cyrilzakka/clinical-trials huggingface dataset:
Delivering a Digital Health Intervention to Improve Food Access and Dietary Quality Among Adults With Hypertension

A total of 65 participants with hypertension and low access to high quality food will be enrolled to test the feasibility of using commercially available grocery delivery services, simultaneous to a robust behavioral intervention, to improve adherence to the Dietary Approaches to Stop Hypertension (DASH) eating pattern. The behavioral intervention will include skills training, nutrient goal setting, self-monitoring via dietary tracking, personalized text message feedback, and adaptive health coaching. Participants will also receive a membership to Instacart+ and weekly grocery list recommendations from a health coach. The primary outcome will be indicators of feasibility, including acceptability, demand, implementation and practicality and adaption. Change in DASH adherence and blood pressure will also be evaluated. The intervention period for participants will be 4 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years of age or older
* Has hypertension, defined as a systolic BP of 130-159 mmHg and/or diastolic BP of 80-99 mmHg, whether or not taking hypertension medication.
* Resides in a census tract defined as low access by the United States Department of Agriculture (USDA)
* Resides in a zip code serviced by the grocery delivery app
* BMI 18.5 kg/m2+
* Has a smartphone with a data plan
* Willing to receive daily text messages
* Can participate in online videoconference visits
* Can read and write in English

Exclusion Criteria:

* Participating in another related research study
* Cardiovascular disease event in the last 6 months
* Active cancer
* Recent hospitalization due to psychiatric condition or event
* Pregnancy or planned during the study period
* BMI 37 kg/m2 or higher
* Documented dementia
* On kidney dialysis
* Instructed to eat a low potassium diet
* Planned or recent bariatric surgery
A Study of FMT in Patients With AML Allo HSCT in Recipients

This is a randomized, double-blind, placebo-controlled clinical trial of Fecal Microbiota Transplant (FMT) in 2 independent cohorts (60 acute myeloid leukemia patients undergoing intensive chemotherapy and 60 Allo-HCT patients). Participants in each cohort will be randomized in a 2:1 ratio to receive up to 3 treatments of FMT vs. placebo after each exposure to antibacterial antibiotics until 3 months after randomization.


Eligibility Criteria:
Inclusion Criteria:

* Age≥ 18 years
* Cohort A: Patients undergoing intensive induction chemotherapy for acute myeloid leukemia (AML; newly diagnosed or relapsed/refractory).

  \* Any intensive regimen with planned \~4 weeks of inpatient stay
* Cohort B: Allo-HCT patients

  \* Any allogeneic transplant regimen with planned GVHD prophylaxis containing generic IV Mycophenolate Mofetil (MMF) and tacrolimus (Tac)
* Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control until at least six months post-FMT/placebo
* Voluntary written consent signed before performance of any study-related procedure not part of normal medical care

Exclusion Criteria:

* Planned continuation of antibacterial antibiotics after the first neutrophil recovery (ANC \> 1,000)
* Patients who are currently receiving or recently received (within 28 days) other investigational agents.
* Pregnant or breast feeding. The FDA has not classified this agent into a specified pregnancy category. Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
The Use of 2% Chlorhexidine Gluconate Impregnated Cloth Bathing in Preoperative Skin Preparation

To compare the use of towels impregnated with 2% chlorhexidine gluconate in the traditional preoperative bath with 2% chlorhexidine gluconate in preventing the occurrence of surgical site infection among patients undergoing potentially contaminated elective surgery.

This is a pilot randomized controlled clinical trial, composed of patients submitted to potentially contaminated elective surgeries, randomly assigned to an intervention group, consisting of those who used towels impregnated with pre-operative CHG 2% and control group, composed of by the pre-operative bath with 2% conventional / liquid CHG. Both used the products the night before and the morning of surgery and received verbal and written guidance.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over
* literate
* undergoing potentially contaminated elective surgeries
* admitted on the day before the surgical treatment or in the triple three-day hospital stay prior to surgery, without an infectious or otherwise infected process
* correctly follow the instructions for the use of towels impregnated with chlorhexidine gluconate 2%
* follow the instructions for the use of chlorhexidine gluconate 2%

Exclusion Criteria:

* submitted to previous surgeries, in a period of less than thirty days, or ninety days in the case of a prosthesis implant
* present skin lesions or known allergy to chlorhexidine gluconate 2%
* patients submitted to videolaparoscopic surgeries and vaginal surgeries
* patients who had daily use of products containing antiseptics (creams and / or liquid or bar soaps containing CHG, triclosan or similar) in their daily activity; or who had used antibiotics or similar drugs two weeks before and during the period of data collection.
Decreasing Loneliness in Older Adults

The purposes of this study are: (1) decrease loneliness and social isolation and increase social competence and social integration of older adults experiencing loneliness; (2) examine an intervention process grounded in a theoretical model that was developed in a previous study. The intervention process is tailored to the participants' barriers and abilities, and includes up to 10 personal meetings with an activities counselor and several group meetings.


Eligibility Criteria:
Inclusion Criteria:

* age 65 or over
* residing in the Tel Aviv region

Exclusion Criteria:

* having known mental illness including schizophrenia, depression, bipolar disorder, and dementia
Pamidronate Prophylaxis in Multiple Myeloma 30 mg/Month Versus 90 mg/Month

Multiple myeloma is a malignant hematological disease dominated by monoclonal plasma cells in the bone marrow. Major symptoms are related to the bones due to an increased bone resorption and a decreased bone formation leading to bone pain and increased risk of fractures. The normal osteoclasts are responsible for bone degradation through stimulation from the malignant plasma cells. Bisphosphonates have been shown to inhibit the osteoclast activity but may have serious side-effects due to renal toxicity and the optimal dose have not been established.

In a randomized double blinded design it is aim to compare the standard of monthly injections of 90 mg pamidronate with 30 mg.

The primary end-point is physical function estimated by EORTC QLQ-C30 questionnaire at 12 months after starting the treatment in newly diagnosed treatment demanding multiple myeloma. Secondary end-points are skeletal related events, cost-utility analysis, response, response duration and survival and quality of life with respect to fatigue and pain.

Patients with newly diagnosed treatment demanding multiple myeloma are after informed consent and approved inclusion criteria randomised by telephone call to Copenhagen Trial Unit (CTU) and information on the target dose is send to the distributor, Amgros, and the local pharmacy for preparation of the pamidronate solution. Infusion is given for 2½ hours.

Before starting treatment the patient has to fulfil the first EORTC QLQ-C30 questionnaire that is send to the quality of life secretariat in Oslo, Norway. Subsequent questionnaires are mailed directly to the patients every third month.

The infusions are continued for 3 years and may be extended further upon the patient's request.

Every third month the number of skeletal event, the response and complications are recorded.

Skeletal X-rays are performed 9 and 24 months after starting the treatment.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosed multiple myeloma with treatment demanding disease

Exclusion Criteria:

* Life-expectancy less than 3 months, another active malignant disease, treatment with bisphosphonates for more than 3 months within the last 6 months, patients with creatinine above 400 µmol/l 4 weeks after starting chemotherapy, patients who cannot cooperate for monthly infusions, patients who do not give their informed consent
Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment

Rationale:

The diaphragm is the principal respiratory muscle, which separates the thorax from the abdomen. Hyperinflation of the lung places the diaphragm at a mechanical disadvantage, shortens its operating length and changes the mechanical arrangement of costal and crural components of the diaphragm and consequently decrease the tension that can be developed and the amount of transdiaphragmatic pressure that can be produced. Reducing the lung hyperinflation could improve the diaphragm function mechanically. One of the treatments to reduces lung hyperinflation is the bronchoscopic treatment using endobronchial valves. To our knowledge the change in diaphragm function after bronchoscopic endobronchial valve treatment was never investigated.

Objective:

To investigate the change in diaphragm function after bronchoscopic lung volume reduction treatment with endobronchial valves (EBV).

Study design:

Observational study in which the study population will be asked to perform some additional test during regular visits for the bronchoscopic lung volume reduction treatment with valves.

Main study parameters: Change in diaphragm function 6 week after EBV treatment measured by ultrasound. The main outcome will be diaphragm motion (difference between maximum in- and expiration).


Eligibility Criteria:
Inclusion Criteria:

1. Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves
2. Patient read, understood and signed the Informed Consent Form

Exclusion Criteria:

There are no exclusion criteria for this study.
Adapted Physical Activity, Health-related Quality of Life and Satisfaction With Care in Hospitalized Children

The aim of this study is to assess the efficacy of adapted physical activity intervention on health-related quality of life and satisfaction with care in hospitalized children and adolescents.

This is a randomized controlled study. The hypothesis is that children practicing adapted physical activity during their hospitalization present a higher health-related quality of life and satisfaction with care than those who do not.


Eligibility Criteria:
Inclusion Criteria:

* Length of hospital stay (more than 3 days)
* Children or parents able to understand and read French
* No medical contra-indications to physical activity
* Children hospitalized in 3 specific departments at Nancy Children's Hospital:

  * Médecine Infantile 1 et 3(paediatrics)
  * Médecine Infantile 2 (haematology-oncology, immunology department)
  * Chirurgie orthopédique et Brûlés (orthopaedic surgery and Burned)
* Children and parents being agree to participate in the study

Exclusion Criteria:

* No written informed consent
* Children hospitalized less than 3 days
* Medical contra-indication to physical activity
* Children already included in that study (former hospitalization)
Study of Human Adipose Tissue (LOSHAT)

The investigators will study the influence of initial fat cell size/number and adipose function (in particular lipolysis) on weight development over very long time periods (years). By comparing investigations of fat biopsies or blood samples obtained at baseline, the investigators will determine the association between adipose morphology/function and changes in weight or development of metabolic complications (e.g. metabolic syndrome, glucose intolerance, type 2 diabetes, dyslipidemia and hypertension).

The investigators will ask all subjects that have previously been examined at the investigators laboratory (from 1992 and forward) in studies of adipose tissue function if they are interested to participate in a new study.

Previously obtained results from examinations of adipose tissue, anthropometric measurements and blood samples will be used as baseline. In addition, saved blood samples and samples from old fat biopsies can be re-investigated in some cases.

The new investigation includes a questionnaire that the subjects can answer by mail or email. In addition, anthropometric measurements and blood pressure determination will be performed at a primary health care center and blood samples will be collected for analysis of fasting glucose, HbA1C and lipids.

Information regarding all previously investigated subjects will also be collected from several Swedish national patient registries such as the Patient Register, Prescribed Drug register and Cause-of Death register.

Eligibility Criteria:
Inclusion Criteria:

* Previously participated in examinations at the investigators laboratory and donated adipose tissue.
* Previously participated in examinations at the investigators laboratory and donated blood samples that can be used to estimate lipolysis with a formula.

Exclusion Criteria:

* Decline to participate after invitation.
* Severe Psychiatric disease.
* Type 1 Diabetes
* Participants that have undergone bariatric surgery will be exluded in the primary analysis but will be analyzed separately in a secondary analysis for all above mentioned outcomes.
HFHO vs CPAP During Thoracic Surgery

A single institutional cross-over study design to compare between high flow humidified oxygen (HFHO) device versus conventional CPAP for non-ventilated lung during thoracic surgery.

The investigators hypothesize that HFHO may be an alternative tool to supply oxygen to non-ventilated lung during one lung ventilation. CPAP can improve oxygenation at a cost of lung hyperinflation which is an unwanted condition during thoracic surgery especially the video-assisted one.

Recruiting adult patients who undergo lung surgeries that requires one-lung ventilation. Exclusion criteria include the followings:-

1. Emergency case.
2. Patients with severe COPD(Chronic Obstructive Pulmonary Diseases).
3. Patients with moderate baseline hypoxemia (SpO2 \< 90% on room air).
4. Patients with severe hemoptysis.
5. Patients with upper or lower airway abnormalities.
6. Patients undergo pulmonary lavage.
7. Patients with known pulmonary hypertension.
8. Patients with known pulmonary/tracheobronchial infections.
9. Patients with suspected difficult airway.
10. Patients with BMI over 35.
11. Pregnant patients.

Following a standard anesthetic practice. All participants will receive an intravenous based anesthetic with or without regional blocks. The appropriate sized double lumen endobronchial tube will be placed and fiberoptic bronchoscope is used to verify a proper position. Patient will also get an arterial line for frequent ABG (Arterial Blood Gases) samplings.

Computer generated randomization will divide patients into 2 groups. Baseline ABG will be drawn. After one lung ventilation commenced for 20 minutes, the 2nd ABG will be drawn, the surgeon who was blinded to the intervention will evaluate the quality of lung collapse using 5-point Likert scale. Then, patients will either receive a CPAP or HFHO (depends on randomization) for 20 minutes. Up on 1st intervention completion, the 3rd ABG and lung collapse evaluation will be performed.

Following the first intervention, the non-ventilated lung will be suctioned out and wait for 20 minutes. Another ABG will be sampled at this point.

The patient will receive the 2nd alternative intervention (CPAP or HFHO- depend on their randomization) for 20 minutes. The final ABG and lung collapse evaluation will be performed.

If any severe hypoxemia/ hypercarbia and marked violation of protocol occurs. Patients will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* All adult \> 18 years of age undergoes lung surgeries that required one-lung ventilation

Exclusion Criteria:

* emergency case
* severe COPD
* moderate baseline hypoxemia
* pulmonary hypertension
* difficult upper/lower airway
* BMI \> 35
* severe pneumonia
* bronchial lavage
* massive hemoptysis
Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure

Aim of the clinical multicenter study (OptimEx-CLIN) is to assess the optimal exercise intervention in patients with Heart Failure with preserved Ejection Fraction (HFpEF; also termed diastolic heart failure) that will best improve peak oxygen uptake (Peak Vo2) and additionally diastolic function (assessed echocardiographically). The investigators hypothesize that exercise training reverses HFpEF and that intensity of exercise training is more important than duration.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary (structured exercise \< 2x 30 min/wk)
* At least 40 years old
* Preserved systolic function LVEF \> 50%
* Signs and symptoms of heart failure class NYHA II or III
* Diastolic dysfunction (E/é \> 15 or E/é 8-15 and NT-proBNP \> 220 pg/ml)
* Clinically stable for \>= 6 weeks
* Optimal medical treatment for \>= 6 weeks
* Written informed consent

Exclusion Criteria:

* Non- HFpEF causes for HF symptoms (significant valvular or coronary disease, uncontrolled hypertension or arrhythmias, primary cardiomyopathies)
* Significant pulmonary disease (FEV1 \< 50% predicted, COPD GOLD III-IV)
* Inability to exercise or conditions that may interfere with exercise intervention
* Myocardial infarction in the previous three months
* Signs of ischemia during exercise testing
* Comorbidity that may influence one- year prognosis
* Participation in another clinical trial
Protection Against Pneumococcal Infection in Children With T1DM

Children/ young people with diabetes may be at a higher risk of acquiring certain infections. These infections include those caused by a bacterium called the pneumococcus which can cause pneumonia, meningitis and ear infections. In the UK older children with diabetes are given a vaccine against the pneumococcus bug called Pneumovax (or PPS23 for short). Although PPS23 causes a good immune response in children over 2 years of age it is not actually known how well PPS23 protects against infection in children of any age. In addition there is some data in adults and children that PPS23 may result in a reduced response to future doses of pneumococcal vaccines (hyporesponsiveness). Because of the lack of information on how well PPS23 protects and potential hyporesponsiveness the investigators would like to study the use of an alternative vaccine against pneumococcus called Prevenar13 (or pCV13). This vaccine is known to be safe and to work well in babies and young children and there have been no concerns about hyporesponsiveness. It has been approved for use in children up to 17 years of age but there is little information on the size and duration of immune response to PCV13 in children aged 6 years and older.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T1DM and being followed in the Oxfordshire Children's Diabetes Service.
* Aged between 6 years and 17 years.
* Parent/legal guardian willing and able to give informed consent.
* No previous immunisation with a pneumococcal conjugate vaccine (PCV).
* Willing to allow the General Practitioner to be notified of participation in the study.

Exclusion Criteria:

* Known allergic reaction to the vaccine antigen or any of the excipients.
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil

The sponsor electively terminated the study because the risk mitigation measures, deemed necessary after an unforeseen safety event, could not be effectively implemented within this protocol while maintaining study timelines within a reasonable time frame.

This study will evaluate atacicept's effects in subjects who have lupus nephritis, at least 2 g/day of protein in the urine, and are already taking mycophenolate mofetil. The evaluations will include the concentrations of atacicept in the blood, the effects of atacicept on immunoglobulins (antibodies), and any side effects. The first subjects will be given a low dose. Following periodic reviews of the trial data, subsequent subjects are planned to receive one of 2 progressively higher doses of atacicept.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, ≥ 18 years of age, who provide written informed consent
* Subjects must have a diagnosis of SLE satisfying ≥ 4 of 11 ACR criteria, and must have had a renal biopsy during screening or within the previous 18 months demonstrating class III (A or A/C), IV (A or A/C), V, or concomitant III/V or IV/V LN as defined by the International Society of Nephrology/Renal Pathology Society (ISN/RPS).
* Subjects must have a urine protein: creatinine ratio ≥ 2 mg/mg (≥ 226.2 mg/mmol), and either a positive test for antinuclear antibody (ANA) (HEp-2 ANA ≥ 1:80) and/or anti-double stranded deoxyribonucleic acid (dsDNA) (≥ 30 IU/mL) at screening.
* Subjects must have started induction therapy for LN at least 5 months prior to Trial Day 1, be considered to have received continuous treatment for LN during the 5 months prior to Trial Day 1, and have received a stable dose of MMF ≥ 1 g/day, with or without corticosteroids, for at least 8 weeks prior to Trial Day 1.

Exclusion Criteria:

* Recent changes in immunosuppressant, ACD inhibitors for ARBs
* Use of azathioprine, cyclosporine, tacrolimus, or cyclophosphamide or other biologics within 8 weeks prior to Trial Day 1.
* Serum IgG \< 6 g/L
* Estimated Glomerular Filtration Rate (GFR) ≤ 30 mL/min per 1.73 m2
* History of Demyelinating Disease
* Significant Hematuria and/or Proteinuria due to a reason(s) other than LN. Evaluation should be done according to the local standard of care
* Breast feed or pregnancy
* Legal Incapacity or limited legal capacity