cyrilzakka/clinical-trials huggingface dataset:
Impact of Pacing Output and Cycle Length on QRS Morphology

Current recommendations for pacemapping are based on expert opinion and animals models. Present study sought to evaluate the influence of different parameters of pacemapping on QRS morphology. Pacemapping is performed with different cycle length (fixed burst vs. coupling interval) and stimulation output (maximum output vs. threshold) and resulting QRS complexes are compared to clinical PVC and the standard of care to determine the optimal parameter setting in pacemapping.

Pacemapping is a common technique to determine to origin of ventricular ectopy during catheter ablation of premature ventricular contractions (PVC). During the pacemapping process an electrical pacing stimulus is applied via the ablation catheter and the resulting QRS complex is compared the clinical target PVC. The higher the consistency between the stimulated QRS complex and the clinical PVC, the nearer the catheter is located to the origin of ectopy.

Current recommendations for the execution of pacemapping are based on expert opinion and animals models. The investigators sought to assess for the first time in a clinical real life setting the different parameters for pacemapping (i.e. Cycle length and stimulation output). Therefore during the pacemapping process in routine PVC ablation pacing is performed with different cycle length (fixed burst vs. coupling interval of PVC) and different electrical output (maximum output vs. stimulation threshold). The resulting QRS morphologies are on the one hand compared to the ablation target (clinical PVC) and on the other hand to the suggest standard of care (Coupling interval at pacing threshold) to determine the optimal setting of parameters in pacemapping.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing PVC ablation

Exclusion Criteria:

* patients \<18 years
* patients not able to consent
* pregnancy
* contraindication for PVC ablation
* unavailability of vascular access
* patients with complex congenital heart disease
* expected hemodynamical instability during pacemapping
Impact of a Nutritional Intervention Program for Weight Control During Pregnancy

This is a randomized clinical trial for evaluate the impact of a nutritional intervention in the weight control of pregnant women according to the nutritional status, and consequently, the reduction of pregnancy complications.

The sample of this study will be composed by 318 pregnant women in the pre-natal care unit of the Health Center in Viamão city / Rio Grande do Sul, including women between the 10th and 25th weeks of gestation, aged up to 35 years old. The eligible pregnant women will be invited by the fieldworks to participated in the trial after be informed about the overall aims of the study. These women willing to participate will be randomly allocated to either the intervention or control group. The intervention group received specific guidelines about feeding practices appropriate to each nutritional status.

Data on pregnant women will be collected through a questionnaire in both groups, and to assess the food intake, three 24-hour food recall will be applied in the interventional group and two recall in the control group, in initial and final gestational period. In all appointments pregnant women of the two groups will be weight and classified according to Body Mass Index of pre-gestational (BMI).

The dietary advices will be elaborated by the author of the project and nutrition graduation students of Federal University of Health Science of Porto Alegre.


Eligibility Criteria:
Inclusion Criteria:

* Women between the 10th and 25th weeks of gestation
* To concern in the prenatal care group in basic health unit

Exclusion Criteria:

* Pregnant with diseases that require specific treatment at the onset enrollment (HIV, diabetes, hypertension and anemia)
* Women 36 years or older.
Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.

Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.

The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug, in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to correct atrial fibrillation. Once this phase of the study is completed, a second phase with a different study design will be conducted. The second phase is an open-label, follow-up phase to the first study. The follow-up phase will continue to evaluate the long-term safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.


Eligibility Criteria:
Inclusion criteria:

* Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening
* Require the procedure of cardioversion (electric shock to correct abnormal rhythm)
* In the investigator's opinion, is likely to maintain sinus rhythm after cardioversion.
* Be anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines.

Exclusion criteria:

* Previously unsuccessful electrical cardioversions
* Failed to respond to any Class III antiarrhythmic drugs
* Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that:

* has spread to other parts of the body (metastatic);
* has a certain type of abnormal gene called "BRAF"; and
* has not received prior treatment.

Participants in this study will receive one of the following study treatments:

* Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic.
* Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home.
* Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home.

This study is currently enrolling participants who will receive either encorafenib plus cetuximab with chemotherapy or chemotherapy alone.

The study team will monitor how each participant responds to the study treatment for up to about 3 years.

The purpose of the study is to evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of-care chemotherapy in participants with previously untreated BRAF V600E-mutant mCRC. Since encorafenib has not previously been combined with chemotherapy, the tolerability and PK of EC in combination with mFOLFOX6 and in combination with FOLFIRI will be evaluated in separate cohorts in the safety lead-in portion of the trial in order to identify which chemotherapy combination is to be used in the Phase 3 portion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Safety Lead-In = Male/female ≥ 18 years old
* Phase 3 and Cohort 3: Male/female ≥ 16 years old (where permitted locally)
* Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation
* Prior systemic treatment in metastatic setting: 0-1 regimens for Safety Lead In; none for Phase 3 and Cohort 3. (Note: Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis \< 6 month from end of adj/neoadjuvant treatment )
* Measurable disease (Phase 3 and Cohort 3)/ Measurable or evaluable disease (Safety Lead-in)
* ECOG PS 0-1
* Adequate organ function

Exclusion Criteria:

* Tumors that are locally confirmed or unknown MSI-H or dMMR unless participant is ineligible to receive immune checkpoint inhibitors due to a pre-existing medical condition
* Active bacterial or viral infections in 2 weeks prior to starting dosing
* Symptomatic brain metastases
Clinical Study of Oral Midazolam Combined With Esketamine Administered Intranasally for Pediatric Preoperative Sedation

Children are prone to anxiety and even fear before surgery, and such adverse emotions may not only lead to poor induction of anesthesia, but also increase the incidence of postoperative agitation and even lead to postoperative behavioral changes in children. There are many ways to relieve pediatric anxiety, including preoperative medication, games, and cartoons. Preoperative medication is the most commonly used method to relieve pediatric anxiety.The most commonly used pediatric preoperative sedation drugs are midazolam and esketamine.However, oral midazolam may not produce a sedative effect in 20-40% of patients. A good preoperative anxiety-reducing effect was seen in only 60-80% of cases.Therefore, this trial investigates whether the intranasal combination of esketamine with oral midazolam can produce better results than each of the two drugs alone. This will provide a reference for the selection of safe, reliable and appropriate preoperative sedation methods for pediatric patients and provide evidence-based support for comfort care.

A trained member of the research team obtained a baseline The Modified Yale Preoperative Anxiety Scale(mYPAS) after obtaining consent. And corresponding study medication is administered about 30-40 minutes before the anesthesia induction.Vital signs were measured every 5 min after study medication administration.The sedation scores of the children were recorded with University of Michigan Sedation Scale (UMSS) every 10 minutes.The onset time of satisfactory sedation and parental separation anxiety scale was noted.Then recorded the degree of cooperation during inhalation anesthesia induction and recovery times.Moreover, recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.

Eligibility Criteria:
Inclusion Criteria:

1. with American Society of Anesthesiologists (ASA) physical status I or II；
2. aged 2-6 years；
3. children with weight for age within the normal range
4. were scheduled lower abdominal and perineal surgery with an expected operation time shorter than 30 minutes.

Exclusion Criteria:

1. Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
2. contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either esketamine or midazolam;
3. with any nasal pathology,organ dysfunction;
4. recently respiratory infection, mental disorder;
5. other reasons that researchers hold it is not appropriate to participate in this trial.
Evaluating the Role of the Addition of Ovarian Function Suppression (OFS) to Tamoxifen in Young Women

The purpose of this study is to compare 5-year disease free survival rate (DFS rate) between the hormone receptor positive breast cancer patients who were added Goserelin to Tamoxifen for ovarian function suppression after neo-/adjuvant cytotoxic chemotherapy and the hormone receptor positive breast cancer patients who were treated with Tamoxifen.

* To compare overall Survival(OS) between the patients added Goserelin(ZOLADEXTM) to Tamoxifen and the patients treated with Tamoxifen alone in premenopausal status
* To compare 5-year disease free survival rate (DFS rate) between the patients who took tamoxifen only in postmenopause and the patients added Goserelin(ZOLADEXTM) to Tamoxifen for inducing ovarian function suppression in premenopause
* To determine the tolerability and safety of Tamoxifen with or without concomitant Zoladex

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have undergone excision of the primary breast mass, proven histologically to be invasive breast adenocarcinoma.
2. Patients must be within 3 months after the last cycle of chemotherapy.
3. Patients must have the history of normal menstruation prior to the start of chemotherapy.
4. Stage I, II or III
5. Woman, less than or equal to 45 years of age
6. Hormone receptor status : ER+ve and/or PgR+ve
7. WHO performance status 0, 1 or 2.
8. Patients who were treated with cytotoxic chemotherapy in pre- or post- surgery.
9. Adequate haematological function defined by haemoglobin 10g/dL, neutrophil count 1.5x109/L and platelets 100x109/L.
10. Adequate hepatic function defined by AST and ALT 2.5xupper limit of normal. Alkaline phosphatase 5xupper limit of normal, unless bone metastases in the absence of liver disease. Renal function adequate defined by creatinine\<175mmol/L.

Exclusion Criteria:

1. Patients whose primary breast cancer was classified as:

   * ER(-),ER unknown
2. Patients with the history of hysterectomy or oophorectomy
3. Sarcomas or squamous cell carcinomas of the breast are not eligible.
4. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell / squamous cell carcinoma of the skin.
5. Investigational drugs given within the previous 4 weeks.
6. Patients known to be on any unlicensed non-cancer investigational agent.
7. Patients with thrombocytopaenia (platelets \<100 x 109/l or on anti- coagulant therapy (contra-indicated due to risk of bleeding with i.m. injection of Zoladex).
8. Patients treated with CMF(cyclophosphamide/methotrexate/5-fluorouracil) as prior chemotherapy
9. Patients who are pregnant or lactating are ineligible.
Prospective Evaluation of CT Guided Ablation of Cardiac Ganglionated Plexi

Despite progress made in treating atrial fibrillation with catheter ablation, outcomes remain suboptimal with pulmonary vein isolation alone. Ablation of ganglionated plexi (GP) has been shown to be beneficial in patients with atrial fibrillation although optimal strategies of localization of these regions have yet to be determined. The investigators aim to develop a novel strategy of CT guided GP localization to guide ablation in patients with atrial fibrillation. The investigators also aim to clarify the network of innervation between GP to clarify the optimal ablation strategy. This is an observational, single-center study evaluating feasibility and efficacy of CT and high frequency stimulation (HFS) guided GP mapping and ablation in patients with AF undergoing catheter ablation with pulmonary vein isolation. Patients will undergo HFS and CT guided mapping of GPs followed by allocation into one of 8 different GP ablation approaches in a non-randomized fashion.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 years
4. History of AF with plan to undergo catheter ablation

Exclusion Criteria:

1. Contraindication or unwillingness to undergo CT imaging or catheter ablation.
2. Pregnancy or lactation
Incidence of Cardiovascular Diseases in Patients With Hypopituitarims

The aim of the present study was therefore two-fold: 1) to make a retrospective comparison of incidence of non-fatal stroke and cardiac events between a large cohort of patients with confirmed GHD on replacement therapy (including GH) and a control cohort from the general population; 2) to compare the prevalence of DM and cardioprotective medication between the cohorts at the time of questionnaire distribution with adjustment for possible confounders and effect modifiers.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed GH deficiency

Exclusion Criteria:

* Not confirmed GH deficiency
From Genetics to Transcriptomics to Unravel the Mechanisms Behind a Poor Outcome in Multiple Sclerosis

MS is a heterogeneous disease either in its response to treatment or clinical manifestation. Indeed, the natural history of MS is varying from a benign condition to a devastating and rapidly incapacitating disease. Clinical heterogeneity could also be cellular and / or molecular. The aim is to identify from OMIC analyses, at the early stage of the disease, differentially expressed molecules and / or cell subpopulations derived from CD8 + T lymphocytes and / or CD4 + T lymphocytes and / or B lymphocytes and monocytes from patients with aggressive versus non-aggressive, compared to a cohort of healthy controls


Eligibility Criteria:
Inclusion Criteria :

Common criteria for retrospective MS patients:

* Patients aged 18 years or older
* Clinical isolated syndrome (CIS) with or without dissemination in space
* Patients affiliated to an appropriate health insurance

Criteria for Aggressive MS group

• Start of a 2nd line therapy within the two years following the CIS

Criteria for Non aggressive MS group

* No conversion according to McDonald criteria from clinical isolated syndrome to multiple sclerosis within 2 years or
* Conversion based to McDonald criteria treated or not with first line disease modifying therapy within 2 years.
* Have a minimum of least 2 years of follow-up.

Healthy volunteers

* Aged 18 years or older
* No history of clinically isolated syndrome or MS

Pairing criteria :

* Age +/- 5 years
* Sex

Prospective MS Patients

* Patients aged 18 years or older
* Clinical isolated syndrome (CIS) with or without dissemination in space
* Patients affiliated to an appropriate health insurance

Exclusion Criteria :

* Ongoing participation to a another study
* Refusal to genetic analyses
* Immunosuppressive drug at the time of blood collection
* Adults under a legal protection regime (guardianship, trusteeship, judicial safeguard)
* Pregnancy
Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study

The aim of this study is to evaluate user preference and ease of use of the FreeStyle InsuLinx system, compared to current methodology, when used at home by subjects with diabetes.

Subjects will also be comparing the ease of use of the FreeStyle InsuLinx system with comparator meters.


Eligibility Criteria:
Inclusion Criteria:

* Subject with Type 1 or 2 diabetes on a bolus regime (U100 insulin), one or more bolus injections per day for at least 6 months;
* Age 18 yrs and above;
* Regularly testing SMBG 3 or more times per day;
* Willingness to test at least 4 times per day.

Exclusion Criteria:

* Know to require a bolus injection of more than 50U in a single dose;
* Has previously used either the InsuLinx or assigned comparison meter;
* Participated in structured diabetes management training in the last 6 months
* Is currently on an insulin pump;
* Has concomitant disease that, in the Investigator's opinion, may compromise patient safety;
* Is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management;
* Female subject who is pregnant or planning to become pregnant during the course of the study.
Heart Monitoring Device After Acute Myocardium Infarction

Verify the effectiveness of a Heart Monitor in preventing events in patients over 18 years after acute myocardial infarction in a clinical unit. Patients with neurological disease or congenital heart disease we excluded from the study.

Heart Monitor can detect early intercurrences. Objective: To verify the effectiveness of a Heart Monitoring system in preventing events in patients after acute myocardial infarction. Methodology: This is a randomized clinical trial to be developed in a clinical unit and will include patients over 18 years , post-acute myocardial infarction who were transferred from the ICU emergency or hemodynamic to clinical unit. Patients with neurological disease or congenital heart disease will be excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years
* patients post-acute myocardial infarctium

Exclusion Criteria:

* patients with neurological disease
* patients with congenital heart disease
Continuous Intraocular Pressure (IOP) Measurement and Ability to Detect Treatment Effect

Continuous intraocular pressure (IOP) measurement with a contact lens sensor may provide more information on the drug-related IOP change than 24-hour IOP measurement with Goldmann applanation tonometry (GAT.

* Participants are washed ot from all glaucoma medication for 6 weeks
* one eye per participant is investigated (study eye)
* 24-h intraocular pressure (IOP) curve is obtained with Goldmann tonometry and Sensimed contact lens sensor tonometry twice, in 14 days
* for Sensimed contact lens curves median values (in arbitrary units), for Goldmann applanation tonometry, mean and SD values are used to characterize the curves, for comparisions % changes are used for the corresponding time periods
* treatment (travoprost 0.005% 1/day) is given to all eyes for 3 months 24-h Goldmann and Sensimed IOP curves are repeated
* IOP curves are determined in arbitrary units and mmHg, respectively, and compared for reproducibility (untreated phase) and relative (%)change (untreated curve vs. under treatment curve) with both methods, respectively

Eligibility Criteria:
Inclusion Criteria:

* primary open-angle glaucoma (POAG), ocular hypertension(OHT)
* 18 years or older
* C/D \<= 0.7
* no risk for visual field damage
* IOP \> 22 mmHg

Exclusion Criteria:

* Pregnancy and lactation
* Known intolerance to travoprost, topical anesthetic
* Previous ocular surgery at any time
* Previous ocular laser treatment within 1 year
Readmission After Adrenalectomy

to evaluate early hospital enterance after pheo surg.


Eligibility Criteria:
Inclusion Criteria:

* patients with pheo

Exclusion Criteria:

* non reactive
* missed data
Analysis of Biomechanical Parameters and Return to Sport After Hip Arthroscopy

The aim of this prospective study is to describe dynamic movement parameters in active patients who underwent surgery between 3 and 6 months after hip arthroscopy, focusing on movements such as jumping, squatting and acceleration. By examining the relationships between these different parameters and the return to sporting activities, and by integrating different angle and alignment measurements per- and post-operatively, we hope to find predictive factors for successive rehabilitation in athletes, which could lead to more personalized rehabilitation protocols.


Eligibility Criteria:
Inclusion Criteria:

* Hip arthroscopy for labrum lesion
* athlete prior to arthroscopy with desire to return to sport

Exclusion Criteria:

* Previous surgery or pathology of the operated lower limb
* Contralateral hip operated
* Neurological pathology affecting movement
* Medical condition contraindicating participation in sports
* Dementia or inability to complete questionnaires and assessments
* Pregnant or breast-feeding patient
* Patient under protective supervision
* Patient not covered by a social security scheme