cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Atenativ in Patients with Congenital Antithrombin Deficiency Undergoing Surgery or Delivery

Assess the incidence of the composite of thrombotic events (TEs) and thromboembolic events (TEEs) in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition.


Eligibility Criteria:
Inclusion Criteria:

1. Adult male or female patients ≥18 and ≤80 years of age. Solely in the US, 4 male or female patients between ≥12 and \<17 years of age will be enrolled into the PK phase, and the treatment phase, if needed
2. Level of antithrombin ≤60%
3. Personal or family history of TEs or TEEs
4. For the Treatment Phase: either a) non-pregnant surgical patients scheduled for elective surgical procedure(s) known to be associated with a high risk for occurrence of TEs or TEEs, or b) pregnant patients of at least 27 weeks gestational age who are scheduled for caesarean section or delivery
5. For female patients of childbearing potential entering the PK Phase who are not known to be pregnant, and for female surgical patients of childbearing potential entering the Treatment Phase for any procedure other than caesarean section or delivery, a negative urine pregnancy test at screening and at baseline
6. Patient has provided informed consent

Exclusion Criteria:

1. Requires emergency surgery or emergency caesarean section
2. Has undergone surgery within the last 6 weeks
3. History or suspicion of another hereditary thrombophilic disorder other than antithrombin deficiency (e.g., activated protein C \[APC\] resistance/Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation \[G20210A\], or acquired \[lupus anticoagulant\] thrombophilic disorder)
4. Malignancies, renal failure, or severe liver disease (aspartate aminotransferase \[ASAT\] \>5 times the upper limit of normal)
5. Body mass index \>40 kg/m2 (for non-pregnant patients, only)
6. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ
7. History of anaphylactic reaction(s) to blood or blood components
8. Refusal to receive transfusion of blood-derived products
9. Administration of any antithrombin concentrate or antithrombin-containing blood product other than the study medication within 14 days of either of the two phases of the study
10. Prior diagnosis of heparin-induced thrombocytopenia
11. TE or TEE within the last 6 months
12. Female patients who are nursing
13. Have participated in another investigational study within the last 30 days
Peripheral Nerve Stimulation to Reduce Hypoxic Events

This study is designed to determine if using peripheral nerve stimulation in conjunction with pulse oximetry as an adjunct to traditional monitoring in the PACU reduces the frequency and severity of sedation related apnea and hypoxic events.

The primary effectiveness objective is to determine if transcutaneous stimulation will generate a respiratory response capable of reducing the extent and duration of oxygen desaturations in patients with presumed risk of obstructive sleep apnea (OSA) who have received some form of anesthesia or sedation. The primary safety objective is the demonstration that the peripheral nerve stimulation is safe for the use of preventing or reducing the sedation related hypoxemic events.

Eligibility Criteria:
Inclusion Criteria

* Males and females \> 18 yrs old
* Flemon's Score \> 15
* Able to provide written informed consent
* Having gynecological, colorectal, orthopedic surgery, and urologic surgeries
* Baseline oxygen saturation on room air \> 96%

Exclusion Criteria:

* Peripheral neuropathy involving the upper extremities
* Procedures requiring direct admission to the ICU or any site other than the post-anesthesia care unit from the OR
* Diagnosed obstructive sleep apnea (OSA) and / or use of continuous positive airway pressure (CPAP) or biphasic positive airway pressure (BiPAP) in the PACU.
* Presence of any implantable electric devices, including internal defibrillators, pacemakers, or left ventricular assist device (LVAD)
* Post-procedure temperature \< 35.5 Celsius or evidence of vasoconstriction
* Presence of metal hardware in either arm or in either shoulder
* Patients lacking access to the bare skin on an arm after surgery.
* History of atrial fibrillation
* History of bundle branch block
* Females from menarche to menopause that do not have a current negative pregnancy test or surgical history preventing pregnancy.
Effect of Dianatal Obstetric Gel (Cross-linked Polyacrylic Acid) on Outcomes in Vaginal Delivery

Perineal massage at the end of labor stage 2 has been investigated in 2 randomized controlled trials using a water soluble lubricant. In one trial a significant reduction of labor stage 2 has been found, both trials did not show a significant increase of perineum integrity.

In the HCB Swiss Study both a significant reduction of labor stage 2 by 30 % as well as a significant increase of perineal integrity have been shown. No adverse events have been reported.

(see also Obstetric gel shortens second stage of labor and prevents perineal trauma in nulliparous women: a randomized controlled trial on labor facilitation. Schaub AF, Litschgi M, Hoesli I, Holzgreve W, Bleul U, Geissbuhler V. J Perinat Med 2008; 36 (2): 129-135).

Today's practice- Lubricants are widely used to enable manual vaginal examination during labor. In Israel midwifes are using Almond Oil for perineal massage at the end of labor stage 2 to protect the perineum. It has been shown for the first time that the use of the Dianatal Obstetric Gel facilitates vaginal childbirth in humans. Dianatal has been introduced to the EU markets in 2008.


Eligibility Criteria:
Inclusion Criteria:

* Maternal age between 18 and 40 years
* signed written informed consent,
* intention for vaginal delivery,
* nulliparous state or multiparous state
* singleton baby in vertex presentation
* estimated birth weight between 1500 g and 4500 g
* low risk pregnancies at term and late preterm (34 to 42weeks of gestational age)

Exclusion Criteria:

* contraindications for vaginal delivery
* indications for an amnion infection syndrome
* suspect for fetal malformations
* indications for cephalopelvic disproportion
* severe concomitant diseases of the mother
To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg

To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Nitrous Oxide Versus Intravenous Sedation for Anesthesia

This study is a multi-site, double-blinded, randomized, non-inferiority clinical trial of inhaled nitrous oxide with oxygen (N2O/O2) versus intravenous (IV) sedation, with fentanyl and midazolam, for pain management in adult women having a pregnancy termination procedure between 12 and 16 weeks gestational age.

This study will evaluate whether nitrous oxide is a feasible and acceptable alternative to IV sedation for pain management during early second trimester D\&E. Primary endpoints will include maximum procedural pain using the visual analog scale (VAS) as well as satisfaction with anesthesia using the Iowa Satisfaction with Anesthesia Scale.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* pregnancy termination at gestational age of 12-16 weeks
* able to read and understand either English or Spanish
* able to obtain reliable post-procedure transportation

Exclusion Criteria:

* contraindications to outpatient pregnancy termination
* contraindications to nitrous oxide use (such as pernicious anemia, current treatment with bleomycin chemotherapy, active upper respiratory illness, or COPD)
* intrauterine fetal demise
* chronic narcotic use
* known adverse reaction to nitrous oxide, Fentanyl, or Versed
Citrate Versus Heparin in Continuous Renal Replacement Therapy :

This study is a prospective, multicenter, open-label randomized trial comparing regional citrate anticoagulation (RCA) with heparin-free protocol. The function mode was continuous venovenous hemodiafiltration (CVVHDF) in post-dilution mode. The investigators measured hemodynamic changes at certain time points after starting CRRT (0, 6, 12, 24, 48, 72 hr).Levels of inflammatory cytokine (IL-1β, IL-6, IL-8, IL-10 and TNF-ɑ) were measured at day 1 and day 3

Twenty patients were randomized into heparin group and 11 patients were in citrate group. The cardiac performance were not significantly different between 2 groups at every time point. The inflammatory cytokines declined similarly in both treatment arms. The maximum filter survivial time was longer in a RCA group but not reach statistically significant (44.64±26.56 hr vs p=0.693 in citrate and heparin free group respectively).There was no serious side effects dung both treatment arm even in the group of liver dysfunction patients.

Eligibility Criteria:
Inclusion Criteria:

* need for CRRT,
* no contraindication to CRRT

Exclusion Criteria:

* patients with previous history of chronic kidney disease (CKD) (baseline serum creatinine \> 2 mg/dL (male) or \> 1.5 mg/dL (female)
* history of renal transplantation
* known pregnancy
* previous dialysis within 30 days
* severe liver disease
* end stage heart disease or untreatable malignancy
* moribund patients with expected survival less than 30 days
* previous use of heparin or other anticoagulant, antiplatelet within 7 day except use for deep vein thrombosis
* active bleeding at the time of enrollment and/or severe coagulopathy
* receiving blood or blood components prior to enrollment
* hemoglobin less than 7.5 g/dL and/or platelet count less than 100,000/mm3
* previous underlying clotting disorders such as hypercoagulable state
* severe malnutrition (Body mass index (BMI ) less than 18)
* underwent CRRT for other reasons besides acute kidney injury (AKI)
ANGIOLITE PMCF Study ( rEPIC04F )

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Angiolite sirolimus eluting stent to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Angiolite sirolimus eluting stent.

The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Angiolite Sirolimus Eluting Stent in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with ANGIOLITE according to routine hospital practice and following instructions for use
* Informed consent signed

Exclusion Criteria:

• Not meet inclusion criteria
Validity and Reliability in Measuring the Subacromial Space by Using Ultrasound

To investigate validity and reliability in measuring the subacrominal space by using ultrasound


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects age range 19-35 years

Exclusion Criteria:

* With any pain in the upper extremities and back
A Multi-center 12-week Study of HMS5552 in T2DM

This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type 2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will receive placebo.

Glucokinase (GK, also called hexokinase IV or D) can phosphosphorylate glucose to glucose-6-phosphate (G-6-P) in pancreatic β-cells and liver cells, which represents the first step of glucose metabolism. GK also acts as a glucose sensor and exerts a key role in maintaining glucose homeostasis. HMS5552 is a 4th-generation GK agonist or activator (GKA), which was originally licensed from Roche and subsequently developed by Hua Medicine. HMS5552 has been shown to activate GK in pancreatic beta cells, liver and intestinal epithelial cells. It regulates systemic blood glucose through a variety of mechanisms including directly enhancing insulin release (pancreas), inhibiting production of endogenous glucose (liver) and by indirectly promoting GLP-1 release (enteroendocrine L-cells).

Eligibility Criteria:
Inclusion Criteria:

1. Male \& female, 40\~75 years old
2. T2DM patients，anti-hyperglycemic drug-naïve and on diet \& exercise for at least 3 months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone
3. HbA1c 7.5\~10.5% at screening and pre-randomization
4. Fasting plasma glucose (FPG)7.0\~11.1 millimole/liter (mmol/L, local lab) at screening, and 7.0\~13.3 millimole/liter (mmol/L, central lab) at pre-randomization
5. BMI: 19\~30kg/m\^2 \& TG\<5.5mmol/L

Exclusion Criteria:

1. T1D，secondary DM, pre-DM
2. kidney diseases or eGFR MDRD\<60ml/min/1.73m\^2
3. unstable CVDs
4. liver diseases
5. mental or CNS diseases
Use of CO2 Detectors to Help Provide Effective Breaths During Resuscitation of Preterm Newborns

Effective ventilation is the single most vital intervention to improve outcome of resuscitation in the neonatal population. Assessments of effective ventilations are based on clinical parameters, but may be difficult due to inexperienced personnel as well as observer variability. End tidal CO2 detectors (ETCO2) have been shown to improve effective ventilation in manikin model as well as in video recordings of selective infants where obstructive breaths were recognized objectively by means of lack of colour change.

This is a trial evaluating the use of a qualitative end tidal CO2 monitor device during mask ventilation in the delivery room. The investigators hypothesize that using a colorimetric carbon dioxide detector during mask ventilation, it could facilitate recognition of obstructed breaths and reduce the duration of bradycardia and desaturations.


Eligibility Criteria:
Inclusion Criteria:

Preterm infants 24+0/7 to 32+0/7 weeks who require mask ventilation during resuscitation

Exclusion Criteria:

1. Infants with impaired pulmonary circulation (eg. Cardiac arrest, pulmonary atresia, severe pulmonary stenosis
2. Infants with congenital airway anomalies
A Multi-center, Randomized, Subject Blind, Active Controlled Design Clinical Study to Evaluate the Efficacy and Safety of Volus as Compared to PowerFill® for Temporary Penile Enhancement

The purpose of this study is to evaluate non-inferial study of the after using Volus application, compared to the powerfill.


Eligibility Criteria:
Inclusion Criteria:

1. Male subjects aged above 20 and below 65. (20≤male≥65)
2. be rating himself, when screening, as "Small or Very Small" on Self-Questioned Questionnaire ( SQQ) including the question: " How do you rate your penile size? // Very small, Small, Normal, Big, Very Big?"
3. During the study period, subjects will not received any treatments associated with penile enhancement.
4. Subjects will sign an informed consent form

Exclusion Criteria:

1. Prior treatment for penile enhancement (e.g. fat, dermal graft).
2. Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention
3. Allergic to hyalluronic acid.
4. Inflammatory or/and infectious disease on penis that can affect on this study
Does Use of Rapid Response EEG Impact Clinical Decision Making

This study is designed as a prospective, non-randomized, observational, multicenter clinical trial. The primary aim of this study is to observe if the use of the rapid responds electroencephalography (EEG) system impacts physician decision making. Secondary aims include exploring the safety and performance information of the Ceribell EEG system compared to conventional EEG system. The study will recruit physicians (Faculty physicians and Trainees) at up to five institutions and examine the impact of rapid response EEG when providing care to patients in whom EEG recording has been ordered for clinical reasons.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing clinically ordered EEGs.

Exclusion Criteria:

* None
Bioequivalence Study of Methacholine for Inhalation (pharmacodynamics)

This trial was divided into two parts. This is the scecond part. The second part is the pharmacodynamic equivalence study of patients, which is a single-dose, randomized, open, two-cycle, two-sequence crossover design, and plans to enroll 40 subjects.


Eligibility Criteria:
Inclusion Criteria:

1. adults 18 years old ≤ age ≤65 years old, gender is not limited.
2. Lung function test FEV1≥70% of the predicted value, and FEV1/FVC≥0.7. 3. Patients with clinically diagnosed asthma or others willing to accept bronchial stimulation test.

4. Patients who use contraindicated drugs (β2 adrenergic receptor agonists, anticholinergics, oral bronchodilators, antihistamines, leukotriene receptor antagonists) may be discontinued during the prescribed period prior to airway reactivity examination.

5, voluntary enrollment, signed informed consent, compliance is good, can cooperate with the test observation.

Exclusion Criteria:

1. there is a history of allergy to this reagent.
2. Patients with a history of heart disease who have difficulty tolerating bronchial provocation tests.
3. Patients who had received thoracic or abdominal surgery within 6 months before the trial.
4. Patients who had undergone surgery for intracranial, eye, ear, nose and throat, and respiratory diseases within 6 months before the trial.
5. Patients with respiratory diseases such as pneumothorax or infectious diseases such as tuberculosis.
6. Patients with diseases that may be affected by the use of cholinergic drugs (epilepsy, bradycardia, coronary artery occlusion, vagus nerve tension, thyroid disease, arrhythmia, peptic ulcer, urinary tract disorders, etc.).
7. Patients with a history of drug dependence or alcohol dependence.
8. Severe circulatory system diseases, liver and bile system diseases, digestive tract diseases, urinary system diseases, kidney diseases, blood diseases, endocrine system diseases, immune system diseases, malignant tumors, etc.
9. Patients who are taking cholinase inhibitors (for myasthenia gravis).
10. Patients with unexplained urticaria.
11. Pregnant and lactating women.
12. The subjects had dyspnea, wheezing or wheezing on the test day.
13. have myocardial infarction or stroke, combined with hypertension (systolic blood pressure \>200mmHg, diastolic blood pressure \>100mmHg) patients.
14. Poor coordination of basic lung function examination and failure to meet quality control.
15. Patients who have used drugs that affect airway contractile function and airway inflammation before the trial and can not be stopped (bronchodilators, glucocorticoids, antiallergens and triene receptor antagonists, etc.).
16. Current smokers, those who had quit smoking for less than one year at the time of screening, and those who had a smoking history of more than 10 pack-years.
17. Patients admitted to hospital for exacerbation of asthma within 12 weeks.
18. combined with patients with respiratory diseases (such as COPD) that may affect the efficacy and safety evaluation of the drug.
19. Researchers believe that there are any cases that are not suitable for inclusion.
Effect of Stellate Ganglion Block on Meniere's Disease

Stellate ganglion block (SGB) has been the alternative treatment of Meniere's disease for years. However, objective evidence of the effect of SGB was still lack. The investigators conducted a randomized controlled study to examine the immediate effects of SGB in SP/AP of electrocochleography (ECoG).

Ten patients were randomly assigned to receive stellate ganglion block. These ten patients made up the experimental group. Another ten patients in the control group were assigned to receiving one dosage of oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with unilateral Meniere's disease, according to the criteria of the American Academy of Otolaryngology-Head and Neck Surgery, AAO-HNS (1995)

Exclusion Criteria:

* patients with coagulopathy,
* arrhythmia,
* myocardial ischemia,
* glaucoma,
* pregnant,
* chronic otitis media or externa, and
* past history of middle or inner ear surgery were excluded.
Sonographic Venous Doppler Imaging in Acute Kidney Injury

The first presentations of patients with acute kidney injury (AKI) are usually to the emergency departments. While the mortality rate is 5-10% in uncomplicated AKI, it is between 40-90% in patients hospitalized in the intensive care unit. Therefore early diagnosis and treatment of AKI in the emergency department is important in terms of morbidity and mortality.

Sonographic evaluation of the venous system (hepatic, portal and renal vein) may be useful for diagnosis. Studies conducted so far have generally been based on predicting cardiorenal AKI and renal poor outcomes and have been designed in general ICU conditions.

In this study, the investigators aimed to determine the diagnostic value of sonographic venous Doppler imaging in terms of distinguishing subgroups of AKI in patients presented to the emergency department with AKI.


Eligibility Criteria:
Inclusion Criteria:

* AKI diagnosis

Exclusion Criteria:

Patients

* with end-stage renal failure (stage 4),
* who received 500 mL IV fluid or 40 mg diuretics,
* who are pregnant,
* with renal transplantation,
* with cirrhosis and liver malignancy,
* with postrenal AKI,
* who were referred from another center after starting treatment,
* who do not give consent for the study.
Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics in Patients With Mitochondrial Myopathy

This is a developmental protocol to determine the MRI based 31P-MRS changes seen in subjects with mitochondrial myopathy using our dynamic exercise protocol and to identify the ideal variable(s) to represent mitochondrial function.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women ≥ age 18 years old with primary mitochondrial myopathy
2. Known alteration in electron transport chain activity (\<25 % activity of ETC) or known mutations in mitochondrial gene.

Exclusion Criteria:

Failure based on standard clinical MRI Screening form - the form is intended to establish the safety of subjects participating in the MRI scan without divulging any confidentiality information -