cyrilzakka/clinical-trials huggingface dataset:
Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure

The aim of the study is to investigate whether a continuous interdisciplinary intervention improves medication adherence (primary efficacy endpoint) and leads to a reduction of hospitalizations and mortality (primary safety endpoint) in elderly patients with chronic heart failure. The intervention, consisting of regular contacts with the local pharmacy and weekly dosing aids, aims to improve medication adherence and management.


Eligibility Criteria:
Inclusion Criteria:

* Age: 60 years and older
* Chronic heart failure (CHF)
* Stable CHF medication including a diuretic
* Hospitalization for decompensated heart failure within past 12 months OR a value of ≥ 350 pg/mL for BNP or ≥ 1,400 pg/mL for NT-proBNP
* Written informed consent

Exclusion Criteria:

* Use of a weekly dosing aid
* Unwillingness or inability to visit a participating pharmacy once a week
* Planned cardiac surgery
* Life-expectancy \< 6 months
* Unwillingness or inability to comply with the study protocol (including drug abuse or alcohol dependency)
* Participation in other studies (currently or in the last 4 weeks)
Postoperative Analgesia in Laparoscopic Abdominal Surgery After Exparel Via TAP or Local Infiltration

This study evaluates differences in how administering liposomal bupivacaine via two different methods affects postoperative pain control in laparoscopic abdominal surgery patients. Half the participants will receive liposomal bupivacaine via a transverses abdominis plane block while the other half will receive liposomal bupivacaine via local infiltration.

Liposomal bupivacaine is a newer formulation of a local anesthetic that is commonly used for local infiltration, peripheral nerve blocks, and neuraxial anesthesia. This new formulation allows the effects of bupivacaine to last up to 72 hours as it is slowly released from a liposome. It is FDA approved for local infiltration and has recently been approved for interscalene blocks.

A transversus abdominis plane block is a fascial plane block that is performed routinely for postoperative pain relief for some abdominal incisions. It is performed by placing local anesthetic between the internal oblique and transverses abdominis muscle planes where it will provide analgesia to several dermatomes of the abdomen in hopes of improving postoperative pain relief and reducing postoperative opioid requirement.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective laparoscopic colorectal surgery at UWMC requiring inpatient stay

Exclusion Criteria:

* Patients on chronic pain mediations equaling or exceeding \> 25 morphine daily equivalents
* Patients allergic to bupivacaine
* Patients with ASA status IV, V, or VI
* Patients unable to consent
* Patients that are pregnant
* Patients that are incarcerated
* Patients receiving procedures in addition to laparoscopic colorectal procedure
* Patients on systemic anticoagulation precluding them from regional blocks
Extension in AS: Sustainability of Benefits, Safety and Tolerability

This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as well as to generate additional data on the sustainability of clinical benefits, safety and tolerability during long-term administration of secukinumab.


Eligibility Criteria:
Inclusion Criteria: patients having completed the "core study" CAIN457F2305, indication for treatment extension. -- Exclusion Criteria: history of hypersensitivity to secukinumab or to any drug of similar chemical classes, use of any investigational drug other than secukinumab during the "core study" CAIN457F2305.
Neural Mechanisms Underlying Alcohol Induced Disinhibition

Forty 18-year-old social drinkers will be selected from the sample tested in specific aim 1 ("Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted Self-administration of Ethanol (CASE)"; ClinicalTrials.gov identifier: NCT01063166). The functional magnetic resonance imaging blood-oxygen-level-dependent (fMRI BOLD) activity related to disinhibition measured with the Stop Signal task will be assessed during a continuous infusion of alcohol, clamping the arterial Breath Alcohol Concentration (aBAC) at 60 mg% for approximately one hour. It will be examined whether this fMRI BOLD activity is associated with the initial drinking trajectories and the alcohol consumption at age 18 and at age 20 identified in specific aim 1. Furthermore, fMRI will be used with the Taylor Aggression Paradigm to determine which brain areas mediate increased physical aggression during the same continuous infusion of alcohol as described above. All participants will undergo an alcohol and a placebo fMRI session.


Eligibility Criteria:
Inclusion Criteria:

* male and female Caucasian volunteers aged 18 years/0 months to 19 years/11 months;
* written informed consent by the subject;
* habitual social drinking during the two months preceding participation, defined by at least one drinking day in any two weeks-interval;
* at least one prior experience of alcohol intoxication
* being able to abstain from tobacco use for four hours without developing nicotine withdrawal symptoms;
* effective contraception in female participants;
* consenting to abstain from any illegal substance use for 2 weeks prior to participation;
* living within 15 km (9.5 miles) from downtown Dresden;
* sufficient information concerning alcohol use in both parents and in at least four second-degree relatives

Exclusion Criteria:

* prior medical treatment due to alcohol use;
* current or prior history of any serious disease, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, alcohol or drug dependence, but not alcohol abuse;
* current history of Axis-I psychiatric illness, including premenstrual dysphoric disorder;
* current or prior history of alcohol-induced flushing reactions;
* positive urine screen for cannabinoids, cocaine, amphetamines, opiates, or benzodiazepines;
* light or non-drinkers: averaging less than 2 standard drinks per week in the preceding two months;
* intention to become pregnant
* pregnancy or positive urine pregnancy screening or breast-feeding;
* any alcohol intake on the test day or the day before;
* use of medications known to interact with alcohol within 2 weeks of the study;
* positive hepatitis or HIV at screening, provided the subject consented to these tests
* any conditions posing safety issues with the fMRI scan, such as ferromagnetic implants, cardiac pacemakers or insulin pumps
Aquatic Exercise Study for Breast Cancer Patients With Lymphedema

The purpose of this study is to determine what effects aquatic exercise has on participants with Lymphedema.

This pilot study will examine the effectiveness of aquatic exercise in reducing Lymphedema. The study is designed for breast cancer patients who have developed Lymphedema following cancer treatment. Potential study participants should have explored conventional treatments such as decongestive therapy and lymph drainage massage before joining the study.

There are two groups that the participants may choose from until enrollment for the group has reached its capacity.The active arm of the study will attend 12 one-hour aquatic exercise classes and classes will be held in an indoor heated pool. There is no cost to the participants.Both the active arm and the control group (not attending aquatic exercise classes) will have 3 measurement assessments that will compare the circumference and volumetric measurement of arms, as well as height, weight and body mass index (BMI).

Both group will fill out a program questionnaire. Quality of life survey taken at baseline, week 6, month 6 and 12 will be compared. A follow up questionnaire will be completed at 6 and 12 month intervals, and annually for five years.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients with Lymphedema
* Patients must have received standard Lymphedema treatment (Complete Decongestive Therapy) prior to participating in the study.
* Patients undergoing treatment will require written permission from their physician
* Complete an assessment by a licensed physical therapist before beginning the exercise program
* Patients must sign a consent form to participate

Exclusion Criteria:

* Patients undergoing treatment without physician's written permission
* Patients with health problems that contraindicate exercise
* Patients are not eligible if the physical therapy assessment identifies a contraindication to participation

Inclusion of Women and Minorities:

- Men, women and minorities with breast cancer related lymphedema are eligible
STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)

Study of multimodal-imaging guided stereotactic body radiotherapy (SBRT) for ventricular tachycardia (VT) ablation.

STRA-MI-VT study is a spontaneous, open-label, not randomized, prospective clinical trial.

The objective of the study is to evaluate the safety and efficacy of SBRT in strictly selected patients with refractory VT.

Multimodal cardiac imaging combined with electroanatomic mapping to provide a specific patient's tailored SBRT treatment plan choosing amang different linear accelerators.

Eligibility Criteria:
Inclusion Criteria:

* ICD/S-ICD recipients with refractory VT
* Not eligible for conventional catheter ablation or -in alternative- that have undergone failing conventional catheter ablation attempts, refusing surgery for the treatment of the arrhythmia.
* LVEF ≥ 20%.
* Age ≥ 50 years.
* Signed an IRB approved written informed consent document.

Exclusion Criteria:

* Previous radiotherapy with cardiac involvement.
* Pregnancy or breastfeeding.
* Active myocardial ischemia.
* Acute revascularation in the past 120 days.
* Acute hemodynamic instability (cardiogenic shock/NYHA IV).
* Serious disease with presumed life expectancy less than 12 months.
* Any condition that is deemed a contraindication in the judgment of the investigators.
Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840)

This study will be performed to evaluate and document the safety and efficacy of infliximab (Remicade®) in the treatment of chronic inflammatory diseases in big cohorts in the daily routine practice of rheumatologists, gastroenterologists, and dermatologists.

The study population was chosen from a non-probability sample.

The safety population consisted of all participants with at least one documented infusion of infliximab.

The evaluable population consisted of all participants that were \>=18 years of age with a recorded indication for infliximab use, that had available baseline data, and with at least 3 infusions of infliximab within the first 16 weeks of the study. Baseline characteristics are provided for this population.

Eligibility Criteria:
Inclusion Criteria:

* Participants treated with infliximab by rheumatologists, gastroenterologists, and dermatologists for chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or Crohn's disease.

Exclusion Criteria:

* None
IOP Pattern in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After LPI

The purpose of the study is to determine the relationship of the intraocular pressure patterns recorded during 2 sessions using Triggerfish, before and after elective laser peripheral iridotomy in angle closure glaucoma patients


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Primary Angle Closure (PAC) or Primary Angle Closure Glaucoma (PACG) with indication for Laser Peripheral Iridotomy (LPI). PAC is defined by the presence of a partial or complete iridotrabecular contact(ITC) in more than 2 quadrants with either raised intraocular pressure (IOP) (ie. more than 21 mmHg) and/or PAS; however, with normal optic disc and visual field. PACG is defined by the presence of ITC with either raised IOP and/or PAS, and evidence of glaucomatous optic disc and visual field
* No IOP-lowering drug treatment or a 4-week wash-out period prior to Study Day 0
* Aged ≥18 years, of either sex
* Not more than 6 diopters spherical equivalent on the study eye
* Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

* History of acute angle closure glaucoma on the study eye
* Secondary angle closure glaucoma on the study eye
* History of ocular surgery within the last 3 months on the study eye
* History of ocular laser treatment, including previous LPI on the study eye
* Corneal or conjunctival abnormality precluding contact lens adaptation on the study eye
* Severe dry eye syndrome on the study eye
* Patients with allergy to corneal anesthetic
* Patients with contraindications for silicone contact lens wear
* Patients not able to understand the character and individual consequences of the investigation
Program Intensive Habilitation (PIH) for Young Children With Early Brain Damage

By longitudinal, prospective research in children with neurodisabilities including severe motor impairments and their parents to explore the beneficial effects of participating in an intensive habilitation program on the child's adaptive functioning and parental empowerment in order to treat and reduce the consequences of early brain damage.

Evidence-based knowledge about the effects of intensive training programs for children with severe early brain damage is limited since research on this topic has methodological weaknesses and shows conflicting results. As intensive training programs require extensive efforts from the child, parents and professionals and represent major costs, the importance of scientifically proven effects is considerable. This research project aims to measure the effects of an intensive habilitation program for young children with severe early brain damage on the child's adaptive, motor, language and social functioning and on parental empowerment, family functioning and stress. In this randomized controlled trial (RCT) 90 children will be divided into an intervention group participating in a Norwegian developed program of intensified habilitation of 12 months duration and a control group, who will receive "services as usual" during the same time period. Between-group analyses will then be performed. Due to a stepped wedge design, the control participants will then be offered training in year two of participation. Within-group analysis of results before and after training will then be performed for all participants. Standardized measures with high responsiveness in documenting intervention effectiveness will be used as primary outcome measures. Intensive training groups will be offered in all Health Regions in Norway and if successful be implemented as standard clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* age 2 - 6 years at the start of the program
* a diagnosis of severe cerebral palsy or similar motor disability of non-progressive etiology (GMFCS level IV-V),
* being able to participate in group sessions
* having parents who want to take an active part in their child's training
* least one of the parents must speak fluent Norwegian or English.

Exclusion Criteria:

* children with progressive disorders
* co-morbidity like autism spectrum disorder, severe visual and hearing impairments or intractable epilepsy that worsen with physical activity.
Psychosocial Wellbeing Following Stroke

The purpose of this feasibility study is to develop and initially test a dialogue-based psychosocial intervention aimed at promoting coping and psychosocial wellbeing following an acute stroke. The intervention is carried out by primary care registered nurses or other appropriate health professionals. The intervention included persons with and without aphasia.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or above
* acute stroke
* 4-8 weeks poststroke

Exclusion Criteria

* Other serious disease
Netrin-1 & Hepatocellular Carcinoma HCC

Netrin-1 is a dependence receptor ligand participating in the pathology of several cancer types. It is up-regulated in chronic liver diseases, cirrhosis and HCC. We hypothesize that netrin-1 may play a detrimental role in HCC. The goal of this project is to characterize netrin-1 signals in HCC samples with ad hoc controls, to investigate the benefit of capturing netrin-1 in preclinical models of HCC and to try to define patients groups the most likely to benefit from this targeting approach in the clinic.


Eligibility Criteria:
Inclusion Criteria:

* any patient suffering from HCC
* age \>18
* informed consent provided

Exclusion Criteria:

- absence of informed consent
Experience in Borderline Ovarian Tumors

Borderline ovarian tumors (BOTs) comprise 15-20% of primary ovarian neoplasms and represent an independent disease entity among epithelial ovarian cancers. The present study aimed to report the 8-year experience of a single center on the management and outcomes of consecutive BOTs patients. From January 2010 to December 2017, all patients with BOTs undergoing surgical treatment were included. Demographic, clinical, and pathological data were reviewed retrospectively.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years,
* Patients affected by borderline ovarian tumors (BOT) of any histological type and any FIGO stage,
* Women undergoing surgical treatment with both laparoscopic and laparotomic approaches.

Exclusion Criteria:

- Women affected by ovarian cancers
Signaling Pathways Targeting Colorectal Cancer in Egypt

Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second leading cause of cancer-related death worldwide. In Egypt, CRC constitutes 4.2% of all cancers with median age is 50 years old.

The TP53-induced glycolysis and apoptosis regulator (TIGAR) is a transcriptional target of p53. TIGAR functions as a fructose-2,6-bisphosphatase, decreasing the flux through the main glycolytic pathway. Consequently, glucose metabolism diverted into the pentose phosphate pathway (PPP). This results in TIGAR-mediated increase in cellular NADPH production, which contributes to the scavenging of ROS by reduced glutathione and thus a lower sensitivity of cells to oxidative stress-associated apoptosis. PPP also produce ribose phosphate for DNA synthesis and repair that play a role in tumor development and cell survival in tumor microenvironment. A high expression level of TIGAR was observed in cancers such as breast cancer, hepatocellular carcinoma, intestinal cancer, and glioblastoma. These studies suggested that TIGAR may act as an oncogene that support cancer progression.

The tripartite motif containing 59 (TRIM) proteins have been implicated in many biological processes including cell differentiation, apoptosis, transcriptional regulation, and signaling pathways.

It is related to several cancers. The oncogenic effect of TRIM59 on tumor proliferation and migration has been studied in various cancers, including gastric cancer, osteosarcoma, lung and CRC. The biological activity of TRIM59 has been observed to be closely associated with the regulation of P53. TRIM59 interacts with P53, leading to P53 ubiquitination and degradation, and consequently promotes tumor growth and migration. TRIM59 functions as an oncogene in CRC progression. It also activates the PI3K/AKT pathway. Increased activity of this pathway is often associated with tumor progression and resistance to cancer therapies. AKT can control TIGAR protein translation by activation of mTOR.

Targeting TRIM59 inhibition will inhibit PI3K-Akt pathway downregulate TIGAR protein translation. This is in turn downregulates GSH levels, increases ROS production, leading to cell death and blocks the cellular proliferation and survival of cancer cells leading to tumor regression. Therefore, TRIM59 protein can serve as a new potential therapeutic target for CRC.

Eligibility Criteria:
Inclusion Criteria:

* All Patients confirmed histopathologically to have early stages of colorectal cancer.
* Risky group patients (including those with ulcerative colitis, chron's disease, familial adenomatous polyposis).

Exclusion Criteria:

* Patients with previous history of CRC treated with chemotherapy or presence of other types of cancer.
Pulmonary Hypertension Prevention in Hemodialysis

Pulmonary hypertension is a new complication described in hemodialysis patients. in the last year these patients were treated by calcium carbonate orally to control serum phosphor. Calcium phosphor deposits in pulmonary artery can explain this phenomena. The investigators want to investigate the new phosphor non calcium containing agents in hemodialysis patients and to measure the pulmonary pressure.

The investigators will measure pulmonary blood pressure before and after treatment with new phosphor binders, non calcium containing.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis Patients without fistula

Exclusion Criteria:

* Heart Disease
Benefits of a Belly Dance Psychomotor Intervention

The aim of the present study is to analyze the effects of a psychomotor intervention program mediated by belly dance in adult women. This Quasi-experimental study is a controlled trial with one arm. Participants will be allocated to one group which will be i) control and ii) experimental. That is at first i) will attend a control period without intervention (6 weeks) and at second ii) will attend an intervention period participating on the intervention program mediated by belly dance (12 weeks). Participants will be accessed at a baseline, at post control and at post intervention.

Sedentary lifestyles has been identified as one of the main causes for the development of pathologies as are cardiovascular diseases and of mental health problems such as anxiety and depression. Associated with this, psychomotor factors can also be negatively affected as well as the perception of well-being. Women's daily life associated with tasks accumulation is referred to as a barrier to engaging in physical have progressively made it more difficult for them to perform formal physical activity (Barranco-Ruiz, 2020). Dance can help in this scenario because it is a pleasurable activity that favors social and intrapersonal relationships, working simultaneously on factors such as balance, motor coordination, agility, body awareness, and rhythm, having a positive impact on quality of life and well-being. In this way, dance, through its various components associated with movement, can assume a character of health promotion, also making possible a space of attention for women (Hernandes et al, 2018). Studies have already been carried out focusing on the effects of belly dancing on body image, quality of life and self-esteem in women with cancer, experienced and professional experienced and professional belly dancers/practitioners, elderly women with depression, pregnant women and depression, pregnant women and those with chronic pain (Boing, 2018; Toberna, 2020; Castrillon, 2017). No studies were found that looked at psychomotor factors (balance, agility and body body awareness), or indicators of well-being focused on body image, movement image and and mood states.

The proposed study has a quasi-experimental design with two pre-tests and one post- test, with only one group, the experimental group being its own control. In this way, we will apply Pre-test 1 and after six weeks without intervention, we will apply Pre-test 2 in order to obtain the results referring to the control group. After that, we will start the intervention itself, which will last twelve weeks and will culminate with the Post test 1.

Eligibility Criteria:
Inclusion Criteria:

* Woman aged \> 17 years and \<60 years
* Availability to participate in the program

Exclusion Criteria:

* Presence of cognitive impairment (Mini-Mental State Examination);
* Presence of motor impairment, neurological problems or diseases compromising the program participation;
* Unavailability to participate in the program.