cyrilzakka/clinical-trials huggingface dataset:
Cardiac Rehab Retrospective Review (CR3)

All patients enrolled in the Austrian LifeVest Registry will be retrospectively screened for successfully completed ambulatory or stationary rehabilitation program. Baseline characteristics, complete rehab data, outcomes and follow up data, as well as wearable cardioverter defibrillator(WCD)-derived data will be collected from these patients.

Specifically, performance data from the start of the exercise training (ET) will be compared to the end of ET; including type of training, exertion, time and duration will be collected. In addition, WCD recorded data such as automatically and manually recorded ECGs, compliance, and TRENDS data will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Prescribed WCD as part of the Austrian WCD registry population from 2014-2018
* Partial (\>50%) or full completion of a rehabilitation program when wearing the WCD in Austria
* ≥18 years old and able to give informed consent

Exclusion Criteria:

- none
Benefit of the Use of 3D Models and Tools in Hepatectomy Planning for Hepatocarcinomas

The aim of this study is to assess the benefit of 3D models in the planning of hepatic resection by comparing the changes in the surgical plan based on the analysis of conventional preoperative images (CT-scan and MRI), compared to the surgical plan based on the analysis of 3D reconstruction.

The detailed anatomical description of the liver described by Couinaud in 1954 is the basis for hepatic surgery. Surgical resection is the approach leading to the best survival rate in case of liver cancer. In hepatocarcinomas, systematic removal of the infected liver segment is considered the most effective technique to eliminate tumour, potential satellite nodules and avoid vascular spread. Resectability rate highly depends on the analysis of preoperative images. However, in 20% of cases, there are modifications compared with the initial surgical plan leading to an increase in morbidity rate.

In 2002, Couinaud highlighted the difficulty of identifying portal pedicles, especially because of anatomical variations, and recommended the use of a three-dimensional reconstruction from images provided by a helical scanner.

The hypothesis of the study is that 3D models would improve surgical planning leading to a decrease in intra-operative adjustments and mortality.

The aim of this multicentric, prospective study is to assess the benefit of 3D models in the surgical management of hepatocarcinomas, more specifically in the detailed analysis of 3D vascular structures and in the surgery planning with resection merges evaluation. The validation of this virtual method will be built on the comparison of the surgical plan based on the analysis of conventional preoperative images (CT-scan and MRI) and the surgical plan based on the analysis of 3D reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a hepatocarcinoma, eligible for surgical resection
* Patient over 18 years old
* Patient able to understand the study and provide written informed consent
* Patient affiliated to the French social security system.

Exclusion Criteria:

* Patient with other liver tumours
* Patient whose general condition is not suitable for study participation (WHO ≥ 3)
* Patient with a condition preventing its participation to study procedures, according to investigator's judgment
* Patient with contraindications to injected CT-scan or MRI: allergic reaction to contrast agents, kidney failure, pacemaker, claustrophobia
* Pregnancy or breastfeeding
* Patient in exclusion period (determined by a previous study or in progress)
* Patient in custody
* Patient under guardianship.
The Effect of Massage Ball Application on Blood Pressure, Fatigue and Anxiety in Pregnant With Preeclampsia

The aim of this study is to determine the effect of massage ball application on arterial blood pressure, fatigue and anxiety in pregnant women diagnosed with preeclampsia.

Hypertensive disorders are one of the common disorders in pregnancy that cause complications in the mother and the fetus. Preeclampsia, one of the hypertensive disorders of pregnancy, is defined as the presence of hypertension, proteinuria or organ damage that occurs after the 20th week of pregnancy. Preeclampsia affects 5% to 7% of all pregnancies. It causes more than 70,000 maternal deaths and 500,000 fetal deaths worldwide each year. Preeclampsia is among the main causes of maternal mortality and morbidity. Preeclampsia is the first cause of maternal death due to hypertension. According to the report on causes of maternal death in our country, 14.2% of pregnant women died due to hypertensive diseases in 2019. Pregnancy-induced hypertension is the second leading cause of maternal deaths. Preeclampsia causes increased blood pressure in pregnant women, cardiovascular diseases, cerebrovascular accidents, and dysfunction in organs such as the liver, kidney and uterus. In addition to affecting the systems, it is also a condition that causes anxiety and fatigue in pregnant women. The most effective treatment for preeclampsia is delivery. In hospital, treatment includes MgSO4 therapy, blood pressure monitoring, urine monitoring, a high-protein and salt-restricted diet, and control of fetal movements and midwifery care to keep blood pressure at normal levels and prevent eclampsia. In addition to medical treatment in preeclampsia, complementary treatments such as music therapy, acupuncture and massage are also used. Massage application helps relax the muscles. It is stated that massage applied to pregnant women positively affects anxiety, blood pressure and fatigue. Equipment such as tennis ball, golf ball and massage ball are used for muscle relaxation. It is thought that massage ball application, one of the methods used in massage, will reduce anxiety, fatigue and be effective in lowering blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* In the 20th - 40th week of pregnancy,
* Least literate,
* Does not have any diagnosed problems related to fetal health,
* Diagnosed with preeclampsia,
* Will be hospitalized for at least 3 days,
* Not having any physical or mental disability,
* Those who are over 18 years of age,
* Agreeing to participate in the research,
* Women with loss of sensation/sensation,

Exclusion Criteria:

* Those with chronic hypertension,
* Diagnosed with eclampsia,
* Those with HELLP findings,
* Hospital stay of less than 3 days,
Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System

A prospective, single-center, first in man study to evaluate the safety and efficacy of WeFlow-EndoSeal Aorta Vascular Plug System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the dissecting aneurysm of descending thoracic aorta after aortic dissection repair.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 80 years old, no gender limitation;
* The patient was diagnosed with a dissecting aneurysm of the descending thoracic aorta after the repair of the main artery dissection, and the treatment indications were one of the following:

  1. Aortic dissection aneurysm diameter ≥ 5.5cm
  2. The diameter of descending thoracic aorta dissection increased rapidly ≥5 mm/ year
  3. Symptoms associated with dissection progression, such as chest and back pain
* The diameter of false lumen approximately 1 cm superiorly to the celiac trunk ≤40 mm
* Appropriate anatomical conditions were assessed by imaging to allow the adjustable bend conveyor to enter the pseudolumen through tears of the iliac artery, subrenal aorta, or renal artery levels.
* Those who can understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form by themselves or their legal representative, and are willing to complete the follow-up according to the protocol requirements.

Exclusion Criteria:

* Aortic rupture;
* Continuous malperfusion of internal artery branches caused by dissection;
* Had previously received false lumen embolization;
* Proximal type I endoleak after aortic repair;
* Abdominal aortic dissection aneurysm diameter \> 5 cm
* Infectious aortic disease, arteritis, Marfan syndrome (or other connective tissue diseases);
* Acute systemic infection;
* History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
* Cardiac function Grade IV (NYHA rating) or LVEF \< 30%;
* Hematological abnormalities: leukopenia (WBC \< 3×10\^9/L), anemia (Hb \< 90 g/L); Coagulation dysfunction, thrombocytopenia (PLT count \< 50×10\^9/L);
* Renal insufficiency: serum creatinine \> 150 umol/L (or 3.0 mg/dL) and/or advanced kidney disease requiring renal dialysis, as determined by the investigator after thorough analysis;
* Severe liver insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds the normal upper limit by 5 times; Serum total bilirubin (STB) exceeded the normal upper limit by 2 times;
* Allergic to contrast agents, anesthetics, plugs, and delivery materials;
* Pregnant, breastfeeding or cannot contraception during the trial period;
* Participated in clinical trials of other drugs or devices during the same period;
* Life expectancy is less than 12 months (such as advanced malignant tumors);
* Investigator judged that not suitable for interventional treatment.
Allogeneic Bone-patellar Tendon-bone Transplantation

Objective To investigate the mid-term clinical effect of bone-patellar tendon-bone (BPTB) graft double-bundle reconstruction of the anterior cruciate ligament (ACL) of the knee joint under arthroscope.

The purpose of the present study was to report a unique technique of Double-bundle anterior cruciate ligament reconstruction (DB-ACLR) with a bone-patellar tendon- bone (BPTB) allograftand compare the clinical outcome of the new technique with that of the nonanatomic conventional transtibial Single-bundle anterior cruciate ligament reconstruction (SB-ACLR) with a BPTB allograft. The hypothesis was that the DB-ACLR with a BPTB allograft is technically feasible and may be superior in restoring anterior and rotational stability of the knee joint. Meanwhile, the back-pushing KT- 2000 arthrometer was used to confirm whether there were advantages of DB-ACLR in total anteroposterior stability.

Eligibility Criteria:
Inclusion Criteria:

From July 2005 to June 2008, 3757 ACLRs were performed in our department. A total of 111 patients chose to use allografts, and the other patients chose autologous semitendinosus and gracilis tendons (STGs). The patients selected DB or SB reconstruction based on their understanding about the information from the surgeons. Following the criteria of a prospective randomized study, 56 patients undergoing ACLRs with BPTB allografts were included in our study and were divided into a DB group and a SB group, each with 28 patients. 25 DB and 27 SB patients completed the final follow-up. Only patients between 16 and 50 years old who were undergoing primary operation were included, and younger patients had to have radiographic confirmation of a closed epiphysis.

Exclusion Criteria:

The exclusion criteria included age more than 50 years, narrow middle intercondylar width (\<12 mm measured during operation with the knee flexed to 90°), revision reconstruction, multiligament injury, bilateral ACLRs, total meniscectomy or more than one-third partial meniscectomy, and severe cartilage injury.
Identification of Vocal Biomarkers to Monitor the Health of People with a Chronic Disease

The CoLive Voice research project aims to identify vocal biomarkers of severe conditions and frequent health symptoms. The project is based on digital technologies and statistical algorithms. This is an international anonymous survey where vocal recordings are collected simultaneously with large validated clinical and epidemiological data, in the context of various chronic diseases or frequent health symptoms in the general population.

With the objective of using vocal biomarkers for diagnosis, risk prediction/stratification and remote monitoring of various clinical outcomes and symptoms, there is a major need to develop surveys where audio data and clinical, epidemiological and patient-reported outcomes data are collected simultaneously.

The objectives of CoLive Voice are:

* To launch an international anonymized survey where vocal recordings are associated with large validated clinical and epidemiological data, in the context of various chronic diseases or frequent health symptoms in the general population
* To extract audio features and train supervised machine learning models to identify key candidate vocal biomarkers of the aforementioned chronic conditions or related symptoms.

Participants will be recruited online and will complete the survey using a web application.

They will first answer a detailed questionnaire on their health status and then do 5 different voice records:

1. read a 30 sec prespecified text (from the Human Rights Declaration),
2. sustain voicing the vowel /aaaaaa/ as long and as steady as they can at a comfortable loudness
3. cough 3 times
4. breath in and out deeply 3 times
5. Count from 1 to 20 at a normal speed

Vocal records will be pre-processed and converted into features, meaning the most dominating and discriminating characteristics of a vocal signal. Following the selection of features, machine or deep learning algorithms will be trained to automatically predict or classify the clinical, medical or epidemiological outcomes of interest, from vocal features alone or in combination with other health-related data.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents and adults \> 15 years
* With or without health conditions
* From all countries

Exclusion Criteria:

* Children \< 15 years
Shifting Away From Pain: a Neurocognitive Approach in Treatment of Whiplash

The broad aim of this study is to investigate the effect of a modern neuroscience approach, which combines education on pain neuroscience with cognition-targeted exercise therapy and stress management, on brain structure and networks in patients with chronic whiplash-associated disorders (CWAD) in comparison to a control physiotherapy treatment.

This project runs in parallel to a larger randomized-controlled trial (RCT) in which the 'modern neuroscience approach to WAD' is compared to usual care evidence-based physiotherapy (clinical trial registration number: NCT03239938). For the current study, additional magnetic resonance imaging (MRI) measures will be taken in a subsample of patients, who will be recruited from this larger RCT. In addition, a pain-free age- and sex-matched control group will be recruited for comparison.

The current study consists of 2 MRI measurements that will take place at the University Hospital of Ghent (UZ Gent): baseline (pre-treatment) and follow-up (post-treatment; approximately 16 weeks after baseline). After pre-treatment assessment, the patients will be randomly allocated to the modern neuroscience approach or usual care physiotherapy, as part of the RCT.

Eligibility Criteria:
CWAD group:

Inclusion Criteria:

* Experienced a whiplash trauma which is at least 3 months old and causes pain since at least 3 months, with pain experience with a mean pain frequency of 3 or more days per week, and with self-reported moderate to severe pain-related disability, established by a score of 15 or more of a maximum of 50 on the Neck Disability Index
* Patients classified as WAD II or WAD III on the modified Quebec Task Force Scale
* Native Dutch speaker
* Not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain a steady state)
* Refraining from consuming caffeine, alcohol and nicotine in the hour before the MRI scans (in both measurement times: before the start of the rehabilitation and after the end of the rehabilitation).

Exclusion Criteria:

* Neuropathic pain
* Being pregnant or having given birth in the preceding year
* Chronic fatigue syndrome
* Fibromyalgia
* Cardiovascular disorders
* Epilepsy
* Endocrinological disorders
* Rheumatic disorders
* Psychiatric disorders
* History of neck surgery
* Loss of consciousness during/after the whiplash trauma
* MRI incompatible health condition (e.g., pacemaker, metal prosthetic devices)
* Psychiatric condition and ongoing medication that would alter emotional or sensory processing
* Claustrophobia.

Healthy volunteers: (matched for age and gender). Additional exclusion criteria include for healthy volunteers

* a history of a chronic pain syndrome
* a pain condition in the last six months for which treatment was sought
Perioperative Inflammatory Response Assessment in High-risk Patients Undergoing Noncardiac Surgery

Postoperative cardiovascular complications are common after noncardiac surgery. The association between perioperative inflammation and the occurrence of cardiovascular complications after surgery is still unknown. Therefore, we will evaluate as our primary aim the association between patients with increased postoperative inflammation, assessed with C-reactive protein measurements, and the occurrence of major cardiovascular complications after noncardiac surgery. We will further evaluate the influence of perioperative inflammation on the occurrence of postoperative acute kidney injury. We will also evaluate the association between inflammation and the influence on Days-At-Home within 30 days. Furthermore, we will evaluate the association between increased inflammatory biomarkers and postoperative N-terminal pro brain natriuretic peptide (NT-proBNP) concentration.


Eligibility Criteria:
All patients need to meet all of the following criteria for inclusion (1-4):

1. Surgery planned for more than two hours
2. ≥ 45 years of age
3. Provide written informed consent AND
4. Fulfill ≥ 1 of the following criteria (A-K)

Inclusion Criteria:

* NT-proBNP ≥ 200 ng/L
* Troponin T \> 25 ng/L
* History of coronary artery disease
* History of peripheral artery disease (PAD)
* 75 years or older
* History of transient ischemic attack (TIA) or stroke
* Current smoking or cessation of smoking within 2 years
* Diabetes or currently taking anti-diabetic drug
* Hyperlipidemia
* History of hypertension or currently taking an antihypertensive drug
* Atrial fibrillation

Exclusion Criteria:

* Patients on immune-suppressive therapy
* ICU patients undergoing surgery
* Preoperative Sepsis/systemic inflammatory syndrome (SIRS) needing ICU treatment
* Preoperative hemodynamically instable patients, who require vasopressor or inotropic support
* History of severe heart failure (defined as left ventricular ejection fraction (LVEF) \< 30%)
* Liver cirrhosis
* Chronic inflammatory bowel diseases (CIBD)
* Severe rheumatic diseases requiring immunosuppressive treatment
Information Consultation by Radiotherapy Manipulator

The medical teams are increasingly sought by patients to get the most possible information, probably expressed in a different form and thereby supplementing the information already received. Coulter et al. reached similar conclusions in their study of the writings of patient information documents. They point out, moreover, the best adaptation of the patients better informed compared to those with less or no information.

This need for information varies over time. It is present before treatment begins, continues during treatment and persists after treatment. Given the specific features of radiotherapy, the manipulators are important interlocutors to participate in the accompanying caregiver time.

In conclusion, the quality of information delivered to the patient has been poorly evaluated, let alone with validated tools in this area.

The impact of information on the tolerance of the treatment also needs to be confirmed, knowing that an informed patient seems less anxious and better prepared for future treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer of the head and neck, esophagus, stomach, breast, rectum, anal canal, prostate, lung, bile duct, pancreas or female genital histologically proven
* Patient being treated by radiotherapy alone or combined with chemotherapy / immunotherapy, exclusive treatment or adjuvant
* Age over 18 years

Exclusion Criteria:

* Patient has been treated with radiation to the tumor site
* Patient with metastatic stage disease
* Patient targeted for hypofractionated radiotherapy
20070360 Incident Dialysis

Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to 18 years of age on hemodialysis for \> 3 and less than or equal to 12 months prior to enrollment into the study
* Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) \> 300 pg/mL (31.8 pmol/L); or biPTH \> 160 pg/mL (17.0 pmol/L)
* Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations greater than or equal to 8.4 mg/dL (2.1 mmol/L)
* Subject will be able to complete the study, to the best of his/her knowledge
* Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria:

* Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) \> 800 pg/mL (84.9 pmol/L); or biPTH \> 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening
* Parathyroidectomy (partial or full) less than or equal to 6 months before entering screening
* Anticipated parathyroidectomy (partial or full) within 6 months after randomization
* Have a scheduled date for kidney transplant surgery
* Received cinacalcet since initiating hemodialysis
* Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening
* Subject is pregnant (eg, positive HCG test) or is breast-feeding
* Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment)
* Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
* Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance
* Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator
* Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).