cyrilzakka/clinical-trials huggingface dataset:
Impact of the Implementation of Dance Therapy Workshops on the Quality of Life of Adults With Disabilities Institutionalized Within the Medico-social Establishments of the Univi Group

Dance is a multimodal activity involving motor, cognitive, sensory and sensory-motor skills as well as emotional and social skills. A growing body of research shows that the creative arts and physical exercise are able to alleviate disability, improve social interactions.

The Associative Group UNIVI wants to evaluate through this study the effects of the practice of dance on the quality of life of the disabled adults accomodates in social medical establishments of UNIVI group

this research is an interventional study involving the human person of category 2 involving only minimal risks and constraints, it is multicentric and longitudinal prospective. This is a before/after study to measure the effects of the implementation of a dance therapy activity on the quality of life of the adults with disabilities housed in the 5 establishments of the univi group.

The dance therapy will be deployed in all the medico-social establishments participating in the study over a period of 12 weeks.

To do this, dance therapists will be recruited to provide these classes.

The dance-therapy will be carried out:

* in groups of 10 to 12 people who have given their informed consent,
* at least twice a week per group,
* over a period of 30 to 45 minutes maximum twice a week for 3 months. Several groups per establishment can be planned depending on the number of people who can and want to be included in the dance workshop.

  940 participant in the study will be inclued and followed at 1 month, 3 months and 6 months after the end of the dance therapy workshops.

Eligibility Criteria:
Inclusion Criteria:

* Adults with disabilities residing in medico-social establishments, including participant under guardianship or curatorship
* informed consent to participate in the study
* Participant with a minimum of language skills to understand instructions and simple questions

Exclusion Criteria:

* Contraindication to the practice of dance
* Adults with disabilities temporarily housed
* Severe cognitive and/or behavioral disorders that do not allow you to follow a dance workshop
* Permanent bed rest
* Non-affiliation to a social security scheme
Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance

Congenital cytomegalovirus (CMV) infection is the leading cause of non-genetic neurosensory deafness and affects 0.5 to 1% of births. Twenty to thirty per cent of children will develop deafness, some of whom will progress gradually to profound bilateral deafness.

No curative treatment is currently offered for this deterioration in hearing and management involves the use of a hearing aid or cochlear implant. Many studies describe the utility of antiviral treatment on the course of the deafness. These mostly involve neonates with multi-system symptomatic forms of the infection who have been given 6 weeks of ganciclovir possibly switched to valganciclovir, which has shown benefit in stabilising auditory loss, or even improvement.

Congenital cytomegalovirus (CMV) infection is the leading cause of non-genetic neurosensory deafness and affects 0.5 to 1% of births. Twenty to thirty per cent of children will develop deafness, some of whom will progress gradually to profound bilateral deafness.

No curative treatment is currently offered for this deterioration in hearing and management involves the use of a hearing aid or cochlear implant. Many studies describe the utility of antiviral treatment on the course of the deafness. These mostly involve neonates with multi-system symptomatic forms of the infection who have been given 6 weeks of ganciclovir possibly switched to valganciclovir, which has shown benefit in stabilising auditory loss, or even improvement.

Eligibility Criteria:
Inclusion Criteria:

* Children ≥ 6 months old and \< 12 years old
* Past history of proven congenital CMV infection
* Auditory threshold of between 40 and 90 dB in at least 1 ear.

Exclusion Criteria:

* Bilateral deafness \> 90 dB
* Contraindication to valganciclovir, particularly: Neutropenia with a known neutrophil count of \<500/mm3, Hb\<8g/dl or platelets\< 25,000/mm3 (FBC to be confirmed before randomisation)
* Past history of neutropenia on valganciclovir or allergy to the compound
* Renal impairment with creatinine clearance of \< 10 ml/min/1.72m2 (confirmation of renal function before randomisation) according to the Schwartz equation
* Patients on other antiviral treatment
* Gastrointestinal absorption problems
* Patients participating in a biomedical research project on a medicinal product or similar product
Effect of Aerobic Exercise on Blood Pressure Changes

This study will evaluate the effect of an aerobic training program versus a strength training program on the autonomic nervous system at rest and in response to challenge.

The purpose of this study is to compare the effectiveness of an aerobic exercise program versus a strength training program in altering RR interval and blood pressure variability as indices of autonomic nervous system regulation of the cardiovascular system. Subjects will be tested at rest and in response to challenge.

This study will enroll healthy, young (age 18-45) sedentary individuals at Columbia University Medical Center and St. John's University. At an initial screening visit, potential participants will be screened for exercise activity and will also undergo a test of aerobic capacity. Subjects will be eligible if they are not exercising regularly and do not exceed American Heart Association standards for average fitness (VO2max ≤ 43 and 37 ml/kg/min for men and women respectively). Exclusion criteria include current symptoms of affective disorder, psychosis, or substance abuse, current usage of psychotropic medication, and any medical condition that affected the autonomic nervous system or cardiovascular system.

Eligible participants will then be randomly assigned to 12 weeks of either an aerobic conditioning program or a strength training program. At study entry, heart rate, respiratory rate, and blood pressure will be measured; an ECG will be used to measure heart activity. Questionnaires will be completed to assess anger, tension, depression, and fatigue. Participants in the aerobic conditioning program will attend four 1-hour exercise sessions per week, which will focus on increasing cardiovascular fitness through running and other forms of aerobic exercise. The strength training program will also include four sessions per week, with the focus on increasing muscle endurance and strength. At the end of the 12-week programs, participants will begin a 4-week period of deconditioning, during which they will discontinue all exercise. Evaluations will be repeated at the end of the 12-week programs, and at the end of the 4-week deconditioning period.

Eligibility Criteria:
Inclusion Criteria:

* Average cardiorespiratory fitness level, as defined by the American Heart Association (VO2 max \[maximum oxygen consumption\] less than 43 ml/kg/min for men and less than 37 ml/kg/min for women)
* English speaking
* Ambulatory
* Sedentary

Exclusion Criteria:

* Use of psychotropic medications
* Past or current psychiatric disorder
* Heart disease
* High blood pressure
* Diabetes mellitus
* Neurologic disease
The Effect of Inspiratory Muscle Training and Respiratory Physiotherapy on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in Patients With Robotic Heart Surgery

During the past decade, especially with the advancement of technology, major innovations and developments have been observed in the field of surgery. Cardiac surgery is one of the important area of the surgery who renews itself day by day and adds innovations to the nature in terms of patients' comfort. One of the greatest developments in cardiac surgery in this sense is the tendency to reduce the size of the incisions with less interventional procedures. Robotic surgery is getting more and more meaningful in this area. Despite the downsizing of the surgical incisions, postoperative pulmonary complications have not completely disappeared in the robotic cardiac surgery. Major respiratory problems following traditional cardiac surgery are gas exchange problems, atelectasis, decreased coughing force and sputum retention. The effectiveness of respiratory physiotherapy applied after traditional cardiac surgery for the resolution of these complications has been proved by various investigations. Inspiratory muscle training (IMT) has been found to improve autonomic modulation in heart failure patients as well as to increase inspiratory muscle strength in applied patient populations, reduce blood pressure in hypertensive patients, and increase functional capacity in elderly individuals. Considering these benefits, when inspiratory muscle training is given to people with traditional cardiac surgery, respiratory muscle strengths, respiratory functions and functional capacities are increased compared to those not given to these patients. However, although there are complications after robotic cardiac surgery, there are no studies in the literature about respiratory physiotherapy or inspiratory muscle training. Thus, the subject of this study is the comparison of the effects of standard respiratory physiotherapy and standard respiratory physiotherapy plus inspiratory muscle training on the respiratory functions, respiratory muscle strength and functional capacity of the patients with the robotic heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* Being suitable for robotic cardiac surgery,
* Being hospitalized to have a robotic heart surgery,
* No complications during surgery,
* To be extubated in intensive care unite after surgery ,
* Stable clinical condition,
* To be transferred from ICU to the hospital room on the first day after surgery.

Exclusion Criteria:

* Chronic obstructive pulmonary disease,
* Unstable angina,
* Acute decompensated heart failure,
* Acute pericarditis and myocarditis,
* Complex arrhythmia,
* Uncontrolled hypertension,
* Serious orthopedic and neurological impairment,
* Uncontrolled diabetes,
* Body Mass Index \> 30.
Prophylaxis of Venous Thrombo-Embolism in Cancer Patients Under Palliative Care

To determine the efficacy and to measure the complications of prophylactic anticoagulation using low-molecular weight heparin in adult cancer patients under palliative care


Eligibility Criteria:
Inclusion Criteria:

* Cancer patients in palliative care
* Patients fully informed about their condition
* Signed informed consent
* No exclusion criteria

Exclusion Criteria:

* Absence of advanced cancer
* Cancer previously cured
* Venous thromboembolism diagnosed within 6 months prior to inclusion
* Absence of discerning capacity
* Active anti-thrombotic treatment with heparins or coumarines
* Thrombocytopenia \<50G/l
* PTT \>45sec
* TP\<35%
* Active bleeding
* Renal failure \<20ml/min
* Past history of heparin-induced thrombocytopenia
Weaning From Prolonged Mechanical Ventilation

Patients requiring the use of artificial ventilation (also called mechanical ventilation) for more than 21 days account for more than 37% of all ICU costs. As such, these patients are now transferred to centers that specialize in weaning patients from the respirator; these units are referred to as long-term acute care (LTAC) facilities. Despite the increase of LTAC facilities, research on the fastest method for disconnecting the patient from the respirator is lacking. In addition, little information is available regarding the long-term survival and quality of life after a prolonged course of artificial ventilation. The purpose of this study is to determine the fastest method for disconnecting the patient from the respirator at a LTAC facility and its effect on long-term survival and quality of life.

Patients requiring prolonged mechanical ventilation (defined as more than 21 days) account for more than 37% of all ICU costs. As such, these patients are now transferred to centers that specialize in weaning from mechanical ventilation, so called long-term acute care (LTAC) facilities. Despite the proliferation of LTAC facilities, research on methods for expediting weaning is lacking. In addition, little information is available regarding long-term survival and patient's perception of quality of life after a prolonged course of mechanical ventilation.

In patients receiving mechanical ventilation in an ICU, randomized trials have revealed that ventilator duration was significantly influenced by weaning methods. The two most common weaning methods are pressure support and spontaneous breathing trials. Unlike the ICU, the relative efficacy of these two techniques in weaning patients requiring prolonged ventilation at a LTAC facility is largely unknown. The aim of this proposal is to determine whether the length of time required for weaning from prolonged ventilation differs with pressure support versus spontaneous breathing trials. The second aim is to determine the long-term impact of prolonged ventilation on survival, functional status and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical Ventilation for at least 21 days

Exclusion Criteria:

* Hypoxemia (oxygen saturation \< 90% with fractional inspired O2 concentration \> 0.40, and positive end-expiratory pressure \> 5 cm H2O
* Hemodynamic instability (requiring intravenous vasoactive agents, such as dopamine \> 5 mg/kg/min)
* Profound neurological deficits (large stroke)
* Documented bilateral phrenic nerve injury
* Previous admission to RML Hospital
* Life expectancy less than 3 months
Studying Gene Expression and Location in Samples From Patients With Brain Tumors

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to brain tumors.

PURPOSE: This research studies gene expression and location in samples from patients with brain tumors.

OBJECTIVES:

* To determine the expression and subcellular localization of nei endonuclease VIII-like 3 (NEIL3) in brain tumors.

OUTLINE: Tissue microarray samples are analyzed for NEIL3 expression and subcellular localization by immunohistochemical methods.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Tissue microarrays (TMA) samples from the Biopathology Core
* Samples from patients diagnosed with brain tumors

  * Progenitor, or blast, cell origin

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191)

To characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian cancer


Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years of age.
* Histologically confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
* Progression of disease after the most recent anticancer treatment. At least 1 prior chemotherapy regimen must have included a taxane.
* Platinum-sensitive ovarian cancer defined by recurrence or progression of disease \> 6 AND \< 24 months after completion of the most recent platinum-based therapy.
* Measurable disease as defined by RECIST 1.1.
* ECOG performance status of 0 or 1.
* Completion of all therapy for the treatment of cancer 2 weeks before the start of study therapy and recovered.

Exclusion Criteria:

* Evidence of platinum-refractory ovarian cancer defined as recurrence or progression during the first 6 cycles of or \< 6 months after the beginning of first-line platinum based chemotherapy.
* Evidence of platinum-resistant ovarian cancer defined as recurrence or progression within 6 months after completing the most recent platinum-based therapy.
* More than 3 prior lines of cytotoxic chemotherapy for ovarian cancer.
* Prior malignancy (other than ovarian cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years.
* Breastfeeding and pregnant.
* Known central nervous system metastases and/or carcinomatous meningitis.
* Subjects with active cardiovascular disease not medically controlled or those who have had myocardial infarction in the past 6 months..
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction.
Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients

Cutaneous leishmaniasis (CL) is endemic in Israel and is caused by Leishmania major or Leishmania tropica. CL is usually a benign disease and limited to the skin. One of the local treatment available is intralesional (IL) Pentostam injection. During the current study the investigators will monitor the adverse effects of this treatment and will follow up the recovery of the lesions after Pentostam injections.

Cutaneous leishmaniasis is usually treated by topical intervention. In more severe cases intralesional Pentostam injection may be applied. This treatment is extremely efficient but painful, however without the known adverse effects of IV Pentostam treatment.

In this study the investigators will follow systematically all leishmania patients who are receiving the intralesional treatment. A structured questionnaire will be filled up in each doctor visit.

The current study goal is to examine the adverse effects and the patient reaction to this treatment, and to follow the recovery of lesion(s) after this treatment including the number of IL injections which was needed.

Eligibility Criteria:
Inclusion Criteria:

* Cutaneous leishmaniasis patients
* Treatment by IL Pentostam
* Age above 18 years

Exclusion Criteria:

* Children and pregnant women will not participate in the study
Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury.

At present, there is still a lack of standard and effective treatment strategies and procedures for radiation intestinal injury. Studies have shown that thalidomide can effectively treat refractory gastrointestinal bleeding caused by vascular malformation. Therefore, The investigators designed a single-center, open-label, randomized controlled study to evaluate the efficacy and safety of thalidomide combined with glutamine in the treatment of radiation intestinal injury.

Screening: This phase will not last longer than one week, and the subject will be assessed for eligibility after signing the informed consent form.

Treatment: Subjects were randomly assigned to three different treatment groups for 8 weeks.

Follow-up: The subjects' defecation status was recorded every day during treatment, telephone follow-up was conducted every two weeks, and laboratory indicators (including blood routine, stool routine, etc.) were tested every four weeks. The test was terminated one week after treatment and the improvement of subjects' stool blood was assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old, gender is not limited;
* Patients with hematochezia symptoms of chronic radiation intestinal injury: Due to the lack of diagnostic gold standard for radiation intestinal injury, a comprehensive analysis of clinical, endoscopic, imaging and histopathological findings was mainly performed to make the diagnosis of radiation intestinal injury on the basis of excluding infectious and other non-infectious intestinal injuries. Exposure to radioactive sources is a necessary factor in the diagnosis of radiation intestinal injury, and tumor activity or recurrence should be excluded.
* The proportion of dominant defecation bleeding in total defecation times in the week before treatment is not less than 20%;
* ECOG score: 0-2.

Exclusion Criteria:

* Patients with hemodynamic instability;
* Patients with obvious liver and kidney function injury: bilirubin, aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR\<60ml/min or dialysis patients;
* Patients allergic to thalidomide or glutamine;
* Patients whose primary disease was gastrointestinal malignancy;
* Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.;
* Female patients during pregnancy and breastfeeding (including patients with reproductive needs);
* Patients infected with HIV;
* Patients who cannot cooperate with regular follow-up and review of laboratory indicators;
* any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.
Prebiotics and Mental Health: Behavioural

A behavioural study of the microbiota-gut-brain axis in brain development and mental health

Research suggests that modifying microbial ecology therapeutically via the intake of so-called 'psychobiotics' could help reduce stress responses and symptoms of anxiety and depression (Burnet \& Cowen, 2013; Dinan, Stanton, \& Cryan, 2013; Tang, Reddy, \& Saier, 2014). The term psychobiotics refers to both, beneficial gut bacteria (probiotics), as well as prebiotics, which enhance the growth of beneficial gut bacteria (Sarkar et al., 2016). In a recent study, Schmidt and colleagues explored the effects of prebiotics on the secretion of the stress hormone cortisol and emotional processing in healthy volunteers (Schmidt et al., 2015). They found that cortical awakening response was significantly lower after BimunoÒ-galacto-oligosaccharides (Bimuno) intake over 4 weeks compared with placebo. Moreover, participants exhibited decreased attentional vigilance to negative information in a dot-probe task. Given that anxious people show increased biases towards negative information (Bar-Haim, Lamy, Pergamin, Bakermans-Kranenburg, \& van, 2007), this suggests that prebiotic intake may be useful in modifying anxiety-related cognitive mechanisms.

These findings will be extended to a sample of late adolescents in order to investigate how prebiotic intake for 4 weeks affects cognitive functioning, psychological well-being and gut microbiota a sample of 60 undergraduate students (aged 18-25 years).

At time 1 (pre-assessment), participants in both groups will undergo comprehensive behavioural and psychological testing to establish baseline measures of cognitive functioning and psychological well-being (such as anxiety levels) and asked to collect a stool sample at home for 16s rRNA sequencing of the microbiome. Group 1 will then receive a daily dosage of a galactooligosaccharide (GOS) prebiotic over 4 weeks, whereas group 2 will receive a placebo over the same period. At time 2 (post-assessment), both groups will again undergo cognitive and psychological testing and stool sampling.

Hypothesis: It is predicted that the treatment group (GOS) will show improvements in behavioural indices of emotion regulation (e.g. dot probe task) and in self reported psychological measures related to emotion regulation (e.g. anxiety) in comparison to the placebo group. Changes/differences in gut microbiome samples will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Females
* Aged between 18-25

Exclusion Criteria:

* Clinical levels of anxiety and/ or co-morbid diagnoses (e.g. depression)
* Current or previous neurological disorders
* Current or previous psychiatric disorders
* Current or previous gastrointestinal disorders
* Current or previous endocrine disorders
* Antibiotic use 3 months prior to the study
* Regular use of pre- and probiotics, including 3 months prior to the study
* Vegan diets
* BMI \>30