cyrilzakka/clinical-trials huggingface dataset:
The Correlation Between the Barium Examination and High Resolution Impedance Manometry

In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic swallowing studies. High resolution impedance manometry could help us to measure the bolus flow according to the impedance changes. However, the comparison between two approach methods of postoperative recovery of swallowing function is still inconclusive. In this study, we aimed to examine the correlation between high-resolution manometric and videofluoroscopic (Barium) measurements of the swallowing function.

In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic swallowing studies. High resolution impedance manometry (HRIM) could help us to measure the bolus flow according to the impedance changes. However, the comparison between two approach methods of postoperative recovery of swallowing function is still inconclusive.

In this study, we aimed to examine the correlation between high-resolution manometric and videofluoroscopic (Barium) measurements of the swallowing function.

For the patients and method decription, consecutive patients who will fulfill the criteria of elective esophagectomy patients aged \>= 20 will be enrolled. After got the inform consent, these patients receive the swallowing function by barium examination and HRIM.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving elective esopagectomy

Exclusion Criteria:

* patients with major organ disease, such as heart, lung, or liver disease
* patients with coagulopathy
Influence of a Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) on Embryonic Aneuploidy Rate and Developmental Potential

A single centre randomised controlled trial investigating the influence of a novel prematuration system (PMS) using a phosphodiesterase-3 inhibitor for in-vitro maturation of oocytes - pilot study.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers, either with PCOS/PCOS-like ovaries, or with normal ovaries, who undergo oocyte donation for research
* AFC at least 10
* AMH: \> 5 μg/L
* Female age \< 36 years

Exclusion Criteria:

* major uterine or ovarian abnormalities
A Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial

The purpose of this study is to provide access to continued treatment for subjects who participated in other Astellas sponsored trials and for whom the investigator feels the subject may benefit from continued treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subject must currently be participating in an Astellas sponsored linsitinib trial that has ended with respect to the overall study analysis.
* Subject must not have met criteria for discontinuation or have progressed on the current linsitinib study in which they are participating.
* Subject must be deriving benefit from continued treatment.
Duodenal Exclusion for the Treatment of T2DM

Evaluation of duodenal exclusion procedure for the treatment of T2DM


Eligibility Criteria:
Inclusion Criteria:

1. Age between 20 and 65 years
2. BMI between 23 and 34
3. Oral agents or insulin to control T2DM
4. Inadequate control of diabetes as defined as HbA1c \>/ 7.5
5. Understanding of the mechanisms of action of the treatment

Exclusion Criteria:

1. More than 10 years of T2DM diagnosis
2. More than 7 years of insulin use
3. Previous abdominal operations
4. Coagulopathy
5. Liver cirrhosis
6. Unable to comply with study requirements, follow-up schedule or give valid consent.
7. Currently pregnant.
Newcastle Disease Virus (NDV) for Cancer Patients Resistant to Conventional Anti-cancer Modalities

NDV is a virus tht is harmful in chicken, but harmless in man. There are 2 major sub-strains of NDV, one oncolytic and one non-oncolytic. Oncolytic NDV (MTH-68H) preferentially homes and replicates in cancer cells and therefore, administration of NDV intravenously or preferentially intra-tumor, either by direct injection or by injection into an afferent artery results in direct lysis of tumor cells. NDV activates apoptotic mechanism in cancer cells and thus, results in natural cell death.

Both oncolytic and non-oncolytic NDV were used clinically in hundreds of patients with different types of cancer worldwide. NDV were proved harmless in man. Clinical studies were done for more than a decade and the efficacy of NDV was documented on pre-clinical animals models as well as in man.

For a large number of patients with metastatic cancer and chemotherapy resistant hematological malignances, no cure can be provided by conventional anti-cancer modalities, new treatment options are urgently indicated. The goal of the study is to use NDV, in order to provide such treatment for patients in need.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the following disease category will be eligible:

Patients with metastatic lung cancer, metastatic GI cancer, metastatic urogenital cancer, skin and soft tissue cancer.

* Failure to anti-cancer modalties and evidence of progressive disease despite optimal application of all relevant available anti-cancer modalities.
* Consenting patients.
* The patient should sign a consent form stating that he/she will make sure to avoid any contact with chicken or any other species of birds.

Exclusion Criteria:

* Not fulfilling any of the above criteria.
* Moribund patients or patients with life-expectancy \<3 months.
* Karnofsky performance status \<60%.
* Pregnant or lactating women.
* Active local or systemic infections requiring treatment.
* Co-morbidity or life-threatening clinical condtion other than the basic cancer.
Water and Land-based Aerobic Training in Breast Cancer Survivors

Background: Breast cancer is the type of cancer that mostly affects women in the world. Although physical and psychological side effects accompany cancer and the aggressiveness of the treatment, regular practice of physical exercise is considered a non-pharmacological tool to improve the quality of life of breast cancer survivors. The present study aims to evaluate the effects of aerobic training programs in aquatic and land environments plus a health education program, compared with a health education program alone, on cancer-related fatigue and other health-related outcomes in breast cancer survivors.

Methods: The WaterMama trial is a randomized, single-blinded, three-arm, parallel, superiority trial. Forty-eight women, ≥18 years of age, who have completed primary treatment and been diagnosed with stage I-III breast cancer are recruited. Participants are randomly allocated on a 1:1:1 ratio to 12-week interventions of aerobic exercise training programs either on the aquatic or land environment two times per week plus health education, or an active-control group receiving health education intervention, once a week. Cancer-related fatigue (primary outcome), physical fitness (i.e., muscle strength of the knee extensors, muscle thickness and muscle quality of quadriceps, resting heart rate, maximum oxygen consumption, and performance in functional tests), mental health (i.e., depressive and anxiety symptoms), cognitive function, pain and quality of life are measured before and after 12 weeks of intervention. The analysis plan will use an intention-to-treat approach and protocol criteria.

Discussion: The conceptual hypothesis is that both training programs plus health education positively affect cancer-related fatigue, physical fitness, mental health, cognitive function, pain, and quality of life compared to the health education group alone. Additionally, it is expected that the aquatic program plus health education to provide more significant effects on cancer-related fatigue and physical parameters due to its multi-component character, with a consequent greater positive impact on other investigated parameters in this group.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with stage I-III breast cancer;
* Aged ≥ 18 years old;
* Have completed primary treatment for breast cancer (including surgery, chemotherapy, and/or radiotherapy) for at least six months and at most 12 months before the start of the intervention, regardless to be or not on hormonal treatment;
* Willingness to participate in either intervention group, as well as not to have a fear of the aquatic environment.

Exclusion Criteria:

* Presence of serious orthopedic, cardiovascular, or cardiopulmonary conditions that limit physical exercise participation;
* Major psychiatric or cognitive disorders;
* Active metastatic or locoregional disease;
* Severe nausea, anorexia, or another condition that makes it impossible to participate in the exercise;
* Engagement in regular exercise for more than 75 min weekly.
* Or were otherwise not cleared by their oncologist.
T1rho Imaging of Liver in Presence of Iron

Liver T1rho is elevated in response to accumulation of extracellular matrix proteins during fibrosis. The presence of hepatic iron overload; however, can shorten the T1rho value. With proper correction, we can remove this confounding factor and improve the reliability of T1rho for early diagnosis of liver fibrosis.

Patients with early-stage liver fibrosis confirmed by biopsy will be recruited at the Prince of Wales Hospital (Hong Kong). Thirty patients and twenty healthy volunteers will be recruited. The liver iron content will be measured using the established T2\* MRI relaxometry. Breathhold black blood T1rho relaxometry will be used to collect T1rho data. The measured T1rho will be retrospectively corrected to remove the shortening effect caused by iron.

We will use ANOVA to compare the measurement with and without fibrosis. We will use Pearson correlations between the disease state and the imaging measurements, and ROC analysis to determine the diagnostic value of the proposed method.


Eligibility Criteria:
Inclusion Criteria:

* Between age 18 and age 55
* Informed written consent obtained

Exclusion Criteria:

* Contraindications to MRI such as the presence of metallic implants, claustrophobia and pregnancy
Online Mindfulness-based Tic Reduction

Tourette Syndrome (TS) and Persistent Tic Disorder (PTD) are chronic and potentially disabling neurobiological conditions. Although a range of pharmacological and psychosocial treatments exists, a significant number of individuals either do not respond to the current treatments, find them unacceptable, or cannot access them. Thus, it is essential that researchers continue to pursue novel treatment approaches that can also be easily disseminated to those in need.

Initial pilot data suggest that a mindfulness-based intervention may be beneficial for adults with tic disorders. In the present study, the researchers aim to further develop this mindfulness-based intervention, adapt it to be delivered online and pilot test the intervention with a small group of participants. The data from this pilot test will inform a subsequent randomized controlled trial comparing online mindfulness-based tic reduction to online psychoeducation, relaxation, and supportive therapy.

The specific aim is to determine the feasibility and acceptability of Online Mindfulness-based Tic Reduction in 6 adults with TS or PTD.

The researchers hypothesize that Online Mindfulness-based Tic Reduction will be feasible and acceptable to adults with tic disorders as measured by participant satisfaction, qualitative participant feedback, home practice compliance, dropout, and adverse events.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older,
2. possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
3. fluent in English
4. residing in the United States,
5. either not be taking any tic suppressant medication or other psychotropic medication or be at a stable dose for 8 weeks prior to the baseline assessment and throughout the study

Exclusion Criteria:

1. be receiving concurrent psychotherapy for the duration of the study
2. have prior extensive experience with mindfulness and/or meditation and
3. cannot have another medical or psychological condition that would prevent the individual from fully engaging in the study or require a higher level of care (e.g., suicidality).
Intraoperative Soft Tissue Balance in TKA

The purpose of this evaluation is to evaluate the intraoperative soft tissue balance as assessed by the Orthosensor device, to measure the perioperative gait and function with the Muvr tracking device, and to correlate this soft tissue balance with early functional outcomes in the Persona total knee system.

This is a single surgeon, prospective, controlled study consisting of 50 patients with a primary indication of OA who are eligible for primary total knee arthroplasty using the Persona total knee system.

The patients are equally divided in two groups; patients in group 1 will receive traditional, manual soft-tissue balancing during surgery. For the purpose of the study, the balance will be quantitatively assessed at the end of the case, by means of surgeon-blinded VERASENSE measurements before and after cementation. For the patients in Group 2, intra-operative sensor feedback will be used in creating a quantitatively balanced knee (VERASENSE, OrthoSensor Inc.). Thereby, a quantitatively balanced knee is characterized by a mediolateral load differential below 15lbs at 10-45-90 degrees of flexion.

Post-operatively, the patients will be evaluated using the Muvr device at the day of surgery, day of discharge and 2, 6, and 12 weeks, and 1 year postoperatively. This device will provide quantitative feedback on different gait metrics as well as function during activities of daily living such as stair climbing / stair descent, walking, and timed get up and go testing.

During each post-operative visit, the following metrics will be recorded:

* Active and passive range of motion
* Implant alignment
* Patient reported outcomes by means of Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Forgotten Joint Score (FJS)

Eligibility Criteria:
Inclusion Criteria:

1. Patient has a primary indication of osteoarthritis and is eligible for primary total knee arthroplasty using the Persona total knee system
2. Patient is willing and able to provide written Informed Consent prior to study surgery
3. Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form

Exclusion Criteria:

1. Patient does not have a primary indication of osteoarthritis
2. Patient does not have access to internet or mobile device or understand how to use phone/app
3. Patient is not eligible or will not receive the Persona total knee system
4. Patient has not provided written Informed Consent
Safety, Feasibility and Clinical Utility of Critical Care Transesophageal Echocardiography in Hong Kong

Critical care echocardiography is increasingly recognized as an essential skill for intensivists to achieve during their training and fellowship. It serves to provide critical information to guide clinical management in patients with hemodynamic collapse and respiratory insufficiency. While transthoracic echocardiography (TTE) could be adequate for assessment in most situations, patient factors such as body habitus, presence of chest drains and tubes, presence of thoracic surgical dressings, requirement of high ventilatory support may impede operators from obtaining satisfactory images for evaluation. Moreover, operators in TTE require time and experience for adequate skill and technique acquisition. In specific pathologies such as infective endocarditis, presence of thrombus in left atrial appendage, and evaluation of intracardiac shunts, TEE has been shown to be superior to TTE for proper and accurate diagnosis. Therefore, TEE is widely accepted as the preferred and essential modality for echocardiographic examination especially in European countries. Countries such as France and North American have included critical care TEE as a core curriculum in the critical care training pathway.

In Hong Kong, only basic critical care echocardiography using TTE is required during training and in clinical practice. TEE evaluation is mostly performed in cardiac surgery units by cardiac anesthetists and in stable patients by cardiologists. Critical care TEE is seldom performed by intensivists independently for hemodynamic assessment and evaluation of cardiopulmonary failure. This study describes the safety, feasibility, and clinical utility of critical care TEE by critical care fellows in a university-affiliated institute providing tertiary care to the territory. With implementation of this essential technique in a single center, this study serves to act as a generalizable guidance to achieve an ultimate goal of incorporating this technique as core curriculum in critical care training in parts of the world where critical care TEE is not well established.


Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 18; AND
* Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital in Hong Kong; AND
* Intubated for invasive mechanical ventilation; AND
* Clinically indicated for transesophageal echocardiography (TEE)

Exclusion Criteria:

Patient possessing absolute contraindication(s) to TEE examination according to the ASE guideline 2013:

* Perforated viscus
* Esophageal stricture
* Esophageal tumor
* Esophageal perforation
* Esophageal laceration
* Esophageal diverticulum
* Active upper gastrointestinal bleed
Activating and Connecting Teens (ACT) Study

National data indicate over 650,000 children and adolescents are exposed to physical, sexual, or emotional abuse or physical or emotional neglect each year. Moreover, youth with a history of childhood maltreatment (CM) are at least twice as likely to develop depression and are at substantial risk for nonresponse to current best practice depression interventions (i.e., cognitive behavioral therapy and antidepressants) compared to non-maltreated peers. Research suggests that CM increases risk for depression through disruptions in the positive valence system, such as reward processing, and Behavioral Activation (BA) may be an alternative depression intervention that targets these deficits. This proposal will examine whether BA intervention reduces depression and anhedonia in a sample of depressed adolescents, aged 13-18, with variable histories of CM exposure (BA Group). A total of 30 depressed adolescents will be recruited to undergo a 12-week course of BA. All participants will undergo clinical assessment to measure depression symptoms and anhedonia at baseline (Week 0) and post- (Week 12) treatment.


Eligibility Criteria:
Inclusion Criteria Behavioral Activation Group:

- current diagnosis of clinical depression (minor or major) will be recruited as study participants in the Behavioral Activation (BA) Group

Exclusion Criteria:

* IQ \< 80;
* non-English speaking youth or parent;
* current PTSD diagnosis;
* lifetime history of a developmental (e.g., autism), neurological (e.g., epilepsy), psychotic, bipolar, or substance disorder;
* current psychiatric (e.g., antidepressants) or other mood altering medication (e.g., steroids) other than AD/HD medication;
* requiring a higher level of care (i.e., inpatient hospitalization) due to suicidality or other mental or physical health related problem.
* Any youths who are currently being maltreated will not be enrolled to ensure that participants do not have active safety concerns.
* Full course of other evidence-based depression intervention
Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control

The purpose of the study is to access the change in mean daytime systolic blood pressure in participants with essential hypertension not adequately controlled (defined as mean systolic daytime ambulatory blood pressure ≥ 135 mmHg) and randomly assigned to either an intervention group with one-time only Direct Observed Therapy (DOT) immediately followed by ABPM or a control group with standard ABPM.

More than 1 billion people world wide suffer from hypertension (HT), leaving it the world´s top rank risk factor and contributor to global disease burden. Cardiac disease, stroke, kidney disease and dementia are diseases related to HT with high economic burden on societies and each year 9.4 million people die as a direct consequence of HT.

Estimated \< 50 % of hypertensive patients adhere to preventive hypertensive medication after 1 year of treatment.

Poor adherence to antihypertensive treatment have by many been explained partly by the silent nature of hypertension, the risk of side effects from antihypertensive medication, treatment expenditures and the patient health perspectives.

In a randomized controlled trial design we plan to enrol 20 subjects, the limited number explained by the study being part of the initial planning of a larger scale trial organized by the research group, to invistigate the change in ambulatory bloodpressure with or with out Direct Observed Theraphy prior to meassurement, as a one-time-only medication adherence check.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and above
* Residing in Oslo/Akershus
* Ambulatory Systolic Daytime Blood Pressure ≥ 135 mmHg
* ≥ 2 antihypertensive medications
* Be able to read and write Norwegian

Exclusion Criteria:

* Critical illness, ongoing treatment
* Known atrial fibrillation
* Known heart valve stenosis
* Myocardial infarction, angina pectoris or stroke the past 6 months
* Known severe renal impairment (eGFR \< 30 ml/min/1.73 m2)
* History of DOT prior to ABPM
* Participation in other interventional study
An Assessment of 4 Different Bearing Types in Hip Replacement Types to Analsye the Lowest Wear Rates of Polyethylene

The aim of the study is to assess the ideal bearing surfaces in hip replacement by comparing 4 different combinations. In a hip replacement this means what the head and the socket liner are made of.

In hip replacements, arguably the most important thing for survivorship is what rubs against what.

Traditionally surgeons used metal (Cobalt-Chrome) against a conventional polyethylene (plastic). More recently (around 15 years ago) a newer more dense type of polyethylene (called XLPE) had been developed and a new type of head called Oxidized Zirconium was also developed.

In this trial, adults who were undergoing hip replacements were randomized assigned into one of the four groups:

Group 1: old plastic vs metal head Group 2: Old plastic against Oxidized Zirconium Group 3: New plastic versus metal head Group 4 New plastic vs Oxidized Zirconium

All patients were followed up for a minimum of 10 years to assess which group wore the most amount of polyethylene and which group had the best survival rate.

Eligibility Criteria:
Inclusion Criteria:

* All adults with no history of cancer, infection of the hip and with the capacity to make informed consent for the trial

Exclusion Criteria:

* those under the age of 18 and over 65. Those with a history of cancer and infection. Those without the capacity to make an informed consent.