cyrilzakka/clinical-trials huggingface dataset:
Regulatory Post Marketing Surveillance (rPMS) Study of Rybelsus (Oral Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

The aim of this study is to assess the safety and effectiveness of Rybelsus initiated according to label in adults with Type 2 Diabetes Mellitus (T2DM) under routine clinical practice conditions. Participants will get Rybelsus as prescribed by study doctor. The study will last for about 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

* The decision to initiate treatment with commercially available Rybelsus has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
* The participant with T2DM is scheduled to start treatment with Rybelsus based on the clinical judgment of their treating physician as specified in the approved label in Korea
* Informed consent is obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
* Male/female age greater than or equal to (\>=) 19 years at the time of signing informed consent

Exclusion Criteria:

* Participants who are or have previously been on Rybelsus therapy
* Known or suspected hypersensitivity to Rybelsus, the active substance or any of the excipients
* Previous participation in this study. Participation is defined as having given informed consent in this study
* Female participant who is pregnant, breast-feeding or intends to become pregnant and is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by Korea regulation or practice)
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Family or personal history of multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC)
Dexlansoprazole Absorption and Marginal Ulceration After Gastric Bypass

In Switzerland, the most commonly performed bariatric procedure is the proximal Roux-en-y gastric Bypass surgery. Since marginal ulceration is a known complication after this Operation, a Proton pump Inhibitor (PPI) prophylaxis is prescribed postoperatively. Bariatric surgery may have an impact on the absorption and consequently on the efficacy of drugs. There are only very little data on the pharmacokinetics of PPIs following PRYGB.

The aim of this study is to analyze the serum concentration of dexlansoprazole preoperative and after PRYGB surgery in patients taking PPI prophylaxis and to examine the incidence of marginal ulcers postoperatively in the same population.

This prospective, monocentric study includes 30 patients undergoing a proximal Roux-en-Y gastric Bypass surgery and receiving 6 months of postoperative PPI prophylaxis with Dexilant (dexlansoprazole). The aim is to examine if the LPRYGB has an impact on the absorption of dexlansoprazole. Peripheral blood samples from the study participants are obtained at fixed time points after oral Administration of a capsule Dexilant preoperatively as well as 3 and 6 months after surgery. The incidence of marginal ulceration in the same patient population is assessed by upper endoscopy 6 and 12 months after surgery. The surgery, the PPI prophylaxis and the upper endoscopy 12 months post-surgery aren't for study purpose. Data collection is made by measuring serum drug concentration, patient questionnaires, pill count and upper endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent for study and surgery as documented by signature
* Male and Female Patients over 18 years old eligible for bariatric surgery at the Department of General Surgery, Limmattal Hospital, according to criteria of the Swiss Study Group for Morbid Obesity (SMOB) and international Guidelines
* BMI ≥ 35
* Failure of conservative Treatment for 2 years
* Type of surgery: LPRYGB
* Helicobacter pylori negative
* Smoker (≥ 1 cigarette daily)
* Women in reproductive Age: negative pregnancy test

Exclusion Criteria:

* Contraindication for a bariatric surgery according to SMOB-criteria
* Contraindication for PPIs
* Pregnant or breastfeeding women
* Pre- or intraoperative decision for other type of surgery than LPRYGB
* Active malignancy
* Chronic liver disease Child-Pugh B or C
* Abuse of drugs or alcohol
* Suspect of non-compliance
Comparative Analysis of a Non-contact Respiratory and Heart Rate Monitor Vs. a Conventional Clinically Validated Reference Monitor

This is a prospective pivotal study in patients admitted/visiting the cardiology ward and/or outpatient clinics for various indications.

The study will be conducted in two stages. The first stage will comprise a pilot study with 10 subjects, which will be completed and analyzed prior to initiation of the second stage. The two studies are independent and are included in the same protocol for logistical reasons. The second stage of the study, which will include 120 subjects, is pivotal and intended to validate the Gili BioSensor System.

Testing procedure will include seating the subject in either a steady chair in front of a table, or in bed with the bedrest raised in front of a cardiac table (or similar). The subject will be seated for 5 minutes to reach a physiological steady state. During this time, the subject will be connected to the reference device according to the manufacturer's guidelines. The investigational device will be placed on a stable surface in front of the subject (table / cardiac table or similar) and will point to the left side of the subject's chest. Both the investigational and reference devices will be temporally synchronized to maintain coordinated recording. Following the 5-minute resting period, both investigational and reference devices will be activated for a comparative recording session to acquire at least 180 seconds (3 minutes) of evaluable data. Each 60-sec interval will be used separately for comparative analyses.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18, male or female
* Hemodynamically stable as assessed by the investigator
* Willing and able to sign informed consent

Exclusion Criteria:

* Inability to consent/comply with study protocol
* Presence of a condition that may interfere with the devices' performance (e.g. nausea, vomiting, persistent coughing, tremor, mouth breathing, etc.)
* Use of reflective garment, (e.g. sequin, silk, or similar), or highly textured garments (e.g. fur, thick lace, shaggy wool etc.).
* Parallel participation in another clinical trial
Combined Use of Radiofrequency-ablation and Balloon-septostomy in the Creation of a Stable Inter-atrial Communication

Though graded balloon-atrial-septostomy (BAS) has been accepted as an effective palliative therapy for severe pulmonary arterial hypertension, spontaneous closure of septostomy is not uncommon. Radiofrequency-catheter-ablation (RFA), which has the potential to cause irreversible damage around the rim of created inter-atrial communication, might contribute to prevent the spontaneous closure. In patients with severe pulmonary arterial hypertension, the combined use of RFA and BAS (CURB) is investigated to create a stable inter-atrial communication.

Balloon atrial septostomy (BAS) is an important palliative therapy in patients with refractory pulmonary arterial hypertension. However, the incidence of spontaneous closure is higher, which limits the clinical utilization of this procedure. Radiofrequency catheter ablation (RFA) has the potential to cause irreversible damage around the rim of fenestration created with BAS, which might prevent the re-adhesion of the septal remnants. In addition, RFA on fossae ovalis might reduce the elastic recoil of local tissue and contribute to create larger inter-atrial fenestration with same BAS procedure. In this study, the patients between 18 and 60 years of age who have severe pulmonary arterial hypertension associated with right heart failure refractory to medical therapy or severe syncopal symptoms may be eligible for this study (idiopathic severe pulmonary arterial hypertension or severe pulmonary arterial hypertension associated with repaired congenital heart disease). These patients will be randomized 1:1:1 to control group, single-RFA group and double-RFA group:

1. In control group: only BAS is carried out.
2. In single-RFA group: after BAS procedure identical to control group, RFA is performed immediately around the rim of created inter-atrial fenestration.
3. In double-RFA group: the first step is RFA on fossae ovalis; and then the other two steps are identical to the single-RFA group (BAS and RFA around the rim of fenestration).

The immediate size of created fenestration will be determined with intra-cardiac echocardiography, and the patency and size of fenestration will be followed up for 12 months. During the period of follow up, the other evaluations will include the exercise tolerance, cardiac index, systemic arterial oxygen saturation and so on.

Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic severe pulmonary arterial hypertension;
2. Severe pulmonary arterial hypertension associated with repaired congenital heart disease;
3. World Health Organization functional class III or IV with right heart failure refractory to medical therapy;
4. Severe syncopal symptoms;

Exclusion Criteria:

1. Mean right atrial pressure \>20 mm Hg;
2. Room-air resting arterial oxygen saturation \<85%;
3. Left ventricular end diastolic pressure (LVEDP) \>18mm Hg;
4. Pulmonary vascular resistance \>55 wood units/m2.
5. Severe right ventricular failure on cardio-respiratory support
6. The predicted one-year survival \<40%;
IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)

This Phase 1, multicenter, open-label trial will assess the safety and feasibility of IFx-Hu2.0 as adjunctive therapy to pembrolizumab in adult patients (≥18 years) with non-cutaneous Merkel Cell Carcinoma. Nine subjects will receive IFx-Hu2.0 as a visceral lesion injection in a single lesion followed by pembrolizumab.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Life expectancy equal to or greater than six months.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
4. Active disease measurable by CT or MRI, measurable lesions are lesions that can be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded).
5. Must be recurrent and/or unresectable Stage III or Stage IV American Joint Committee on Cancer (AJCC) (8th edition) and have histologically confirmed Merkel cell carcinoma

   a. Must have at least one visceral injectable lesion equal to or greater than 3 mm
6. Subject should be CPI naïve i.e., no prior therapy with CPI including but not limited to Pembrolizumab, avelumab, ipilimumab, nivolumab.
7. Tumor tissue from an archival core biopsy or resected site of disease must be provided for biomarker analyses. If archival tissue is not available, then a new biopsy should be performed.
8. Adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol.

Exclusion Criteria

1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with protocol requirements.
2. Subjects with active brain metastases, with the exception of treated brain metastases that have imaging proving stability at least 4 weeks after treatment, no new metastases, and not requiring steroids.
3. Subjects with recurrent resectable MCC
4. Subjects who have received prior systemic chemotherapy
5. Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study.
6. Active, known, or suspected autoimmune disease. Potential subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. Low grade autoimmune toxicity is NOT an exclusion under this criterion.
7. A condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of IFx-Hu2.0 administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
A Clinical Study to Evaluate the Efficacy and Safety of Subcutaneous JS005 Injection in the Treatment of Adults With Moderate to Severe Chronic Plaque Psoriasis

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of JS005 in 702 adult patients with moderate-to-severe chronic plaque psoriasis

The study consisted of four periods: screening period (up to 4 weeks), induction period (12 weeks), maintenance period (40 weeks) and follow-up period (8 weeks). This study planned to recruit 702 subjects, who were randomized into JS005 300mg group (234 subjects), JS005 150mg group (234 subjects) and placebo group (234 subjects) at a ratio of 1:1:1, and were stratified by whether they had previsouly received biologic treatments (continuous biologic treatment for ≥3 months at recommended doses or intolerance for safety reasons) and body weight (≥70 kg or \< 70 kg).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily particpate in this clinical study and sign the informed consent form.
2. Male and female patients aged 18-75 years at the time of screening (both inclusive).
3. Fertile female subjects must be willing to use a highly effective contraceptive method during the study period and 20 weeks (expected 5 half-lives) after the last study drug administration and have a negative pregnancy test during the screening period and prior to randomization.

Exclusion Criteria:

1. Pregnant and lactating women.
2. A history of inflammatory bowel disease or other conditions with a high risk of perforation (e.g., severe gastrointestinal ulcers, etc.) or with other active autoimmune diseases (e.g., systemic lupus erythematosus, Sarcoidosis, etc.).
3. Have a type of psoriasis other than chronic plaque psoriasis (e.g., pustular, erythrodermic, and guttate psoriasis), drug-induced psoriasis, or have an active inflammatory skin disease other than psoriasis
4. Use of phototherapy, including but not limited to ultraviolet A phototherapy (with or without psoralens), ultraviolet B phototherapy, or excimer laser within 4 weeks prior to randomization. Subjects are unwilling to avoid excessive sunlight exposure within 4 weeks prior to randomization and during the study period;
5. A (current) history of systemic infection or serious infection requiring hospitalization and/or intravenous anti-infective therapy (e.g., antibiotics, antifungal agents, antiviral agents) within 12 weeks prior to randomization; a history of any active infection, other than common upper respiratory infections, within 2 weeks prior to randomization;
A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder

The study will involve a 3-week (15 session) randomized double-blind clinical trial of two repetitive transcranial magnetic stimulation (rTMS) conditions in patients with treatment resistant depression. rTMS site selection will be localized from structural MRI scans.

The patients will be randomized to one of two conditions

1. rTMS targeted to the border of Brodmann area 46 and Brodmann area 9,
2. rTMS targeted to premotor cortex (this condition will act as the non-dorsolateral prefrontal cortex targeted control).

The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis. At study end response criteria is defined as a 50% reduction in total MADRS score and remission defined as a MADRS score of less than or equal to 10.

Other outcome measures administered fortnightly are: BPRS (Brief Psychiatric Rating Scale), CORE (measure of melancholic symptoms), BDI (Beck Depression Inventory), CGI (Clinical Global Impression Scale), GAF (Global Assessment of Functioning Scale). A cognitive battery is also administered.

Inclusion Criteria:

* Moderate to severe depressive symptoms as indicated as MADRS \>20
* Failure to respond to a minimum of two antidepressant medications
* No increase or initiation of new antidepressant therapy in the four weeks prior to entering the trial Exclusion Criteria
* Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
* Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker
* In the opinion of the investigator, are a sufficient suicide risk to require immediate electroconvulsive therapy
* Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another axis 1 disorder

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe depressive symptoms as indicated as MADRS \>20
* Failure to respond to a minimum of two antidepressant medications
* No increase or initiation of new antidepressant therapy in the four weeks prior to entering the trial

Exclusion Criteria:

* Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
* Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker
* In the opinion of the investigator, are a sufficient suicide risk to require immediate electroconvulsive therapy
* Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another axis 1 disorder
Effectiveness of ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Procedures

To assist in guiding a rigid interventional instrument percutaneously, to a designated point within the body by means of CT visualization.

The ActiSight™ Needle Guidance System is an optical navigation system designed to assist physicians performing percutaneous interventions under CT guidance. The system allows the user to select an obstacle free path to a target lesion based on pre-procedure CT images, and then provides real-time information for guiding the interventional tool towards the target along the selected path.

The ActiSight™ Needle Guidance System employs a miniature video camera mounted on the needle and a reference pad attached to the skin to register the needle into the CT image space, and thus, track the needle advance towards the target. CT scans are used as needed to verify the location of the needle.

The primary objective of this study is to demonstrate the effectiveness of the ActiSight™ Needle Guidance System in assisting in CT-guided percutaneous procedures.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 18 years of age or older at the time of enrollment.
* Subjects meeting all medical conditions for percutaneous CT guided. procedures in the chest, abdomen or pelvic, with safe path to lesion.
* Written informed consent to participate in the study.
* Ability to comply with the requirements of the study procedures.

Exclusion Criteria:

* Having co-morbidities that would clinically preclude them from an image guided procedure as determined by the operating physician.
* Significant coagulopathy that cannot be adequately corrected.
* Patients who have a medical contraindication to sedation (Lidocaine allergy).
* Pregnancy or lactation.
* Participation in an investigational trial within 30 days of enrollment.
Comparing Radical Surgery and Radical Radiotherapy as First Definitive Treatment for Primary MCC

A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC

A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC with an observational study for patients ineligible for the randomised trial.

Eligibility Criteria:
Inclusion Criteria:

General Inclusion Criteria for All Patients:

1. Patients newly diagnosed with histologically-proven MCC (either primary and/or regional nodal disease)
2. Completion of clinical and radiological staging investigations, including CT imaging (or other modality) of regional nodal basin(s) and major viscera (and SLNB if clinically appropriate) to identify regional and distant metastases
3. No confirmed distant metastases beyond the regional nodal basin (i.e. not stage IV disease)
4. Suitable for radical treatment to achieve disease control
5. Able to give valid informed consent
6. Consent for collection of data and tissue samples and follow up
7. Life expectancy six months or greater in relation to general fitness and co-morbidities

Additional Inclusion Criteria for Rational Compare:

1. Patients newly diagnosed with histologically-proven primary MCC
2. In the opinion of the SSMDT, the primary MCC can be encompassed both within a wide surgical margin and within a radiotherapy field, and the SSMDT is in equipoise regarding WLE or radiotherapy as first treatment
3. A minimum margin of 1 cm surrounding the MCC achievable by either radiotherapy or surgery
4. Consent for randomisation into Rational Compare

Exclusion Criteria:

1. The primary MCC has already been treated radically with WLE (surgical margins \>10 mm) or radiotherapy
2. Intended use of regional or systemic chemotherapy for MCC (including molecularly targeted agents and immunotherapy)
Effects of Trunk Stabilization Training Device on Balance Ability for Stroke Patients

The purpose of this study is to assess the effectiveness of Balance pro(SBT-330:trunk stabilization training device) for stroke patients reduced balance ability

after being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. Subjects who pass the screening test will randomize in a 1:1 ratio to experimental group(conventional rehabilitation + trunk stabilization training device, 30min each, 20days) or control group(conventional rehabilitation + conventional rehabilitation, 30min each, 20days). And then, They receive a registration number within 7 days and proceed with the pre-intervention test.

Eligibility Criteria:
Inclusion Criteria:

* Stroke patients 40 years or older (within 2 years of onset)
* Those who have no problems with visual function in conducting and conducting clinical trials
* Patients who are found to have decreased balance ability after stroke (BBS score is 21-40 points)
* Those who do not have orthopedic diseases in both lower limbs
* Subjects with cognitive functions capable of fulfilling and carrying out instructions
* Those who voluntarily consent to the clinical trial

Exclusion Criteria:

* Subjects with intellectual disabilities to the extent that they are unable to perform instructions
* Subjects taking drugs that may affect the study
* Subjects with skin and musculoskeletal abnormalities for which the device cannot be worn
* Patients with neurological disorders other than stroke and other disorders that may affect balance
* Other subjects who are judged to be unsuitable for this study
Initiation of Hydrocortisone for the Treatment of Septic Shock

The purpose of this study : 1）to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration in septic shock patients.


Eligibility Criteria:
Inclusion Criteria:

1. age 18 years old or older;
2. onset of septic shock within 6 h

Exclusion Criteria:

1. Systemic corticosteroid therapy within the last 3 months before septic shock;
2. high-dose steroid therapy;
3. immunosuppression;
4. refusal of the attending staff or patient family.