cyrilzakka/clinical-trials huggingface dataset:
Enhancing Donated After Cardiac Death (DCD) Utilization With Thrombolytic Therapy

We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.

The waiting list for kidney and liver transplantation continues to increase in the United States, and therefore the need grows for additional donor organs. Utilization of organs donated after cardiac death (DCD) could be one way to increase organ availability, however there are risks associated with poorer clinical outcomes, including delayed graft function and in livers specifically, ischemic-type biliary strictures (ITBS). We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older
* Subjects willing/able to provide written consent
* Subjects willing/able to comply with study requirements
* Subjects who will receive a solitary organ transplant

Exclusion Criteria:

* Subjects requiring multi-organ transplants
* Women who are pregnant
* Subjects with current severe systemic infection
* Subjects with an active infection
Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants Above 19 Years of Age With Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective oral venetoclax is in participants with AML . Adverse events and change in disease activity will be monitored under routine clinical practice.

Venetoclax is an approved drug for treatment of Acute Myeloid Leukemia (AML). Around 600 participants of age 19 years and above will be enrolled in the study in multiple medical institutions across South Korea.

Participants will receive oral venetoclax tablets as prescribed by their physician in the routine clinical practice. Participants will be observed for 7 cycles ( each cycle is 28 days).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

--Acute Myeloid Leukemia (AML) participants who have been prescribed oral Venetoclax tablets for the first time according to the approved label.

Exclusion Criteria:

* Participants with contraindications to Venetoclax as listed on the approved local label.
* Participants receiving Venetoclax in clinical trials.
Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with essential tremor (ET).

This study is evaluating a new technique for performing Thalamotomy for tremor control. While current techniques have possible invasive or radiation effects, the use of ExAblate if totally non-invasive and without any radiation. After informed consent and screening, eligible subjects will be undergo an ExAblate treatment. All subjects will be followed at 1 day, 1 week, 1, 3, 6 and 12 months and for up to 5 years as directed by their doctor.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, age 22 years and older
* Subjects who are able and willing to give informed consent and able to attend all study visits
* Subjects with a diagnosis of Essential Tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder
* Subject exhibits a significant disability from their ET despite medical treatment
* Subjects should be on a stable dose of all ET medications for 30 days prior to study entry
* Subject is able to communicate sensations during the ExAblate Transcranial procedure

Exclusion Criteria:

* Subjects with unstable cardiac status
* Severe hypertension
* Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
* Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function
* Significant claustrophobia that cannot be managed with mild medication
* Current medical condition resulting in abnormal bleeding and/or coagulopathy
* Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
* History of intracranial hemorrhage
* History of multiple strokes, or a stroke within past 6 months
* Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
* Are participating or have participated in another clinical trial in the last 30 days
* Subjects unable to communicate with the investigator and staff
* Subjects with a history of seizures within the past year
* Subjects with brain tumors
Environmental Factors and the Gut Microbiome - Endocannabinoid Axis

The general objective of this project is to investigate the interplay of the gut microbiome - endocannabinoid axis with host environmental factors and intestinal, metabolic and mental health status in free-living adults with various metabolic statuses and lifestyles.

The gut microbiome and the endocannabinoid system (ECS) could be interacting together and influence local enteric and peripheral metabolic functions and mental health.

The association of some host environmental factors (e.g. age, metabolic status, dietary habits) with gut microbiota composition and function has been investigated but, to our knowledge, little is known about their influence on the ECS.

There is also a need to better understand the influence of these factors and the interplay between the gut microbiota and the ECS and their relationship with intestinal, metabolic and mental health.

The investigators therefore propose to fill this knowledge-gap in the general population of adults with various body composition, dietary habits and daily physical activity levels.

Eligibility Criteria:
Inclusion Criteria:

* Computer and internet access
* Understanding of written French

Exclusion Criteria:

* Intestinal pathologies
* Pregnancy or breast-feeding
* Recent significant weight variations
* Recent completion of antibiotic treatment
* Alcohol consumption over sex-specific recommendations
Improvement of Executive Functions With the CO-OP Method in the Adult Subject After Stroke

The research focuses on top-down intervention approaches and more specifically on the Cognitive Orientation to daily Occupational Performance (CO-OP) method in the rehabilitation of executive function disorders in adult post-stroke subjects in chronic phase. The main objective of this study is therefore to improve performance in significant activities of daily living for people with chronic post-stroke dysexecutive disorders.

Today, approaches to intervention with adults after stroke can be categorized into two groups: bottom-up approaches (neurodevelopmental, sensory integration, mental imagery, cognitive stimulation, perceptual-motor/kinesthetic training...) and top-down approaches (task-oriented approach, neuromotor task training, occupational performance coaching, the CO-OP approach). Although bottom-up intervention approaches have existed for several years longer than top-down approaches, in general, top-down intervention approaches have shown better results.

In the latest work with post-stroke adults with objective cognitive impairment, the data indicate the relevance of CO-OP in improving performance and satisfaction, attention, inhibition and flexibility or apathy.

This study aims to demonstrate the effectiveness of the CO-OP approach in adult post-stroke patients in chronic phase, specifically on planning function, through the Single Case Experimental Design methodology by randomized intervention (3 patients) over 6 weeks of treatment and 10 weeks of evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Stroke responsible for a dysexecutive syndrome authenticated by the GREFEX battery
* Stroke more than 6 months old (chronic phase)
* Social security affiliation
* Signing of a free and informed consent following clear and detailed information.

Exclusion Criteria:

* Disorder of comprehension objectified by the - LAnguage Screening Test (LAST) (minimum score 4/8 in expression and 6/7 in comprehension)
* Significant anosognosia of dysexecutive syndrome
* Pregnant women
* Neurological condition other than stroke or psychiatric disorder
* Patient following a rehabilitation with a liberal therapist targeting executive functions during the period of participation in the study.
Enhancing Quality of Life for Nursing Home Residents

Many persons with dementia exhibit behaviors that caregivers find difficult to manage. The purpose of this study is to test the effectiveness of individualized recreational activities for reducing agitation and passivity in persons with dementia.

Most persons with dementia exhibit behavioral symptoms, such as agitation and passivity, at some time in the course of their illness. These behaviors are a source of caregiver burden and often precipitate nursing home placement. There are a number of drugs that can be used to treat these behaviors, but they are costly and have serious adverse effects in a sizable number of people. Non-drug interventions, such as recreational activities, are recommended as the first line of treatment for behavioral symptoms. However, we don't know which activities are most effective for individual residents. The "one size fits all" approach has not been very effective. We are testing an approach that individualizes activities for residents based on their personality style of interest and functional level. We anticipate that this approach will be more effective for reducing behavioral symptoms than routine activities given to all residents. Consenting residents are assessed for personality and functional level and are videotaped during a baseline period and during activities so we can reliably measure behaviors, affect and engagement.

Eligibility Criteria:
Inclusion Criteria:

* English speaking; diagnosis of dementia; a willing informant who knows the subject well and who can provide past personality and other data; a stable dose of any psychoactive drug from pre-baseline through final observation; and presence of agitation or passivity.

Exclusion Criteria:

* delirium or an unstable medical condition; history of Parkinson's disease, Huntington's disease, seizure disorder, stroke, alcoholism, drug abuse, head trauma with loss of consciousness, or psychiatric illness preceding the onset of memory loss; severe vision or hearing impairment; and receiving a new psychoactive medication within the past 30 days.
Best Therapy for Patients With Neuroendocrine Tumors

A prospective observational study containing three arms comprising different therapeutic measures to treat patients with neuroendocrine tumors in advanced stages. The therapy arms include local ablative therapy such as TACE or SIRT, surgery and RFA with peptide receptor radiotherapy.

Study design:

Prospective observational study comparing ablative measures as TACE or SIRT with surgery/RFA and with peptide receptor radio-therapy in patients with advanced well-differentiated neuroendocrine tumors with lymph node or distant metastases (N1, M1) Prospective evaluation Primary end points: time to progression Secondary end points: survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index) Non-randomized cohort study Number of patients needed in all groups: 70 per group, 210 overall Evaluation of response to therapy every 3-6 months by imaging, clinical status, weight, quality of life, Karnofsky-index Cross-over allowed if therapy changes

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven neuroendocrine tumor (WHO class I-II, TNM grading 1-2)
* Advanced disease with lymph node or distant metastases (N1, M1) undergoing cytoreduction by surgery/local ablative therapy or peptide receptor radiotherapy
* curative intent of all therapies possible

Exclusion Criteria:

* Undifferentiated neuroendocrine carcinoma (WHO class III, TNM grading 3)
* secondary tumor
* advanced carcinoid heart disease requiring surgery
Impact of Interval Training on Sympathetic Hyperactivity and Vascular Function

In this study, the investigators are testing the hypothesis that reduction in sympathetic activity would be greater following high-intensity interval training (HIIT) than moderate-intensity continuous training (MICT) and correspond with improvements in peripheral vascular function, and skeletal muscle function in patients with heart failure with reduced ejection fraction (HFrEF).

In this study, the investigators are testing the hypothesis that reductions in sympathetic activity would be greater following high-intensity interval training (HIIT) than moderate-intensity continuous training (MICT) and correspond with improvements in peripheral vascular function, and skeletal muscle function in patients with heart failure with reduced ejection fraction (HFrEF). To test this hypothesis patients with chronic heart failure (30 - 65 years), left ventricular ejection fraction ≤40%, Functional Classes II-III), are being randomized into exercise with HIIT, MICT or no training (NT) three times/week for 12 weeks. Muscle sympathetic nerve activity is assessed by microneurography. Brachial artery flow-mediated dilation (FMD), blood flow and vascular conductance were assessed by ultrasonography. Blood pressure (BP) and heart rate (HR) by are being measured via finger photoplethysmograph and peak oxygen uptake (V̇O2peak) by a cardiopulmonary exercise test on ergometer cycle for leg. Biopsy samples from the lateral vast of the thigh are being collected for analysis of the intracellular mechanisms in the skeletal muscle. Exercise training is being conducted under supervision at the Heart Institute, School of Medicine, University of São Paulo. Both HIIT and MICT are performed on a cycle ergometer, three times per week for 12 weeks, and training sessions were matched for energy expenditure (i.e., an isocaloric energy expenditure of 200 Kcal/session). The intensity of the MICT session is established based on the HR and workload levels corresponding to anaerobic threshold and respiratory compensation point (RCP). The intensity of the HIIT session is established based on the HR and workload levels corresponding to 5% above the RCP. All exercise sessions were performed under the supervision of an exercise physiologist. The patients in the NT group were instructed to avoid any regular exercise program or any non-supervised exercise protocol during the study. All patients are being assessed before (pre) and after (post) both exercise training modes or control, no training.

Eligibility Criteria:
Inclusion Criteria:

* Functional Class II to III of New York Heart Association
* Left ventricular ejection fraction ≤40%
* Peak oxygen uptake (V̇O2) \<20 ml•kg-1•min-1

Exclusion Criteria:

* Myocardial infarction within three months
* Unstable angina
* Acute heart failure
* Pacemaker
* Pulmonary disease
* Chronic renal disease
* Peripheral neuropathy
* History of stroke
* Untreated hypo/hyperthyroidism
* Body mass index (BMI) \>30 kg/m2
* History of smoking
Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)

The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07_001CR (NCT01458171).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed the preceding follow-up study ZLB07_001CR.
* Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years and \<20 years of age at the time of obtaining informed consent), according to the competencies of the subject.

Exclusion Criteria:

* Pregnancy or nursing mother.
* Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for study ZLB07_001CR.
* Subjects who are planning to donate blood during the study.
* Known or suspected antibodies to the IMP, or to excipients of the IMP.
* Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.
Evaluation of Ion Releasing Hybrid Restorative Material

Esthetic and mechanical evaluation of calcium and phosphate releasing hybrid restorative material and fluoride releasing hybrid restorative material versus the conventional nanofilled resin composite in proximal carious lesions over 1 year follow-up according to the USPHS criteria.

3 groups of 45 patients will receive class II restorations by using calcium and phosphate releasing hybrid restorative material (Activa Presto), fluoride releasing hybrid restorative material (Giomer), and conventional nanofilled resin composite. Then these restorations evaluated at 24 hours after placement, 1 month, 3 months, 6 months and 12 months according the modified USPHS criteria in terms of fracture, marginal adaptation, retention, anatomic form, marginal discoloration, surface texture, and color match.

Eligibility Criteria:
Inclusion Criteria:

* Patient-related criteria:

  * Patients consulting in one of the outpatient clinics listed above.
  * Patients can tolerate necessary restorative procedures.
  * Provide informed consent.
  * Patients accept the one year follow-up period.
  * Patients are within middle age group (25-40years).
  * Cooperative patients.
  * Patients don't have any medically compromised conditions.

Tooth related criteria:

* Teeth with primary proximal carious lesions in posterior teeth with no pulpal involvement.
* Teeth should have contact with the adjacent teeth.
* Teeth are vital according to pulp-sensitivity tests.
* No active gingival or periodontal conditions.

Exclusion Criteria:

* • Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.

  * Pregnant women; as radiographs are prohibited.
  * Allergic Patients to any of the restorative materials, including anesthetics.
  * Uncooperative patients will not follow the instructions or attend the appointments.

Tooth related criteria:

* Retained deciduous teeth; as the research is targeting only permanent teeth.
* Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
* Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests) indicating irreversible pulpitis.
* Negative sensitivity tests, periapical radiolucencies, and sensitivity to axial or lateral percussion indicating pulp necrosis.
* Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study.
* Teeth with cervical caries; which can't be evaluated on periapical radiographs.
Measuring Beliefs and Norms About Violence Against Women

The objective of our study was to determine the extent to which contextual information about the circumstances of intimate partner violence affects participants' responses to questions about their personal attitudes toward intimate partner violence.

In national studies conducted throughout sub-Saharan Africa, survey data indicate that there is widespread acceptance of intimate partner violence by both men and women (Alio et al., 2011, Mann \& Takyi, 2009, Rani et al., 2004, Uthman et al., 2009). For women, the proximate context of gender-unequal norms has important public health impacts. Men who report beliefs consistent with gender-unequal norms are more likely to be perpetrators of sexual violence (Shannon et al., 2012). Women are more likely to be victimized when they and their partners report concordant beliefs about the acceptability of intimate partner violence (Alio et al., 2011). And finally, women who live in areas characterized by gender-unequal norms about intimate partner violence are at greater risk for having their reproductive health compromised (Hung et al., 2012, Tsai \& Subramanian, 2012). Accurate measurement of norms about intimate partner violence therefore has important implications for understanding the health risk environment for women.

The Demographic and Health Surveys (DHS), which are nationally representative surveys conducted worldwide, have served as an important source of information on norms about intimate partner violence. However, a cross-country analysis of DHS data showed that minor deviations in survey wording may account for substantial cross-country variation in the extent to which women provide survey responses consistent with acceptance of intimate partner violence (Yount et al., 2011). Furthermore, in-depth interviews conducted among Bangladeshi women suggest that affirmative responses to DHS-style questions may better reflect their perceptions of prevailing norms or their individualized assumptions about contextual details rather than true beliefs about their acceptance of intimate partner violence (Schuler \& Islam, 2008, Schuler et al., 2011). Taken together, these lines of inquiry suggest important limitations in the accuracy with which the DHS measure women's attitudes towards intimate partner violence.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older
* Emancipated minors aged 16-18 years
* Considers Nyakabare Parish their primary place of residence
* Capable of providing informed consent

Exclusion Criteria:

* Minors younger than 18 years, with the exception of emancipated minors
* Does not consider Nyakabare Parish their primary place of residence
* Unable to communicate with research staff, e.g., due to deafness, mutism, or aphasia
* Persons with psychosis, neurological damage, acute intoxication, or an intelligence quotient less than 70, as determined in the field by non-clinical research staff in consultation with a supervisor