cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

To study the efficacy and safety of finerenone in patients with primary aldosteronism

This is a prospective and randomized study involving patients with primary aldosteronism(PA). All paticipants will be randomized into finerenone group(Intervention group) and spironolactone group(Control group) and to compare the antihypertensive effect in patients with PA.

If the self-measured blood pressure of patients at home continues to be greater than 140/90 mmHg at 2-4 weeks, spironolactone or finerenone should be increased to 40mg qd, and electrolytes should be reviewed at 2 weeks after dosed.

Eligibility Criteria:
Inclusion Criteria: Patients who meet the following criterion can be included in this study.

1. Patients know the whole process of the trial and voluntarily accepted randomization, intervention and follow-up.
2. Patients voluntarily participated in the study and signed an informed consent, willing to complete all follow-up visits as required.
3. Aged between 18-70, male or female, with legal capacity.
4. eGFR≥60(ml/min/1.73 m2)
5. Patients with PA and substandard blood pressure (≥140/90mmHg) who didn't take any antihypertensive drugs or who had been using antihypertensive drugs other than MRA steadily for 2 weeks or more

Exclusion Criteria: Patients with one of the following conditions will be excluded in this study:

1. To assess patients with poor compliance who had difficulty fully participating in the study, or who refused to sign written informed consent for the study
2. Patients with heart failure (New York Heart Association (NYHA) class III or IV), liver transaminase levels were more than 2 times higher than the upper limit of normal, estimated glomerulus filtration rate\<30ml/min/m2
3. Patients with serum potassium \> 5.0mmol/L without potassium supplementation
4. Patients with stroke or acute coronary syndrome within 3 months
5. Pregnant or lactating women
6. Patients currently receiving sex hormone or glucocorticoid therapy
7. Patients with a history of uncontrolled malignant tumor
8. Patients who took MRA within 2 weeks
Rotation and Movement System, Postpartum Cesarean Sections

In the first half hour of a cesarean advertisement, the service-oriented mother will not be mobile and will need support to get fit in bed and start getting started. The patient turning and movement system will provide a lot of convenience to the mother who does not have enough support.

With the remote control system, the mother will be easily turned to the desired side in the bed and it will be ensured that she takes the desired position with less pain and more comfort.

While studies on the Patient Turning and Movement System have been conducted on long-term bedridden patients, there is no scientific study examining its effects in the obstetric field. For the reasons mentioned above, the aim of this research is; The aim of this study is to investigate the effect of Patient Turning and Movement System on postpartum early postpartum breastfeeding success, pain and postpartum comfort in puerperant women who delivered by cesarean section and to contribute to the literature.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-35.
* Primiparity.
* Having a transverse cesarean section.
* At least primary school graduate.
* No high-risk pregnancy.
* Absence of any complications in the puerperal and newborn during the delivery and postnatal period

Exclusion Criteria:

* Having an open wound on the body and/or an allergic disease diagnosis on the skin.
* Development of puerperal complications (bleeding, infection, fever).
* At risk of convulsions; have diseases such as eclampsia, epilepsy.
* Having a body mass index above 40 (morbidly obese).
* Having any contraindications for breastfeeding.
* Having chronic opioid, antidepressant, and psychoactive drug use.
A Clinimetric Test of Spinal Sensors in Measuring Spinal Mobility in Axial Spondyloarthritis

This is a clinimetric study to validate the use of IMU spinal sensors to measure the range of spinal movement in a group of patients with axial spondyloarthritis.

One of the most important goals of therapy in axial spondyloarthritis is to improve and/or preserve spinal mobility. In the early stages of the disease, spinal stiffness is reversible but eventually the spine can fuse causing permanent loss of flexion. Traditional tests for spinal mobility using tape measures are inaccurate and do not capture many aspects of kinematics such as spinal rotation or speed of movement. There is also a need for wearable sensors to give patients feedback and encourage more regular exercise.

The investigators will be using IMU spinal sensors to measure spinal ROM in a group of 40 patients with axial spondyloarthritis. The investigators will be testing aspects of inter-rater and intra-rater reliability, comparing sensor reliability to the accuracy of the traditional tape measure test (BASMI).

Eligibility Criteria:
Inclusion Criteria:

-Confirmed diagnosis of axSpA according to the ASAS criteria

Exclusion Criteria:

* Severe joint or spinal pain at the time of the study
* Severely restricted hip movement
* History of previous vertebral fracture
* History of previous spinal surgery
* Major scoliosis deformity
* Pregnancy
Study Evaluating the MindMotionPRO for Early Post-stroke Upper-limb Rehabilitation

Randomised controlled multi-centered study using MindMotionPRO, an immersive virtual reality based system for upper limb motor rehabilitation in early post-stroke patients. The study aims to evaluate the ability of MindMotionPRO technology to increase the rehabilitation dose. Effectiveness will be evaluated by validated rehabilitation performance scales. Cost-effectiveness will be assessed by the resource utilization.

The goal of the study is to show that MindMotionPRO is a tool that allows a patient to increase the amount of rehabilitation therapy performed. This study will measure the rehabilitation dose, as measured by the duration of the rehabilitation session and the number of exercises performed by the patient. The study hypothesis is that patients in the MindMotionPRO group will spend more time performing rehabilitation exercises than in the Self-Directed Prescribed exercises group. The effectiveness of the MindMotionPRO versus Self-Directed Prescribed Exercises will also be measured, based on the change in rehabilitation performance measures. The cost-effectiveness will be measured by the resource utilization, as defined by the time spent by the therapist providing the rehabilitation session.

Eligibility Criteria:
Inclusion Criteria:

* Male/female \> 18 years old
* First ever unilateral supratentorial ischemic stroke with contralateral upper extremity weakness
* 1 to 6 weeks post-stroke
* Able to give informed consent
* Not participating any other intervention studies
* Experiencing motor difficulties in using the paretic arm, with a FMA-UE score in the range of 20 to 40 out of 66
* Stroke severity with NIHSS score between 5 (mild) and 14 (moderate) out of 42
* The participant is expected to remain available (geographically stable) for 4 months after enrolment.

Exclusion Criteria:

* Any medical condition compromising the safety or the ability to take part to the study (such as insufficient vision or hearing, inability to participate to therapy session, inability to communicate, upper limb condition not linked to stroke, uncontrolled blood pressure, uncontrolled diabetes, co-morbidity)
* Recurrent and moderate to high upper limb pain limiting delivery of rehabilitation dose
* History of more than one epileptic seizures since stroke onset or uncontrolled epileptic seizure
* Mild to severe cognitive impairment (Mini mental state exam (MMSE) score \< 24/30)
* Depression (Hospital Anxiety and Depression Scale \> 8/21)
* Moderate to severe hemispatial neglect compromising the ability to take part to the study, as determined by the Bells tests (\> 6 errors)
* Brain stem stroke
The Effect of Increasing Dialysate Calcium on T50 in Subjects With Secondary Hyperparathyroidism and ESKD

Patients with end-stage kidney disease (ESKD) have an increased risk of cardiovascular mortality. High parathyroid hormone (PTH) from secondary hyperparathyroidism leads to increased efflux of phosphate and calcium from bone, which exacerbates vascular calcification and increases the risk of bone fractures. The main driving factor for secondary hyperparathyroidism is hypocalcaemia caused by low levels of 1,25-dihydroxy vitamin D and pharmacological supplementation with activated vitamin D and oral calcium-containing phosphate-binders are used to control secondary hyperparathyroidism. The amount of calcium used in this context is controversial, as higher calcium load in blood may theoretically increase vascular calcification. Conversely, by alleviating the efflux of phosphate and calcium from bone due to secondary hyperparathyroidism, increasing the load of calcium might actually prevent vascular calcification.

To study this further, we wish to conduct a randomised double-blinded controlled clinical trial of increasing dialysate Ca from 1.25 mmol/L (standard dialysate concentration) to 1.50 mmol/L in patients with ESKD and secondary hyperparathyroidism on maintenance haemodialysis (HD). The overall effect of increased dialysate calcium will be gauged by its effect on serum calcification propensity (T50) and on markers of bone turnover.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Treatment with thrice-weekly maintenance HD for ESKD for \> 3 months.
* Dialysate calcium of 1.25 mmol/L (standard concentration).
* Plasma ionised calcium \< 1.35 mmol/L (average of last 3 months).
* Plasma intact PTH \> 14 ρmol/L.
* Plasma total alkaline phosphatase \>90 U/L
* Negative pregnancy test and use of highly effective and safe contraception.
* Able to give written informed consent.

Exclusion Criteria:

* Treatment with peritoneal dialysis.
* Clinical bone fracture within the last 6 months.
* Treatment with bisphosphonates, denosumab, romosozumab, or teriparatide within the last 3 months.
* Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of the trial.
* Pregnancy or breastfeeding.
Effects of Multimodal Analgesia on Serum MCP-1, BDNF, and MiRNA-124 in Hysterectomy Surgery

The inflammatory process is the main mechanism in the occurrence of acute postoperative pain. It is also the main risk for the development of acute pain into persistent pain. Inflammation occurs in the process of peripheral sensitization and central sensitization with various inflammatory mediators. Postoperatively, there will be proliferation and activation of microglia and astrocytes which will then activate inflammatory receptors and signaling cascades of neurotransmitters, cytokines, and chemokines. There has been a lot of clinical research evidence that multimodal analgesia can adequately treat acute pain and can prevent the development of acute postoperative pain into persistent pain and chronic postoperative pain, but the molecular mechanisms are not fully understood.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective hysterectomy
* American Society of Anesthesiologists (ASA) physical status 1 to 3

Exclusion Criteria:

* allergy to studied drugs
* history of chronic pain
* history of hepatitis, depression, peptic ulcer, or acute myocardial infarction
* receive intraoperative massive blood transfusion
* prolonged coagulation
* body mass index \>35 kg/m2
* patients with neurological deficits
* taking anti-platelet medications
Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC

The purpose of this study is to evaluate the tolerability and efficacy of the addition of rofecoxib to first-line chemotherapy, and to evaluate the efficacy of prolonged continuous infusion of gemcitabine in combination with cisplatin in the treatment of patients affected by advanced non-small cell lung cancer.

The primary end-points of the GECO study

* To evaluate the tolerability of three innovative schedules of treatment for advanced NSCLC
* To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy in the treatment of patients affected by advanced NSCLC
* To evaluate the efficacy of prolonged continuous infusion (p.c.i.) of gemcitabine, with the fixed infusion rate of 10 mg/sqm/minute) versus the standard administration in 30 minutes, in combination with cisplatin, in the treatment of patients affected by advanced NSCLC

Four treatment arms are planned.

* ARM A standard treatment : cisplatin + gemcitabine
* ARM B cisplatin + gemcitabine + rofecoxib
* ARM C cisplatin + p.c.i. gemcitabine (10 mg/sqm/minute)
* ARM D cisplatin + p.c.i gemcitabine (10 mg/sqm/minute) + rofecoxib

The phase II part of the study for experimental arms B, C and D will be conducted to evaluate tolerability in the three treatment arms.

The phase III study for efficacy has been designed according to a factorial 2x2 model with the planned comparison of

* The efficacy of rofecoxib: A + C (arms without rofecoxib) vs B+D (arms with rofecoxib)
* The efficacy of p.c.i. gemcitabine: A + B (arms with standard infusion of gemcitabine) vs C+ D (arms with p.c.i gemcitabine)

Eligibility Criteria:
Inclusion Criteria:

* Cytologic or histologic diagnosis of non-small cell lung cancer
* Disease stage IIIB or IV
* Age less than 70 years
* ECOG performance status 2 or less
* Patients with cerebral metastases are permitted if they are asymptomatic and do not require radiation therapy concomitant with chemotherapy
* Negative history of allergy to non-steroidal anti-inflammatory and/or sulphonamide drugs
* Patients previously treated with radiation therapy are permitted if at least 4 weeks have passed since last therapy
* Written informed consent

Exclusion Criteria:

* Previous chemotherapy
* Previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)
* Neutrophil \< 2000/mm3, platelets \< 100,000/mm3, haemoglobin \< 10 g/dl
* Creatinine \> 1.25 x the upper normal limits
* GOT and/or GPT and/or Bilirubin \> 1.25 the upper normal limits in absence of hepatic metastases
* GOT and/or GPT and/or Bilirubin \> 2.5 the upper normal limits in presence of hepatic metastases
* Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
* Inability to comply with follow-up
Cognitive Activation Therapy for MCI: A Randomized Control Study

Mild cognitive impairment (MCI) describes an initial phase of cognitive decline, usually among older adults, in which a person notices a decline in attention or memory, and performs worse than normal on cognitive tests of such. People with MCI are more likely to develop Alzheimer's disease or related dementia than others their same age, and so MCI is thought of as an early warning sign of progressive cognitive decline.

While some forms of MCI may be brought about by purely genetic causes, other cases may be due to a withdrawal of cognitive engagement with the world. In these cases, a rigorous program of cognitive training may be beneficial, halting or reversing symptom progression.

The current study will evaluate a multifaceted cognitive activation program on older adults with MCI. This group program is intensive, running for 10 weeks, 3 times per week, for a total of 100 hours of training. Training consists of meditation exercises for broad attention activation, Tai Chi exercises to integrate cognition with body awareness, and cognitive training through computerized attention, memory, and problem solving exercise.

Subjective impressions and objective measures of cognitive ability will be measured before and after the intervention. The investigators will also examine effects on mood and levels of daily function. Results will be compared to a waitlisted control group. The control group will subsequently be entered into a home-based version of the program for 10 weeks, with assessment before and after training, to look at the importance of the group meeting dynamic in promoting cognitive change.


Eligibility Criteria:
Inclusion Criteria:

* Subjective complaint about decline in memory or attention
* \> 1 deviation below age-norm performance on memory or attention tasks
* Independence in daily living
* English speaking

Exclusion Criteria:

* Neurological disorders (including aphasias) or reversible causes of dementia (e.g., hypothyroidism or B12 deficiency)
* Montreal Cognitive Assessment (MOCA) score \< 24
* Clinical mood disorder such as depression or anxiety
* Other serious medical conditions that preclude participation in the program
Olanzapine Versus An Active Comparator in the Treatment of Schizophrenia

The purpose of this study is to determine how Olanzapine compares to an active comparator in the treatment of schizophrenia


Eligibility Criteria:
Inclusion:

1. You must be between the ages of 18 and 75. If you have reached your 76th birthday, you will not be able to participate
2. You must have been diagnosed with schizophrenia
3. You must be able to visit the doctor's office as scheduled for the next 7 months

Exclusion:

1. You have a serious medical illness, such as heart, liver, or kidney disease (Note: If you are uncertain about a particular condition, discuss it with your doctor.)
2. You are either pregnant or breastfeeding
Mobile Technology for Reducing and Preventing Adolescent Suicide

This single-group open-label trial will evaluate the feasibility and preliminary efficacy of a suicide prevention mobile application when used as an adjunct to usual care in adolescents.

This study will enroll 20 adolescent (age 13-17) inpatients at elevated risk for suicide. Participants will download the app onto their phones during their inpatient stay and will complete a single therapy session involving psychoeducation and crisis response planning. Participants will be encouraged to use the app on their own in addition to their usual outpatient services to learn and practice suicide prevention skills. Participants and their parents will be interviewed 1, 4, 8, 12, and 16 weeks after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient psychiatric patients who have attempted suicide (lifetime) or have documented suicide ideation and a plan to harm themselves at admission
* Understand written and spoken English
* Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher
* Willing and able to complete enrollment procedures
* Parent/guardian (and youth) able to understand the nature of the study and provide written informed consent (assent for youth)
* Willing to agree to release of information to their parent/guardian and providers when clinically indicated.
* Discharge plan includes aftercare within the Hartford HealthCare system (to facilitate coordination of care during follow up)

Exclusion Criteria:

* Patients with active psychosis
* Patients experiencing substance withdrawal
* Currently enrolled in other treatment studies for the symptoms and behaviors targeted
* Patient unwilling or unable to wear mask during in-person study procedures
* Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit profile with respect to the Smartphone App.
* Any other psychiatric or medical condition (e.g., intellectual disability) or custody arrangement that in the investigator's opinion would preclude informed consent/assent or participation in the trial.
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways

Multicentric interventional prospective study with collection of biological samples as part of a routine care research


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years.
2. Male and female sex.
3. Any patient with cancer (see list in the body of the protocol) requiring treatment by surgical resection and / or who will start treatment with mAb or BiTE.
4. Patient information and signed informed consent.
5. Subjects affiliated (or beneficiary) to a social security scheme

Patients treated for immune complications by immunosuppressants may be included (corticosteroids, etc.).

Exclusion Criteria:

1. History of severe systemic autoimmune disease.
2. Pregnant or breastfeeding patient
3. Impossibility or refusal to sign informed consent
4. Patient under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems

This cluster randomized pragmatic clinical trial will test the effectiveness and feasibility of embedding the Tele-Savvy intervention, a psychoeducational program for family and other informal caregivers of older adults living in the community with Alzheimer's disease and related dementia (ADRD), in two health care systems/clinical sites: UConn Health in Farmington, Connecticut, and Emory Healthcare in Atlanta, Georgia.

This cluster randomized pragmatic clinical trial will test the effectiveness and feasibility of embedding the Tele-Savvy intervention, a psychoeducational program for family and other informal caregivers of older adults living in the community with Alzheimer's disease and related dementia (ADRD), in two health care systems/clinical sites: UConn Health in Farmington, Connecticut, and Emory Healthcare in Atlanta, Georgia. A total of 100 caregivers, 50 at each study site, will participate in this pilot study. At each site, 30 caregivers will be randomly assigned to receive the Tele-Savvy intervention, and 20 caregivers will be randomly assigned to receive the self-guided Caregiving During Crisis online program.

All 100 caregivers will complete identical self-administered questionnaires to measure the caregiver-specific outcome measures in this pilot study. Outcome measures will include caregiver mastery (primary outcome), caregiver response to specific memory and behavioral problems, and caregiver stress. Also, we will employ process measures of participation and engagement in the interventions for caregivers in both arms of the trial, as well as implementation outcomes via surveys with clinicians and Information Technology staff at each of the two clinical sites responsible for programming electronic medical records to enable capture and storage of caregiver outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Identified by EHR systems and confirmed by a health care provider as a family member or unpaid significant other who provides care at home for an older adult (age 65 or older) living with ADRD
* English speaking
* Able to understand study procedures and comply with them for the entire length of the study
* Access to appropriate video and audio technology to be able to participate in interventions

Exclusion Criteria:

* Unwilling to be randomized to receive either Tele-Savvy or Caregiving During Crisis
* Planning to admit the person living with ADRD to a nursing home on a long-term basis within 6 months of randomization.