cyrilzakka/clinical-trials huggingface dataset:
Individualized Management for Long Gap Esophageal Atresia

The treatment of long gap esophageal atresia (LGEA) in neonates is one of the most challenging congenital malformations in neonatal surgery. Usually the proximal and distal segments of the esophagus are too far apart, which leads to primary anastomosis abandoned. Thus various techniques have been used including Circular and spiral myotomies、Foker and Kimura elongation and gastrointestinal replacement. They are being widely used but bring more complications and less effectiveness. And considering about the absence of definite guideline for the diagnosis and treatment of LGEA worldwide, We prepare to use a preoperative staged stress function procedure for elongation of the proximal and distal segments, then to obtain an exact evaluation of the pouch status to achieve an individualized protocol of diagnosis and treatment utilizing the native esophagus to establish esophageal continuity for patients with LGEA.

Patients with diagnosis of LGEA(gap distance\>3.5cm) will be accepted to the program.

After accepted to our center, the patients will feed by gastrostomy tube to keep nutritional status remain well controlled. Continuous suction in the upper pouch will be applied to avoid aspiration pneumonia.

We will design a bouginage with baroreceptor. Then the stress function will be performed as following steps. The designed bouginage will be inserted into the upper esophagus pouch through oral cavity with a certain downward longitudinal force to increase esophageal length by tissue stretch and growth, it will be performed 10-15 minutes each time once/twice a day. While the elongation of distal pouch will be achieved via the gastrostomy using the same bouginage to give upward pressure, the program will be operated under X-ray firstly to avoid injury or false passage formation,it can be performed in the ward thereafter. The gap length and the diameter of the pouch will be evaluated every 1-2 weeks. During the elongation period, continuous upper pouch suctioning and nutritional support were maintained.

When the gap distance is short enough，the method of surgery will be decided，including end-to-end anastomosis、Livadites、flip-flap and choice of thoracoscopy use. The purpose of the program is to achieve the exact management and treatment for patients with LGEA and help promoting the use of the new technology.

Eligibility Criteria:
Inclusion Criteria：

* Patients with long gap esophageal atresia（LGEA）which the gap lenth≥3.5cm；
* with（out）tracheoesophageal fistula（TEF）

Exclusion Criteria:

* Patients with LGEA which can not accept the staged stress function
Aqueous Humor Level of Cytokines in Polypoidal Choroidal Vasculopathy and Change of Cytokines After Photodynamic Therapy

This is a prospective, comparative control analysis. The investigators want to evaluate the aqueous humor levels of vascular endothelial growth factor in polypoidal choroidal vasculopathy and the effect of photodynamic therapy and combination treatment of photodynamic therapy and Lucentis (Ranibizumab)on the level of vascular endothelial growth factor.

To compare the effect of combination therapy of intravitreal injection of Lucentis™ and photodynamic therapy versus only photodynamic therapy on aqueous humor vascular endothelial growth factor level in polypoidal choroidal vasculopathy patients to establish the vascular endothelial growth factor expression after photodynamic therapy and the direct effect of Lucentis™ on this increased vascular endothelial growth factor level. Additionally the investigators want to examine the vascular endothelial growth factor , tumor necrosis factor alpha, interleukin-2, interleukin-6 and interleukin-8 level of aqueous humor in symptomatic, active polypoidal choroidal vasculopathy patients.

Eligibility Criteria:
\<Polypoidal choroidal vasculopathy group\>

Inclusion Criteria:

* Male or Female patients ≥ 45yrs of age
* Best corrected Visual acuity 20/30 to 20/320 Snellen equivalent using ETDRS chart measured at 4 meters
* Signed written informed consent
* Evidence of Polypoidal choroidal vasculopathy , active in disease activity.
* Presence of subfoveal, juxtafoveal or extrafoveal active characteristic macular polypoidal lesions on indocyanine green angiography
* Confirmed to be active in disease activity by fluorescein angiography
* The total lesion must have the greatest linear dimension less than 5400 microns ( \~9 MPS Disc Areas ) as delineated by indocyanine green angiography
* Had not been treated in the past
* Patients willing and able to comply with all study procedures

Exclusion Criteria:

* Previous history of laser photocoagulation,photodynamic therapy,anti VEGF therapy, submacular surgery in the study eye
* Have known hypersensitivity to Visudyne® and Lucentis™
* Previous treatment with external-beam radiation therapy or transpupillary thermotherapy
* History of vitrectomy
* Intraocular surgery,yttrium aluminum garnet(YAG) laser\< 1month before day 0
* Additional eye disease that could compromise visual acuity
* Ocular inflammation
* Vitreous hemorrhage
* Uncontrolled glaucoma
* Current use or of likely need for systemic medications known to be toxic to the eye.
* Inability to obtain fluorescein angiography and indocyanine green angiography, due to media opacity, allergy to the dye or lack of venous access
* Are participating in another clinical study.
* Disciform scar
* Mental illness that precludes the patient from giving informed consent
* Patients who are considered potentially unreliable

\<Control group\>

-Age matched patients with cataract without other ocular diseases such as glaucoma, high myopia, ocular ischemic diseases, retinal disease, or with systemic diseases like diabetes mellitus.
Effects of Neuromuscular Electrostimulation on Scapular Stability

Injuries and shoulder pain are common problems in handball, more often among female athletes. The impact on performance and participation shows the need to work on the risk factors to minimize the damage. It has been found an association between scapular dysfunction and pain in the shoulder. Currently there are many exercise programs, but few with electrotherapy implemented. The aim of the study is to assess the effect of a therapeutic physical exercise program for scapulo-humeral stabilitation with and without electrotherapy on scapular stability, glenohumeral internal rotation and external rotation strength.


Eligibility Criteria:
Inclusion Criteria:

* To have more than 18 YO
* To be female
* To do at least 5 hour of sport training per week in last two years
* To be part of federated club that allows them in their weekly practice to participate in recreational matches or small local championship during weekends.
* To have scapular diskinesis by McClure scale

Exclusion Criteria:

* To have an actual injury
* To have an history of injury in last 12 months
* To take drugs that can affect to control motor.
* To be part or participate in a control motor program or specific prevention program
* To have a recent surgery in last year in upper or back.
* A score below 45 points on the Personal Psychological Apprehension Scale.
Early Exposure to OMT Prevents Long LOS

The application of osteopathic manipulative treatment (OMT) in preterm infants has been demonstrated to be effective in reducing length of stay (LOS). The scope of the present study is to investigate the association between earlier exposure to OMT and reduction of LOS in premature infants


Eligibility Criteria:
Inclusion Criteria:

* preterm infants born at age between 29 and 37 weeks
* osteopathic treatment performed \< 14 days after birth
* preterms born in the same hospital

Exclusion Criteria:

* Gestational age \< 29 weeks
* Gestational age \> 37 weeks
* First OMT performed after 14 days from birth
* genetic disorders
* congenital disorders
* cardiovascular abnormalities
* proven or suspected necrotized enterocolitis with or without gastrointestinal perforation proven or suspected abdominal obstruction
* pre/post surgery patients
* pneumoperitoneum
* atelectasis
* Newborn from an HIV seropositive/drug addicted mother
* respiratory disorders
* transferred to/from other hospital
* admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Sessions in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease in Germany

Phase III study to test the hypothesis that treatment with pelacarsen (TQJ230) 80 mg Q4W compared to placebo significantly reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia (a) and established cardiovascular disease currently undergoing lipoprotein apheresis in Germany on a weekly schedule.

Lipoprotein apheresis to date is the only approved therapeutic option for cardiovascular (CV) risk reduction in patients with severely elevated Lp(a) levels in Germany. Lipoprotein apheresis is an expensive, burdensome, and time-consuming procedure. The current study (CTQJ230A12302) will investigate if treatment with pelacarsen (TQJ230) 80 mg Q4W vs placebo reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia(a) and established CV disease

Eligibility Criteria:
Inclusion Criteria:

* Patients currently undergoing lipoprotein apheresis for isolated Lp(a) on a weekly schedule in Germany for ≥ 12 months prior to screening with at least 40 sessions within the past 52 weeks prior to randomization
* Lipoprotein(a) (Lp(a))\> 60 mg/dL at screening
* Spontaneous prior myocardial infarction (MI): ≥ 3 months from screening visit to ≤ 10 years prior to the screening visit, and/or
* Ischemic stroke: ≥ 3 months from screening visit to ≤ 10 years prior to the screening visit, and/or
* Clinically significant symptomatic peripheral artery disease (PAD)

Exclusion Criteria:

* Uncontrolled hypertension
* Heart failure New York Heart Association (NYHA) class IV
* History of malignancy of any organ system
* History of hemorrhagic stroke or other major bleeding
* Platelet count \<140,000 per mm3 at screening
* Active liver disease or hepatic dysfunction
* Significant kidney disease
* Pregnant or nursing women
Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis

To date, there are no reliable diagnostic blood markers of adult vasculitis. To date, the diagnosis of vasculitis is based on invasive procedure, biopsy of affected tissues potentially at risk of complication . In addition, there are no reliable biomarkers to predict the evolution of vasculitis (relapse, refractory form ...) necessary for the management of patients (type of treatment, duration ..)

Prospective study, monocentric (CHU de Tours), non-interventional, aimed at finding diagnostic and prognostic biomarkers (both metabolomic and immunologic) in adult vasculitis patients.

Specimen will be collected at diagnosis, month 1, month 3, and month12 and at the time of a possible relapse. 14 ml of additional blood during a blood puncture made for routine care will be collected at each visit as well as clinical data.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 16 years
* Active vasculitis, new diagnosis or relapse
* IgA vasculitis
* ANCA vasculitis
* Giant cell arteritis

Exclusion Criteria:

* Person who has objected to the processing of data
* Pregnant woman
* Patient positive for HIV, HBV, HCV
* Treatment in the previous month with corticosteroids, immunosuppressive drugs or biotherapy.
* Patient unable to understand the information leaflet
* Adult under guardianship or curatorship
Traumacel PULVIS and Traumacel ENDO Applicator in the Post-market Surveillance Phase

Traumacel PULVIS is a sterile absorbable haemostatic plant polysaccharide powder made of the oxidized cellulose. Traumacel PULVIS is designed to stop capillary bleeding as well as to prevent bleeding in the early post-operative stage, for example to stop capillary bleeding from resection areas of parenchymatous organs, muscles, to stop bleeding after endoscopy, mainly rectoscopic, procedures. The broadness of application allows for use in procedures performed in the standard way as well as endoscopically.

Traumacel ENDO Applicator is a single use, flexible, manual apparatus designed to deliver the absorbable haemostatic powder Traumacel PULVIS.

The main objective of this clinical study is to confirm the safety and efficacy of the medical device Traumacel PULVIS and Traumacel ENDO Applicator when used in accordance with their intended purpose.

The partial objectives are: to identify potential incompatibilities of Traumacel ENDO Applicator with other surgical instruments, in particular with different types of trocar cannulas; for both devices (Traumacel ENDO Applicator and Traumacel PULVIS) the identification and analysis of potential emerging risks; confirmation of the acceptability of the benefit-risk ratio; identification of any systematic misuse of the device or off-label use of the device in order to verify the correctness of its intended purpose.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18.
* Surgical intervention.
* Negative pregnancy test of women in fertile age.
* Diffuse soft tissue, vascular or parenchymal haemorrhage after conventional surgical haemostatic methods have not worked or are impractical (e.g. ligation, suture, compression, cauterisation).
* Informed consent.

Exclusion Criteria:

* Hypersensitivity or a known reaction to oxidized cellulose.
* Age under 18
* A severe clinical condition of the patient (e.g. associated illness, mental disorder) which, according to the investigator, could adversely affect patient safety and/or compliance with the procedures used in the study.
* The patient has participated in another clinical study involving a haemostatic product within 30 days prior to enrolment, or another such clinical study is planned during the subject's participation in the study.
* Pregnancy or lactation.
* If during the procedure itself, there was no need to use the test agent
* Application of any other topical haemostatic product prior to application of the test agent to the same site.
Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach

This study was designed to investigate the analgesic effect of bilateral superficial cervical plexus block in patients undergoing robot-assisted endoscopic thyroidectomy. The investigators hypothesized that bilateral superficial cervical plexus blockade would reduce the patient's pain score by more than 10 (on a VAS scale of 0\~100) compared to a placebo group and control group.


Eligibility Criteria:
Inclusion Criteria:

* ASA class 1 or 2 adult patients scheduled for robot-assisted endoscopic thyroidectomy

Exclusion Criteria:

* Patient refusal
* Bleeding diathesis
* Allergies to local anesthetics
* Patient unable to read consent form (Foreigner, illiterate)
* Pregnant women
Ephedrine Doses to Prevent Maternal Hypotension After Spinal Anesthesia in Cesarean Section

This randomized controlled trial aims to compare the effectiveness of different doses of ephedrine infusion in preventing maternal hypotension following spinal anesthesia in parturients undergoing cesarean sections. The study includes 120 participants, aged 18-40 years, with American Society of Anesthesiologists (ASA) physical status II, who are scheduled for elective cesarean delivery. The primary objective is to determine whether low-dose ephedrine infusions at 1.25 mg/min or 1.5 mg/min effectively reduce the incidence of maternal hypotension, with secondary outcomes assessing the need for rescue ephedrine, incidence of side effects (nausea, vomiting, tachycardia), and neonatal Apgar scores. Researchers will compare three groups-saline, 1.25 mg/min ephedrine, and 1.5 mg/min ephedrine-to evaluate their impact on maternal hemodynamic stability.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cesarean section
* Self-identified as female
* American Society of Anesthesiologists (ASA) physical status II
* Aged between 18 to 40 years
* Full-term singleton pregnancies planned for cesarean delivery under spinal anesthesia

Exclusion Criteria:

* Body mass index (BMI) ≥ 40 kg/m²
* Height less than 145 cm
* Presence of severe neurological or psychiatric conditions
* History of pre-eclampsia
* Severe renal or metabolic disorders
* Contraindications to spinal anesthesia
* Antenatal evidence of fetal anomalies
* Cases with severely compromised fetuses requiring immediate general anesthesia
* Baseline systolic blood pressure (SBP) less than 90 mm Hg
* Pregnancy-induced hypertension
* Refusal to provide written consent
Incorporating Multidimensional Psychosocial Interventions Improves the Well-being of Individuals With Epilepsy

The purpose of this study is to incorporate multidimensional self-management programs into the routine care of epilepsy patients. Consenting patients will enroll in one of four interventions that help improve medication adherence, increase seizure awareness and documentation, improve memory and deal with stress and depression.

Though tremendous advances have been made in the diagnosis and treatment of individuals with epilepsy, much remains to be done when it comes to improving their psychosocial well-being. Many individuals with epilepsy have difficulty adhering to treatment, documenting their seizure types, coping with memory difficulties, dealing with stress, and suffer from depression. These factors limit the quality of life of epilepsy patients and prevent them from realizing their full potential.

Patients will enroll in one of four interventions that help improve medication adherence, increase seizure awareness and documentation, improve memory and deal with stress and depression. Patient assessments will be conducted before and after intervention to gauge the efficacy of the programs.

The specific aims of this study are to assess the feasibility and patient acceptability of incorporating multidimensional self-management and psychosocial interventions into routine epileptic care, as well as, determine whether these incorporations improve self-management, quality-of-life, and other measures of well-being.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of epilepsy using established criteria
* Patient self-identified as own primary caregiver
* English fluency
* Ability to provide informed consent
* Ability to complete the study assessments

Exclusion Criteria:

* History of non-epileptic seizures
* History of cognitive impairments that prevents them from providing informed consent and completing study assessments
Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC

The phase 3 study is to compare the efficacy and safety of palonosetron, a long-acting 5-HT3 receptor antagonist, by buccal film delivery compared to IV injection for the prevention of chemotherapy-induced nausea and vomiting. Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.

This is a phase 3 randomized, double-blind, parallel group study designed to evaluate the efficacy and safety of palonosetron HCL buccal film versus IV palonosetron for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy (MEC).

Subjects are randomized into two treatment groups, one with the experimental study drug palonosetron in buccal film, the other one with the control treatment using Palonosetron hydrochloride IV injection. Palonosetron PK will be assessed in a subgroup of each treatment group (two sample points, 10% of subjects).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, at least 18-years of age;
2. Provide written informed consent;
3. Chemotherapy naïve subject with histologically or cytologically confirmed malignant disease; or chemotherapy non-naïve subject with histologically proven diagnosis of cancer;
4. Karnofsky index ≥ 50;
5. Be scheduled to receive MEC to be administered on Day 1;

Exclusion Criteria:

1. Unable to understand or cooperate with study procedure；
2. Received any investigational drug 30 days prior to study entry；
3. Used any drug with anti-emetic efficacy 24 hours prior to treatment and during the study；
4. Enrollment in a previous study with palonosetron；
5. Seizure disorder requiring anticonvulsant medication;
6. Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy；
7. Ongoing vomiting from any organic etiology；
8. Experienced nausea (moderate to severe or vomiting following any previous chemotherapy)；
9. Scheduled to receive moderately or highly-emetogenic chemotherapy or radiotherapy during the study；
10. Known contraindication to 5-HT3 antagonist or dexamethasone；
11. Scheduled to receive bone marrow or stem cell transplant during study;
12. Symptomatic primary or metastatic CNS malignancy;
13. Lactating female.
Pilairo Lab Market Research

The purpose of the study is to observe the Pilairo mask in a lab setting.

The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other commercially available masks for continuous positive airwary pressure (CPAP) therapy.

Eligibility Criteria:
Inclusion Criteria:

* Apnea Hypopnea Indea \>15 from diagnostic study
* Minimum 18 years of age

Exclusion Criteria:

* Inability ot give informed consent
* History of intolerance to CPAP
* Anatomical or physiological conditions making CPAP therapy inappropriate