cyrilzakka/clinical-trials huggingface dataset:
SHARE for Persons With Chronic Conditions and Their Family Caregivers

SHARE-CC is an intervention for families facing the challenges of chronic conditions. SHARE-CC (Support, Help, Activities, Resources, and Education) addresses the need for both members of a care dyad to be actively involved in current and future care planning. This intervention aims to increase knowledge of services, improve communication skills and well-being, and facilitate the understanding of care values and preferences in order to create a mutually agreed upon care plan. This intervention will be tested in a randomized control trial.

This project offers a unique and timely opportunity to evaluate the feasibility, acceptability, and efficacy of the SHARE-Chronic Conditions psycho-social intervention. The project will adapt the SHARE intervention, for use with dyads facing the challenges of chronic conditions. The six-session SHARE-CC program will be implemented and evaluated using a randomized controlled trial with 240 participants in northern Ohio, the San Diego and San Francisco Bay areas in California, and New Jersey.

The SHARE-CC intervention addresses the need for a structured approach that targets both members of a care dyad and empowers them to be actively involved in current and future care planning. It has great potential to not only improve psychosocial outcomes for families, but to also impact healthcare decision-making and utilization.

Persons with chronic conditions and their caregivers will be interviewed prior to (Time 1) and after participating (approximately 4 months post-Time 1) in the SHARE-CC intervention or PWCC control group.

Eligibility Criteria:
Inclusion Criteria:

PWCC:

* Living in geographic area of organizations delivering service
* Living at home rather than in an institutional setting
* Have a family CG as defined below
* Confirmed diagnosis of at least one chronic illness (e.g., heart disease, diabetes, COPD, arthritis, kidney disease, stroke, HIV-AIDS, etc.)
* Require assistance with two or more activities of daily living (e.g., shopping, managing medications, dressing) or receives help with complex medical care tasks (e.g., wound care, preparing special meals); and
* Short Blessed error score between 0 and 6 demonstrating normal cognitive function.

For CGs to be eligible

• must be the PWCC's spouse/partner, adult child, in-law, grandchild, step-child, or other close family member who has or will have primary responsibility for providing assistance to the PWCC

Exclusion Criteria:

* Out of geographic areas
* a primary diagnosis of a neurocognitive disorder (e.g. Alzheimer's Disease or related dementia)
* a mental health condition (e.g., schizophrenia, bipolar disorder, major depression)
* a traumatic brain injury,
* intellectual or developmental disability
* individuals experiencing extreme difficulty adjusting and coping to the diagnosis
* individuals in the terminal phase of a chronic condition (i.e., eligible for Hospice).
Gerofit and Cognition

Over 50% of the Veterans enrolled for VA health care are over the age of 65. Dementia prevalence increases with age, and with the increase in the population of people ages 65 and older, the total number of people with dementia is also increasing. Older Veterans often have comorbid PTSD, major depression and traumatic brain injury so that they are at 2 to 5 times the risk for cognitive impairment and dementia compared to the general population. There is evidence that exercise interventions in sedentary older adults could improve both physical and cognitive function. However, there have been very few studies on the effects of exercise on cognition in older Veterans and do not reflect the broader ethnic and health-status diversity of Veterans. Thus, improved knowledge of the role of exercise on cognition as well as the predictive power of biomarkers could have a major beneficial impact on Veterans' functional independence and quality of life. The investigators hypothesize that participation in the VA Gerofit exercise program will improve cognitive function in older Veterans and that blood and muscle biomarkers will predict these improvements.


Eligibility Criteria:
Inclusion Criteria:

* All Veterans eligible for VA Gerofit program 65 years and older
* Clearance by PCP to participate in Gerofit exercise program

Exclusion Criteria:

* Inability to perform ADLs
* Significant cognitive impairment
* Inability to function independently without assistance
* Unstable angina; proliferative diabetic retinopathy
* Oxygen dependent
* Unwillingly to commute and/or not able to provide own transportation to Gerofit
* Incontinence
* Open wounds
* Volatile behavioral issue or unable to work successfully in a group environment/setting
* Active substance abuse
* Homelessness
Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis

Low levels of tissue carnosine and mitochondrial dysfunction appears to accompany multiple sclerosis (MS), with oral carnosine might be applicable to tackle impaired bioenergetics and oxidative stress in MS, and perhaps win back neuromuscular function. However, several formulations of carnosine have shown limited applicability due to restraints in brain delivery or tissue performance. No human studies so far evaluated the impact of innovative carnosine formulation (Karnozin EXTRA) in MS. Here, we will evaluate the impact of supplemental carnosine on neuromuscular performance, brain biomarkers of carnosine metabolism, and health-related quality of life in a case series of patients with MS.

Multiple sclerosis (MS) is a complex autoimmune disorder that affects millions of people around the world, negatively interfering with different aspects of health and everyday life. Being the most frequently seen demyelinating disease, MS prevalence varies considerably, from high levels in North America and Europe (\> 100/100,000 inhabitants) to low rates in Eastern Asia and sub-Saharan Africa (2/100,000 population). Due to its rather high prevalence in developed countries, the development of effective and applicable strategies to prevent or manage MS becomes a must for the medical community. Among other factors, it appears that low levels of tissue carnosine and mitochondrial dysfunction accompany MS, with oral carnosine might be applicable to tackle impaired bioenergetics and oxidative stress in MS, and perhaps win back neuromuscular function. However, several formulations of carnosine have shown limited applicability due to restraints in brain delivery or tissue performance thus pushing both industry and researchers to find bioavailable and effective formulation of carnosine. No human studies so far evaluated the impact of innovative carnosine formulation (Karnozin EXTRA) in MS. Here, we will evaluate the impact of supplemental carnosine on neuromuscular performance, brain biomarkers of carnosine metabolism, and health-related quality of life in a case series of patients with MS.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Body mass index 19 - 30 kg/m2
* Free of major chronic diseases or acute disorders besides MS
* Fulfilled 2017 McDonald Criteria for the diagnosis of MS

Exclusion Criteria:

* Pregnancy
* Psychiatric comorbidity
* Use of dietary supplements within 4 weeks before study commences
* Unwillingness to return for follow-up analysis
* Abnormal values for lab clinical chemistry (\> 2 SD)
* Immunotherapy for the past 6 months
* Treated with systemic corticosteroids during the 30 days before study commences
Targeted Screening of At-Risk Adults for Acute HIV-1 Infection

In this research, the investigators want to see if early detection of HIV infection can be improved by testing young adults who seek urgent health care from pharmacies and healthcare facilities with symptoms similar to those people get with recent HIV infection.

Specific objectives:

1. What proportion of people presenting with these symptoms are HIV positive at the point of seeking urgent health care?
2. What proportion of those who test negative or where the result is unclear (one rapid test positive and one negative) at first rapid HIV testing, will test positive two weeks later?
3. What is the best way (SMS, phone call or home visit) to remind people to come for the second test after two weeks?
4. Will young adults who seek urgent health care for fever, body pains, diarrhoea or an STD from pharmacies or health facilities find it acceptable to be invited for an HIV-1 test at the time of health care seeking?

Hypotheses

1. Targeted screening for AHI among patients seeking health care for symptoms compatible with AHI or sexually transmitted disease (STD) will identify AHI cases in more than 1% of those screened.
2. Intense follow-up of patients evaluated for AHI will improve rates of repeat HIV-1 testing 2-4 weeks after initial health-care seeking, relative to standard practice (i.e., recommendation to return for testing on a given date).


Eligibility Criteria:
Inclusion Criteria:

* symptom score of 2 or more: Confirmed fever (≥37.5 °C axillary), reported diarrhoea, or evidence of STD (variable score=2); reported body pains, or report of more than one sexual partners in past 2 months (variable score=1)
* resident in Mtwapa or Shanzu or planning to stay in Mtwapa for approximately 4 weeks duration
* willing to give locator information (including mobile phone number)
* negative or unknown HIV status

Exclusion Criteria:

* patients not meeting inclusion criteria
Prevalence and Risk Factor of NP in Women With LUTS

The knowledge of prevalence and risk factors of nocturnal polyuria might be important for the treatment of women with lower urinary tract symptoms (LUTS). Thus, our aim is to describe the prevalence and risk factors of nocturnal polyuria in women with LUTS.

Between September 2010 and January 2019, all women with LUTS visiting urogynecological department of a medical center for urodynamic evaluation were reviewed. Nocturnal polyuria was defined when the proportion of night-time voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of night-time voided volume over 24-hour voided volume was greater than 20% for \<65 year-old women. Backward stepwise multivariable logistic regression analysis was performed using all statistical variables in the univariate logistic regression analysis. P \< 0.05 was considered as statistical significant.

Eligibility Criteria:
Inclusion Criteria:

* Women with lower urinary tract symptoms
* Complete a 3-day bladder diary

Exclusion Criteria:

* \<20 y/o or \> 85 y/o
* Regular urethral catheterization or intermittent self-catheterization
* Urinary tract infection or chronic inflammation in the previous 2 weeks
* Bladder calculus
* Neurogenic bladder due to radical hysterectomy or injury of the central nervous system
* History of pelvic radiotherapy or a preexisting malignant pelvic tumor.
Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis

This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.


Eligibility Criteria:
Inclusion Criteria:

* male or female between 18 and 75 years of age;
* have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;
* currently demonstrating moderately active disease

Exclusion Criteria:

Patients will be excluded from admission to the study if they have/are:

* a history of allergy or hypersensitivity to salicylates or aminosalicylates;
* a history of extensive small bowel resection (\>1/2 the length of the small intestine) causing short bowel syndrome;
* current renal or hepatic disease;
* participated in any drug or device clinical study within 30 days of entry;
* currently enrolled in any other clinical study;
* received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;
* received any other topical rectal therapy during the week prior to the Screening Visit;
* received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;
* received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);
* received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;
* received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;
* if female, positive pregnancy test, or lactating.
Safety of Various Mode of Delivery of Iron Supplement on Iron Toxicity Markers in Preschool Children

The purpose of study is to evaluate and compare the effect of iron supplementation when given as iron tablet or fortified biscuit or combined with zinc in the form of tablet on morbidity and iron toxicity markers among children aged 24-36 months.

The study will be carried out in two phases in Sangam Vihar, Delhi. The survey will be conducted to identify children in the age group of 24-36 months. After obtaining consent, an enrollment form with detailed socio-demographic information about the child will be filled. Blood and urine samples will be collected for estimation of iron status, oxidative stress, immune and interleukin markers. Based on iron status, two randomization lists will be generated i.e. one for iron sufficient and other for iron deficient children. Children will be randomly allocated to receive one of the four interventions (60 in each group) for 180 days. The intervention will be either Iron Tablets (IT) or Iron and Zinc tablets (IZ) or Biscuits fortified with Iron (IB), or Placebo tablets (CO). Children in the iron groups (IT and IB) will receive 12.5 mg/day of iron. Children allocated to receive Iron and Zinc (IZ group) will receive 10 mg/day of Zinc in addition to 12.5 mg/day of Iron. The fortified biscuits (IB) will be formulated by CFTRI, Mysore, India and will have iron in the form of iron sulphate. The iron (IT group) or iron and zinc (IZ group) fortified dispersible tablets will be procured from WHO manufactured by Nutriset (Maluanlay, France). Tablets will have iron salt in the form of ferrous sulphate and zinc in the form of zinc sulphate. The interventions at the baseline on Day 3, on Day 30 (on completion of Phase -I) and on Day 180 (on completion of Phase-II) will be given at the clinic prior to the post 3 hour blood collection. Regular supplementation will be given at home. Children will be followed up on a biweekly basis by the field worker for delivery of the intervention, collection of morbidity and compliance information from the mother/caretaker of the child. During follow-up, blood sample for interleukin levels will be taken in the event of an illness such as diarrhea, pneumonia, fever and severe illness/hospitalization. At the completion of Phase-I (on day 30) and Phase - II (on day 180), the blood and urine samples will be collected again for estimation of iron status, oxidative stress, immune and interleukin markers.

Eligibility Criteria:
Inclusion Criteria:

* between 24-36 months of age
* not severely malnourished or ill requiring hospitalization
* willing to stay in the study area for 6 months
* consent to participate

Exclusion Criteria:

* not consented
* severely malnourished or ill requiring hospitalization
Cost-Utility Analysis Hospital Versus Home in Multiple Myeloma

Bortezomib needs repetitive visits at hospital for injections. Hospital-at-Home (HaH) might be an attractive and suitable alternative in this situation.

This study aim to perform a cost-utility analysis of two different strategies in several HaH structures within the Grand Est region in France.

Bortezomib is a standard therapy of newly-diagnosed multiple myeloma and is also approved for relapsing disease, requiring the patients to travel to the outpatient-hospital (OH) once a week for several months. Hospital-at-Home (HaH) might be an attractive and suitable alternative in this situation.

This study aim to perform a cost-utility analysis of two different strategies in several HaH structures within the Grand Est region in France: exclusive hospital-based Bortezomib administration versus combined administration in both OH and HaH.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age 18
* Enrolled in a social security scheme
* Diagnosis of multiple myeloma in first line or relapse
* Treatment plan including Bortezomib, adopted in a multidisciplinary meeting in a department of Hematology in Nancy (main investigator), Reims, Strasbourg University Hospitals or Metz-Thionville and Mulhouse local state-run hospitals
* The patients must have agreed to the treatment protocol and to take IV or PO associated drugs prescribed in addition to Bortezomib
* The patients must meet the 2003 eligibility criteria of the National Agency for Accreditation and Evaluation in Health (ANAES) for chemotherapy at home:

  * Absence of severe adaptive or psychological disorders, ability to understand the protocol
  * Absence of cognitive impairment
  * Availability and agreement of the attending physician
  * Home safety and hygiene
* Do not decline to participate in the research and share their personal data

Exclusion Criteria:

* Already participating in another trial
* Have a follow-up and/or treatment for another condition requiring a particular care during the Bortezomib treatment period
Trial of Prompt Mental Health Care

Anxiety and depression are among the most common mental disorders in the population. Anxiety and depression have significant consequences at the individual, family and community level, and mental illness is estimated to cost the Norwegian society 180 billion Norwegian kroner annually. The majority of this amount is accounted for by anxiety and depression disorders. Meanwhile, access to mental health services to treat these disorders is limited. The proportion of people who do not receive treatment of those who are in need of treatment is estimated to be over 50%.

Prompt Mental Health Care (PMHC) is a pilot project initiated in 2012 by the Directorate of Health commissioned by the Ministry of Health, with the goal of increasing access to evidence-based treatment for adults with anxiety disorders and mild-to-moderate levels of depression. The treatment offered is cognitive behavioural therapy and should lead to reduced levels of symptoms of anxiety and depression, improved quality of life and better employability. PMHC is based on the English program "Improving Access to Psychological Therapy (IAPT)", which is established in virtually all health communities in England.

The evaluations of IAPT and PMHC have until now been based on relatively weak research designs which make it difficult to know to what extent the initiative really has the desired effect. In this study, PMHC is compared with a control group that receives treatment as usual (often provided by the general practioner) in two PMHC pilot sites (Kristiansand and Sandnes). Participants are randomly assigned to either the PMHC or the control group. The investigators aim to include 1100 clients in the study.

The key objectives of this study are to investigate whether PMHC treatment is more effective as compared to treatment in the control group with regard to symptoms of anxiety and depression, work participation, functional status, and mental well-being. Cost-effectiveness of PMHC is also examined.


Eligibility Criteria:
Inclusion Criteria:

* PHQ-9/GAD-7 scores above cut off Level
* Being above 18 years of age and a resident in the pilot sites
* Basic verbal and oral Norwegian proficiency

Exclusion Criteria:

* Entitled to secondary care services due to eating disorder, suicide risk, bipolar disorder, severe depression, invaliding anxiety, psychotic symptoms, severe substance abuse, and personality disorder.
* Two or more previous treatment attempts without effect.
* Serious physical health problem as prime problem
Valsalva Manœuvre in the Diagnosis of Left Ventricular Failure in Chronic Obstructive Pulmonary Disease Exacerbation

Left ventricular failure (LVF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD).

This association is frequently underestimated with regard to the difficulty of clinical diagnosis .

The investigators expect that Valsalva Maneuver (VM) could be useful in this issue.


Eligibility Criteria:
Inclusion Criteria

* We included in this group, patients with a history (previous history) of COPD who consulted the emergency room for an exacerbation of COPD defined by a respiratory rate\> 25c/min and a pH \<7.35 and a PaCO2 \>6 KPa.
* This group is also divided into two groups according to clinical expert assessment and the BNP value: Group1 : BNP\> 400pg/ml, Group2 : BNP \<400PG / ml

Exclusion Criteria:

* We excluded from this study patients with Prominent cardiac arrest
* Rhythm disorders including severe tachycardia arrhythmia
* Auricular fibrillation
* Hemodynamic instability requiring the use of vasoactive drugs and a contre indications of non invasive ventilation such us consciousness disorders with a Glasgow score \<12/15,a swallowing disorder
* A significant bronchial obstruction ,the upper airway obstruction , in upper gastrointestinal bleeding in progress, an extreme obesity and Cirrhosis or cancer.
* We are also excluded patients who did not cooperate and those who refused the study.