing CABG surgery was compared between patients who received an intravenous continuous insulin infusion (CII) for tight glycemic control with those who received an CII for conventional glycemic control, during the intraoperative period.

Research Design and Methods: This study implemented a quasi-experimental design with a convenience sample of 144 patients with DM undergoing CABG surgery at a major hospital in Amman, Jordan.

Objectives: Intraoperative glycemic stability and control among patients with diabetes mellitus (DM) undergoing coronary artery bypass grafting (CABG) surgery remains a significant concern. In this study, the intraoperative glycemic stability among diabetic patients undergoing CABG surgery was compared between patients who received an intravenous continuous insulin infusion (CII) for tight glycemic control with those who received an CII for conventional glycemic control, during the intraoperative period.

Research Design and Methods: This study implemented a quasi-experimental design with a convenience sample of 144 patients with DM undergoing CABG surgery at a major hospital in Amman, Jordan. Participants were randomly assigned to either a tight glycemic control group (n=72) or a conventional glycemic control group (n=72). Patients who received the tight glycemic control protocol had significantly more consistent and lower mean intraoperative BG levels than those who received the conventional glycemic control protocol. The tight glycemic control protocol resulted in significantly lower BG levels and fewer variations across each time-point and more consistent and stable BG levels than the conventional glycemic control protocol.

Eligibility Criteria:
Inclusion Criteria:

* adult Jordanian patients
* diagnosed with DM
* who had been scheduled to CABG surgery

Exclusion Criteria:

* Participants who were immunosuppressed were excluded from the study.