cyrilzakka/clinical-trials huggingface dataset:
Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation

A streamlined AF ablation procedure done without PV mapping as a daycase is more effective than anti-arrhythmic drugs at reducing all hospital episodes for recurrent atrial fibrillation.

AVATAR-AF is a multicentre, randomised controlled study comparing a streamlined AVATAR-protocol ablation procedure to anti-arrhythmic therapy in patients with documented paroxysmal AF who are considered to be failing current strategy for AF. A secondary control arm will also compare the AVATAR-protocol to conventional AF ablation. 300 patients who are on no prior anti-arrhythmic, 'pill-in-pocket' or taking regular anti-arrhythmics will be randomised in a 1:1:1 manner to a treatment strategy of either AVATAR-protocol ablation, anti-arrhythmic therapy or conventional AF ablation and followed-up for 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Documented paroxysmal atrial fibrillation
2. Modification or initiation of anti-arrhythmic agent required for symptom control
3. Males or females eighteen (18) to eighty (80) years of age
4. Suitable candidate for catheter ablation
5. Signed informed consent

Exclusion Criteria:

1. Contraindication to catheter ablation
2. No carer to enable daycase discharge
3. Arrhythmias other than AF documented unless they have had curative ablation (eg. for atrial flutter)
4. No documentation of sinus rhythm within 3 months
5. Valvular or coronary heart disease needing regular follow up
6. EF \<45% or moderate/severe LV dysfunction
7. Active gastrointestinal disease
8. Renal failure with creatinine \>200 μmol/L or on dialysis
9. Active fever or infection
10. Life expectancy shorter than the trial
11. Allergy to contrast
12. Severe cerebrovascular disease
13. Bleeding or clotting disorders or inability to receive heparin
14. Uncontrolled diabetes (HbA1c ≥73 mmol/mol or HbA1c ≤64 mmol/mol and Fasting Blood Glucose ≥9.2 mmol/L)
15. Serum Potassium \[K+\] \<3.5 mmol/L or \>5.0 mmol/L
16. Malignancy needing surgery, chemotherapy or radiotherapy
17. Pregnancy or women of child-bearing potential not using a highly effective method of contraception
18. Must not have previous (4 weeks prior to screening) or current participation in another clinical trial with an investigational drug or investigational device
19. Unable to give informed consent
20. Uncontrolled thyroid disease defined as abnormal thyroid function tests causing cardiac manifestations within the last 6mths
21. Unable to attend follow up visits
Changing Talk to Reduce Resistiveness to Care

The investigators are interested in reducing problem behaviors of nursing home residents with dementia that make providing care difficult. The investigators call these behaviors resistiveness to care. Previous research has found that resistiveness to care occurs more frequently when staff use certain types of communication. An inservice program will be provided to all nursing staff in your nursing home to teach staff about communication practices to reduce resistiveness to care. The research study will see whether changing communication will reduce resident resistiveness to care. If effective, the communication training may then be used to improve care in other facilities.

By doing this study, researchers hope to learn if changing communication practices will reduce resistiveness to care in nursing home residents with dementia.


Eligibility Criteria:
Staff:Inclusion criteria for CNAs are:

* age 18 years old or greater (age of legal consent in Kansas and Missouri), signed informed consent,
* permanent employment in the NH,
* primary assignment to a specified unit,
* and English speaking
* Staff must have been assigned to care for the resident at least twice weekly in the past month (documented in NH staffing records). This will assure that staff-resident dyads have established relationships and will control effects of variability in contact between dyads during days when data are not being collected.

Resident inclusion criteria are:

* a diagnosis of Alzheimer's disease or related dementia documented in their medical records,
* documentation of daily RTC over the past week,
* and ability to hear staff communication (from the most recent MDS).

Exclusion criteria for CNAs include:

* non-English speaking,
* temporary employment, -and age under 18 years.
* If more than one CNA volunteers as a partner for a participating resident, a random selection will be made to determine which CNA will participate. Small variations in contact between staff and residents in dyads are anticipated due to PMMA policies for consistent CNA assignment to neighborhoods. Therefore dyads will have repeated contacts.

Exclusion criteria for residents include:

* diagnosis with Huntington's disease,
* alcohol-related dementias,
* schizophrenia,
* manic-depressive disorder,
* deafness,
* and mental retardation.
Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage

Intrauterine balloon tamponade (IUBT) is recommended worldwide as the second-line therapy to treat postpartum hemorrhage. While much literature demonstrates the effectiveness of this therapy, little is known about how long the IUBT should be used once placed. Though it is common to use IUBT for 12-24 hours, the balloon may be equally effective when used for shorter durations of time, which could have beneficial effects for patients and hospitals. The proposed study is a pragmatic randomized controlled trial of non-inferiority comparing two durations of time for intrauterine balloon tamponade placement, 6 and 18 hours, in controlling postpartum hemorrhage.

The specific aims of the proposed study are to determine: 1) whether quantitative blood loss significantly differs when the balloon is removed in 6 hours compared to 18 hours, 2) whether hemorrhage-related morbidity differs when the IUBT is kept in place for 6 or 18 hours, and 3) whether shorter duration of IUBT placement has beneficial effects including shortened postpartum hospital stays, improved maternal-infant bonding, and reduced postpartum pain prior to maternal discharge from hospital.

We hypothesize that, once hemorrhage control has been achieved with IUBT placement, there is no clinically significant difference in postpartum blood loss when the balloon is removed 6 hours after placement compared to 18 hours after placement.


Eligibility Criteria:
Inclusion Criteria:

* Women at Denver Health and Hospital Authority (DHHA) who have an IUBT placed for postpartum hemorrhage due to uterine atony will be approached for enrollment in the study.

Exclusion Criteria:

* Women will be excluded from the study if they: are less than 18 years of age; had a cesarean delivery; are unable to consent for themselves; have a preexisting or acquired clotting factor disorder such as von Willebrand or hemophilia, disseminated intravascular coagulation, or therapeutic anticoagulation at time of delivery; would refuse blood product transfusion; have a fetal demise or birth of a previable fetus; or are incarcerated at the time of delivery. Women who do not speak English or Spanish will be offered enrollment if a phone interpreter is available to review the consent, but will be excluded from the survey portion of the study.
Pharmacogenetic Study in Patients Received Iron Chelating Agent

To investigate effect of genetic variations on the toxicities and find optimal target population, the investigators planned to analyze the genetic polymorphisms of UDP-glucuronosyltransferase.

Transfusion-associated iron overload induces systemic toxicity. Recently, deferasirox, a convenient long acting oral agent, has been introduced in clinical practice with promising efficacy. However, some patients experience drug-related toxicities and cannot tolerate it. To investigate effect of genetic variations on the toxicities and find optimal target population, we planned to analyze the genetic polymorphisms of UDP-glucuronosyltransferase 1A (UGT1A) subfamily, multi-drug resistance-associated protein 2 (MRP2) and breast cancer resistance protein (BCRP) among pediatric patients received deferasirox.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who received deferasirox because of transfusion associated iron overload (Transfusion associated iron overload was defined as ferritin ≥ 1,000 ng/mL in patients who needed over 8 units of RBC transfusions per a year).
2. Patients with written informed consents

Exclusion Criteria:

Patients or parents refusal
Comparing the Effectiveness of Two Family-based Therapies in Treating Young Children With Obsessive-Compulsive Disorder

This study will compare the effectiveness of family-based cognitive behavioral therapy to family-based relaxation therapy in treating young children with obsessive-compulsive disorder.

Obsessive-compulsive disorder (OCD) is a type of anxiety disorder that affects approximately 1 in 200 children. Although feelings of anxiety, fear, and uncertainty are a normal part of life and growing up, for some children these feelings and emotions become chronic, relentless, and progressively worse if left untreated. OCD is characterized by obsessions, or repeated unsettling thoughts, causing a person to perform repeated actions called compulsions. Children are typically not diagnosed with OCD until they are between the ages of 8 and 12, leaving many young children undiagnosed. Additionally, no psychotherapy treatments have been designed for young children who are under the age of 8 and have OCD. The purpose of this study is to develop and evaluate a family-based treatment program for children, ages 5 to 8, who have been diagnosed with OCD.

Participants in this open-label study will be randomly assigned to receive either cognitive behavior therapy (CBT) or relaxation therapy for 12 sessions over a period of 14 weeks. All children will undergo a 3-hour screening that will include a psychiatric evaluation and the completion of questionnaires. Parents of participating children will attend the first two treatment sessions without their children during which they will be introduced to the treatment program and will learn various skills to be used throughout treatment. The other 10 1-hour sessions will be attended by both the parent and child. Participants assigned to receive CBT will learn skills to help control OCD. Education about OCD, family therapy, parent training to manage child behavior problems, and anxiety management will be included in the CBT sessions. Participants assigned to receive relaxation therapy will discuss general family functioning, issues related to OCD, and other behavioral problems the child may be experiencing. Treatment will also include education about OCD; affective education, during which participants will learn how to recognize feelings; muscle relaxation techniques; and guided imagery. Participants in both treatment groups will receive weekly homework assignments after each session to practice skills learned. Parents will also be asked to monitor their child's behavior and practice the learned skills with their child as often as possible. If treatment has not been successful after the 14-week period, the child will be offered an alternative treatment. All participants will be assessed before treatment; at 5, 9, and 14 weeks of treatment; and at 3, 6, and 12 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for OCD
* Parent willing to sign informed consent

Exclusion Criteria:

* History or current diagnosis of pervasive developmental disorder(s), thought disorder, or mental retardation
* Psychotic symptoms
Study of the Glutaminase Inhibitor CB-839 in Leukemia

Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. To exploit the dependence of tumors on glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be tested in this Phase 1 study in patients with leukemia.

This study is an open-label Phase 1 evaluation of CB-839 in subjects with leukemia. Part 1 is a dose escalation study to identify the recommended Phase 2 dose as a single agent and in combination with azacitidine. Patients enrolled into Part 2 will be treated with the recommended Phase 2 dose. As an extension of Part 2, patients with relapsed/ refractory or newly diagnosed AML will be treated with CB-839 in combination with azacitidine.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may predict responsiveness in later studies), and tumor response.


Eligibility Criteria:
Inclusion Criteria

* Diagnosis of AML or ALL, relapsed or refractory after at least 1 prior treatment regimen. Newly-diagnosed patients ≥ 60 years old who have refused or are considered unfit for standard chemotherapy regimens or stem cell transplantation are also eligible.
* Patients must have no available approved therapies that confer clinical benefit
* All patients must have bone marrow involvement of their tumor, with documented blast percentage of \> 5%.
* Peripheral blood blast count must be ≤ 30,000 cells/µL.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* Adequate hepatic, renal, and cardiac function

Exclusion Criteria

* Any other current malignancy
* Patients with acute promyelocytic leukemia (APL)
* Treatment with an unapproved, investigational agent within 21 days of the first dose of study drug
* Allogeneic hematopoietic stem cell transplant or Donor Lymphocyte Infusion within 90 days prior to to the first dose of study drug
* Active GVHD
* Unable to receive medications by mouth
* Major surgery within 28 days before Cycle 1 Day 1
* Uncontrolled, active infection; patients who are known to have HIV infection/ seropositivity, Hepatitis A, B, or C, or CMV reactivation
* Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days prior to Day 1
* Refractory nausea and vomiting or other situation that may preclude adequate absorption
* Conditions that could interfere with treatment and procedures
Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain

The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of amoxicillin/clavulanic acid combination on post-operative pain and swelling in adult patient with symptomatic apical periodontitis.

Medical and dental history will be obtained from all patients participating in this trial. Clinical and radiographic evaluation for each tooth included in this study will be recorded.

Clinical diagnosis of symptomatic apical periodontitis is to be confirmed.

After single-visit root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (taking oral tablet 1000 mg of Amoxicillin/ clavulanic acid combination) or control group (taking placebo tablet).

Each patient will receive a 7-day diary to record postoperative pain and swelling.In case of pain, the participant will be instructed to take an analgesic. Post-operative pain will be measured as a primary outcome on 11-point scale (NRS) at the following time points: 6, 12, 24, 48, 72 hours and 7 days. The occurrence of swelling will be reported by participant as a secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with symptomatic apical periodontitis who do not have evidence of spreading infection or systemic involvement.
2. Mandibular posterior teeth with positive response to percussion.
3. Patients with non-contributory systemic condition.
4. Patients who can understand pain scales and able to sign informed consent.

Exclusion Criteria:

1. Patients allergic to penicillin.
2. Patients who have a draining sinus tract.
3. Retreatment cases.
A Study to Learn How Different Amounts of the Study Medicine Called PF-07314470 Are Tolerated and Act in the Body in Healthy Adults

The purpose of this clinical trial is to learn if the study medicine (called PF-07314470) is safe and how it gets in and out of the body in healthy people.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy males aged 18 to 45 years and healthy females aged 18 to 55 years
* Body Mass Index (BMI) of 16-32 kg/m2, and a total body weight greater than 50 kg (110 lb); for Japanese participants only, a total body weight greater than 45 kg
* for Japanese participants only, enrolling as Japanese must have 4 biological grandparents who were born in Japan.

Key Exclusion Criteria:

* Evidence or history of clinically significant medical or psychiatric conditions
* Prior or current use of any prohibited medications
* History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening
* Pregnant or breastfeeding females, males with partners currently pregnant, or males or females pursuing artificial reproductive technologies
* Use of tobacco/nicotine containing products
An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma

A dose-escalation study designed to determine the safety, maximum tolerated dose (MTD), anti-melanoma activity, antibody blood levels and progression-free survival (PFS) in participants with malignant melanoma receiving IMC-20D7S either every 2 weeks or every 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participant has histologically or cytologically confirmed cutaneous, mucosal, or uveal malignant melanoma which has progressed after or during at least 1 treatment with standard cytotoxic treatment or/and immunotherapy \[for example (e.g.), treatment with cytokines, monoclonal antibodies, and vaccines\] and is not regarded to be a candidate for a potentially curative, higher priority treatment for melanoma
* Participant is ≥18 years of age
* Participant has either measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or evaluable disease
* At least 21 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. Relative to participant's treatment with non-approved biological products (eg, monoclonal antibodies), a minimum of 2 half-lives must have passed for eligibility to be considered
* Participant has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤1 according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.02 (NCI-CTCAE v4.02)
* Participant has adequate hematological function, hepatic function, and renal function

Exclusion Criteria:

* Participant has undergone major surgery \[e.g., laparotomy, thoracotomy, removal of organ(s)\] within 21 days prior to study entry
* Participant has elective or planned surgery to be conducted during the trial
* Participant has documented and/or symptomatic brain or leptomeningeal metastases
* Participant is receiving systemic steroids or other immunosuppressive medications. (Intermittent use of steroid-containing medications e.g., for asthma exacerbation or for skin lesions is permitted)
* Participant has an uncontrolled undercurrent illness
* Participant has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm
* Participant has a known allergy to any of the treatment components (monoclonal antibodies or other therapeutic proteins such as fresh frozen plasma, human serum albumin, cytokines, or interleukins). In the event that there is suspicion the participant may have allergies, the participant should be excluded
* Participant is pregnant or lactating
* Participant has known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) infection
Acute-On-Chronic Liver Failure in Zagazig University Hospitals

Rationale:

To identify the prevalence of Acute-on-chronic liver failure in Zagazig University Hospitals.

The question of the research:

How much the prevalence of Acute-on-chronic Liver Failure in Zagazig University Hospitals?

The aim of the work:

The aim of the study is to identify the presence of Acute-on-chronic Liver Failure in Zagazig University Hospitals

Objectives:

To estimate the prevalence of Acute-on-chronic Liver Failure in Zagazig University Hospitals.

Subjects and Methods:

I . Technical Design:

* Site of the study: Gastroenterology and Hepatology Unit- Zagazig University Hospitals
* Sample size: ''all patients admitted to Gastroenterology and Hepatology Unit with the criteria of ACLF according to EASL-AASLD from June 2017 to December 2017 were included in this study''.

II . OPERATIONAL DESIGN:

* Type of the study: a prospective study.
* Full medical history - taking.
* Full clinical examination.
* Laboratory investigations including Routine laboratory investigation " CBC, Liver functions test, kidney functions test and prothrombin time "

III. Administrative Design:

* Approvals obtained for performing the study from the official or governmental department.
* An ethical committee from the faculty of medicine and patients included in the study.

Results:

Collected data will be presented in tables and suitable graphs and analyzed according to standard statistical methods


Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to Gastroenterology and Hepatology Unit with the criteria of ACLF according to EASL-AASLD will be included in this study.

Exclusion Criteria:

* no any exclusion criteria
Systems Analysis and Improvement Approach for the Hypertension Care Cascade

As undiagnosed and untreated hypertension is one of the largest drivers of cardiovascular disease in sub-Saharan Africa approaches are needed to optimize the hypertension care cascade. The HIV treatment platform in low and middle income countries provides a robust, scalable foundation to address other chronic care priorities, such as hypertension. This proposal will evaluate an evidence-based intervention designed to improve chronic care services (the Systems Analysis and Improvement Approach (SAIA)) for hypertension detection and management in people living with HIV, and will build evidence on how to achieve rapid, sustainable and scalable improvements in services that can dramatically improve population health in resource-limited countries.


Eligibility Criteria:
Inclusion Criteria:

* (A1) Frontline Health Workers / Health Facility Managers currently working in outpatient, emergency or related (pharmacy, laboratory) services at one of the study clinics in Manica and Sofala provinces, Mozambique; (A2) District Health Supervisors currently employed in a study district in Manica and Sofala provinces, Mozambique regularly engaged in service provision or management of HIV-infected and/or hypertensive populations; and (A3) Clinical Experts currently working in Mozambique in the clinical delivery of HIV and/or hypertension care and treatment or (B1) People Living with HIV \>14 years old (B2) access HIV care and treatment services via outpatient/emergency services in study clinics. \>14 years is being used as the current Ministry of Health forms only use the age bounds of \<15y, \>14y and there is significant concern by the Mozambican Ministry of Health to minimize additional data collection when not absolutely necessary.

Exclusion Criteria:

* (A1) not currently working as a Frontline Health Worker/Health Facility Manager at a participating study facility or (A2) not currently working as a District Health Supervisor in a participating district or (A3) not currently working in Mozambique in the clinical delivery of HIV and/or hypertension care and treatment or (B1) HIV-negative or of unknown status or (B2) \<15 years old or age not recorded, (B3) or pregnant or postpartum.