cyrilzakka/clinical-trials huggingface dataset:
Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This is a Phase II, open-label, multi-drug, multi-centre study designed to assess the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of novel combination therapies in participants with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.

Approximately 240 participants will be assigned across 6 substudies, with approximately 40 evaluable participants of the confirmed recommend dose by SRC for study intervention in each corresponding substudy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at the time of signing the ICF.
* Body weight \> 35 kg.
* Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
* Has measurable target disease assessed by the Investigator based on RECIST 1.1.
* ECOG PS zero or one.
* Life expectancy of at least 12 weeks.
* Adequate organ and bone marrow function.
* Has central lab confirmed Claudin18.2 status at screening from archival tumour collected within past 24 months or from a fresh biopsy when Substudy 3, Substudy 4 or Substudy 6 is open for recruitment.

Exclusion Criteria:

* Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by in situhybridisation) or indeterminate gastric or GEJ carcinoma.
* Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression.
* Participants with ascites which cannot be controlled with appropriate interventions.
* Active infectious diseases, including tuberculosis, HIV infection, or hepatitis A/B/C.
* Uncontrolled intercurrent illness.
* Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.
* History of another primary malignancy.
* Previous treatment with an immune-oncology agent.
* Previous treatment with any modalities of Claudin18.2 target therapy or MMAE exposure (when Substudy 3, Substudy 4, or Substudy 6 is open for recruitment).
Board Game Project for Adolescents with Tourette Syndrome

The study aims to investigate the effectiveness of using a board game to improve adolescents' tics, mental health, and interpersonal interactions.

This study utilizes a randomized control study design. According to the situated learning theory and qualitative research findings, this study develops a board game. This study enrolled adolescents with Tourette syndrome aged 12 to 18 as the subjects. Participants played board games at home at least once (about 60 minutes) a week for four consecutive weeks. The control group received the usual standard of care (psychoeducation regarding Tourette Syndrome and one 50-mg tablet of pyridoxine daily). The effectiveness indicators include self-reported status of positive mental health, tics severity, social adjustment, and depression by adolescents with TS.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents between the ages of 12 and 18 years were diagnosed with Tourette Syndrome or chronic tics disorder by a pediatrician, according to the DSM V.
* Ability to speak and understand Mandarin.
* Adolescents and their parents were willing to participate and fill in consent forms.

Exclusion Criteria:

· Adolescents with Tourette Syndrome have mental illness and serious diseases.
Study Comparing Two Ventilation Modes NAVA (Neurally Adjusted Ventilatory Assist) Mode and Spontaneous Breathing With Inspiratory Pressure Support (IPS) Mode in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube.

This is a multicenter, prospective, randomized, open-label study which compared two ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter is considered as the reference ventilatory mode) in patients admitted to the ICU for acute respiratory failure and ventilated with an endotracheal tube. NAVA mode allows to minimize patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Patient ventilated with endotracheal tube for more than 24 hours
* Return for at least 30 minutes to spontaneous ventilation allowing IPS with a level of pressure support \<30 cm H2O;
* Level of sedation =\< 4 on the Ramsay scale in the absence of medical decision to increase the level of sedation;
* Fraction of inspired oxygen (FiO 2) =\< 50% with a positive end-expiratory pressure (PEEP) =\< 8 cm H2O;
* Absence of administration of high-dose vasopressor therapy defined by:

  1. norepinephrine \> 0.3 mcg / kg / min;
  2. dopamine \> 10 mcg / kg / min;
* Estimated duration of mechanical ventilation \> 48h00

Exclusion Criteria:

* Contraindication to the implementation of the NAVA endotracheal tube, ie any contraindication to the implementation of a gastric tube or to the repositioning of a tube already in place:

  1. Recent gastrointestinal suture ;
  2. Esophageal varices rupture with gastrointestinal bleeding within 4 days prior to inclusion;
* Therapeutic limitation or active treatment discontinuation;
* Pregnant women;
* Minors;
* Protected adults;
* Patient already included in the study;
Ventilatory Effect on Speed of Anesthesia Under Various Inhaled Anesthetics

Three groups of patients are going to have minor surgery under general anesthesia with inhaled anesthetics and different ventilatory setting (Tidal volume: 8, 10, 12 ml/kg, respiratory rate: 10/min each). Group A (Sevoflurane) will use sevoflurane, group B (Desflurane) will use desflurane, and group C (Isoflurane) will use isoflurane. It will be observed differences among the groups for ventilatory effects on speed of induction.

Duration of this randomised controlled trial will be about 3 months. Estimated sample size will be 36 patients(12 in each group).

No premedicant will be given. The anesthetic workstation and a circulatory circuit will be prefilled with 1.0 MAC of inhaled anesthetic that will be selected randomly.

* Group A (n=12): Sevoflurane 2.0 vol%
* Group B (n=12): Desflurane 6.0 vol%
* Group C (n=12): Isoflurane 1.2 vol%

Each group has 3 subgroups according to the ventilatory setting that will also be randomly determined.

* Hypoventilation: tidal volume 8 ml/kg, respiratory rate 10 /min
* Normoventilation: tidal volume 10 ml/kg, respiratory rate 10 /min
* Hyperventilation: tidal volume 12 ml/kg, respiratory rate 10 /min

Patients will be preoxygenated with 100% oxygen (5 L/min) for 5 minutes under pulse oximeter, EKG, and noninvasive blood pressure monitoring. Bispectral index (BIS) monitor will be applied.

The induction of general anesthesia will start with propofol (2 mg/kg), rocuronium (0.8 mg/kg) and remifentanil infusion (0.1 mcg/kg/min). The size of a tracheal tube will be 7.5 mm (ID) for male, 7.0 mm (ID) for female. After intubation, anesthesia workstation will be connected to the tracheal tube. Ventilation will start, and that point will be time 0. During 720 seconds, inspiratory (PIgas) and end-tidal concentration of inhaled anesthetics (ETgas), end-tidal partial pressure of carbon dioxide, and BIS will be measured at time 0, 30, 60, 90, 120 ,150, 180, 240, 300, 360, 480, 600, and 720 seconds. Mean blood pressure and heart rate will also be recorded every 2 minutes. Fresh gas flow will be kept at 6 L/min with 100% oxygen.

The fraction of ETgas/PIgas will be analyzed with nonlinear mixed effects modeling.

Estimated sample size will be 36 patients (12 in each group, 4 in each ventilatory settings).

Eligibility Criteria:
Inclusion Criteria:

* ASA PS I, II
* Age: 20-60 years male and female
* Elective schedule with minor surgery
* BMI \< 30

Exclusion Criteria:

* Patients with pulmonary, cardiac, endocrinal, neuromuscular and neurological diseases or past history
* Upper airway anomaly or deformity
* ASA PS III or higher
* Pregnant women
* BMI \>= 30
Whole Body Exercise in Spinal Cord Injury: Effects on Psychosocial Function

Persons with spinal cord injury (SCI) are confronted with a multitude of psychological and physiological changes post-injury leading to seemingly insurmountable barriers to participating in daily life. After injury persons with SCI engage in fewer social interactions, spend more time sedentary, and are less likely to leave the home. This leads to restricted social participation that, in turn, contributes to greater psychological problems and negatively impacts the lives of adults with SCI. Intense, structured exercise has substantial potential benefits for improving psychosocial wellbeing among persons with SCI, but accessible exercise options are few and cannot achieve high intensities of whole-body exercise. This work will use approaches to overcome the barriers to intense exercise. The investigators will use hybrid functional electrical stimulation row training (FESRT) to allow for a more intense exercise stimulus, potentially having a greater impact on psychosocial wellbeing. There is initial evidence that persons with mobility impairments who are highly physically active demonstrate better psychosocial wellbeing compared with those who have low levels of physical activity. A limitation to understanding the influence of exercise on psychosocial wellbeing is the lack of robust and time-dependent measures. The investigators will use a smartphone-based research application to measure psychosocial well-being, thus decreasing self-report bias and capturing in-the-moment behavioral and self-report data.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years of age)

  * Be in good health (asymptomatic for acute treatable illness) and medically cleared to exercise
  * Own an iPhone or Android smartphone with the capacity to download and run the research platform (able to log into to the relevant app store, install the app on their own phone, and run the app).
  * Be able to understand, communicate with and be understood by research personnel or Interpreters
  * Be interested in participating and provide informed consent
  * Have a SCI with motor or sensory deficits and use a wheelchair as primary means of mobility
  * Have an injury level only as high as C4 to allow sufficient arm function for rowing

Exclusion Criteria:

* Participants will not have previously completed FESRT
* Acute illness
* Musculoskeletal injuries that have not healed completely
* Had heart surgery or are status post-myocardial infarction (MI) in the last 4 to 6 months, -Unstable angina
* Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg)
* uncontrolled dysrhythmias
* Recent history of congestive heart failure that has not been evaluated and effectively treated
* Severe stenotic or regurgitant valvular disease
* Hypertrophic cardiomyopathy
* Unhealed pressure ulcer Stage 2 or higher at relevant contact sites during exercise.
App Based Dexterity Training in Multiple Sclerosis

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the most common cause of non-traumatic disability in young adults (Kamm et al. 2014; Vanbellingen \& Kamm, 2016). It is a heterogeneous disease, which is associated with long-term disability, leading to reduced quality of life (QoL). Disease-modifying pharmacological therapies (DMT) decrease activity and progression of the disease, and symptomatic pharmacological treatments reduce complaints to a certain extent, however MS patients often still suffer from various neurological deficits during the course of their disease (Kamm et al. 2014). Consequently, specific non-pharmacological therapies are needed in order to further reduce disability, eventually resulting in better QoL (Lamers et al. 2016; Vanbellingen \& Kamm, 2016).

Impaired dexterity is a frequently observed impairment, affecting up to 76% of patients with MS (Johannson et al. 2007). The different neurological deficits caused by MS, such as ataxia, spasticity, sensory-motor deficits, and apraxia may be alone or in combination, impair manual dexterity (Kamm et al. 2012; Heldner, Vanbellingen et al. 2014). MS patients experience impairments in the performance of several activities of daily living (ADL), such as grooming, cooking, etc. Sometimes these problems are even associated with loss of work, and lack of social integration (Chruzander et al. 2013).

The effectiveness of the app based exercises still needs to be proven. With respect to dexterity, a first new app has been developed called "Finger Zirkus", by a team of experts including an occupational therapist, graphic designer, and IT expert. The app is already available to be downloaded from google play store or apple store (see for more details: www.fingers-in-motion.de).


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for MS patients are as follows: males and females, age 18 to 75, diagnosis of MS (primary or secondary progressive, relapsing-remitting) following the McDonald criteria (Polman et al. 2011). In addition, patients must report difficulties in manual dexterity that impact ADL and/or have a pathological nine Hole Peg Test (9HPT) or Coin Rotation test (CRT) according to cut-off values (Mathiowetz et al. 1985; Heldner, Vanbellingen et al. 2014).

Exclusion Criteria:

* The exclusion criteria will be other conditions that may hand function or, impaired cognitive functioning (Mini Mental Status Examination score less than 24).
Effect of Pursed-lips Breathing Combined With Aerobic Walking Exercise on Oxygenation and Activity Endurance in Lung Cancer Patients After Lobectomy

The effects of pursed-lip breathing or aerobic walking exercise in increasing muscle strength and motility and relieving dyspnea have been proved. However, patients with lung cancer often have decreased lung function and exercise capacity after lobectomy. The aim of this study was to explore the effects of pursed-lip breathing combined with aerobic walking exercise on postoperative oxygenation and exercise tolerance of lung cancer patients underwent lobectomy.

An randomized controlled trial was used. Sixty eligible subjects from the Department of Thoracic Surgery of a regional hospital in central Taiwan participate in this study. A total of sixty subjects were randomly and equally assigned to the experimental group, control group I and control group II, to carry out postoperative both pursed lip breathing and aerobic walking exercise, pursed lip breathing, and aerobic walking exercise respectively. All three interventions were conducted 3 times a day, each lasting 15 minutes, from the 1st to 5th day after the operation. Pretests were done before the start of the three interventions on the first postoperative day, and posttests were done after the completion of the three interventions on the 5th postoperative day. Data including 6-minute walking test, Dyspnea Visual Analogue Scale, Rating scale of perceived exertion, peak expiratory flow rate and SpO2 were collected.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged over 20 who have been informed of the research process and are willing to participate and sign consent.
* Participants with clear consciousness, the ability to communicate in Mandarin or Taiwanese, and the ability to walk independently.
* Participants diagnosed with lung cancer who have undergone lung lobe resection surgery.

Exclusion Criteria:

* Changes in the surgical plan, not undergoing at least a single lung lobe resection.
* Deterioration of postoperative condition, making it impossible to correctly perform pursed lip breathing or aerobic walking exercises.
Valsartan/Hydrochlorothiazide Combination in the Treatment of Severe Hypertension

The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed severe hypertension

Exclusion Criteria:

* Inability to discontinue all prior antihypertensive medications
* Heart failure of any kind
* History of stroke, transient ischemic attack, myocardial infarction, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease
* Diabetes with poor glucose control
* Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.
The Feasibility of a Facebook Group-based Program for Foot Self-management Support of Adults With Diabetes in Canada

The primary objective of this study is to examine the feasibility of a Facebook group-based program to support adults with diabetes in their foot self-care and prevention of foot ulcers.

The sub-objectives are:

1. To determine the recruitment and retention rate of participants in the study. 2. To assess the acceptability of the Facebook group program among participants. 3. To determine the level and pattern of engagement by the participants within the Facebook group platform. 4. To determine the efficacy of the Facebook group program and how it works to improve diabetic foot care-related outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type I or II diabetes;
* 18 years of age or older
* reside in Canada
* Proficiency in the English language - understanding, speaking, reading, and writing.
* Have an active Facebook account or willing to create one
* Have access to the internet and computer or smartphone

Exclusion Criteria:

* Declined consent
* Did not provide follow-up contact information
* Completed less than 60% of the baseline survey
C-peptide Correlation With Microvascular Complications in T1DM

The purpose of this study is to investigate the presence of residual insulin secretion in patients with DM1 and its correlation with the possible protection against early microvascular and macrovascular complications, emphasizing on the functionality of the myocardium.

The study will include approximately 200 patients, male and female, with DM1 who are being followed in the outpatient diabetic clinic of our hospital.

Each patient will visit the Research Laboratory of the Diabetes Centre of our Department. The visit will take place in the morning in a fasting state of about 12 hours. Demographic data will be recorded along with the patients' habits, lifestyle, current medication and complete medical history of concomitant diseases.

This will be followed by anthropometric measurements (weight, height, BMI) and afterwards blood samples will be taken for the determination of urea, creatinine, glucose, HbA1c and lipids. Part of each blood sample will be collected in tubes containing EDTA to determine fasting c-peptide concentrations. The presence of microalbuminuria will be assessed from a morning urine sample by calculating urinary albumin to creatinine ratio (ACR).

The functionality of the heart's autonomic nervous system will be assessed through the use of heart rate variability (HRV) measurements, using the standard Ewing's tests panel: deep inhalation, standing up and Valsalva's manoeuvre. Changes in blood pressure when changing from the supine to the standing position will also be recorded. Subsequently, the distensibility of the large vessels will be determined, by calculating the conduction velocity of the pulse wave between the carotid and the femoral artery (pulse wave velocity (PWV)).

Finally, a full transthoracic echocardiographic study will be carried out to assess functionality, systolic and diastolic, of the left ventricle (LV).

All data will be recorded in an electronic database for statistical processing.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Informed consent form

Exclusion Criteria:

* Known macrovascular complications
* Known serious microvascular complications
Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1)


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 16 and over, and classified as having pulmonary arterial hypertension
* Subjects who meet the following conditions on right heart catheterization at screening or baseline: mean pulmonary arterial pressure of ≥ 25mmHg and pulmonary capillary wedge pressure of ≤ 15mmHg at rest
* Subjects whose baseline 6-Minute Walk test distance is \>100 m and \<450 m

Exclusion Criteria:

* Significant Hepatic and/or renal disorder
* Subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic ischemic optic neuropathy (NAION)
* Subjects who are currently receiving nitrates or nitric oxide donors in any form, ritonavir, ketoconazole and itraconazole
Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye

The objective is to assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia.

This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), patient-reported spectacle independence questionnaire (PRSIQ), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.

Eligibility Criteria:
Inclusion Criteria:

* • Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using an EDF IOL

  * Meet the requirements for on-label implantation of the EDF IOL
  * Gender: Males and Females.
  * Age: 40 or older.
  * Willing and able to provide written informed consent for participation in the study.
  * Willing and able to comply with scheduled visits and other study procedures.
  * Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
  * Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or toric IOL.
  * Have 20/32 (0.2 logMAR) or better potential acuity in both eyes

Exclusion Criteria:

* • Irregular astigmatism (e.g. keratoconus)

  * Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)
  * Monocular status (e.g. amblyopia)
  * Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty)
  * Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
  * Diabetic retinopathy
  * Macular pathology (e.g. ARMD, ERM)
  * History of retinal detachment
  * Subjects who have an unstable acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
  * Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).