cyrilzakka/clinical-trials huggingface dataset:
Concurrent Radiotherapy and Weekly Chemotherapy of PF for Postoperative Locoregional Recurrence of Esophageal Cancer

The purpose of this study is to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy of 5-FU and cisplatin in patients with postoperative locoregional recurrence of esophageal squamous cell carcinoma.

The most optimal management for postoperative locoregional recurrence of oesophageal squamous cell carcinoma is still controversial. Several studies have reported the feasibility and efficacy of concurrent chemoradiotherapy (CCRT), mostly with three-weekly or four-weekly schedule of chemotherapy. However, treatment compliance was not quite satisfactory, probably due to treatment-related toxicities. Since CCRT with weekly chemotherapy regimens have demonstrated a favorable toxicity profile as well as promising survival in certain types of cancer, the investigators aimed to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy with 5-fluorouracil (5-FU) and cisplatin for patients with postoperative locoregional recurrence of oesophageal squamous cell carcinoma in the investigators center.The prescribed dose of radiotherapy is generally 60Gy/28fr to tumor and 50Gy/28fr to the clinical target volume.The concomitant chemotherapy is cisplatin 25mg/m2 on day 1, 5-FU 1176mg/m2 on day 1-3, repeated weekly for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. R0 resection for primary esophageal squamous cell carcinoma with two-incision esophagectomy (Ivor Lewis approach)25 or three-incision (right thoracotomy, midline laparotomy and left cervical incisions) esophagectomy with cervical esophagogastric anastomosis.
2. Absence of previous thoracic radiotherapy.
3. Cervical and/or thoracic postoperative recurrence (biopsy proven or positron emission tomography/computed tomography (PET/CT) proven or follow-up computed tomography (CT) showed progression of disease).
4. Absence of distant metastasis at recurrence.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2

Exclusion Criteria:

1. Younger than 18 or older than 70 years of age.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 3 or above
3. Other cancer history.
4. Serious cardiac, liver, or pulmonary disease.
5. Previous radiotherapy history
Evaluation of a Spherical Hydrophilic Acrylic Intraocular Lens

Evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens

To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) at 12-24 month postoperative.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any gender, aged 18 years or older at the time of the surgery
* Patients who had an uncomplicated (no intra-operative complication) aged-related cataract surgery
* Currently implanted with the study IOL into the capsular bag in at least one eye
* One-year post surgery follow-up (365 days -14 days/+365 days) for the study eye at the time of the postoperative visit
* Patient is willing and capable of providing informed consent
* Patient is willing and capable of complying with visits and procedures as defined by this protocol

Exclusion Criteria:

* Preoperative corrected distance visual acuity (CDVA) better than 0.3 LogMAR (0.5 decimal) or CDVA not available preoperatively
* Preoperative documented endothelial cell count of less than 2000/mm2 (if available)
* Any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss
* Any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
* Any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
* Any preoperative documented clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
* Any preoperative documented history of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis
* Any preoperative acute infection (acute ocular disease, external/internal infection, systemic infection)
* Any previous preoperative intraocular and corneal surgery
* Preoperative documented uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
* Preoperative documented or current systemic or ocular pharmacotherapy that effects patients' vision
* Any other preoperative documented or current pathology or condition that could be a risk for the patient according to the investigator opinion
* Women during pregnancy and/or lactation at time of enrollment into the study
* Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
* Patients whose freedom is impaired by administrative or legal order
* Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patients' vision
Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

The main side-effect of Implanon is the changes induces in bleeding patterns including amenorrhea, infrequent to irregular bleeding and frequent and prolonged bleeding; without any previous symptom and it was characterized as "breakthrough bleeding" (BTB). BTB is the main causes of early discontinuations. Unfortunately, there is no indication to predict prior to insertion what sort of bleeding pattern any individual woman may have after insertion and the proposed treatments were disappointed. Nevertheless, previous studies with other progestin-only contraceptives (including Implanon) provide evidence that the provision of adequate and intensive counseling to potential users and new acceptors about bleeding changes can help to improve method continuation.

The availability of Implanon in the public sector could help in the development of strategies to introduce the method in the public sector network and the training of medical residents.

100 women were either allocated to received Implanon contraceptive implant, the LNG-IUS or TCu380A copper-IUD. The women were allocated according to their preference on each of the contraceptive methods.

half of the women will receive the common counseling at the clinic and the other 50% will receive intense counselling about menstrual changes induced by these three contraceptive methods. The continuation rate up to one year will be evaluated through life-table analysis

Eligibility Criteria:
Inclusion Criteria:

* Women 18 to 40 years
* New users of Implanon, IUDs and the LNG-IUS TCu380A

Exclusion Criteria:

* Contraindications to contraceptive methods
General Anesthesia and Autonomic Nervous System in Children

The objective of the ANESPEDIA study is to describe in a pediatric population (aged from 4 to 8 years old) receiving elective surgery, the impact of general anesthesia on autonomic nervous system and their kinetics of early postoperative course (24 hours).

Some physiological factors such as sport activity or pathological as sepsis, certain chronic diseases or diabetes are known to modulate the overall autonomic activity and the intrinsic capacity of the individual to regulate its sympathovagal balance. These influences can alter the physiological autonomic balance sometimes with positive consequences on the Cardiac frequency-breathing control, blood pressure adjustment depending on the position of the individual, on the status of blood volume, but sometimes deleterious with bad regulation of sinus cardiac activity and respiration rate.

General anesthesia is recognized as one of the factors that can modify more or less sustainable the sympathovagal autonomic balance. While many studies described the effects of anesthesia on the autonomic nervous system, most data are done in adult subjects. For the child who sees intrinsically autonomic physiological changes related to its maturative status, assessment of the impact of anesthesia in the pediatric population in per and postoperative was never realized.

Eligibility Criteria:
Inclusion Criteria:

* Post-anesthesia Monitoring in pediatric intensive care units or Pediatric Surgery Hospital North of Saint Etienne.
* Compendium of the form signed by the holder of parental authority

Exclusion Criteria:

* Child with pathologies reaching the central nervous system or the brain stem.
* Children with a severe pathology of cardio-respiratory or heart being referred to treatment.
* Children requiring emergency surgery or trauma or septic or inflammatory context
The Effect of Peripheral Nerve Blocks on Postoperative Analgesia in Elective Cesarean Section

The goal of this prospective randomized study was to compare the efficacy of transversus abdominis plane block and transversalis fascia plane block for postoperative analgesia in patients undergoing elective cesarean section under spinal anesthesia.

The main question\[s\] it aims to answer are:

\[Is transversalis fascia plane block more effective in postoperative analgesia? \]

\[Is there a difference between the duration of postoperative first analgesia requirement? \] Since the pain scores after the block at the end of the operation will be evaluated during the postoperative 24 hours, the participants will be asked to give a value between 0 and 10 in certain time periods.

This prospective, randomized trial was conducted at Başakşehir Çam and Sakura City Hospital by the Declaration of Helsinki. After ethics committee approval (decision no: 2022-74, date: 09.03.2022) and written informed consent was obtained from all patients, the trial was conduct-ed according to Consolidated Standards of Reporting Trials (CONSORT) guidelines.A total of 150 patients were divided into two groups: transversal fascia plane block (TFPB group) and Transversus abdominis plane block (TAPB group).VAS values, time to first analgesic requirement, analgesic requirements, nausea \& vomiting and pruritus were evaluated for 24 hours postoperatively (6th hour (T2), 12th hour (T3), 24th hour .

Eligibility Criteria:
Inclusion Criteria:

* 20-50 years old pregnant woman
* ASAII-III
* Patients accepting spinal anesthesia

Exclusion Criteria:

* Morbid obesity(BMI \>40)
* Patients who are switched to general anesthesia in an unexpected perioperative situation
* Patients with placental anomaly
* Patients with bupivacaine allergy
* Fetal distress situations too urgent to wait for spinal anesthesia and patients who do not want spinal anesthesia
Intraosseous (IO) Cefazolin and Vancomycin in Primary Total Knee Arthroplasty (TKA)

The goal of this clinical trial is to compare the efficacy of intravenous (IV) and intraosseous (IO) antibiotic administration techniques during primary total knee arthroplasty (TKA) in adults undergoing a TKA procedure at Houston Methodist Hospital. The main questions it aims to answer are:

Does IO administration of vancomycin and cefazolin protect against perioperative exposure risks? Is there a difference in post-operative complication rates between IV and IO administration of these drugs?

Participants will be randomized to receive either the standard of care IV administration of Vancomycin and Cefazolin, or the IO administration of Vancomycin and Cefazolin.


Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled to undergo an elective primary total knee arthroplasty.
* Patient is able to understand the study design and intervention and gives informed consent to participate in the study.
* Patient is 18 years or older.

Exclusion Criteria:

* Contraindication to receiving vancomycin or cefazolin.
* Body mass index (BMI) \> 40.
* Uncontrolled Diabetes (defined as A1c \> 7.5%).
* Patient received or is scheduled to receive IV vancomycin or cefazolin within 7 days prior to their planned procedure.
* Any hardware, condition, or anatomic status that prevents the tibial tubercle from being a viable intraosseous injection site.
* Refusal to participate
* Any condition, in the opinion of the primary investigator, that deems the participant unsuitable for participation in the research study.
Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) Response

The purpose of this study is to determine whether a Cognitive and Behavioral group Therapy (CBT) + Mindfulness Based Cognitive Therapy (MBCT) decreased relapses and hospitalizations and improved outcomes (depressive and manic symptoms, self-esteem, and quality of life) in a large sample of refractory bipolar I patients on mood stabilizers.

In recent years, various controlled studies showed that psychoeducational interventions have been effective in decreasing relapse and improving outcomes for bipolar disorders. However, samples were often small, compromising statistical power, and with a large variety of patients. The investigators therefore tested if a CBT group psychoeducation program + MBCT decreased relapses and improved outcomes in a large sample of refractory bipolar I patients on mood stabilizers. Patients were tested at recruitment, at 6-month follow-up CBT and at 2-month follow-up MBCT using clinical interviews and self-report questionnaires. The primary outcome measure of efficacy was relapse during the follow-up requiring either hospitalization, modification of treatment or HDRS ≥ 16 or MRS ≥ 6. The secondary outcome measure was symptomatic and functional improvement.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years
* Men and women
* Addressed to the CBT unit of the Clinique des Maladies Mentales et de l'Encéphale - CMME- (Sainte Anne Hospital)
* Having a bipolar I or II disorder (224 patients) or eating disorder (224 patients) : bulimia or discorder of use alcohol or gambling (224 patients)
* mood stabilizer treatment for more than six months, for bipolar patients
* Understanding and speaking French fluently
* Patient agreeing to participate and signing the consent form

Exclusion Criteria:

* Age \<18 or\> 65
* current manic, hypomanic, or depressive episode for bipolar patients
* Score on the Hamilton Depression Rating Scale - HDRS greater than or equal to 16
* Score on the Mania Rating Scale - MRS higher or equal to 6 for bipolar patients
* Schizophrenic disorder
* Severe somatic pathology (cancer, heart, kidney or respiratory failure, central neurological disorder), scalable, or are likely to be life-threatening in a period of less than one year
* Refusal of a mood stabilizer treatment for bipolar patients
* Inability to respond to assessment (eg failure or deterioration of mental ability.)
* No affiliation to a social security scheme
* Private topics of liberty by judicial or administrative decision
* Pregnant women

For bipolar patients, the presence of rapid cycling, family history of bipolar disorder, comorbid Axis I and II disorders, protective measures (curatorship or guardianship) are not exclusion criteria.
Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?

A multicenter cross-over cluster randomized controlled trial protocol study in newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (positive pressure ventilation \[PPV\]) for resuscitation in the delivery room comparing a T-piece resuscitator device versus resuscitation bag.

Design: A multicenter cross-over cluster randomized controlled trial. Our hypothesis is based on the assumption that ventilating depressed newborns with a T-piece resuscitator will be more effective than SIB by increasing the proportion of resuscitated newborns with heart rate (HR) ≥ 100 beats per minute (bpm) at two minutes of life as a proxy for successful resuscitation.

Population: Newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (PPV) for resuscitation in the delivery room.

(need for assisted ventilation at positive pressure: Heart Rate \[HR\] \< 100 beats per minute \[bpm\], apnea, gasping, cyanosis and/or hypotonia)

Intervention: PPV will be performed with a T-piece resuscitator (Neopuff® group) with positive end expiratory pressure.

Control: PPV will be performed with a self inflating bag (SIB group) with and without PEEP.

Both devices will be used with face masks, and a peak inspiratory pressure (PIP) of 25 cm H2O will be used to begin ventilation with PEEP of 0 cm H2O in the subgroup without PEEP valve, 5 cm H2O in the subgroup with PEEP valve in the SIB group, and 5 cm H2O in the Neopuff® group.

Objective: To compare the effectiveness of both instruments in reaching a heart rate of ≥ 100 bpm in depressed newborns of ≥ 26 weeks' gestational age (GA) after the initiation of positive pressure ventilation (PPV) with face mask.

Primary Outcome: Proportion of newborns with HR ≥ 100 bpm at 2 minutes of life.

Type of Comparison: Which of the two devices Neopuff TM or Self Inflating Bag (NP/SIB)will be more effective for ventilation of the newborn, by increasing the proportion of resuscitated newborns with heart rate (HR) ≥ 100 beats per minute (bpm) at two minutes of life as a proxy for successful resuscitation.

Eligibility Criteria:
Inclusion criteria:

Live-born infants of ≥ 26 weeks' GA with HR \< 100 bpm requiring resuscitation with positive pressure ventilation with mask in the delivery room according to the current AAP/AHA recommendations

Exclusion Criteria:

Infants requiring intubation from birth. Newborns of \< 26 weeks´ GA. Newborns presenting major congenital malformations. Multiple births. Problems (difficulty or malfunctioning) with the device assigned.
Genetic Drug Study of Mycophenolic Acid (CellCept) in Pediatric Kidney Transplant Patients

The purpose of this study is to determine how genes influence the response to mycophenolate mofetil (CellCept) in children who have had a kidney transplant. The study will look at how differences in some genes effect blood levels of mycophenolate mofetil over time in children, how often side effects occur and the way that children respond to mycophenolate mofetil.

The results may lead to better dosing based on individual needs.

This is an open label, inpatient-outpatient prospective observational study to determine whether the inter-patient variability in mycophenolic acid (MPA) pharmacokinetics and exposure, adverse events and clinical response in pediatric transplant patients (ages 2-18 years) is associated with identifiable pharmacogenetic factors. Specific aims: 1.) To determine whether common polymorphic variations in the uridine diphosphate-glucuronosyltransferases (UGTs) are associated with inter-individual variability in MPA pharmacokinetics and exposure (by affecting MPA metabolism). 2.) To determine whether common polymorphic variations in the uridine diphosphate-glucuronosyltransferases (UGTs) are associated with inter-patient differences in the incidence of adverse events (by affecting the formation of the acyl-glucuronide metabolite). Enrolled subjects will have been receiving mycophenolate mofetil as part of their clinical standard of care. It is anticipated that the clinical portion of the study will last up to 4 hours at one study visit to include one pharmacogenetic blood sample and 4 pharmacokinetic blood samples collected out to 3 hours post-dose. Safety data to be collected will include standard of care physical exam and safety laboratory tests as well as data on adverse events and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects and non-pregnant female subjects aged 2 to 18 years who are about to receive a kidney transplant and will be on post transplant MMF containing immunosuppressive therapy.
* A signed and dated institutional review board (IRB) approved parental/guardian informed consent form and an IRB approved child assent form if applicable.
* Subjects with stable kidney allografts who are on a stable regimen of MMF (with tacrolimus and steroids)
* May have clinically important abnormalities on clinical and /or laboratory evaluations, only as these abnormalities relate to an underlying condition as determined by the principal investigator.

Exclusion Criteria:

* Children receiving cyclosporine therapy that may interact with MPA entero-hepatic recycling.
* Any medical condition(active or chronic) or prior surgery that may interfere with the pharmacokinetics of MMF as determined by the principal investigator.
* Concomitant medication that may interfere with the pharmacokinetics of MMF as determined by the principal investigator.
Sentinel Node Biopsy Alone or With Axillary Dissection After Primary Chemotherapy

Many doctors believe that breast cancer patients scheduled for pre-operative chemotherapy whose cancer has spread to the axilla (determined by palpation plus ultrasound) should not receive sentinel node biopsy after chemotherapy, but proceed directly to removal of all the axillary lymph nodes.

In this study, breast cancer patients with operable medium-size cancer (T2) scheduled for pre-operative chemotherapy, and a disease-free or a metastatic axilla, are prospectively assigned to receive sentinel node biopsy as part of their post-chemotherapy surgical treatment (whose main aim is to remove the cancer in the breast).

Irrespective of whether the axilla is disease-free or metastatic before chemotherapy, if the removed sentinel nodes are disease-free on histological examination (pN0) after chemotherapy, then no further axillary treatment is given. If however the sentinel nodes contain cancer, then the other axillary lymph nodes will be removed surgically.

The study hypothesis is that, irrespective of whether the axilla is disease-free or metastatic before chemotherapy, patients with negative axillary sentinel nodes on histological examination (pN0) after chemotherapy, and who are no given further axillary treatment, will do as well as pN1 patients whose axillary lymph nodes are completely removed (a more aggressive treatment).


Eligibility Criteria:
Inclusion Criteria:

* cT2 cN0/1 breast cancer
* Scheduled for neoadjuvant chemotherapy,
* Informed consent,

Exclusion Criteria:

* Previous malignancy at another site
* Synchronous breast cancer at diagnosis
* Distant metastasis at diagnosis
* Clinically involved axilla (cN1) after neoadjuvant chemotherapy
Tailored Antiplatelet Therapy During Percutaneous Coronary Intervention in Patients With Diabetes Mellitus

The researchers aimed to investigate the effect of point-of-care platelet function assay on the periprocedural cardiac enzyme elevation in patients with diabetes mellitus.

All patients who are supposed to undergo coronary angiography were loaded with clopidogrel (300mg) and aspirin (300mg) at D-1. If patients were determined to implant coronary stent after diagnostic coronary angiography, their platelet function is assayed with Verifynow-ADP (Accumetrics). If patients have \>270 unit in the assay, they are randomized to abciximab or control group. After successful stent implantation, cardiac enzymes (CK-MB, Troponin-I) are followed at 8hr, 16hr and 24hr. Clinical outcomes including bleeding complications are assessed at 1 month.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were determined to implant drug-eluting coronary stent
* Diabetes mellitus (type 1 or 2)

Exclusion Criteria:

* Age \<18 years or \>80years
* Patients with acute myocardial infarction
* Patients with history of cerebral hemorrhage ever or ischemic infarction within 2 years
* Patients with history of major surgery (abdominal, thoracic, intraocular) within 6 months
* Patients who have have allergy to antiplatelet medications (aspirin, clopidogrel, abciximab)
* Patients who are on anticoagulation therapy
* Serum creatinine \>2.0mg/dl or ALT/AST \> 3 times of upper normal limit (120 U/L)