cyrilzakka/clinical-trials huggingface dataset:
Comparison of CRT-D and CRT-DX Systems (CRT-NEXT)

The principal objective is to test non-inferiority of the CRT-DX system as compared to a conventional CRT-D system, in terms of the combined endpoint of mortality, hospitalizations due cardiovascular causes, any complication leading to loss of lead functionality, in the subset of patients without evidence of sinus dysfunction on optimal therapy.

Resting heart rate is strongly associated with incident worsening Heart Failure (HF) and mortality. Current devices for cardiac resynchronization (CRT-D) normally provide atrio-ventricular (AV) sequential pacing modes during resynchronization, but the best pacing programming strategy is not clear.

On the one hand a basic rate of 50 to 70 bpm (optionally with some rate-responsive function) could be considered for therapy up-titration, specifically betablockers; on the other hand, increasing pacing rates may partially reduce benefits from resynchronization, reducing filling time and contractility reservoir.

The Pegasus investigation is the only large randomized investigation comparing DDD with 70 bpm basic rate to DDD(R) @40 bpm. Results showed no difference in investigation endpoints, including mortality and HF-hospitalization.

These results may support the use of a device implementing both a CRT function and a right ventricular single-lead with and an atrial sensing dipole (CRT-DX system). This system can track ventricular pacing and resynchronization following atrial sensing, even if it cannot provide atrial pacing support. It should be assessed whether such limitation is counterbalanced by the advantages related to the reduced number of necessary leads, with simplified implantation and less complications.

The objective of the investigation is to assess whether atrial pacing support is really necessary in the subset of patients with indication to CRT-D and no evidence of sinus dysfunction on optimal therapy. The investigation will test the hypothesis that a CRT-DX system is not inferior to a conventional CRT-D system in this class of subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients ≥ 18 years old
2. Patients willing to participate in the investigation and signing the Patient Informed Consent (PIC) Form;
3. Indication to CRT-D implant according to current ESC Guidelines on cardiac pacing and cardiac resynchronization therapy
4. Sinus rhythm at time of implant;
5. Optimized medical therapy according to current ESC Guidelines
6. Rest heart rate (HR) \>45 bpm at baseline ECG, with betablocker therapy at optimal medical dosage; or, if rest HR\<45 bpm: maximum heart rate at the 6- minute walking test \>85 bpm.

Exclusion Criteria:

1. Any indication to atrial pacing according to current guidelines;
2. Both: resting heart rate \<45 bpm at baseline ECG, with betablocker therapy at optimal medical dosage and maximum heart rate at the 6-minute walking test \<85 bpm;
3. NYHA Class IV;
4. Permanent Atrial Fibrillation
5. Replacement of/upgrading from previously implanted pacing system;
6. Dialysis patients;
7. Pregnant or breast-feeding women.
Effects of a Short-term Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial

This study aims to test whether sleep improvements, following 6 weeks of high-intensity interval training exercise among adult women exposed to a traumatic event, are mediated by improvements in heart rate variability or decreased anxiety and hyperarousal symptoms.

A total of 60 women with below-average sleep quality and physical activity levels who also screen positive for PTSD on the Post-traumatic Diagnostic Scale (PDS-5) will be randomized to either six weeks of exercise training or a waitlist control. Twenty minutes of high intensity interval training will be performed three times per week for six-weeks. Heart rate variability will be measured at rest, during, and following a cognitive task. Psychometric measures supported by strong validity evidence will assess self-reported anxiety and PTSD symptoms, and sleep quality.

Eligibility Criteria:
Inclusion Criteria:

* self-reported exposure to a traumatic event
* persistent (\> 1 month) PTSD-related symptoms adequate to screen positive for PTSD or self-reported history of a prior PTSD diagnosed by a health care professional.
* poor sleep quality (Pittsburgh Sleep Quality Index \>5)
* failure to meet recommended level of aerobic or resistance training during leisure time. Physical activity for U.S. adults (\<150-mins of moderate or 75-mins of vigorous physical activity \[or a combination\] per week and/or \< 2 days a week of resistance training targeting the major muscle groups).
* able to safely perform high-intensity exercise
* aged 18-39 years
* non-smoker
* willing to avoid alcohol and vigorous physical activity 24 hours before visiting the lab
* willing to avoid caffeine for 12 hours before visiting the lab

Exclusion Criteria:

* Pregnant, lactating, or plans to become pregnant over the next 2 months.
* Individuals who started taking medication for anxiety or depression-related symptoms within the last month.
* Individuals currently taking beta-blockers or other medications/substances (marijuana and other illegal drugs) that impact heart rate.
* History of reproductive disorders (e.g., premenstrual dysphoric disorder or polycystic ovary syndrome), cardiovascular (e.g., cardiac arrhythmia), or pulmonary disorders (e.g., asthma).
* Pain intensity of 8 or greater in the thigh or foot in the past month
* Probable alcohol use disorder
Health Benefits of Whole-body Vibration

The overall goals of this pilot investigation are to determine 1) the feasibility of conducting home based WBV studies, and 2) to determine if sub-acute home based WBV can improve a) exercise capacity, b) conduit- and micro- vascular function, and c) skeletal muscle function.

Cardiovascular disease (CVD) is the leading cause of death in the world and many comorbid conditions (i.e. diabetes, obesity) can affect overall CVD risk. There is increasing interest into the role that skeletal muscle health plays in mediating CVD risk, particularly in metabolic disease states (ie. obesity and diabetes). Whole body vibration (WBV) has emerged as an exercise mimetic that may be more tolerable than traditional modes of exercise, such as treadmill walking/running or cycling. Similar to traditional exercise modalities, WBV can elicit beneficial metabolic effects. In fact, a single bout of WBV increases circulating concentrations of IL-6, which correspond with the normalization of glucose and insulin in obese individuals. The proposed pilot investigation will provide the foundation to begin understanding the molecular and physiological mechanisms of how sub-acute WBV can improve overall CVD risk. We hypothesize that home based WBV will decrease CVD risk by improving skeletal muscle and vascular function via a decrease in systemic inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Men and women (\> 18 yrs old)
* All races

Exclusion Criteria:

* \<18 years old
* Clinical diagnosis of hepatic, cardiovascular, or renal disease
* Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
* Pregnancy
* Direct vasoactive medications (i.e. nitrates)
Comparative Effects of Paraffin Bath Therapy and ESWT on Quality of Life and Sleep in De Quervain Tenosynovitis

There is no study in the literature comparing effects of both paraffin bath therapy and Extracorporeal Shock Wave Therapy (ESWT) on life and sleep quality of patients with De Quervain Tenosynovitis . The aim of this study is performing this comparison.


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older
* Meeting De Quervain diagnostic criteria
* Not having applied any physical therapy modality to the hand-wrist in the last 1 month
* Not using pain medication in the last 1 month,
* Not using local anesthetics or steroid injections on the hand-wrist in the last 3 months
* Have received written consent to participate in the study, and have come to the last control at the 6th week.

Exclusion Criteria:

* Neurological diseases (especially neuropathies),
* Malignancy
* Rheumatological diseases
* Pregnancy
* History of hand/wrist fracture or surgery
* Hand/wrist trauma in the last 1 month
* Coagulation disorder diseases
Virtual Training Based on Supersets vs. Concurrent Training in Women.

There are different forms of physical activity proven to improve muscular strength and cardiorespiratory fitness. One of them is concurrent training, which is defined as the combination of two or more physical capacities in the same session (resistance and endurance training). Another modality is superset training, which is characterized by performing two or more exercises for the same muscle group, or a different muscle group, consecutively, with minimal recovery between them.

To date, the evidence has shown studies comparing different resistance training protocols, vs. aerobic training, and vs. concurrent training, performed in various ways, on muscle strength and cardiorespiratory fitness. Most of these studies involved men with resistance training experience, and little research linked women. It should be noted that no study found has used virtual training to test the effects of superset training compared to concurrent training in women with low to moderate levels of physical activity.

Therefore, this study aims to identify the effect of a superset training program vs. a concurrent training program on muscle strength, cardiorespiratory fitness, motivation, adherence, and health-related quality of life in women with a low to moderate level of physical activity for eight weeks virtually.

Sixty women will be randomly assigned to two groups (superset and concurrent). The interventions will be carried out virtually asynchronously, only sessions 1, 5, 9, 13, 17, and 21 will be supervised synchronously. Follow-up will be done through WhatsApp messages. Both groups will have a training frequency of 3 times a week for eight weeks. In the training sessions, strength exercises with self-loading (crunches, one leg squat, side plank, push up, deadlift, lumbar extension stretch, row, glute bridge, front raise) and/or aerobic exercises (floor tape squat, jumping jacks, skaters). Each group will execute the same number of series and repetitions during the 8 weeks, the performance of strength exercises will be standardized at 45 bpm throughout the protocol, and aerobic exercises at 70 bpm. Intensity will be controlled by resting between sets, starting with 90 seconds in week one, decreasing by 15 seconds every two weeks until reaching 45 seconds.

Each participant will have initial and final evaluations to measure muscle strength in lower, middle, and upper kinetic chains. Queen's College test will be used to assess cardiorespiratory fitness, BREQ-2, and SF-12 questionnaires will be used to measure motivation and health-related quality of life respectively.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women
* Physical activity (\<600 to ≤1500 MET/min/wk)

Exclusion Criteria:

* Diabetes
* Hypertension
* History of cardiovascular disease
* History of coronary heart disease
* Osteoporosis
* Pregnancy
* Breast-feeding women
* Psychological, neuromotor, and/or osteo-muscular conditions that may affect participation in an exercise program.
Development of an in Vitro Hematopoietic Culture System and Application to Myelodysplastic Syndromes.

Myelodysplastic syndromes (MDS) are myeloid hemopathies characterized by ineffective clonal haematopoiesis, peripheral cytopenias and a predisposition to the occurrence of acute myeloid leukemias. Their diagnosis involves a cytological evaluation of the medulla, while their prognosis, in addition to extrinsic factors depending on the patient himself (age, comorbidities), intrinsic factors. The cytological evaluation is subject to a certain subjectivity since qualitative and the diagnosis is sometimes difficult in the absence of marker of clonality. More and more studies emphasize the interest of flow cytometry (CMF) in the diagnosis of SMD: by looking for qualitative and / or quantitative aberrations of the expression of membrane markers, CMF allows to establish scores Diagnosis that we have put in place within the laboratory. However, these studies are based on a static model that studies the phenotypic characteristics of patients at a given time but does not really reflect ineffective hematopoiesis. A dynamic model for in vitro reproduction of hematopoiesis would be an innovative tool for the study of SMD. This project aims to develop and standardize a system of differentiation in liquid medium of hematopoietic stem cells (CSH) in mature cells by studying each stage of the differentiation in terms of proliferation, apoptosis and phenotypic expression. HSCs will be obtained by CD34 + sorting from the medullary sample at diagnosis: the investigator will study cell proliferation, apoptosis and the acquisition of surface markers, in order to identify the quantitative and qualitative abnormalities associated with the differentiation of haematopoietic progenitors Smart. This should make it possible to identify diagnostic and prognostic factors in terms of response to treatment, acutism and survival.


Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosis, major ≥18 years
* Explained in the blood disease department for cytopenia (s)
* For which diagnosis of myelodysplastic syndrome is considered
* Justifying a diagnostic bone marrow (myelogram)
* Having been informed of the progress of this study by the referring physician of the patient during the consultation and having expressed their non-opposition

Exclusion Criteria:

* High-grade myelodysplastic syndromes on IPSS score (intermediate -2 or more) on preliminary cytological analysis
* Acute mesoblastic leukemia from the outset
Clinical and Instrumental Assessment of Meniscal ROOT Tears Treated Through Suture to the Posterior Cruciate Ligament

The menisci are crucial for knee stability and functionality. Composed of fibrocartilaginous structure, they have an anatomical and biomechanical arrangement that makes them essential for load transmission and the prevention of osteoarthritis. Meniscal root lesions, known as "ROOT tears," compromise their protective function on the cartilage, leading to increased contact pressures between the tibia and femur and, over time, the development of osteoarthritis. Early diagnosis of these lesions is difficult and often the first detection is incidental. The subsequent challenges are significant due to a lack of pre-operative planning. A possible solution is a surgical technique involving arthroscopic suture of the posterior meniscal root along with the posterior cruciate ligament. This procedure does not require pre-operative planning and is applicable even in cases of incidental diagnosis.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 50 years at the time of surgery;
2. Male and female gender;
3. Patients undergoing surgical treatment for at least one year for "ROOT" type meniscal lesions using arthroscopic suturing to the posterior cruciate ligament;
4. Pre-operative MRI performed.

Exclusion Criteria:

1. Patients no longer reachable;
2. Patients who refuse consent to the study;
3. Previous meniscectomy before surgery;
4. Previous ligament injuries before surgery;
5. New traumatic injuries after surgery;
6. Advanced knee osteoarthritis (Outerbridge grade III-IV) at the time of surgery;
7. Severe knee malalignment (\> 5°) at the time of surgery;
8. Severe obesity (BMI \> 35);
9. Lower limb conditions preventing full weight-bearing during evaluation;
10. Infection or hematological/rheumatic conditions at the time of evaluation.
Deep Brain Stimulation for Treatment Refractory PTSD

This is a phase I, non-blinded, non-randomized, pilot trial for safety and efficacy of deep brain stimulation for PTSD. A substantial number of individuals continue to experience PTSD symptoms despite appropriate medical treatment. In psychotherapy-based studies, over 30% of patients that completed a full course of treatment continue to meet criteria for PTSD. Response rates to treatment with SSRIs are usually no higher than 60%. This study would be the first exploration of a surgical therapy for refractory PTSD. The subgenual cingulate plays a role in mechanisms of this disorders and has been successfully targeted with DBS for the treatment of depression. The development of a therapy that targets brain structures known to play a role in this disease would be a substantial step forward in the treatment and understanding of these conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Female or Male patients between age 18-70
2. Diagnosis of posttraumatic stress disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM V).
3. Treatment Resistance as defined by the persistence of clinical symptoms despite adequate treatment with four modalities, including a) selective serotonin reuptake inhibitors, b) cognitive behavioral therapy, c) other classes of medications and/or psychotherapy.
4. Severe forms of the disease as measured by Clinician Administered PTSD scale (CAPS) scores ≥ 50.
5. A pattern of chronic stable PTSD lasting at least 1 year.
6. Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols

Exclusion Criteria:

1. Any past or current evidence of psychosis or mania (patients with co-morbid depression will not be excluded from the study)
2. Active neurologic disease, such as epilepsy
3. Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
4. Current suicidal ideation
5. Any contraindication to MRI or PET scanning
6. Likely to relocate or move out of the country during the study's one year duration
7. Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.
8. Currently pregnant (as determined by history and serum HCG) or lactating; for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis

This is a Phase 2B randomized, double-blind, placebo-controlled, multiple dose, multicenter study designed to evaluate the efficacy, safety and microbiome alterations associated with two dose levels of SER-287, after pre-treatment with vancomycin, in adult subjects, age 18-80, with active mild-to-moderate ulcerative colitis (UC).

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of UC at least three months prior to screening, and with a minimum disease extent of 15 cm from the anal verge
* Active mild-to-moderate UC
* Inadequate response to, loss of response to, or intolerance of, at least one of the following conventional therapies: 5-ASA compounds, corticosteroids, 6-mercaptopurine (6-MP) or azathioprine (AZA), anti-TNFα, anti-integrin or tofacitinib

Exclusion Criteria:

* Known history of Crohn's disease
* No previous history of treatment for UC (treatment-naïve)
* Subjects on steroid medication who are unable to have steroids tapered and be completely off steroids at least two weeks prior to screening
* Unable to stop steroid enemas or suppositories, or 5-ASA enemas or suppositories, at least two weeks prior to screening
* Subjects who have received any investigational or approved biologic therapy within eight weeks or five half-lives prior to screening (whichever is longer)
* Subjects who have received any investigational or approved non-biologic therapy, except for those specifically listed in the Permitted Concomitant Medications, for the treatment of underlying disease, within 30 days or five half-lives prior to screening (whichever is longer)
* Major gastrointestinal surgery (not including appendectomy or cholecystectomy) within two months before screening, or any history of total colectomy
Antiarrhythmic and Symptomatic Effect of ISIS CRP Rx Targeting CRP in Paroxysmal Atrial Fibrillation

The purpose of this study is to evaluate whether treatment with ISIS CRP Rx can reduce AF (Atrial Fibrillation) burden (percentage of time spent in AF) in subjects with paroxysmal AF


Eligibility Criteria:
Inclusion Criteria:

* Male of female; age over 18 years
* Dual chamber permanent pacemaker implanted
* Confirmed diagnosis of paroxysmal atrial fibrillation with an AF burden of 1 to 50%, as derived from pacemaker diagnostic algorithms
* Able to have pacemaker antiarrhythmic algorithms turned off for the duration of the study
* Able to discontinue all Class I and III antiarrhythmic medication for the duration of the study
* Therapeutically anticoagulated with warfarin or dabigatran, and anticipated to be for duration of the study
* High sensitivity C-Reactive Protein (hsCRP) between 2 and 10 mg/L (inclusive)

Exclusion Criteria:

* Clinically significant abnormalities in medical history, physical examination, or screening laboratory results that would render a subject unsuitable for inclusion
* NYHA class III/IV heart failure
* Impaired left ventricular function of less than 45% determined by echocardiography within 3 months of screening
* Moderate or greater mitral regurgitation assessed by echocardiography within 3 months of screening
* Permanent AF
* Continuous Amiodarone therapy within 90 days prior to Study Day 1
* Treatment with another Study Drug, biological agent, or device within one-month of screening, or five half-lives of study agent, whichever is longer
* Use of systemic corticosteroids or other anti-inflammatory medications including non-steroidal anti-inflammatory drugs (NSAIDs)
* Use of statins, ACE inhibitors or AT-receptor antagonists unless on a stable regimen for at least 3 months prior to dosing and will remain on a stable regimen for the duration of the study
* Uncontrolled hypertension (BP \>160/100)
* Current or expected use of any anticoagulant apart from warfarin or dabigatran
PCI for Patients With ES-SCLC After RCT:a Prospective Randomized Study

prophylactic cranial irradiation （PCI）was verified to decrease the brain metastases rates and improve the overall survival（OS）for patients with limited stage small cell lung cancer.We hypothesis that patients with extensive-stage small cell lung cancer after chemotherapy and thoracic radiation can also benefit from PCI.

Patients with extensive-stage small cell lung cancer achieving CR or PR after chemotherapy and thoracic radiation therapy were randomly divided into observation group and prophylactic cranial irradiation (PCI) group to evaluate the effect of PCI on survival after radiation therapy for thoracic lesions. To preliminarily analyze the clinical characteristics of patients who would benefit from thoracic radiation therapy plus PCI. To explore the optimal treatment modality after chemotherapy + thoracic radiation therapy in patients with extensive-stage SCLC.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old,KPS≥70
* Pathological or cytological diagnosis of stage IV small cell lung cancer (by using AJCC 7th edition staging criteria);
* 1-3 extra-cranial metastatic organs before chemotherapy; 4-6 cycles of CE or EP ；
* CR or PR after chemotherapy；
* no grade ≥II side effects;
* the estimated overall survival time ≥ 3 months;
* no serious medical disease or major organ dysfunction.

Exclusion Criteria:

* Patients with brain or nervous system metastases;
* Presence of high grade radiation comorbidities;
* Patients who are pregnant or lactating