cyrilzakka/clinical-trials huggingface dataset:
Prevention of Functional Decline of Aged Women

The objective of this study is to evaluate the capacity of muscular function and articular amplitude in the aged women who participated in the Support Group and its influence on the prevention of function decline of these women.

To evaluate the capacity of muscular function and articular amplitude in the aged women who participated the Support Group and its influence on the prevention of function decline of these women is use the method: It is an interventional and quantitative research. A questionnaire of identification and instruments will use: a) flexion and extension tests of muscular function and articular amplitude of shoulders, elbows, wrists, hip, knees and ankles, in the beginning and in the end of the program b) educational action c) physical exercise d) the check up of the results after the exercises e) two questions to register the influence of the support group in the functional life of the researched ones.

Eligibility Criteria:
Inclusion Criteria:

* woman with 60 years old or more

Exclusion Criteria:

* woman with less 60 years old
Effectiveness of Health Literacy Enhancement Program Among Older Persons With Physical Multimorbidity

The study aims to examine the effectiveness of individual and family health literacy enhancement program among older persons with physical multimorbidity.

Specific objectives are:

1. To compare self-management, treatment burden, and symptom burden of older persons with physical multimorbidity between before and after receiving the individual and family health literacy enhancement program.
2. To compare self-management, treatment burden, and symptom burden of older persons with physical multimorbidity between those receiving the individual and family health literacy enhancement program and those receiving usual care.

Participants in the control group will receive usual care by physician and nurses during the experimental period. The usual care consists of physical examination, regular treatment protocol, patient education and telephone follow-up by community nurses.

Participants in the interventional group will receive the program which is a group-based intervention developed by the researcher based on the Individual and Family Self-Management Theory (IFSMT) (self-management skills) and the principle of Medagogy (PITS model: Pathophysiology, Indications, Treatments, Specifies) to improve patients' and their families' understanding of disease-related information and self-management skills consisting of goal setting and action plan, self-monitoring, solving problems and decision-making, and emotional control.The program will be divided into 8 sessions. Each session will be lasted for 2 hours with 1 intermittent break (10 minutes), and it will be held twice a week, and the last session will be held 1 week after the 7th session. Therefore, it will last for 5 weeks in total.


Eligibility Criteria:
Inclusion Criteria:

* Age 60-80 years old;
* Having been diagnosed with hypertension and type 2 diabetes for at least 6 months;
* Being able to read and write Chinese language;
* Cognitive intact as measured by the Mini-Mental State Examination (MMSE) with the score ≥ 24;
* Physically independence as measured by the Barthel ADL Index and the score above 12 out of 20 ;
* Willing to participate in the study;
* Having at least a family member who is willing to participate in the study.

Exclusion Criteria:

* Having other diseases or severe complications from their health problems that making them unable to fully participate through all process of the program including ischemic heart disease, myocardial infarction, heart failure, stroke, acute renal failure, diabetic ketoacidosis, and diabetic coma;
Quality of Life, Treatment Experience and Cost of Treatment With Somatostatin Analogues in Patients With Gastroenteropancreatic Neuroendocrine Tumours

Data from this study will contribute additional knowledge regarding patient outcomes and direct somatostatin analogue (SSA) treatment related costs in clinical practice in the Nordic countries. Such knowledge can be of importance in a treatment decision, decision support for development of care, follow up and training of both patients and primary care nurses.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Diagnosed with a Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET) and treated with SSA for at least three months but not more than 3 years
* GEP-NET proliferation index Ki 67 \<10%
* Over 18 years of age

Exclusion Criteria:

* No specific exclusion criteria defined
Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome

A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. Burning mouth syndrome (BMS) is defined as an oral burning sensation in the absence of clinical signs which could justify the syndrome.

Recent studies suggest the existence of neurological factors as a possible cause of the disease.

A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables.

60 patients with BMS, in two groups: case group with 600 mg/day and placebo as control group; with a follow-up of 2 months.

Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome

Exclusion Criteria:

* clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome
Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm

This randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm (AAA) with stentgrafts either with active supra- or infrarenal fixation.

This randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm with stentgrafts either with active supra- or infrarenal fixation. Individuals are planned to be included throughout Scandinavia. After inclusion in the study, baseline data is collected and computerized randomization between the two stent graft fixation types is performed. Follow-up will be scheduled after 1 month and 1,3 and 5 years. Analyses of blood samples to determine renal function are undertaken together with CT scans to detect stentgraft performance at all follow-up visits alongside assessments of health-related quality of life questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Meet criteria for non-ruptured infrarenal/iliac aneurysm
* Suitable anatomy for treatment with an approved device (CE-marked) stentgraft according to the manufacturers' instructions for use for AAA.
* Accepted for treatment with endovascular aortic repair (EVAR) by the participating vascular center.

Exclusion Criteria:

* Ongoing or planned dialysis
* AAA treatment requiring stents or stentgrafts in renal and/or visceral arteries
* Inability to independently complete HRQoL questionnaires due to language barriers
* Anatomical preconditions that do not allow both types of fixation to be used interchangeably, i.e. very advanced suprarenal tortuosity (\>60 degrees), advanced suprarenal dilatation or infrarenal thrombus \>25% of circumference.
Impact of Adipose Tissue Repartition on the Time Course of Vascular Dysfunction - the NUMEVOX Cohort

The NUMEVOX cohort is intended to follow-up the macro and microvascular dysfunction in relation to adipose tissue repartition in patients with metabolic syndrome associated to liver steatosis, sleep apnea. Duration of the follow-up is 3 years for each patient entering the cohort.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* age \> 18 years old
* suspected of metabolic syndrome
* affiliated to french social health care

Exclusion Criteria:

* age \< 18 years old
* pregnancy
* no informed consent
* not eligible for the study (no MS, cancer)
Subcutaneous Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

The investigators are using self administered subcutaneous immunoglobulin (SCIG) in patients with CIDP who require Intravenous immunoglobulin (IVIG). Safety, efficacy, and patient satisfaction will be examined.

Chronic inflammatory demyelinating polyneuropathy (CIDP) is an autoimmune neurological disorder that causes limb weakness and numbness. Many patients require immunosuppressants and plasma exchange (PLEX) to control their symptoms. Intravenous immunoglobulin (IVIG) is also an effective treatment (Hughes et al, 2006 \& 2008; Hughes, 2009; Cocito et al, 2010), and the American Academy of Neurology (AAN) guideline recommended that it should be offered in the long-term treatment of CIDP (Patwa et al, 2012). While effective, IVIG causes systemic side effects in about 5% of patients. These side effects include rash, pruritus, myalgia, fever, chills, headache, low back pain, nausea, vomiting, changes in blood pressure or heart rate, renal failure, and aseptic meningitis (Berger, 2008). For many patients who are chronically treated with IVIG, venous access may be a problem over time. An alternative is the subcutaneous (SC) route, which has been in use since 1980 for primary immune deficiency disorders and is the treatment of choice for this condition in Scandinavia and England (Radinsky et al, 2003). As compared to intravenous (IV) route, SC route maintains higher trough levels of immunoglobulins, increases patient independence, reduces systemic side-effects, and is better tolerated in those who are pregnant or sensitized to Immunoglobulin A (IgA) (Radinsky et al, 2003). In a review of side effects associated with 33,168 SCIG infusions, no severe or anaphylactoid reactions occurred (Gardulf et al, 1995). Patients can self-administer medication, and hence, overall cost may be reduced. A retrospective study of 28 children with primary immunodeficiency in Canada showed that the mean difference in costs between IVIG and SCIG during the study period (1 year on IVIG and 1 year on SCIG) was $4,346 in favor of SCIG (Ducruet et al, 2011). A US$10,100 reduction in cost per year per patient associated with SCIG use was also reported by Gardulf et al (1995) in Sweden. Disadvantages of SCIG include more frequent infusions and local reactions at sites of infusion (transient swelling, soreness, redness, induration, local heat, and itching) in about 1% of patients.

Eligibility Criteria:
Inclusion Criteria:

To qualify, a patient must have CIDP and persistence of significant symptoms (having 2 or more of the following):

* Weakness in any limb,
* Motor fatigue significant to interfere with activities of daily living (ADL) or work,
* Paresthesia of sufficient severity to require a medication,
* Sensory impairment,
* Walking impairment,

AND requires IVIG to control symptoms.

Exclusion Criteria:

1. Thrombocytopenia or other bleeding disorders,
2. Anticoagulation therapy,
3. Severe or anaphylactoid reactions to IVIG,
4. Cancer,
5. Pregnancy,
6. Breast-feeding,
7. Renal insufficiency or failure,
8. Congestive heart failure,
9. Psychiatric illness.
Prostate Cancer Screening: a Pilot Study

Prostate Cancer (PCa) is the second most frequently diagnosed tumour and the third most lethal among men in Europe. The lack of precise tools and examinations to precisely diagnose PCa has caused overtreatment of indolent and low-aggressive PCa, while in some other cases, with aggressive disease, diagnosis and treatment are dangerously delayed because cancer could be potentially missed. The present trial aims to study a new pathway to early diagnose PCa with Magnetic Resonance Imaging (MRI) to identify men who will not need treatment and those who will benefit from radical treatment, thus improving disease control and quality of life.

Men aged 55-65 years with neither previous biopsy nor prostate diseases will be invited in the screening protocol and will perform an initial PSA test. Those cases with PSA ≥ 3 ng/ml will be invited to undergo a urologic examination with computed risk assessment and an MRI, which is a non-invasive test with high positive and negative predictive value in identifying clinically significant prostate cancer. Then, only men with medium-high risk of harbouring clinically significant prostate cancer will be invited to undergo a prostate biopsy to indentify cancer presence and its aggressiveness.

Eligibility Criteria:
Inclusion Criteria:

* age between 55-65 years;
* asymptomatic or paucisymptomatic from a urological point of view;
* no previous prostate biopsy;
* living in the ASL TO5 (Piedmont, Italy);
* signed written informed consent.

Exclusion Criteria:

* positive oncologic anamnesis for prostate cancer;
* previous biopsy or prostate surgery;
* previous radiotherapy of the pelvis;
* any contraindication to MRI examination;
* claustrophobic or uncollaborative subjects.
High Dose-Rate Brachytherapy and/or Intensity Modulated External Beam Radiation Therapy for Prostate Cancer

The principal objective of this study is to demonstrate that patients can safely receive combined High Dose Rate brachytherapy and Intensity-Modulated Radiation Therapy without experiencing a treatment limiting toxicity.

Patients will receive a single High Dose Rate brachytherapy dose of 6 Gy to the prostate, followed by 61 Gy delivered to the prostate and nearby tissues using Intensity-Modulated Radiation Therapy in 28 treatments.

Eligibility Criteria:
Inclusion Criteria:

* TRUS biopsy proven adenocarcinoma of the prostate Pretreatment PSA \<30 ng/ml Gleason's sum \< 8 clinical stage T1 or T2a,b. patients that are at low-intermediate risk for disease beyond the prostate normal liver function for all patients beginning hormone therapy Karnofsky Performance score \> 80 acceptable anesthesia risk as determined through routine pre-operative screening in the VCUHS Diagnostic Testing Clinic

Exclusion Criteria:

* pubic-arch interference or regional disease ( no evidence of metastatic disease for patients whose PSA is greater than 10 ng/ml, Gleason's sum is greater than 6, or T-stage is greater than T2a.

Patients at high risk for distant disease (PSA \> 30 ng/ml, Gleason's sum \> 8 or clinical stage \> T2c), clinically involved seminal vesicles or extension beyond the prostate capsule history of inflammatory bowel disease require steroid or cytotoxic therapy for collagen vascular disease uncontrolled or poorly controlled hypertension uncontrolled or poorly controlled diabetes mellitus history of cancer other than skin cancer within five years of the initiation of protocol treatment history of pelvic irradiation require the routine use of warfarin
Musical Group Intervention for Children in Shelters

The aim of the study is to augment knowledge on interventions for children who live, or have lived, in shelters after exposure to domestic violence. Research questions concern the feasibility of a music group intervention for children. The experiences of children, caregivers, and professionals will be investigated. Additionally, outcomes concerning emotional reactivity, capacity for emotional regulation, quality of life, and psychological health will be evaluated.

Research problem and specific questions The project uses a mixed methods design in a naturalistic setting. Qualitative data concerning how children, caregivers and professionals experience the intervention and quantitative data concerning practical feasibility, adaptions made, and children's reported psychological health and quality of life will be studied. Data will be collected through questionnaires, log-forms, evaluation forms, and interviews with children, parents, and professionals. Thematic analysis and Interpretative phenomenological analysis will be used for qualitative data. Descriptive statistics and non-parametric methods will be used as applicable for quantitative data.

Plan for project realization The music group intervention will be offered to children 3-10 years, who live or have lived at a shelter. In all 12 groups with 4-8 children in each (48-96 children) will be realized. Collaboration with 2-3 shelters is established.

Questionnaires designed to measure psychological health, health-related quality of life, emotion reactivity, and capacity for emotional regulation will be administrated to caregivers pre- and post-intervention. A log-form will be filled out by professionals after each group session. Evaluation forms will be administrated to children, caregivers, and professionals after completing the intervention. Qualitative interviews focusing on feasibility, acceptance, and experiences of the intervention will be carried through with children, caregivers and professionals post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 3-10 years
* Currently living or have lived at shelter together with a caregiver
MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(RBC-02)

This study is aimed to illustrate whether Radiomics combining multiparametric MRI before and after neoadjuvant chemotherapy (NACT) with clinical data is a good way to predict axillary lymph node metastasis and prognosis in invasive-breast-cancer.

This study proposes to build a clinical predictive model to predict axillary lymph node metastasis and prognosis in invasive-breast-cancer patients who received neoadjuvant chemotherapy before surgery. The model is built based on breast MRI signatures extracted and analyzed via deep machine-learning algorithm methods. Invasive breast cancer patients undergo multiparametric MRI at baseline, then undergo multiparametric MRI after received neoadjuvant chemotherapy for at least 4 cycles as planned. After the surgery, responses to neoadjuvant chemotherapy are determined according to the histopathologically examination of the surgically resected specimens. After completion of treatment procedure, patients are followed up for 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Primary lesion diagnosed as invasive breast cancer;
2. Imaging examination confirmed no distant organ metastasis;
3. Received neoadjuvant chemotherapy for drugs such as taxanes, anthracyclines, and platinum as planned;
4. Completed breast MRI examination before or after neoadjuvant chemotherapy;
5. Accepted breast cancer surgery and axillary lymph node dissection;
6. Eastern Cooperative Oncology Group performance status 0-2.

Exclusion Criteria:

1. History of ipsilateral axillary or breast surgery;
2. Inflammatory breast cancer;
3. Bilateral breast cancer;
4. Malignant tumor history in 5 years;
5. Patients with cervical or contralateral axillary lymph node metastasis;
6. Incomplete imaging or medical history data.
Improvement of Physical Activity and Correction of Body Mass Index in School Children

There is an increasing incidence of overweight children in Germany, due to a lack of physical activity.

The aim of this study is to improve physical fitness and activity in school children. Two classes in different schools are provided with additional sport lessons over a period of one year.

The increasing incidence of overweight children in Germany is due to a lack of physical activity and intake of unhealthy food. The importance of physical activity for the prevention of cardiovascular diseases in adults was shown in several trials. Therefore we provide additional sport lessons over the period of one year in two defined schools in Leipzig with the aim to improve physical fitness in school children. Two other classes with the -in germany- usual quantity of sport classes served as control classes.

In all classes at the beginning and at the end of the school year blood samples were taken, and a clinical investigation, a coordination test for children and a spiroergometer were performed. Additionally each child had to fill out a questionnaire.

Endurance training is emphasized in the sport lessons.

Eligibility Criteria:
Inclusion Criteria:

* School class

Exclusion Criteria:

* Condition precluding exercise
Emergency (Red Code) Cesarean Section : Maternal and Fetal Prognosis Depending on Anesthetic Modalities in a Level 3 Maternity Ward

We try to evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome on emergency (Red Code) Cesarean Section.

This study occurred in a Level 3 Maternity Ward.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* emergency "code red" cesarean section

Exclusion Criteria:

* Any other intervention
* Planned cesarean section
Treatment of Pulmonary Hypertension in High-risk Cardiac Surgery Patients Using Inhalational and Intravenous Agents

The aim of this study is to examine and compare the effect of Levosimendan and Milrinone administered intravenously and via inhalation respectively in cardiac surgery patients with pulmonary hypertension and right ventricular dysfunction.

Pulmonary hypertension (PH) is a pathophysiological disorder hemodynamically characterized by increased pulmonary vascular resistance and pressure. This can lead to right ventricle pressure overload and failure, which is worsened by cardiopulmonary bypass (CPB) and extracorporeal circulation and is accompanied by high rates of morbidity and mortality in cardiac surgery patients. Pharmacological agents used to decrease pulmonary vascular resistance and right ventricle afterload are prostaglandins, iloprost, milrinone, nitric oxide (NO) and recently Levosimendan. These agents can be administered intravenously or via inhalation.

In this study, the intravenous administration of Levosimendan will be compared with the inhalational use of milrinone in patients with pulmonary hypertension undergoing cardiac surgery.

In this setting, 40 patients with PH caused by left sided heart disease, will be assigned into two groups:

GROUP A: Intravenous administration of Levosimendan in dosage 6mcg/kg after induction of anesthesia.

GROUP B: Inhalational administration of milrinone in dosage 50mcg/kg after induction of anesthesia.

Before and after the administration of the drug, heart function will be evaluated by hemodynamic measurements obtained by the Swan-Ganz catheter. These parameters will be heart rate (HR), blood pressure (BP), mean pulmonary arterial pressure (MPAP), central venous pressure (CVP), cardiac output (CO), pulmonary capillary wedge pressure (PCWP), cardiac index (CI), systemic vascular resistance (SVR), pulmonary vascular resistance (PVR). Transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE) will also be used.

This study will lead to conclusions regarding the effectiveness of intravenous administration of Levosimendan and inhalational use of Milrinone in the treatment of right heart failure and PH in cardiac surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with pulmonary hypertension due to left ventricular dysfunction based on echocardiographic diagnosis preoperatively
* elective cardiac surgery

Exclusion Criteria:

* primary pulmonary hypertension
* thromboembolic disease
* chronic obstructive pulmonary disease
* emergency surgery
* redo surgery
* inability to consent to the study