cyrilzakka/clinical-trials huggingface dataset:
Diaphragmatic Activity During Weaning With NAVA, a Pilot Study (NAVA: Neurally Adjusted Ventilatory Assist)

The purpose of this study is to describe the diaphragm electromyographic activity (Edi) in healthy lung patients due to obtain a reference to guide the weaning in those patients

We obtained the Edi recording data at each NAVA level during the weaning in NAVA group, and we compared the respiratory parameters between the PSV and NAVA groups

Eligibility Criteria:
Inclusion Criteria:

* Patients who were scheduled for elective major surgery in which admission to the CCU (critical care unit) for postoperative care and short-term mechanical ventilation with rapid weaning were anticipated.

Exclusion Criteria:

* Preoperative altered central nervous system, neuromuscular or lung disease and ASA (american society of anesthesiologists) classification group IV or NYHA (New York heart association) class IV in the case of cardiac patients. At the CCU, before randomisation, we also excluded patients requiring reoperation, and those who exhibited significant postsurgical bleeding, the development of myocardial infarction, and hemodynamic instability.
STN-DBS and the Risk of Sialorrhea

OBJECTIVE: The aims of this study were to assess the incidence rate and risk factors for sialorrhea in the long-term follow-up in a cohort of 170 patients with advanced Parkinson's disease \[84 with deep brain stimulation (DBS) and 86 on medical treatment\].

Design, setting, and participants: This study was a multi-center prospective non-randomized concurrent clinical trial. A total of198 persons with Parkinson disease were referred for DBS between June 2019 and July 2021 and analyzed between June 2023 and July 2023.The primary outcome follow-up visit was conducted 36 months after DBS.

IMPORTANCE: Sialorrhea is a frequent and disabling symptom in patients with PD. No prospective study has been specifically designed to test the effects of DBS on sialorrhea development.

OBJECTIVE: The aims of this study were to assess the incidence rate and risk factors for sialorrhea in the long-term follow-up in a cohort of 170 patients with advanced Parkinson's disease \[84 with deep brain stimulation (DBS) and 86 on medical treatment\].

Design, setting, and participants: This study was a multi-center prospective non-randomized concurrent clinical trial. A total of198 persons with Parkinson disease were referred for DBS between June 2019 and July 2021 and analyzed between June 2023 and July 2023.The primary outcome follow-up visit was conducted 36 months after DBS.

INTERVENTIONS: Bilateral subthalamic nucleus DBS was performed in one study arm and not performed in the other. Both arms of the study completed the drooling rating scale (DRS), the drooling severity and frequency scale (DSFS) and examination of salivary secretion rate.

MAIN OUTCOMES AND MEASURES: The primary outcome was the DRS scores of the patients with PD, with or without STN-DBS 36 months postoperatively. The secondary outcomes included the DSFS scores, saliva secreting rate, ratio of botox injection in different group.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease
* Age between 20 and 80 years
* without drooling
* swallowing function \<5 on the Drooling Rate Scale (DRS).
* Medications affecting drooling had to have stopped medications at least 4 weeks before study entry.

Exclusion Criteria:

* Not he typical PD
* Subjects on warfarin,
* with significant medical illnesses or neuromuscular transmission disorders
* past use of BoNT
* -cognitive impairment (\<23/30 on Mini Mental Status Exam) were excluded.
Popliteal Block for Postoperative Pain in Knee-ankle Soft Tissue Surgery in Cerebral Palsy

Popliteal block is a technique for providing postoperative pain management in children. In this randomized double-blinded study, the investigators evaluated the effects of preoperative popliteal nerve block on postoperative pain and analgesic requirement in children with cerebral palsy (CP) undergoing knee-anckle soft tissue surgery. The Wong Baker faces scale and skin conductance fluctuations will be assessed.

Sevoflurane will be used for anesthesia induction and maintance. Laryngeal mask airway will be placed without neuromuscular blocking agent. In group P (popliteal block), a single dose of 0.3ml.kg(-1) of 0.25% bupivacaine will be performed for popiteal nerve block (with ultrasound guidence). In group C ( control), only plaster cover will be applied without nerve block for sham procedure to provide double-blinded study. Intraoperative heart rate, mean arterial pressure, BIS (bispectral index) values, sevoflurane consumption will be recorded ten minutes interval. Wong Baker faces scale and skin conductance fluctuations will be recorded at postoperative 0, 10th min, 20th min , 1st h, 4th h, 12th h qnd 24th h. Total analgesic consumption (paracetamol orally ) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy
* Scheduled for knee and ankle surgery

Exclusion Criteria:

* Autonomic neuropathy
* Medication with anticholinergic drugs
* Continuous infusion of vasoactive drugs
Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial

The standard non surgical therapy of locally advanced esophageal cancer is based on a definitive concurrent chemoradiotherapy regimen with fluorouracil and cisplatin. One of the alternative regimen which is being studied is the combination of a weekly cisplatin and irinotecan schedule with radiotherapy. This multicentric phase II clinical trial primarily aimed to evaluate the clinical complete response rate and secondary objectives were toxicity profile and survival.

Chemotherapy with weekly cisplatin 30 mg/m2 AND Irinotecan 60 mg/m2 was administered at days1,8,22,29 and concurrently with radiotherapy t days 43,50,64,71. Radiotherapy was delivered day 43 to 75 with 50Gy in 25 fractions/5 weeks.

Eligibility Criteria:
Inclusion Criteria:

* esophageal carcinoma (squamous cell or adenocarcinoma) histologically confirmed
* performance status \<OR=2 (ECOG)
* caloric intake\>1500 KCal/d
* serum albumin \>32 gr/l
* serum creatinine\<120 microgr/l
* total serum bilirubin \< 1.5 mg/ml
* no prior chemotherapy or radiotherapy or surgery for esophageal neoplasm
* no prior history of malignancy other than cell carcinoma of the skin, in siyu cervical carcinoma, or head and neck carcinoma with complete response since 3 years
* written informed consent

Exclusion Criteria:

* Gilbert's syndrome
* cardiac disease as NYHA class 3 or 4
* myocardial infarction within the previous 6 months
* metastatic disease
* histologically proved invasion of tracheobronchial tree
* metastatic disease
Real-world Dosing Patterns of Rivaroxaban in the United States

The primary objective is to assess the proportion of Non-valvular atrial fibrillation (NVAF) patients receiving the standard dose of 20 mg of rivaroxaban or the reduced dose of 15 mg of rivaroxaban.

The secondary objective is to determine if dosing patterns for rivaroxaban may be influenced by baseline chronic kidney disease (CKD) status (as a proxy for measured baseline renal function).


Eligibility Criteria:
Inclusion Criteria:

* NVAF (non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more inpatient or outpatient claims with International Classification of Disease ICD-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion
* Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics
* CHA2DS2-Vasc score ≥2 during the 180 days prior to index rivaroxaban use baseline period
* Evidence of continuous enrollment in MarketScan during 180 days before the date of the first prescription of rivaroxaban

Exclusion Criteria:

* Patients \<18 years of age
* Patients with valvular AF (atrial fibrillation)
* Pregnancy
* Malignant cancers
* Transient cause of AF
* Patients with VTE (Venous thromboembolism), pulmonary embolism or DVT (Deep Vein Thrombosis)
* Patients with major surgery defined as hip or knee replacement
* Prescriptions of OACs (Oral anticoagulants) (apixaban,warfarin, dabigatran, rivaroxaban) before index date
* Prescription of more than one OAC on the index date
Fast-Track Rehabilitation

This study is a prospective observational study which aim to evaluate the feasibility of a total and systematic home respiratory rehabilitation training program in patients who will undergo thoracic surgery, and otherwise tend to define failure reasons.

The aim of this clinical trial is to identify the determining factors which impact a preoperative home respiratory rehabilitation training program success. This success is determined by complete achievement of the program (100%) by the patient.

This rehabilitation program is composed by 4 items:

* Adapted physical activity : 3 averaging cyclo ergometer or physical activity seances per week (25%)
* Physiotherapy sessions : 8 seances with a physical therapist (25%)
* Smokers : Set up of a program to help give up smoking if active smoker (25%)
* Dietetics : If unintentionally weight loss (\>5% total weight in 1 month or \>10% in 6 months) or BMI\<21 , nutritional assessment is conducted and dietetic program is initiated(25%)

Secondary objectives are :

* Assessment of postoperative event onset (30 days) (atelectasis, fibro-aspiration, time spent in resuscitation unit, intubation, revision surgery).
* Link assessment of 100% program success and at least one complication onset.
* Cost assessment of preoperative rehabilitation program
* Evaluation of mean hospitalisation duration post surgery (30 days)
* Average cost assessment of hospitalisation stay per patient.

This study will include 50 patients over 18 years old, addressed to the home heath care provider AGIR à Dom, for rehabilitation before pulmonary parenchyma exeresis.

Patients must perform at least 2 items of rehabilitation program previously described.

This program is an initiative of a pulmonologist or a thoracic surgeon, who include the patient when the date of surgery is scheduled.

Eligibility Criteria:
Inclusion Criteria:

* Patients who need a respiratory rehabilitation before thoracic surgery for lung resection.
* Patients addressed to the home heath care provider "AGIR à Dom",
* Patients must perform at least 2 items of rehabilitation program (Adapted physical activity, Diet, Physiologist, Smoking)

Exclusion Criteria:

* Patients who participate to another interventional research that may impact this study.
* Patients unable to get involved to the training program, depending to the investigator's appreciation.
Optimizing Platelet Isolation (The Cell Study)

The research study is about blood cells (platelets) and their power houses (mitochondria). The investigators want to learn about their behavior in order to ensure that our laboratory procedures are generating optimal results.

The objectives of this study are to assess platelet activation following standard laboratory procedures used in the process of measuring platelet mitochondrial function, and to determine the optimal amount of digitonin needed to permeabilize platelet cell membrane.

Eligibility Criteria:
Inclusion Criteria:

* Age 25-35
* All races
* All ethnicity
* 18.5 - 30 BMI

Exclusion Criteria:

* smoking
* Aspirin intake
* Recreational drug use
* Alcohol intake more than 3 times per week
* Self-reported possibility of current pregnancy
* Known diagnosis of:
* Pre-diabetes
* Diabetes
* High cholesterol
* High triglycerides
* Hypertension
* Anemia
* Autism spectrum disorder
* Attention deficit hyperactivity disorder (ADHD)
* Attention deficit disorder (ADD)
* Severe asthma
* Refusal to stop taking nutritional supplements
* Any other pre-existing medical condition that requires daily medication as determined by the investigators to affect outcome of interest
Effect of Protein Composition on Gastric Emptying

The protein composition of nutrition may affect the rate of gastric emptying and gastric fysiology. This is espesially important in children with neurologic impariment, who commonly rely on tube feedings, have feeding problems, nausea, vomiting, gastroesophageal reflux and delayed gastric emptying. We aim to find out whether 4 different protein sources affect the rate of gastric emptying and electrofysiology in this group of children.

Several factors in nutrition are known to affect gastric emptying rate, such as energy content, temperature, viscosity etc. In infants the protein composition affects gastric emptying. Children with cerebral pasly commonly have foregut dysmotility - with nausea, vomiting, feeding intolerance and gastroesophageal reflux. Tube feedings, usually based on cows milk are commonly used.

Our hypothesis is that the source and thus protein composition of feeding affects gastric emptying rate and electrofysiology.

Using four different tube feedings, standardized for content of fat, glucose and calories, we will measure gastric emptying rate using C13 octanoic acid as well as electrogastrography will be recorded. The protein modules are derived from casein, whey/casein mixture, hydrolyzed whey and aminoacids. Children with cerebral paresis and gastrostomy will be included. Each serves as his / her own control.

The primary endpoint is gastric emptying rate, the secondary endpoint electrogastrography.

Eligibility Criteria:
Inclusion Criteria: Cerebral paresis, user of tube feedings through gastrostomy -

Exclusion Criteria: Use of valproic acid (interferes with breath test). Age \>16 y.

-
Encapsulated Acellular System From Mesenchymal Stem Cells for Dental Pulp Regeneration

To evaluate the security and efficacy in the administration of encapsulated acellular system derived from Mesenchymal Stem Cells as a novel regenerative endodontic procedure which to promote the pulpar regenration.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients (ASA I).
* Patient presenting with a maxillary or mandibular incisor/canine and mandibular premolar with mature apex, pulpal necrosis, and apical radiographic evidence of apical periodontitis (PAI ≥2 and CBCTPAI ≥1).
* Patient presents with a tooth that does not respond to electrical and thermal pulp testing.
* Patients with restorable teeth (considering the definition of class A or B, according to Samet and Jotkowitz classification) without the need for a single fine prosthesis (crown) or major restoration.

Exclusion Criteria:

* Patients not available for the follow-up period (27 weeks).
* Patients who will undergo orthodontic treatment in the next six months.
* Patients with reports of allergies to any material or medication used in the study.
* Pregnant patients.
* Heavy smokers (more than 10 cigarettes per day).
* Patients with a history of systemic diseases that impair immune function, such as diabetes mellitus, immunodeficiency, leukemia, Addison's and Cushing's disease.
* Patients who have used immunosuppressive drugs or chemotherapy, 3 months before the study. Or that they will be irradiated or undergo chemotherapy.
* Patients who have endodontically treated teeth.
* Patients who have teeth with signs of severe root resorption.
* Patients who have teeth with mobility class III or Dens invaginatus.
* Patients who have teeth with a history of avulsion-type dentoalveolar trauma.
* Patients who have teeth with clinical and/or radiographic evidence of root fracture.
* Patients who have teeth that cannot be completely isolated with rubber dam.
* Patients who have teeth with more than one root or root canal.
Phenotypes of Nonproliferative Diabetic Retinopathy in DM 2 Patients Identified by OCT, CFP, RLA and mfERG (DIAMARKER)

To characterise phenotypes of Non Proliferative Diabetic Retinopathy (NPDR) progression using multimodal testing/imaging procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years-old.
2. Diabetes mellitus type 2 according to 1985 WHO criteria.
3. Non-proliferative diabetic retinopathy (ETDRS level \<= 35)
4. Signs of NPDR progression based on existing clinical information:

   1. Retinal thickness (RT) increase (increase in RT above normal range as measured by OCT, considering the macular thickness normative data) in the central subfield, the inner ring and/or the outer ring (leaking phenotype); OR
   2. Neovascular disease activity as shown by microaneurysms (MA) turnover (MA formation rate \>= 2, i.e. number of new MA per year) computed from CFP using the RetmarkerDR software (ischemic phenotype).
5. Informed consent.

Exclusion Criteria:

1. Cataract or other eye disease that may interfere with fundus examinations
2. Any eye surgery or treatment within a period of 6-months.
3. Pregnant or nursing (lactating) women.
4. Patients with chronic or severe kidney disease (glomerular filtration rate, GFR \< 30 mL/min/1.73m2).
5. Patients with acute kidney injury.
6. Patients with known allergic or hypersensitivity reactions to gadolinium, versetamide or any of the inert ingredients.
7. Patients around the time of liver transplantation..
8. Patients with implants containing metals.
A Prospective, Noninterventional Follow-Up Study of Children Aged 23 to 25 Months, Born to Mothers Who Received Hydroxyprogesterone Caproate Injection, 250 mg/mL, or Vehicle for Prevention of Preterm Birth

In the continuing efforts to understand the benefits and risks of in utero exposure to 17P this study is designed to evaluate differences in developmental outcomes of children, aged 23 to 25 months, born to mothers who participated in the 17P Efficacy Trial sponsored by Hologic (Protocol number 17P-ES-003).

This will be a prospective, noninterventional follow-up study designed to provide a developmental assessment of children born to mothers who participated in the 17P Efficacy Trial. When subjects reach an age of 23 months after adjustment for gestational age, they will be screened for developmental delay using the 24 month ASQ version 3. Subjects who score positive (fall below the specified cut-off) for developmental delay in 1 or more domains will be referred for the 24 month Bayley Scales of Infant and Toddler Development (3rd edition, Bayley-III) and a neurological examination.

Eligibility Criteria:
Inclusion Criteria:

* 1. Maternal enrollment which resulted in a live birth in the 17P Efficacy Trial: A Multi-center, Randomized, Double-blind Study of Hydroxyprogesterone Caproate Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery.

  2. During their involvement in the above protocol, mothers must have received at least one dose of study drug (Safety population).

  3. Children between 22 and 25 months of age adjusted for gestational age.

Exclusion Criteria:

* 1. There is no parent/legal guardian available to sign an informed consent. 2. Born to women who are unblinded to study group assignment.
Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors

The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B with inhibitors and is safe to use. Successfully screened participants will be randomly assigned to KN057 Prophylaxis (Arm 1) versus No Prophylaxis (Arm 2) at a ratio of 2:1. Participants in KN057 Prophylaxis will receive KN057 prophylaxis for 52 weeks upon enrollment. Participants in No Prophylaxis will first receive on-demand treatment for 26 weeks, then switch to KN057 prophylaxis for 26 weeks.The trial period is 59 weeks, including a 3-week screening period, a 26-week main trial, a 26-week extension period, and a 4-week follow-up period after the last administration.


Eligibility Criteria:
Inclusion Criteria:

1. Male, 12 to 70 years old at the time of signing informed consent (including the cut-off value), body weight ≥25 kg and BMI \<28 kg/m\^2 at screening;
2. The FVIII or FIX inhibitor test is positive at a high titer (≥5 BU/ml) during the screening period; or the FVIII or FIX inhibitor is detected at a low titer (0.6 BU/ml or the upper limit of normal value \< inhibitor titer \< 5 BU/ml) during the screening period and treatment with bypass agents (rFVIIa or PCC) has been started;
3. ≥6 treated bleeding episodes within 26 weeks before screening;
4. Have not used TFPI antibody drugs before;
5. Be able and agree to elute prior drugs for the treatment of hemophilia.

Exclusion Criteria:

1. Have serious or poorly controlled chronic diseases or obvious systemic diseases;
2. Have a history of thromboembolic disease, or currently have symptoms or signs related to thromboembolic disease or being treated with thrombolytic/antithrombotic therapy;
3. Have high-risk factors for thrombosis: such as a history of coronary atherosclerotic disease, ischemic disease of important organs, vascular occlusive disease, autoimmune diseases with a high risk of thrombosis, or indwelling central venous catheter;
4. The presence of other inherited or acquired bleeding disorders other than hemophilia A and hemophilia B;
5. Being on standard prophylaxis and maintaining it for more than 12 weeks (standard prophylaxis is defined as at least 80% compliance with a predetermined prophylaxis regimen);
6. Ongoing or planned Immune Tolerance Induction treatment;
7. When bleeding occurred in the past, rFVIIa was ineffective and PCC treatment must be used;
8. Known or suspected hypersensitivity to any constituent of the trial product or related products;
9. Have undergone major surgery (as determined by the investigator) within 3 months before screening, or have elective surgery planned during the study.