cyrilzakka/clinical-trials huggingface dataset:
Exploring Taiwanese Womens' Decision-making Regarding Vaginal Birth After Caesarean Section

The incidence of caesarean section (CS) has increased globally. Taiwan's statistics report a higher incidence of repeat CS compared to vaginal birth after caesarean (VBAC). This is concerning, as repeat CS are associated with increased maternal morbidity and mortality, and neonatal respiratory problems. VBAC is an approach which reduces the likelihood of such birth complications. However, there is limited information about Taiwanese women's decision regarding VBAC and their participation in decision-making. There is also a gap in literature about information for women about CS and VBAC.

Ajzen's Theory of Planned Behaviour will theoretically underpin the study. A qualitative descriptive design using purposive sampling of 20 Taiwanese pregnant women who have previously had a CS with a live baby will be recruited from Chang Gung Memorial Hospital in Taiwan. In-depth interviews will be carried out in three phases: (1) between 34 weeks to 38 weeks of women's pregnancy; (2) on the third day after childbirth; and (3) at the fourth week after birth, the end of confinement. Boyatzis' Data Driven approach will be adopted to thematically analyze the data.

Eligibility Criteria:
Inclusion Criteria:

* Have had a previous CS with a live baby
* Currently at 34 to 38 weeks of pregnancy
* Medically eligible for a VBAC
* Have chosen to have a natural birth
* 20 years old and over
* Able to converse in Mandarin and/or Taiwanese

Exclusion Criteria:

* Previous myomectomy
* Previous classical caesarean section
* Two previous caesarean section
* Pregnant with complications
Feasibility and Toxicity of Degarelix for Prostate Downsizing Prior to Permanent Seed Prostate Brachytherapy

This study will investigate the efficacy of Degarelix, a Luteinizing Hormone Releasing Hormone (LHRH) antagonist, to reduce prostate volume prior to permanent seed prostate brachytherapy. There are 2 eligible populations of men, all of whom will have selected brachytherapy as their treatment of choice for their prostate cancer. Either they have an enlarged prostate that requires size reduction to render brachytherapy technically feasible, or they require androgen ablation in conjunction with brachytherapy for optimal tumor control. The hypothesis is that Degarelix will provide \> 30% volume reduction by 3 months in \> 30% of men.

All men will have a baseline transrectal ultrasound for brachytherapy planning that has demonstrated an enlarged prostate with or without pubic arch obstruction. After signing the informed consent document they will have a loading dose of 240 mg Degarelix and then monthly maintenance dose injections of 80 mg until such time as sufficient prostate reduction has occured (2-3 months) or they complete the 6 months of required androgen ablation for their disease status.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of prostate cancer
* Favorable risk disease (cT1 or T2a, Gleason score (GS) 6, and Prostate Specific Antigen (PSA) \< 10 ng/mL)
* Low-tier intermediate risk disease (cT2c,GS=6,and PSA 10-15 ng/mL, OR GS=7 and PSA \< 10 ng/mL)
* Intermediate risk disease AND androgen deprivation therapy recommended by the treating physician for oncologic reasons such as (≥ 50% positive biopsy cores,cT2c,PSA 15-20 ng/mL,GS=7)
* Patient requires baseline planning trans-rectal ultrasound for the purposes of prostate brachytherapy, showing prostate volume \> 40 mL and pubic arch interference (not required for those requiring androgen ablation for oncologic reasons)

Exclusion Criteria:

* castrate serum testosterone level
* previous or concurrent pelvic radiotherapy
* unable to give written informed consent
* contraindications to permanent seed prostate brachytherapy or to androgen deprivation therapy
* prior treatment for prostate cancer
* prior trans-urethral resection of the prostate
* previous therapy with a 5-α reductase inhibitor, anti-androgen agent, or LHRH agonist
* previous therapy with degarelix
Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk Patients

Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation.

Uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists.

The investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (HBR) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.

For decades now, stroke prevention in patients with atrial fibrillation has largely consisted of chronic oral anticoagulation, often with no end in sight. This strategy, however, is associate with a high incidence of bleeding complications, especially when anticoagulation is associated with antiplatelet agents, as it occurs in patients with coronary artery disease undergoing percutaneous coronary intervention.

Known as intermittent, on demand, or 'pill in the pocket' anticoagulation, the strategy of prescribing oral anticoagulation only when is actually needed, has gotten a feasibility boost from recent advancements in both medical therapy and rhythm monitoring technology.

Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation.

Uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists.

The investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (HBR) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.

Eligibility Criteria:
Inclusion Criteria:

* No chronic atrial fibrillation
* Coronary artery disease
* Percutaneous coronary intervention

Exclusion Criteria:

* Contraindications to anticoagulation
* Pregnancy
EMST in Patients Undergoing CRT for HNCA

This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on maintenance of safe and efficient oropharyngeal swallow function in persons with cancer of the head and neck (HNCA) undergoing treatment with radiation therapy or chemoradiotherapy (RT/CRT).

Thirty (30) persons with newly-diagnosed HNCA who will be treated with RT/CRT will be randomized to an 8-week program of either Active Expiratory Muscle Strength Training (EMST) + Standard Care or Sham EMST + Standard Care in order to examine the impact of EMST on swallowing function. The training program will consist of 5 sets of 5 breaths, 5 days per week for 8 weeks, coincident with RT/CRT. Patients randomized to the Active EMST group will use the EMST150 (product name) expiratory muscle strength trainer according to package instructions. Those randomized to the Sham EMST group will use an EMST150 device that has been modified to eliminate resistance to airflow.

All subjects will be evaluated prior to initiation of cancer treatment (baseline assessment), 4 weeks into cancer treatment and again at the completion of cancer treatment (8 weeks after initiation of treatment). Assessment will include measurement of maximum expiratory pressure (MEP), a videofluoroscopic swallow study (VFSS) to objectively document swallow function, and administration of swallow-related quality of life (QOL) questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of cancer in the oral cavity, oropharynx, hypopharynx, or larynx;
* Planned treatment with primary radiotherapy with or without chemotherapy;
* Age 18 or older and able to provide consent;
* Ability to use the EMST150 device (hold in mouth and maintain lip seal)

Exclusion Criteria:

* Primary surgery to the head and neck (neck dissection is permitted);
* Unknown primary tumor;
* Primary cancers of the nasopharynx, paranasal sinuses, salivary glands and skin.
* Progressive neurologic condition affecting muscle strength (e.g. amyotrophic lateral sclerosis (ALS), Parkinson's disease)
* Dysphagia not related to HNCA (e.g. unresolved swallowing difficulty post-stroke or post--traumatic brain injury (TBI))
* Prior history of head and neck radiotherapy
Ticagrelor vs Clopidogrel Effect on MFR in CAD Population

Ticagrelor is one of 3 anti-platelet medications used in patients with acute coronary syndrome (ACS) to prevent further clot formation and further ischemic damage to myocardial tissue. Overall benefits of one drug over the other is neutral in this generally unstable population. In pre-clinical trials, ticagrelor showed secondary effects, involving the release of adenosine to heart muscle where the demand for blood was increased due to a stress condition. Blood flow was increased, potentially preventing potential damage.

This study will compare ticagrelor, currently only approved for use in ACS patients, against clopidogrel by measuring the myocardial blood flow(MBF) during stress to validate this phenomenon. The effect on blood flow will be measurable by using two specific doses of adenosine as the pharmacologic stress and correlating with measurements of blood flow using positron emission tomography (PET) nuclear imaging.

This study hypothesizes that the increase in MBF during intermediate dose adenosine infusion will be greater in ticagrelor treated subjects compared to clopidogrel treated subjects


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Stable coronary artery disease on stable medical treatment.
3. BMI equal to or less than 30 kg/m2
4. No clinically significant abnormalities in baseline laboratory work
5. No clinically significant arrhythmias on baseline 12-lead electrocardiogram
6. Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening and maintain effective contraceptive methods throughout the trial and for 7 days following the end of dosing treatment.

Exclusion Criteria:

1. Any contraindication against the use of clopidogrel, ticagrelor and/or ASA.
2. Oral anticoagulation therapy.
3. History of intracranial bleeding.
4. Recent or active pathological bleeding, such as peptic ulcer.
5. Moderate or severe hepatic impairment.
6. History or risk of bradycardia.
7. Known second- or third-degree AV block without pacemaker
8. Dyspnea (NYHA III/IV), wheezing asthma or COPD.
9. Coronary artery bypass graft (CABG) surgery within 90 days prior to screening or at any time after consent.
10. Percutaneous coronary intervention (PCI) within 90 days prior to screening or at any time following consent.
11. Acute myocardial infarction or acute coronary syndrome within 60 days prior to screening or at any time following consent.
12. Any scheduled surgery during the trial period, including dental.
13. Concomitant therapy with strong cytochrome CYP 3A inhibitor or inducer.
14. Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
15. Known hypersensitivity to the investigational drug or any of its components.
16. Known hypersensitivity to adenosine.
17. Lactose intolerance
18. Breastfeeding or pregnancy.
19. Claustrophobia or inability to lie still in a supine position
20. Unwillingness to provide informed consent
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)

The purpose of this study is to confirm that Ulinastatin is a safe and effective drug and it can reduce the incidence of postoperative hepatic failure in HCC patients. To evaluate that Ulinastatin can improve survival in HCC patients or not.

Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad, still shows a rising trend. Postoperative hepatic failure remains a major reason of liver resection's failure.

• As broad spectrum of enzyme inhibitors, Ulinastatin has the valid therapeutical effect of hepatic failure and hepatic ischemia-reperfusion injury in animal experiment. And it restrain inflammatory mediator to release. But it's lack of clinical evidence that Ulinastatin reduce the incidence of postoperative hepatic failure in HCC patients The purpose of the study is to assess the effort for comparing Ulinastatin's drug protection in patients with hepatocellular carcinoma (HCC) for postoperative hepatic failure and to evaluate that Ulinastatin can improve survival in HCC patients or not.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients \> 35 years and \<=55 years of age.
2. confirmed case (patients with HCC)
3. Tumors can be radical removed and resection volume was 50% to 70%.
4. Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
5. No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³.
6. Karnofsky Performance Score performance over 60.
7. Patients who can understand this trial and have signed information consent.

Exclusion Criteria:

1. Patients who have undergone previous treatment by Ulinastatin.
2. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.
3. Patients with other diseases which may affect the treatment mentioned here.
4. Patients with medical history of other malignant tumors.
5. Subjects participating in other clinical trials.
6. Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C.
7. Patients would not sign the consent to the trial.
An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)

The primary study objective is to evaluate the efficacy of Vayarin_005 on ASD related symptoms in children.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females, ages 6-17 inclusive
2. Must have a valid diagnosis of autism spectrum disorder via a clinical review of the DSM-IV, confirmed by Autism Diagnostic Observation Schedule (ADOS)
3. Clinical Global Impression Scale of Severity of Illness for Pervasive Developmental Disorders (CGI-S-PDD) rating of 4 or higher (moderately ill or worse)
4. IQ \>50 evaluated by KBIT-2 or Stanford Binet Fifth Edition
5. Able, and likely to fully comply with the study procedures and instructions
6. Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.
7. Have normal physical examination and laboratory test results at screening. If abnormal, the finding(s) must be deemed clinically insignificant by the study Clinician.
8. Parents or legal guardian must be able to read, write and speak English
9. Parents or legal guardian have given written informed consent to participate in the study

Exclusion Criteria:

1. The subject is significantly underweight under the 5th percentile or obese above the 95th percentile
2. Clinically significant systemic illness including hepatic, renal, gastroenterological, metabolic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease, as determined by the study clinician.
3. Patients with any primary psychiatric diagnosis other than autism at screening or a known genetic syndrome(s) that cause autism.
4. Suspected or established CNS injury
5. Change in dosage of psychiatric pharmacotherapy or other medications that have central nervous system effects or that affect performance 4 weeks before study initiation and throughout the study phase
6. Use of alpha-agonists, or ADHD medications 4 weeks prior to study initiation and throughout the study
7. Use of dietary supplements, 60 days before study initiation and throughout the study
8. Change in educational/behavioral interventions within one month prior to participation or during the study
9. A known comorbid psychiatric diagnoses of bipolar I disorder, suicidality, or substantial psychotic disorder.
10. Subject who has participated in another clinical trial within 30 days of screening for this trial and/or any experimental treatment for this population
11. Current history of physical, sexual, or emotional abuse
12. History of alcohol or substance abuse as defined by DSM-IV criteria
13. Consumption of \>250 mg/day of caffeine
14. History of allergic reactions or sensitivity to marine products and soy
15. Has any illness which may jeopardize the participants' health or limit their successful trial completion.
16. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending multiple doses in healthy adult male and female subjects. The secondary objectives are to characterize the PK and pharmacodynamic (PD) profiles of ONO-6950 by measuring plasma concentrations of ONO-6950 and pulmonary function.


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoking male or female subjects (18-55 inclusive)
* Body mass index (BMI)of 10-35 kg/m2 (inclusive)
* For females; postmenopausal, non-lactating, and non-pregnant

Exclusion Criteria:

* History or presence of clinical significant disease
Rocuronium Consumption in Etomidate-based and Propofol-based General Anesthesia Under Sevoflurane

Different concentration of sevoflurane was given to maintain anesthesia. The dose of propofol to maintain BIS between 40-60 and the consumption of rocuronium was recorded and evaluated.

2 age group of patients was selected, 40-60 years and above 60 years. Maintenance of anesthesia was carried out using different concentration of Sevoflurane, ie MAC 0.5, 0.75 and 1.0. Bis value was kept between 40-60 and the dose of propofol required was recorded. Rocuronium infusion given in a close loop infusion system for different group was tabulated. The results was then analysed.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 30
* elective Gynaecological/abdominal/urological surgery
* Operation time \< 3hrs
* ASA I/II
* Intubated patients

Exclusion Criteria:

* Coronary artery disease, cardiac, lung, hepatic and renal insufficiency
* Severe uncontrolled HBP
* Obesity (BMI \>30)
* Neuromuscular and metabolic diseases
* Receiving medication known to influence neuromuscular transmission
* Pregnancy
* Psychiatric disorders
* Allergy history to any of the drugs that will be used
Preoperative Corneal Thickness and Postoperative Visual Outcomes After Posterior Lamellar Corneal Transplant

To evaluate the impact of preoperative corneal thickness on visual outcomes following Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial keratoplasty (DMEK)

Patients underwent DSAEK or DMEK for endothelial dysfunction, from October 2013 to November 2016. Patients aged \> 18 years and with an indication for posterior lamellar graft surgery, such as Fuchs dystrophy, were included. Exclusion criteria included a history of penetrating keratoplasty in the study eye and a need for a penetrating keratoplasty following endothelial graft failure. Visual acuity, central corneal thickness (CCT) and graft thickness were measured preoperatively, and at postoperative day 7 and months 1, 3 and 6.

Eligibility Criteria:
Inclusion Criteria:

* Clinically indicated need for posterior lamellar graft surgery (DSAEK or DMEK) such as:

  * Fuchs dystrophy,
  * pseudophakic bullous decompensation
  * or other endothelial dysfunction corneal

Exclusion Criteria:

* were a history of penetrating keratoplasty in the indicated eye
* the technical inability of preoperative CCT measurement
* the need for a penetrating keratoplasty following endothelial graft failure
* severe postoperative complications resulting in unquantifiable visual acuity
Identification of Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of ADHD

The objective of this study is to identification of neuropsychological, genetic and neuroimaging markers and treatment response predictors of attention-deficit/hyperactivity disorder (ADHD). Participants who take the standardized pharmacotherapy (methylphenidate or atomoxetine) for ADHD will be observed for 52 weeks. They will do several neuropsychological, neuroimaging and genetic tests at visit 1\~6.


Eligibility Criteria:
Inclusion Criteria:

1. aged between 6 and 12 years
2. met the Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) diagnostic criteria for ADHD and needed pharmacotherapy.
3. Informed consent

Exclusion Criteria:

1. presence of intellectual disability or learning disorder
2. past and/or current history of bipolar disorder or psychosis or substance use disorder
3. past and/or current history of pervasive developmental disorder, organic mental disorder or other neurological disorder
4. presence of sever suicidal ideation
5. presence of tic disorder or obsessive-compulsive disorder whose symptoms needed pharmacotherapy
6. presence of family history with Tourette's Syndrome
7. took medication with methylphenidate or atomoxetine with last 6 month (or more than 3 month)
8. presence of severe medical condition (ex. cardiologic, liver, kidney, pulmonary, glaucoma)
9. took alpha 2 adrenergic receptor agonist, antidepressant, antipsychotics, benzodiazepine, modafinil, antiepileptic drug or dietary supplement that have a influence on Central Nervous System (CNS).
10. presence of possibility with pregnancy
11. especially for neuroimaging,

    1. uncooperative with claustrophobia or body movement
    2. metal material inside body that can't take off