cyrilzakka/clinical-trials huggingface dataset:
Natural History of COVID-19-Related Atrial Fibrillation

The unCOVer-AF prospective, multicenter registry aims at determining the natural history of atrial fibrillation (AF) via continuous cardiac rhythm monitoring in patients with a first arrhythmic episode during COVID-19 hospitalization.

Coronavirus Disease 2019 (COVID-19) is a novel coronavirus strain disease, which has rapidly spread worldwide with more than 100 million confirmed cases to date. COVID-19 is mainly characterized by respiratory symptoms; however, patients can exhibit a wide range of clinical manifestations, including cardiovascular complications. Among them, supraventricular and ventricular arrhythmias have been described in patients at different stages of disease severity. According to a recent study on 9564 COVID-19 patients, 17.6% developed AF during hospitalization, 65.7% of whom without a past arrhythmic history.

Several factors (e.g., hypoxia, systemic inflammatory response, myocardial injury) may interact with a preexisting substrate and act as a trigger for AF initiation. Nonetheless, the pathophysiology of COVID-19-related new-onset AF remains elusive. It is unknown whether the disease merely acts as a transient arrhythmia initiator or promotes long-term atrial electrophysiological and structural changes which may facilitate AF recurrence and progression.

Therefore, the investigators designed a multicenter, prospective registry to assess the natural history of AF via continuous cardiac rhythm monitoring (ILR, PMK, ICD) in patients with a first AF episode during COVID-19 hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years;
* Confirmed infection with SARS-CoV-2;
* Patients with a first clinical episode of AF ≥30 s at admission or during hospitalization for COVID-19;
* Patients with:

  1. implantation of an ILR, a PMK, or an ICD during COVID-19 hospitalization or within 30 days after hospital discharge, or
  2. an ILR, a PMK, or an ICD implanted before COVID-19 hospitalization.

Exclusion Criteria:

* History of AF or flutter irrespective of type;
* Moderate/severe mitral stenosis;
* Mechanical prosthetic heart valve(s);
* Kidney failure treated with permanent dialysis;
* Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigators opinion could put the subject at significant risk, confound the study results, or interfere significantly with the subject participation in the study;
* Unwillingness to participate.
Leuprolide, Bicalutamide, and Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer After External-Beam Radiation Therapy

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide and bicalutamide, may lessen the amount of androgens made by the body. Implant radiation therapy kills tumor cells by placing material such as radioactive iodine directly into or near a tumor. Giving leuprolide and bicalutamide together with implant radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving leuprolide and bicalutamide together with implant radiation therapy and to see how well it works in treating patients with locally recurrent prostate cancer after external-beam radiation therapy.

OBJECTIVES:

* Determine the feasibility and patient tolerance of interstitial brachytherapy combined with androgen-deprivation therapy for patients with locally recurrent prostate cancer after prior external-beam irradiation.
* Determine the toxicity of interstitial brachytherapy combined with androgen-deprivation therapy in these patients.
* Determine the tumor response to interstitial brachytherapy combined with androgen-deprivation therapy in these patients.

OUTLINE: Patients receive neoadjuvant therapy comprising leuprolide acetate intramuscularly for 3 months and oral bicalutamide once daily for 30 days, beginning on the first day of leuprolide acetate administration. Patients then undergo interstitial brachytherapy implantation with I-125. Following brachytherapy, patients receive adjuvant leuprolide acetate every 3 months for an additional 6 months.

Quality of life is assessed at baseline and at every treatment and follow-up visit.

After completion of study therapy, patients are followed every 3 months for 2 years, every to 4-6 months for 3 years, and then annually thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy-proven adenocarcinoma of the prostate

  * Locally recurrent disease, defined by digital rectal examination and/or rising prostate-specific antigen (PSA)
* No evidence of nodal or distant metastasis (i.e., N0, M0) on physical examination, bone scan, or CT scan of the pelvis
* Clinical stage T1c-T3a disease at the time of recurrence
* PSA \< 10 ng/mL
* Prostate volume by transrectal ultrasonography \< 60 cc
* Received prior external beam radiotherapy

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* WBC ≥ 3,000/μL
* Platelet count ≥ 90,000/μL
* Hemoglobin ≥ 10 g/dL
* Alkaline phosphatase \< 2 times normal
* AST \< 2 times normal
* Normal prothrombin time and partial thromboplastin time
* No significant obstructive urinary symptoms (AUA score ≤ 16)
* No contraindication for general anesthesia

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior transurethral resection of the prostate
Cardiac Resynchronization Therapy (CRT) and Left Ventricular Assist Devices (LVAD) Therapy

Cardiac resynchronization therapy (CRT) or biventricular pacing is a useful treatment for heart failure and those suffering from arrhythmias. The purpose of this research study is to determine the effect left-ventricular pacing has on patients who have a ventricular assist device.

As part of the study participation the following two visits will be completed as listed below.

Baseline Visit: The following procedures will be conducted at this visit:

* Review of past medical history and medical records;
* A limited echocardiogram will be performed. This is a test that uses ultrasound to evaluate the size of the heart and how well the heart is pumping blood.
* The investigators will use a computer-like device, called a programmer, that "talks" to the CRT device using radio signals or by using wanded telemetry to adjust the CRT device's programmed settings. The left ventricular lead of your device will be turned off. The defibrillator will continue to function and back-up pacing will continue if needed.
* Complete the Kansas City Cardiomyopathy Questionnaire (KCCQ).
* A 6 minute walk test will be done.

Regularly Scheduled Clinic Visit: At the next regularly scheduled Left Ventricular Assist Devices (LVAD) clinic visit, approximately 4 weeks after the baseline visit, the following procedures will be done:

* A second limited echocardiogram.
* The investigator will use a computer-like device, called a programmer, that "talks" to the CRT device using radio signals or by using a wand to obtain a report that will give the current program settings and any heart rhythm events that have occurred since the last CRT device was checked. Once the information from the CRT is obtained, the study doctor will reprogram the device to its original settings.
* Complete the Kansas City Cardiomyopathy Questionnaire (KCCQ).
* A 6 minute walk test will be done.

Eligibility Criteria:
Inclusion Criteria:

* Presence of LVAD support and CRT device with working LV lead in patients \> 18years of age
* Left ventricular pacing at time of enrollment

Exclusion Criteria:

* LV lead dysfunction
* Prior AV node ablation
* Presence of total heart block
* Presence of significant bradycardia/lack of underlying rhythm
* Inability to complete 6 minute walk test
* Inability to return to clinic for repeat assessment
* Any LVAD programmed speed change within the prior 30 days
* Any CRT programming changes within the prior 30 days
NAVADYN11 : Hemodynamic Impact of a New Ventilatory Support Mode With Diaphragmatic Synchronization

Despite spectacular advances since the 90s mechanical ventilation used in intensive care units are amply associated with cardio-respiratory complications: nosocomial pneumonia, lung parenchyma lesions induced by ventilation, hemodynamic instability and ultimately to a significant morbidity and mortality.

NAVA (Neurally Adjusted Assist Ventilation) ventilatory support, provides synchronous support, proportionate to patient's respiratory efforts. More "physiological", this mode would decline its efficacy on patient hemodynamic response. However, to date, no study has focused on hemodynamic impact of NAVA. This is precisely the purpose of NAVADYN11 study, which aims to assess NAVA efficacy on cardiac index in pediatric intensive care unit.


Eligibility Criteria:
Inclusion criteria:

* Servo-i with NAVA available at patient admission
* Sedation protocol compatible with NAVA functioning
* Parental consent

Non inclusion criteria:

* Digestive pathology incompatible with gastric tube.
* Deep sedation required defined by score ComfortB \<11 (cranial traumatism...)
* Brain damage incompatible with spontaneous ventilation
* Duration of intubation too short for investigation

Exclusion criteria:

* Clinical worsening requiring treatment and/or management inconsistent with NAVADYN11 research (CPR, emergency surgery ...). However, the investigator is allowed to reiterate investigation when patient stabilized.
Radical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma

Objectives:

The purpose of this study is to evaluate the safety and efficacy of radical surgery combined with dendritic cell-precision multiple antigen T cells in reducing the recurrence and metastasis of liver cancer

Methods:

This study designs a novel therapy using dendritic cell-precision multiple antigen T cells. 60 postoperative patients of hepatocellular carcinoma will be enrolled. They are randomly divided into postoperative routine therapy group and dendritic cell-precision multiple antigen T cells combined with postoperative routine therapy group. Dendritic cell-precision multiple antigen T cells treatments will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.

A total of 60 patients may be enrolled over a period of 1-2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~65 years old, male or female
2. Signed informed consent
3. Diagnosis of hepatocellular carcinoma (HCC), radical surgery was performed
4. The recurrence of HCC was not found after the Operation and no other immunotherapy was carried out
5. The Eastern Cooperative Oncology Group (ECOG) score ≤2
6. Child-Pugh score of liver function ≤ 9
7. Routine blood meets the requirements

Exclusion Criteria:

1. Expected Overall survival \< 3 months
2. Radical surgery was not performed or recurrence was found after operation
3. Liver function is Childs Pugh C
4. Had received other immunotherapy
5. Other serious diseases:the heart,lung, kidney,digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
6. Unable or unwilling to provide informed consent, or fail to comply with the test requirements
A Multiple Ascending Dose Study of DT-216P2 in Patients with Friedreich's Ataxia

The purpose of this study is to evaluate the safety and tolerability, and pharmacokinetics of DT-216P2 administered multiple ascending doses in patients with FA.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18-55 years of age inclusive, at the time of signing the informed consent.
* Genetically confirmed diagnosis of FA, with homozygous GAA repeat expansions in the frataxin gene.
* Stage 5.5 or less on the FSA at screening.
* BMI between 16 and 32 kg/m2 at screening; weight should be \<= 100 kg at screening.
* Male and/or female using protocol defined and regulatory approved contraception.
* Capable of giving signed informed consent.

Exclusion Criteria:

* Any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study protocol.
* Any clinically significant nonmedical conditions and psychiatric disorders that could put the participant at higher risk for participation in the study, influence the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.
* Received an investigational agent within the last 30 days or 5 half-lives, whichever longer, prior to the first dose of study drug, or are in follow-up of another clinical study prior to study enrollment. Exception: Potential participants who are currently on Omaveloxolone must be on stable doses for at least 3 months.
* Is not willing to comply with the contraceptive requirements during the study period, as per protocol.
New Heart Failure Biomarkers in Early Stage Chronic Kidney Disease-Mineral and Bone Disorder

the objective of this study is to :

-Determinate wether the circulating levels of iFGF23 and klotho can be a predictor biomarker of HF in patients with CKD-MBD.

The disorders of mineral metabolism and bone disease are common complications in CKD patients and they are associated with increased morbidity and mortality.

Abnormalities of the vasculature are seen in early CKD, producing vascular stiffness contributing to left ventricular hypertrophy and its pathophysiology involves newly discovered hormones, such as the fibroblast Growth factor 23 (FGF23) and α- klotho.

The FGF receptor and its co-receptor klotho moderate these effects. FGF23 levels inflate early in in the advancement of CKD stage to attain levels in CKD stage 5D.

But we still have few knoweledges if these markers can have some drawbacks for predicting CVD in early stage CKD.

Eligibility Criteria:
Inclusion Criteria:

* Early CKD stage
* Heart failure

Exclusion Criteria:

* Infections
* cancer
* corticoid therapy
* renal replacement therapy
* Advanced CKD stage
Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences

Early in its development, Alzheimer's disease causes not only brain damage affecting different regions of the brain, such as the entorhinal cortex, the anterior cingulate cortex, and the prefrontal lobe, but also a cognitive deficit affecting several functions, such as episodic memory, executive functions, or working memory. Although these different areas and functions are involved in the decision-making process, few studies have focused their research on this subject in the context of Alzheimer's disease. However, a 2008 study showed an early decline in decision-making skills in the disease, but did not link this deficit to cognitive impairment. In addition, decision-making is generally assessed using a test called the Iowa Gambling Task (IGT), which, despite its many advantages, does not have established ecological validity.

In the context of pathology, however, it seems essential to evaluate decision-making in relation to daily life, especially since a deficit in this process would have considerable repercussions on quality of life.

In this study, the investigators seek to better define the disorder by decision-making in early Alzheimer's disease, to understand the links between them with the deficit of other cognitive functions, and to highlight the the consequences that this decline has on patients' daily lives.


Eligibility Criteria:
Inclusion Criteria for patients with Alzheimer's disease :

* Mini-Mental State Examination \> 23
* stable treatment for at least two months
* mother tongue : French

Inclusion Criteria for control :

* general cognitive level in the standard on the following tests : Mini-Mental State Examination and Fast Front End Efficiency Battery
* mother tongue : French

Exclusion Criteria for patients with Alzheimer's disease :

* game addiction
* uncorrected visual and hearing disorders
* other neurological or psychiatric history
* inability to communicate
* delusional or psychotic state

Exclusion Criteria for control :

* game addiction
* psychiatric or neurological disorders
* anxiety and depression symptomatology
Peripheral Intravenous Central Catheter Intervention in Preterm Infants

This study will be conducted to evaluate the effect of grasping reflex stimulation applied during peripheral intravenous central catheter (PIC) intervention on pain and stress in preterm infants receiving treatment and care in the neonatal intensive care unit.

The study was planned in a parallel randomized controlled trial design. The population of the research will be preterm infants followed in the Newborn Intensive Care Unit of Atatürk University Health Research and Application Center between May 2022 and September 2022. Randomization in the sample of the study will be done in the computer environment. Sample size was determined by power analysis. In the collection of data; Preterm Baby Information Form, Preterm Baby Follow-up Form, Neonatal Stress Scale and ALPS-NEO pain and stress assessment scale will be used. In the control group, the PIC intervention will be performed by the investigator in accordance with clinical procedures. In the experimental group, the baby's grasping reflex stimulation will be provided during the PIC attempt.

Eligibility Criteria:
Inclusion Criteria:

* Between 26-32 weeks of gestation,
* Birth weight of 1500 g and below,
* No congenital defects
* who need PIC intervention while receiving treatment and care in the NICU,
* Not receiving sedation at least 3 hours before the PIC procedure,
* No neurological problems
* No surgical intervention
* Recipient of noninvasive mechanical ventilation
* infants whose parents approved the informed voluntary consent form

Exclusion Criteria:

* Painful procedure (invasive procedure, etc.) has been performed in the last hour,
* Infants without parental informed consent form
Motor Imagery Training for Upper Limb Functional Strength in Chronic Stroke Patients

Stroke is a leading cause of upper extremity deficits worldwide. Persistent upper extremity dysfunction affects many post stroke patients and is strongly associated with decreased activities of daily living and poor quality of life.

There is accumulating evidence of a cross-over effect with training of one limb that slightly increase strength and coordination in contralateral untrained limb through neurological adaptations.

One of rehabilitation that is beneficial for stroke patient is motor imagery, a mental rehearsal of a movement that does not include physical movement has been shown to enhance upper limb function.

Evidence demonstrate that MI not only activates motor cortical and subcortical regions but also induces plastic change in motor networks and modulates synaptic activity at spinal level.

OBJECTIVE:

The objectives of this study are:

1. To improve upper limb functional strength.
2. To improve the upper limb coordination.
3. To improve upper limb functional improvement.

HYPOTHESIS

Alternate Hypothesis:

There will be statistically significant difference in effects of motor imagery technique combined with conventional physical therapy and in comparison to conventional physical therapy alone on upper limb functional strength, coordination and functional improvement in chronic stroke. (p\<0.05).

Null Hypothesis:

There will be no statistically significant difference in effects of motor imagery technique combined with conventional physical therapy and in comparison to conventional physical therapy alone on upper limb functional strength, coordination and functional improvement in chronic stroke. (p\>0.05).

Research Design: Experimental study. Randomized Control Trial

Eligibility Criteria:
Inclusion Criteria:

* Stroke duration 6 months onwards (chronic stroke).
* age 45 years and above.
* Both genders.
* Access cognitive function score \> 24 on MoCA.

Exclusion Criteria:

* Patients with any comorbidity, previous surgery and congenital anomly.
* Patient with any fracture/ MSK disorders.
* Score 3 or more on Modified Ashworth scale.
* Patients with hearing impairments
Effect of Isometric Handgrip Exercises on Blood Pressure of Hypertensive Adults

This study is designed to determine the effects of isometric handgrip exercises as compared to aerobic exercises in the hypertensive population, specifically in pre-hypertensives and those with hypertension stage I who are not taking pharmacological treatment. This exercise is designed as part of lifestyle modification for these patients and if proven effective, it can provide an easier to perform exercise regimen as an alternative to be incorporated in the exercise plan of patients who have difficulty in performing aerobic exercises because of musculoskeletal concerns.

Hypertension (HTN) is a significant public health problem, with an increasing worldwide prevalence. The disease has an impact on reducing the quality of life (QOL) and can be life-threatening if not treated early. It is considered the major risk factor for cardiovascular and renal diseases. Complications of hypertension can lead to a variety of serious diseases like stroke, heart attack, and even cardiac and renal failure. Non-pharmacological management via lifestyle modification is focused in the initial stages of HTN through the reduction in alcohol consumption, cessation of tobacco smoking, maintenance of body weight, improvements in nutrition, and increases in physical activity. Physical activity improves health status and prevents the complications of hypertension like stroke and heart failure.

Typically, aerobic exercises in the form of walking and jogging are advised as part of lifestyle modification. effectiveness of resistance training is also worked upon. A relatively newer approach in the form of Isometric Hand Grip exercises (IHG) is also under research because it can serve as a useful alternative for patients who cannot perform aerobic exercises because of musculoskeletal conditions. This study is targeted to assess the effects of IHG exercises, aerobic training, both aerobic and IHG training as well as sham IHG treatment for a comprehensive assessment of effects of IHG training.

Eligibility Criteria:
Inclusion Criteria:

* Pre-hypertension (systolic BP 120-139 mmHg and diastolic BP\<80) or stage I hypertensive patients (systolic BP 140-159 mmHg and diastolic BP 90-99mm Hg.

Exclusion Criteria:

* Patients who are taking antihypertensive agents
* Malignant hypertension
* Physical limitation preventing IHG training (e.g., missing arm, severe hand arthritis, carpal tunnel syndrome, or having a musculoskeletal disorder affecting the upper limb.
* Active systemic illness that restricts exercise
* People doing exercise regularly
* Any other cardiopulmonary, metabolic, neurological, or psychiatric illness.