cyrilzakka/clinical-trials huggingface dataset:
Neurally Adjusted Ventilatory Assist for Non Invasive Ventilation and Patient-ventilator Interaction

The present study aims to compare various parameters reflecting patient-ventilator synchrony during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory failure of various origin.

The present study aims to compare various parameters reflecting patient-ventilator synchrony during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory failure of various origin. The subgroup of COPD patients will be analyzed separately. The effects of various setting of Neurally adjusted ventilatory assist on patient-ventilator interaction will also be explored.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU and treated with Non invasive ventilation for acute respiratory failure of any origin

Exclusion Criteria:

* severe hypoxemia requiring an FIO2\>0.6
* hemodynamic instability
* known oesophageal problem
* active upper gastro-intestinal bleeding
* any other contraindication to the insertion of a naso-gastric tube
* impaired consciousness or absence of patient cooperation
* facial or laryngeal lesions contraindicating the use of NIV
* poor short term prognosis
Effects of Core Strengthening and PNF Pattern on Static Balance and Plantar Pressure in Chronic Stroke Patients

Stroke is a neurological disease characterized by neurological deficits caused by insufficiency of blood supply to brain. Disruption of blood supply to brain can be due to blockage of blood supply (ischemic) or leakage of blood in brain due to rupture of blood vessel (hemorrhagic). 90.5% of global occurrence of stroke was subjected to modifiable risk factors according to Global Burden of Disease study.

This study aims to compare the effects of core strengthening and proprioceptive neuromuscular facilitation on static standing balance and plantar pressure in chronic stroke patients.

Background: Stroke is a neurological disease characterized by neurological deficits caused by insufficiency of blood supply to brain. Disruption of blood supply to brain can be due to blockage of blood supply (ischemic) or leakage of blood in brain due to rupture of blood vessel (hemorrhagic). 90.5% of global occurrence of stroke was subjected to modifiable risk factors according to Global Burden of Disease study.

Objective: To compare the effects of core strengthening and proprioceptive neuromuscular facilitation on static standing balance and plantar pressure in chronic stroke patients.

Methodology: 73 patients were enrolled in this study, 37 patients were assigned into control group while 36 participants were assigned into experimental group. Control group received routine physical therapy while experimental group received core strengthening and proprioceptive neuromuscular technique. Static component of berg balance scale and PoData Stabiliometeric plate was used for plantar pressure and measurement of balance respectively.

Eligibility Criteria:
Inclusion Criteria:

* Age (45-60 years)
* Score of 9 or Higher on static component of berg balance scale
* Having score of equal or less than 2 on Modified Ashworth scale
* Having score of greater than or equal to 24 on Mini Mental State Examination.
* First ever episode of stroke
* Duration of stroke greater than 6 months
* Both genders

Exclusion Criteria:

* Concurrent orthopedic conditions that may hamper standing
* Relevant psychiatric disorders that may prevent from following instructions.
* Medical drugs that may influence intervention
* Conditions contraindicating physical activity
* Use of Cardiac pace maker.
Capnography in Neonates Ventilated With High Frequency Ventilation: Prospective, Observational Multi-Center Study

* This will be an observational study. Respiratory data will be recorded using Capnostream20p. There will be no use in the recorded data for the medical care of the patients. Other clinical data will be captured in the CRF. Similar study is currently conducted in Bnai Zion MC since 2008. Thirty four (34) patients have been recruited without any adverse events.
* During the study the medical team will capture in the CRF the following: Blood gas and distal capnography values at time of sampling, ventilator settings at time of sampling.
* Changes made in the ventilation parameters, blood gas time and results, concomitant treatment (e.g. suction) and concomitant medication (respiratory related e.g. surfactant), vital signs all these will be retrieved from the patient's medical charts.


Eligibility Criteria:
Inclusion Criteria:

* Intubated neonates with double-lumen ETT (Uncuffed Tracheal Tube, Mallinckrodt Inc., Chih, Mexico)
* Neonates that their respiratory condition requires HFV
* Neonates expected to have at least 3 pairs of distal capnography measurements and blood gas samplings.

Exclusion Criteria:

* Intubated neonates with single-lumen ETTs
* Neonates who are ventilated with conventional ventilation
* Any significant medical condition which, at the investigator's discretion, may interfere with the study.
Effect of Cabazitaxel on the QTc Interval in Cancer Patients

Primary Objective:

* To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patients

Secondary Objectives:

* To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction), and QTcN (population specific correction) intervals
* To assess the clinical safety of cabazitaxel
* To assess cabazitaxel plasma concentrations at Cycle 1 at early timepoints (during infusion and up to 5h post end of infusion)

The main period of the study consists of a maximum of 21-day screening phase, then first 2 treatment cycles with cabazitaxel. End of main period will be Cycle 3 or 30 days after last dose if patient discontinues study after 1 or 2 treatment cycles. The duration for a patient for the main period of the study will be about 9 to 10 weeks (screening, 2 cycles).

After Cycle 2, patients will have the option to continue to receive cabazitaxel and should be followed for safety reporting until 30 days after the last dose of cabazitaxel.

Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, and a treatment with a novel taxane agent is considered.

Exclusion criteria:

* Conditions with screening ECG repolarization difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: high degree AV block, pace-maker, atrial fibrillation or flutter
* QTcF \>480 msec on screening Electrocardiogram (ECG)
* Significant hypokalemia at screening (serum potassium \<3.5 mMol/L)
* Significant hypomagnesemia at screening (serum magnesium \<0.7 mMol/L) (Note: Patient may be enrolled after correction of these laboratory abnormalities)
* Patient receives (and cannot discontinue), or is scheduled to receive a QT-prolonging drug

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Psychometric Properties of the Chinese Version of the Five-item Relationship Satisfaction Scale

The aims of this study are to translate the five-item relationship satisfaction scale（RS5) into Chinese and assess its psychometric properties among Chinese patients.

This study will use forward translation, reverse translation, and comprehensive methods to translate the RS5 scale into Chinese ,which will be more in line with the Chinese language and cultural environment. This study will also verify its reliability and validity in a large sample population to form a formal version of the scale. The scale will provide an effective tool for evaluating the degree of relationship satisfaction in China.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old;
* Participants who are married or in a romantic relationship;
* Be able to read and communicate in Chinese.

Exclusion Criteria:

* Those who are unable to communicate due to serious mental or physical illnesses such as deafness, confusion caused by mental illness, etc.
Compare the Accuracy of MindTension Blink Eye Reflex Measuring Device to DANTAC Keypoint Electromyography (EMG) System.

A clinical study aimed to compare the accuracy and precision of the MindTension MT1 auditory evoked response parallel to an FDA cleared device (Natus DANTEC Keypoint).

Mindtension device measures the orbicularis muscle response to auditory stimuli, the device is backed up by an algorithm that calculates several parameters of startle reflex and startle related indices. In the present study we aim to test the validity, accuracy and precision of MT1 system compared to an FDA cleared device, the Natus DANTEC Keypoint EMG system (K944547).

The aim of this clinical trial is to demonstrate the accuracy and precision of the MT1 device to the FDA cleared Natus DANTEC Keypoint EMG system that is used in the EMG unit.

Participants (n=38) will be evaluated for eligibility of inclusion. As this is paired-group design study, patients will be randomized in a 1:1 ratio to group 1 (Right facial side with MT1 device), or group 2 (Right facial side Natus keypoint device), each patient will be tested using both devices at the same time. The test is 6 minutes in duration. The results will be compared within and between subject analysis.

Safety will be assessed through collection and analysis of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Subject's informed consent.
* Healthy subjects, with no known chronic disease.
* Both genders, age between 18-45.

Exclusion Criteria:

* Any current co-morbid Chronic illness.
* Hearing loss.
* Pregnancy.
* Substance abuse during the last 3 months.
* Lack of cooperation.
Determining the Effect of Telephone Counseling Service Provided to Primiparous Mothers on Postpartum Depression

The aim of this study is to determine the effect of telephone counseling services provided to primiparous mothers on postpartum depression.

Hypotheses H01; there is no difference between the postpartum depression score of the telephone counseling services group and the postpartum depression score of the control group.

The study will be carried out in two different groups. The practice will start with meeting the women who give birth will be visited by the researcher at the postpartum clinic at least 6 hours after normal birth and 12 hours after cesarean births.

After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

The researcher will contact the experimental group by phone. He will introduce herself and 6 weeks (during postpartum). It will provide the mother with the consultancy service she needs about herself and the newborn 24 hours a day. After 6 weeks, the training will end and the third researcher will make post-tests of the depression scale to both groups without knowing the experimental and control groups.


Eligibility Criteria:
Inclusion Criteria:

* primiparous women
* Agreeing to participate in the research and obtaining written permission,
* No hearing or vision problems

Exclusion Criteria:

* multiparous women
The Effects of Tiopronin on 3-Aminopropanal Level & Neurologic Outcome After Aneurysmal Subarachnoid Hemorrhage

The purpose of this phase II study is to further assess the safety of tiopronin in aneurysmal subarachnoid hemorrhage(aSAH) patients in order to obtain preliminary data on the efficacy of tiopronin versus placebo in reducing serum and cerebrospinal fluid (CSF) 3AP levels in this patient population.

Funding Source - FDA Office of Orphan Products Development

The annual rate of aSAH in United States is approximately 18 to 24 thousand cases each year. Mortality rates following aSAH range from 30-70% with 10-20% of survivors experiencing severe neurological disability. Following aSAH, a major cause of morbidity and mortality is vasospasm, which causes delayed ischemic neurologic deterioration. There is currently no effective treatment for preventing or ameliorating the damage that occurs following cerebral ischemia. A myriad of neuro-toxins are produced in the ischemic brain resulting in a vicious cycle of cellular death and destruction. The polyamines spermine and spermidine are metabolized by polyamine oxidase (PAO) into putrescine and 3-aminopropanal (3AP).

Tiopronin (Thiola) is an FDA approved drug used for the treatment of cystine stones in patients with cystinuria in the U.S. In Europe, it is also used for the treatment of rheumatoid arthritis and bronchial hypersecretion. In previous animal studies, we demonstrated that tiopronin is able to bind and neutralize the toxic effects of 3AP. We have shown in previous studies that aSAH patients have elevated 3AP levels, and higher levels correlate to a poor neurologic outcome.

The goals of this phase II multicenter, randomized, double-blinded safety and efficacy trial are to (1) further evaluate the safety of the drug in our patient population at the dose established in phase I; (2) demonstrate that tiopronin crosses the blood-brain barrier; (3) show that both serum and CSF 3AP levels are reduced by administration of tiopronin; and (4) demonstrate that a reduction in 3AP levels is associated with improved neurologic outcome in aSAH patients.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to a recruiting center with aneurysmal subarachnoid hemorrhage
* Ability to initiate study drug treatment within 96 hours of aSAH onset.
* Ability to provide either informed or surrogate consent

Exclusion Criteria:

* Hypersensitivity to penicillamine
* Creatinine level greater than 1.5/mm\^3 on admission
* Platelet count of less than 100,000/mm\^3 on admission
* White blood cell count of less than 3.5/mm\^3 on admission
* AST or ALT of greater than 60/L on admission or history of liver failure
* Pregnancy
* History of lupus, Goodpasture's syndrome, myasthenia gravis, pemphigus, nephrotic syndrome, glomerulonephritis, or renal failure
* Patients considered unable to comply with the protocol
Silver-Coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)

The purpose of this study is to determine if the use of a silver-coated endotracheal tube (ETT) can reduce the incidence and/or delay the time of onset of VAP when compared to a non silver-coated ETT in patients who have been mechanically ventilated for \>= 24 hours.

Nosocomial pneumonia is the leading cause of death from hospital-acquired infections.Ventilator associated pneumonia (VAP) develops in a significant percentage of patients who have been ventilated for at least 48 hours, and is associated with high morbidity, mortality,and financial costs. Silver is a well-characterized antimicrobial agent, and is the active agent in multiple medical products used to reduce or control infection. Bard has developed a proprietary antimicrobial ETT, manufactured with a hydrophilic coating containing a fine dispersion of silver salts.

This study compare the incidence and time to onset of VAP in patients intubated for \>=24 hours with a proprietary silver-coated ETT versus those intubated for \>= 24 hours with a standard non-coated ETT.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* expected to be intubated for at least 24 hours
* able to sign Informed Consent

Exclusion Criteria:

* symptoms of bronchiectasis
* severe hemoptysis
* history of cystic fibrosis
* intubated \> 12 hours within previous 30 days
* pregnancy
* participating in a competing trial
Incidence, Long- Term Outcome and Factor Related to Non- Cardiac Postoperative Delirium in Elderly Patients

The purpose of this study is to determine the incidence, long term outcome and factor related to postoperative delirium in elderly patients after non-cardiac surgery.

The investigators have process of quality assurance for the study including data dictionary, data verification of case record form and site monitoring and auditing.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/ 60 years
* American Society of Anesthesiologists (ASA) physical status 1-3
* Undergoing scheduled surgery
* Giving an informed consent

Exclusion Criteria:

* Impaired visual and auditory disturbance
* Cannot communicate with Thai language
* Undergoing neurosurgery
Study of Nicotine for the Prevention of PONV

The purpose of this study is to determine whether nicotine is effective in the prevention of nausea and vomiting in non-smokers undergoing surgery


Eligibility Criteria:
Inclusion Criteria:

* Adults (18-80 years)
* ASA I-II, non-smokers (or ex-smokers who have not been smoking for more than 2 years)
* Undergoing elective surgery (ENT, abdominal, urological, gynaecological); and
* Consenting to take part in the study will be included.

Exclusion Criteria:

* Smokers (cigarette, pipe, cigar)
* Patients undergoing nicotine replacement therapy
* Prolonged postoperative intubation
* Postoperative nasogastric tube
Effect of NMN (Nicotinamide Mononucleotide) on Diminished Ovarian Reserve (Including Premature Ovarian Insufficiency)

The purpose of the study is to understand the effect of nicotinamide mononucleotide (NMN) on patients with diminished ovarian reserve (including premature ovarian insufficiency).

This study aims to evaluate the effects of NMN on reproductive endocrine, immune homeostasis, and reproductive outcomes in women with DOR (including POI), and to explore its underlying mechanisms to provide the intervention strategies for DOR (including POI).

Eligibility Criteria:
Inclusion Criteria:

1. Individuals who are 20 to 40 years old.
2. The concentrations of anti-Mullerian hormone \< 1.1 ng/ml, the values of antral follicle count range from less than 5 to less than 7 and two recordings of serum concentrations of day-3 follicle-stimulating hormone (FSH) ≥10 IU/L.
3. Individuals who can insist on continuous monitoring in the outpatient clinic.
4. Individuals who are not participating in other research projects currently or 3 months before the intervention.

Exclusion Criteria:

1. Individuals who are during pregnant, lactation or menopause.
2. Individuals who had non-46-XX karyotype, or attributed to known genetic etiology.
3. Individuals who had pelvic surgery.
4. Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years.
5. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
6. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
7. Use of medications or traditional Chinese medicine that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 3 months.
8. Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation, or other supplementation such as coenzyme Q10, vitamin E currently or within the past 3 months.
9. Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3 months.
10. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
11. A medical history of severe cardiovascular and cerebrovascular diseases.
12. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
13. Individuals who drink more than 15g of alcohol per day or have a smoking habit.
14. Individuals who need drug treatment for any mental illness such as epilepsy and depression.
15. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.
16. Unable or unwilling to follow the study protocol.
Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery

This phase II clinical trial studies how well soy isoflavones work in preventing head and neck cancer in patients with stage I-IV head and neck cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones may prevent head and neck cancer recurrence.

PRIMARY OBJECTIVES:

I. To determine if short term, preoperative (300 mg/day x 14 treatment days) soy isoflavone supplementation modulates p16 methylation (% CpG sites methylated) and expression of p16, cyclooxygenase 2 \[COX-2\], vascular endothelial growth factor receptor \[VEGF\], epidermal growth factor receptor \[EGFR\], interleukin-6 \[IL6\], p53 and B-cell lymphoma-extra large \[Bcl-xL\] in tumor and non-tumor adjacent mucosa of patients with head and neck squamous carcinoma undergoing curative tumor resection.

II. To estimate correlations of tumor p16 methylation (% CpG sites methylated) with expression of p16 and levels of, IL6, VEGF, and 15-F2t-isoprostane in serum and saliva.

SECONDARY OBJECTIVES:

I. Describe the toxicity of short-term, preoperative treatment with soy isoflavone.

II. To determine overall and relapse-free survival.

OUTLINE:

Patients receive soy isoflavones orally (PO) for approximately 14 days before undergoing surgery.

After completion of treatment, patients are followed up, within the routine cancer management schedule, at 3, 6, 12, and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have pathologically-confirmed, resectable, squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
* Disease must be Stage I, II, III or IVa
* Tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
* Patients must give documented informed consent to participate in this study

Exclusion Criteria:

* Documented evidence of distant metastases
* Ongoing acute medical condition such as uncontrolled coronary artery disease, emphysema, or diabetes mellitus that would preclude surgical resection
* Pregnancy or lactation; patients of child bearing age must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of soy administration
* A medical or psychiatric illness which would compromise the patient's ability to tolerate this treatment or comply with administration of study drug
* Patients residing in prison
* Any patient with a history of breast or ovarian cancer
* Allergy to soy products