cyrilzakka/clinical-trials huggingface dataset:
Spectral Analysis of Central Venous Pressure Waveform

The use of central venous pressure has been abandoned for the assessment of intravascular volume status. The dynamic fluctuation of central venous pressure according to heart rate is quantitatively measured by spectral analysis of the central venous pressure waveform. Its clinical utility in the assessment of intravascular volume status is investigated.

The use of central venous pressure, which is one of the static preload indices, has been abandoned for the assessment of intravascular volume status because of its unreliability. The static preload indices have been replaced with dynamic preload indices, such as stroke volume variation or pulse pressure variation because the dynamic preload indices reliably predict fluid responsiveness and perform better than the static preload indices. However, the periodic component of central venous pressure, which goes with cardiac cycles, has not been investigated. The power corresponding to heart rate from spectral analysis of central venous pressure waveform represents the extent of the dynamic fluctuation of central venous pressure and is assumed to reflect intravascular volume status. It is hypothesized that the spectral power of central venous pressure corresponding to heart rate represents intravascular volume status.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status 1
* Scheduled for donor hepatectomy under general anesthesia

Exclusion Criteria:

* Arrhythmia
* Valvular heart disease
* Coronary artery disease
* Cerebrovascular disease
* Hypertension
* Diabetes mellitus
* Renal insufficiency
* Pulmonary problems
* Any type of liver disease
* Body mass index greater than 35 kg/m2
* Human immunodeficiency virus infection
* Psychosocial problems
* Electrolyte imbalance
* Reoperation
Multimodalitic Imaging in the N-stage of Lung Cancer

This study aims to evaluate the diagnostic efficacy and differences between 18F-FDG PET/CT and MR STIR sequences combined with EBUS-TBNA, 18F-FDG PET/CT combined with EBUS-TBNA, and MR STIR sequences combined with EBUS-TBNA - three types of multimodal imaging for assessing NSCLC N-stage, in order to select the best assessment protocol to guide treatment decisions and prognostic assessments.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy pathologically confirmed NSCLC, or clinically highly suspicious NSCLC (assessed as highly suspicious by the MDT team of this study);
* N1, N2, or N3 confined to the mediastinum and hilum, as assessed by imaging;
* Proposed systematic lymph node dissection without any treatment;
* Appropriate laboratory tests (serum tumor markers);
* All examination intervals ≤ 4 weeks;
* KPS score ≥ 50 (ECOG/WHO equivalent);
* Aged \> 18 years; 8. Patients can fully understand and voluntarily participate in this trial and sign the informed consent; the examination can be completed independently.

Exclusion Criteria:

* Contraindication to EBUS-TBNA operation;
* Presence or history of other malignancies within 10 years;
* Inability to understand the examination procedure or to cooperate.
Aripiprazole in Children and Adolescents With Bipolar I Disorder

The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.


Eligibility Criteria:
Inclusion Criteria:

* Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features

Exclusion Criteria:

* Patients with certain other psychological disorders
* Patients with a co-morbid serious, uncontrolled systemic illness
* Patients with significant risk of committing suicide
Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain

Decathlon has developed kneeMID500-STRONG700 products which are two medical devices designed to be used for sport resumption after mild (kneeMID500) or moderate (KneeSTRONG100) knee sprain or after an Anterior Cruciate Ligament surgery.

The difference between these devices is based on the strength of compression and the knee maintain.

The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeMID500-STRONG700 products to demonstrate safety and performance of these devices in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Subject is aged ≥18 years old
* Subject has a recent mild (grade I) OR moderate (grade II) knee sprain OR an ACL surgery
* The current condition of his/her knee allows the subject to resume usual physical activity
* Subject has been informed and is willing to sign an informed consent form
* Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (18 weeks)
* Subject is affiliated to the French social security regime

Non-inclusion Criteria:

* Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
* Subject has worn a support (knee brace or articulated orthosis) since his/her recent injury
* Subject has resumed regular physical activity since his/her recent injury
* Subject has any medical condition that could impact the study at investigator's discretion
* Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastane, elastodiene)
* Adult subject to a legal protection measure
A Study To Test An Anti-Rejection Therapy After Kidney Transplantation

Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is safer or more effective.

Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for an improved post-transplant treatment, such as the induction therapy used in this study.

Renal transplantation is recognized as the treatment of choice for children with chronic renal failure. However, patient and graft survival rates in young children are unacceptably low. In preliminary studies, OKT3 (a monoclonal antibody) induction therapy received post transplant has been more successful than standard immunosuppression alone in improving graft survival. This study is designed to assess the impact of induction therapy on graft survival in pediatric kidney transplant patients.

Patients are assigned to OKT3 induction or no induction in a 1:1 ratio. Randomization to oral cyclosporine of either Sandimmune or Neoral is also done in a 1:1 ratio. Group 1 receives OKT3 intraoperatively followed by Neoral. Group 2 receives OKT3 intraoperatively followed by Sandimmune. OKT3 is administered at 2.5 mg (if weight less than 30 kg) or 5 mg (if weight above 30 kg) per day for a maximum of 14 days. Group 3 receives IV cyclosporine followed by Neoral. Group 4 receives IV cyclosporine followed by Sandimmune. Oral cyclosporine is administered in a masked preparation. The dose for Sandimmune and Neoral is the same; patients 6 years of age and older begin at a dose of 15 mg/kg/day and patients under 6 years of age receive 500 mg/m2/day. Patients will receive concomitant medications including steroids (IV and po), Nifedipine, anti-CMV therapy, Bactrim, Azathioprine or Mycophenolate Mofetil. Kidney function, incidence of viral infection, graft survival, and incidence of malignancy will be measured to assess the role of OKT3 induction and the role of rejection in graft failure. Graft function will be evaluated at 1-, 2-, and 4-year intervals.

Eligibility Criteria:
Inclusion Criteria

Children and young adults may be eligible for this study if they:

* Are not yet 21 years of age.
* Are receiving their first or second transplant.
* Are not pregnant.
* Agree to practice sexual abstinence or agree to use an effective
* method of birth control/contraception during the study and
* for 1 year after.

Exclusion Criteria

Children and young adults will not be eligible for this study if they:

* Are recipients of multiple organs other than kidneys.
* Are recipients of three or more transplants.
* Are HIV positive.
* Are Hepatitis B surface antigen positive.
Gastrointestinal Study at Orkambi Therapy in CF Patients

Ivacaftor caused a significance increase in weight in patients carrying the G551D mutation and the etiology of this has largely remained unknown but may be due to improved function of the gastrointestinal tract. The combination therapy of Orkambi has been recently approved for subjects with Cystic Fibrosis homozygous for F508del mutation. This provides an opportunity to examine if there are any improvements in gastrointestinal function. The investigators aim to investigate various aspects of gastrointestinal and pancreatic function before and 6 months after the commencement of Orkambi therapy.

To examine the entire intestinal mucosa via capsule endoscopy before and 6 months after Orkambi therapy to ascertain if the inflammatory changes in the intestine have improved. A marker of intestinal inflammation measured in the stool, Calprotectin, will be examined before and 6 months after Orkambi treatment. The investigators hypothesize that the result will be reduced on therapy.

A marker of pancreatic exocrine function, pancreatic elastase, will be examined before and 6 months after therapy to examine if the result has increased indicating improvement of exocrine pancreatic function

Study Population All subjects with CF homozygous for the F508del mutation in Sweden eligible for Orkambi therapy, i.e. above 12 years of age, in total 145 patients in Sweden of which 60 are taken care of at Stockholm CF Center; the investigators aim to examine 20 patients.

Study Duration The duration will be 6 months for each patient.

Eligibility Criteria:
Inclusion Criteria:

* CF patients F508del homozygote
* \>12 years of age
* eligible for Orkambi therapy.

Exclusion Criteria:

* Patients who the patency capsule does not pass within 48 hrs
* FEV1\<30%
* Pregnancy and breastfeeding women
* Liver function blood tests (AST, ALT, Gamma-GT, ALP) \>3 xULN
* Bilirubin \>2 xULN
* AST or ALT alone \>5 xULN
* Previous lung transplant
Adolescent Depression: Video Ads on Instagram

The purposes of this study are to test among adolescent viewers the utility of different types of selfie short video-based messaging to:

1. Reduce stigma and self-stigma related to depression, and
2. Increase treatment-seeking intentions.

Intervention videos will each be self-recorded videos (of \~90-second duration) featuring the same underage professional (ages 16) acting as simulated participant. The investigators will post three brief videos ('video Ads') to achieve similar exposure among Instagram users, 14-18-year-old. The videos are: (a) depression video; (b) depression video adjusted to race experiences, and (c) control videos. All videos will feature by the same Black adolescent girl.

The investigators intend to assign \~10,000 individuals aged 14-18 in a randomized way, in equal proportions, and stratified by sex and race, to view one of the three videos.

Outcomes will include:

1. Primary outcome: engagement (a composite of likes, shares, comments, and views)
2. Secondary outcome: clicks on a designated link at the end of the video ad.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Living in the US
* Ages 14 - 18

Exclusion Criteria:

* None
Irbesartan Versus Amlodipine: The OBI Study

Objective:

1. To study the effectiveness of irbesartan 300mg and amlodipine 10 mg in 24h ambulatory blood pressure values in obese subjects
2. To study the drug specific effect in arterial stiffness
3. To study possible drug mechanisms in obesity (reduction of central adiposity and changing the ratio of leptin to adiponectin)

Study Objectives

1. Primary:

   * Reduction of 24h BP in obese hypertensives
   * Reduction in arterial stiffness
2. Secondary

   * Drug specific effect on new onset of diabetes
   * Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio

Study design

Study drugs: Irbesartan 300mg vs. amlodipine 10mg

Tx duration and follow-up: 12 months

Collected data:

* 24h SBP and DBP in time 0, 1, 12.
* Pulse wave velocity in time 0,1,12.
* Central obesity (total, visceral, abdominal fat) in time 0,1,12.
* Leptin/adiponectin in time 0,1,12.
* BMI, waist/hip ratio in time 0,1, 12.
* Glu, HbA1c, insulin in time 0, 1,12.
* K, Na, Cr, BUN, Chol, Tg, HDL, LDL,ALT, AST in time 0, 1,12. Number of patients: The reduction in mean SBP expected to be 15 mmHg. Previous studies from our group reported an 14mmHg SD for mean SBP. The sample size required at the two sided 5% significance level and 80% power is 40 patients (Lehr's formula)

Number of centers: 1

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 60 years.
2. All patients are going to give their informed consent to participate in the study.
3. Stage I hypertension.
4. BMI \> 30.

Exclusion Criteria:

1. Known oversensitiveness,
2. Chronic renal disease (GFR \< 50 ml/min) or ESRD,
3. Heart or respiratory failure, OR
4. Recent MI, shock, liver deficiency (ALT or AST \> 3 times normal and pregnancy or lactation.
Laser Therapy Versus Electrosurgery For Nasal Telangiectasias

The aim of this study is to compare the efficacy of various treatment options for eliminating nasal telangiectasias. The study will compare the outcome of treating nasal telangiectasias with the following; no treatment (control site), alexandrite laser, pulsed dye laser, combination pulsed dye laser and Nd:YAG 1064nm multiplex laser system and electrosurgery.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Able to give informed consent themselves
* Willing to return for follow up visit
* 0.5 - 3 millimeter Vessel size
* 5 Non-contiguous nasal vascular lesions

Exclusion Criteria:

* Mentally handicapped
* Unable to understand written and oral English
* Incarceration
* Under 18 years of age
* Unwilling to return for follow up
* Pregnant Women
* Vessels less than 0.5 millimeter caliber
* Less than 5 non-contiguous vessels
Awake Local Anesthesia Infiltration Compared to Regional Nerve Block for Hand Surgeries

The study trying to fined out the best anaesthesia technique for hand flexor procedures which provide efficient anaesthesia while providing adequate surgical field exposure \& less blood loss

The current study compared patients scheduled for hand surgical procedures using wide awake local anaesthetic infiltration to those receiving supra-clavicular brachial plexus block. the comparison including adequacy of pain control, blood loss, patient satisfaction, time \& skills needed to provide aesthetic technique.

Eligibility Criteria:
Inclusion Criteria:

* Participants were included if they were to be scheduled for Flexor tendon repair (Interventions involving flexor tendons of the wrist (Flexor Carpi Ulnaris (FCU), Flexor Carpi Radialis (FCR), and/or Palmaris Longus PL), fingers (flexor digitorum Profundus FDP and/or Flexor Digitorum Superficialis FDS) and thumb (Flexor Pollicis Longus FPL)), aged 18 years or over \& of ASA physical status I or II.

Exclusion Criteria:

* Participants were excluded if they were (American society of Anaesthesia) ASA physical status III or IV, refusal of anaesthetic procedure or refuse to participation in the study, documented hypersensitivity to lidocaine, compromised peripheral circulation (Patients with previous vascular injury, vasculitis, Buerger's disease, and scleroderma), evidence of infection at injection site, patients with ischemic heart disease or psychiatric illness and patients with concomitant injuries that needed further operative procedure under general anesthesia or spinal anesthesia.
RESponders and QUadripolar LV Lead in CRT

The purpose of this study is to observe the evolution of the CRTD system with left quadripolar lead, in terms of electrical parameters in all pacing configurations and to evaluate the impact on the clinical outcome.

Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders.

Pacing activation from proximal area with a left quadripolar lead might improve the depolarization pattern.

To explore the effect of CRT pacing on cardiac activity, the investigators will enroll approximately 180 patients who already underwent CRT-D implantation with a quadripolar LV lead.

After implant, as clinical practice, the device will be programmed with distal LV pacing configuration, after 6 months in patient non-responders to CRT therapy the pacing configuration will be changed (proximal configuration).

After 12 months in patients non-responders will be changed the pacing configuration again, choosing, if it is possible, a multi point pacing (pacing activation from multiple separated left ventricular (LV) sites).

Eligibility Criteria:
Inclusion Criteria:

* Be in NYHA II, III or IV functional class with approved standard indication by ESC/EHRA Guidelines
* Successful quadripolar LV lead implant

Exclusion Criteria:

* Less than 18 years of age
* Epicardial Lead
* Life expectancy \< 12 months
* Pregnant or are planning to become pregnant during the duration of the investigation
Locally Advanced NSCLC Treated With Radiochemotherapy: Phase 2 Study on the Value of a Stereotactic Boost

This is a monocentric, non-randomized, open-label, superiority phase II clinical investigation evaluating the efficacy of additional Cyberknife irradiation after a doublet of Platinum Salts-based chemotherapy and concomitant radiotherapy in patients with locally advanced non-small cell lung carcinoma (NSCLC), with an interim analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years old or more
2. ECOG 0 to 2
3. Histologically proven non-small cell lung cancer
4. Stage III non-metastatic tumor, not allowing for immediate surgery
5. Volume(s) on the evaluation scan after neoadjuvant treatment meeting the following criteria:

   * 1 to 3 target volumes of less than 5 cm in greatest diameter
   * And enabling additional irradiation to be carried out in compliance with the manufacturer requirements and with the doses delivered to the organs at risk (OAR/fractions) defined in appendix 2
6. Patients who have received a " Taxcis " treatment consisting in 2 cycles of induction chemotherapy (platinium-based doublet) and then at least 40 Gy of irradiation in combination with at least 2 cycles of concomitant chemotherapy (platinium-based doublet)
7. No contraindication to implantable venous devices (IVDs)
8. Patient who has read the patient information note and signed the consent form
9. If applicable, negative pregnancy test\*
10. Eligible for National Health Insurance in France

Exclusion Criteria:

1. Positive EGFR mutation
2. Exercise-induced dyspnea associated with heart failure equal to or greater than stage III of the New York Heart Association (NYHA) classification, (appendix 3)
3. Coronary syndrome or heart failure in the last three months
4. Pulmonary function test contraindicating radiotherapy: PFT-FEV1 inferior to 1 L.
5. After radio-chemotherapy, presence of any toxicity contraindicating Cyberknife irradiation
6. Vulnerable populations and participants as defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017:

   * Incapacitated participants who have not given or refused informed consent prior to the onset of their incapacity, who are not under the provisions of article 64 ;
   * Pregnant or breast-feeding women who are not covered by the provisions of article 66 ;
   * Adults under legal protection or unable to express their consent.
REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System

The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. The Cardioband is deployed along the posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on the beating heart. A CE mark study with 30 subjects has been completed and documented reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in subjects with moderate to severe MR.

Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa), severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system in the post-marketing setting.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Severe (3+ to 4+) secondary Mitral Regurgitation
3. Symptomatic heart failure (NYHA Class III-IVa) despite guideline directed medical therapy including CRT if indicated
4. The Local Site Heart Team concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy.
5. Transfemoral access and transseptal deployment of the Cardioband is determined to be feasible
6. Subject is willing and able to provide informed consent and follow protocol

Exclusion Criteria:

1. EF \< 20%
2. LVEDD ≥ 70 mm
3. Heavily calcified annulus or leaflets
4. Significant CAD requiring revascularization
5. Active bacterial endocarditis
6. Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
7. Renal insufficiency requiring dialysis
8. Life expectancy of less than twelve months
9. Subject is participating in concomitant research studies of investigational products that have not reached their primary endpoint
10. Pulmonary hypertension ≥ 70mmHg at rest
11. Mitral valve anatomy which may preclude proper device treatment
12. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and/or severe tricuspid regurgitation
13. Severe liver disease
14. Patient is pregnant or lactating
15. Hypersensitivity to Nickel or Chromium
16. Clinically significant bleeding diathesis or coagulopathy
17. History of mitral valve repair
18. TIA or CVA within 3 months
A Non-Interventional Study to Document the Use of Straumann BLX Implants in Daily Dental Practice

Prospective, multi-center, non-interventional observation to document the success and survival rates of Straumann BLX Implants used for tooth replacement in cleared indications up to 1 year after implant placement

Objective of the study is to confirm the safety and performance of Straumann BLX Implants used for tooth replacement in cleared indications up to 12 months after implant placement. Implants used are Straumann® BLX Implant Roxolid® SLActive®. Regular Base (3.5 mm): implant diameters 3.75 and 4.5mm, in lengths 6, 8, 10, 12,14, 16 and 18 mm Wide Base (4.5 mm): diameter 5.5 mm in lengths 6, 8, 10 and 12 mm

Eligibility Criteria:
Inclusion Criteria:

* Patients seeking an implant supported restoration
* all patients with conditions that are in accordance with the IFU
* Patients must provide their informed consent for study participation and must be willing and able to attend control visits
* Patients need to be at least 18 years old

Exclusion Criteria:

-