cyrilzakka/clinical-trials huggingface dataset:
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Israel, as Part of Local Clinical Practice

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
2. Diagnosed with type 2 diabetes mellitus
3. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the Specialist based on local label before and independently from the decision to include the patient in this study
4. Male or female, age above or equal to 18 years at the time of signing informed consent
5. Available HbA1c value below or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice
6. Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of below 14 days

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Treatment with any investigational drug within 30 days prior to enrolment into the study
3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
A Study of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)

The purpose of the study is to evaluate the efficacy of bedaquiline (BDQ) compared with rifamycin when administered as part of a treatment regimen with clarithromycin (CAM) and ethambutol (EB) in adult participants with treatment-refractory Mycobacterium avium complex-lung disease (MAC-LD) at Week 24 for microbiological assessment in mycobacteria growth indicator tube (MGIT).


Eligibility Criteria:
Inclusion Criteria:

* Has body weight greater than or equal to (\>=) 40 kilograms (kg) at screening and on Day 1
* Has radiological evidence consistent with nontuberculous mycobacterial lung disease (NTM-LD) based on a chest Computed Tomography (CT) scan taken within 6 months prior to screening or at screening
* Has at least 2 positive sputum cultures of Mycobacterium avium complex (MAC) (sputum cultures to be taken at least 4 weeks apart): one obtained within 12 months prior to screening, which was documented while being treated for Mycobacterium avium complex lung disease (MAC-LD) for a total of at least 6 months; and one at screening (by central microbiology laboratory)
* Received at least 6 months of consecutive MAC-LD treatment (at least 2 antibiotics for MAC, including a macrolide), that is either ongoing or has stopped within 12 months prior to screening
* No presence of cognitive dysfunction that would impact the completion of the patient reported outcome (PRO) assessments

Exclusion Criteria:

* Had previous exposure to bedaquiline (BDQ)
* Has active Tuberculosis (TB) disease
* Has cystic fibrosis, medically unstable respiratory disease (for example, chronic obstructive pulmonary disease, bronchiectasis, asthma)
* Has one or more cavities \>=2 centimeter (cm) in diameter on a chest CT scan taken within 6 months prior to screening or at screening
* Treatment already includes an injectable/inhaled aminoglycoside within 3 months prior to screening or the investigator deems the participant to be a candidate for an injectable/inhaled aminoglycoside during screening period or at Day 1
Family Telehealth Project for Foster Care Youth

The purpose of this research is to adapt and evaluate the efficacy of an existing family based intervention to be delivered via telehealth to child welfare-involved (CWI) youth and their caregiver of origin.

The goal of this study is to adapt and evaluate the efficacy of an existing empirically supported, family-based affect management intervention to be delivered via telehealth. There are two versions of this intervention: 1) a dyadic version to be delivered to CWI youth and their caregiver of origin, and 2) a caregiver-only version to be delivered to any caregiver (including kinship caregivers) of a CWI youth. The study involves iteratively adapting the intervention with feedback from youth and caregiver participants and stakeholder partners, as well as evaluating the feasibility, acceptability, and preliminary effectiveness of the intervention.

Eligibility Criteria:
Inclusion Criteria:

Eligible youth:

* Will be between the ages of 12 and 18 years
* Will have ongoing child welfare involvement
* Will be proficient in English
* Will have no cognitive impairment which would preclude provision of informed assent

Eligible caregivers for dyadic version:

* Will be the caregiver of origin for the enrolled youth
* Will be proficient in English or Spanish
* Will be cognitively capable of providing informed consent for themselves and their youth

Eligible caregivers for caregiver-only version:

* Will be the caregiver of a youth, between the ages of 12 and 18 years, with ongoing child welfare involvement
* Will be proficient in English or Spanish
* Will have no cognitive impairment which would preclude provision of informed consent

Exclusion Criteria:

* Caregivers whose rights were terminated due to substantiated abuse or neglect.
Efficacy and Safety of 1-year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-risk Procedure

The objective of study is to evaluate the efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.

The Genoss DES is a novel, biodegradable, polymer-coated, sirolimus eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.

The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of 1 year duration of DAPT after Genoss DES implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure from 9 sites in South Korea. The primary endpoint was a deviceoriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 12 months. The key secondary endpoint was a patient-oriented composite endpoint (POCE), defined as a composite of all-cause death, any myocardial infarction, and any revascularization at 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of 19 and over
2. Patients with coronary artery disease treated with GENOSS SES
3. Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants

Exclusion Criteria:

1. Patients with cardiogenic shock at the time of hospitalization
2. Patients who are pregnant or planning to become pregnant
3. Patients with a life expectancy of less than 1 year
4. Patients participating in randomized controlled trials using other medical devices
5. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration (However, other stent insertions are allowed due to failure of GENOSS DES insertion)
To Assess the Safety, Tolerability and Pharmacokinetics of AZD2820 After Single Ascending Doses

This is a randomised, single-blind, placebo-controlled Phase I study to investigate the safety, tolerability and pharmacokinetics after administration of single doses of AZD2820 to healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures.
* Healthy male subjects aged ≥20 - ≤45 years with suitable veins for cannulation or repeated venepuncture.
* Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.
* Have a body mass index (BMI) between≥ 18 and ≤30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
* Provision of signed, written and dated informed consent for genetic research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* A history of erectile dysfunction or anatomic abnormality of the penis (eg, cavernosal fibrosis, Peyronie's disease, or plaques) which interferes with normal erectile function
* Predisposition or history of priapism (eg, sickle cell anemia or trait).
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
Protector™ Versus Supreme® Laryngeal Mask Airway

The goal of this study is to compare the oropharyngeal leak pressure of the Protector Laryngeal mask with the Supreme laryngeal mask. Other secondary parameters will be studied.

The OLP as the primary outcome measurement will be evaluated after insertion of the LMA in each group. We hypothesize that there will be a difference of 4 cm H2O between the 2 masks, because of the different material and slightly different form of the masks. Secondary outcomes will be measured after insertion of the LMA as by protocol. Finally postoperative airway morbidity will be evaluated 3 hours after removal of the LMA.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-75
* ASA 1-3
* Operation on limbs
* written informed consent

Exclusion Criteria:

* known difficult airway
* anatomical abnormalities on airway, Larynx, oesophagus, stomach
* not fastened
* high aspiration risk
* patients with contraindication of laryngeal mask
* BMI \>35 kg/m2
* patients with disease which impairs accurate Investigation of patient
* cardiovascular risk factors
* COPD
* acute disease where anaesthesia is in doubt
* no written consent
Evaluation of the GORE® C3 Delivery System Module

This is an observational Registry designed to obtain early data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System.

This is a retrospective and prospective observational cohort Registry designed to obtain data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System. Patient and device performance outcomes will be collected during treatment and throughout all post-treatment visits, including follow-up extending up to 10 years.

Eligibility Criteria:
Inclusion Criteria:

1. Minimum age required by local regulations (as applicable)
2. Indication for aortic endovascular stent graft repair as determined by the treating physician (refer to current Instructions for Use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System)
The Optimal Treatment for Treatment-resistant Schizophrenia

The Optimal Treatment for Treatment-resistant Schizophrenia

To explore the curative effect and safety of Risperidone，aripiprazole，sodium valproate，modified electroconvulsive therapy(MECT), or Magnetic seizure therapy(MST) with Clozapine in the treatment of treatment-resistant schizophrenia， and to provide the basis for clinical medication.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of schizophrenia according to DSM-V
* 18～60 years old
* 2 prior failed treatment trials with 2 different antipsychotics at doses of at least 600 mg/day chlorpromazine equivalents, each of at least 6 weeks duration;
* Signed an informed consent

Exclusion Criteria:

* patients to be diagnosed according to DSM-V for substance abused, development delayed
* suffering from serious physical disease and can not accept the treatment
* MST contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure
* allergic to risperidone ,aripiprazole, or sodium valproate
* Participated in any clinical subject within 30 days
* Pregnancy or lactation
Assessment of Intraocular Pressure (IOP) Control in Subjects With Open-Angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01% (LUMIGAN®)

The purpose of this study was to assess efficacy and tolerability of travoprost 0.004% vs. bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with open-angle glaucoma or ocular hypertension after 6 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in at least one eye.
* Non-study eye: Intraocular pressure (IOP) able to be controlled with no pharmacologic therapy or on the study medicine alone.
* Willing to discontinue the use of all other ocular hypotensive medications prior to receiving study medication and for the entire course of the study.
* Able to follow instructions, self instill study article, and attend all study visits.
* Best-corrected Snellen visual acuity of 20/200 or better in each eye.
* Sign Ethics Committee reviewed and approved informed consent form.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity or poor tolerance to any component of the preparations used in this study.
* Any abnormality preventing applanation tonometry in either eye.
* Dry eye previously or currently being treated with punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
* Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
* Intraocular conventional or laser surgery \>3 months prior to consent.
* Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
* Progressive retinal or optic nerve disease from any cause.
* Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to Screening or an anticipated change in dosage during the course of the study.
* Any clinically significant, serious, or severe medical condition.
* Women of childbearing potential who are pregnant, lactating, or not using reliable means of birth control.
* Participation in any other study within 30 days prior to Screening.
* Use of any systemic (oral), injectable or topical steroids.
* Other protocol-defined exclusion criteria may apply.
A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Cancer

This phase II clinical study is designed to evaluate the 1 year local tumor control rates after the targeted therapy of intensity-modulated radiation therapy synchronized chemotherapy with nimotuzumab combined with S-1 in local advanced esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* Pathologically or cytologically proven esophageal squamous cell carcinomas in patients staged as T2-4N0-1M0-1b (AJCC 6th TNM staging, M1b limited to clavicular or celiac lymph node metastasis)
* Primary treatment accepted in Chinese Academy of Medical Sciences
* KPS ≥70
* NRS score ≥2
* Cervical or thoracic esophageal cancer histologically proved esophageal cell carcinoma
* Normal organ and marrow function as defined below:

Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 3,500 G/L; Neutrophil: greater than or equal to 1,500 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine within normal upper limits; BUN within normal upper limits; AST/ALT: less than or equal to 1.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; Alkaline phosphatase :less than or equal to 1.5 times the upper limit

* Informed consent

Exclusion Criteria:

* Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer
* Any prior chemotherapy or other cancer treatment prior to this protocol
* With any distant metastasis in liver, lung, bone, CNS or peritoneal transplantation
* History of allergic reactions attributed to contrast medium, similar chemical or biologic complex
* Existing esophageal fistula, perforation and cachexia
* Existing active infection such as active tuberculosis and hepatitis
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
* Participation in other clinical trials currently or within 4 weeks of selection
* Pregnant or lactating females
Medtronic Reveal LINQ™ In-Office 2 (RIO 2) Study United States

The primary purpose of the RIO 2 study is to demonstrate that when the Reveal LINQ™ insertable cardiac monitoring (ICM) system that records subcutaneous ECG insertion procedure performed in the in-office setting is as safe as LINQ™ insertions performed in the traditional hospital setting (operating room, cardiac catheterization or electrophysiology (EP) laboratory).

RIO 2 is a two arm, randomized, prospective, un-blinded, multicenter, non-significant risk study. The primary objective for RIO 2 will be assessed by randomizing subjects to receive their LINQ™ insertion in the office setting or in the traditional hospital environment. Moving the LINQ™ insertion procedure to the office setting is not expected to decrease the complication rate compared to in hospital insertion procedures, however, moving the LINQ™ insertion procedure out of the traditional hospital setting may benefit the patient and reduce the burden to the healthcare system.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is indicated for continuous arrhythmia monitoring with a Reveal LINQ™ Insertable Cardiac Monitor
2. Patient is 18 years of age or older
3. Patient is willing to undergo ICM insertion procedure outside of the cath lab, OR, EP lab setting with only local anesthetic
4. Patient is willing and able to provide consent and authorize the use and disclosure of health information
5. Patient is willing and able to comply with the protocol including the required follow-up

Exclusion Criteria:

1. Patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure
2. Patient has reduced immune function or is otherwise at high risk for infection per physician discretion
3. Current therapy with immunosuppressive agents or chronic steroid use e.g. Prednisone greater than 20mg per day
4. Patient requires hemodialysis
5. Patient with active malignancy or history of chemotherapy or radiation treatment Patient has had a recent (within 30 days) or an active infection including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia.
6. Patient has had major surgery (in the past 6 months)
7. Patient has undergone a procedure which required central venous or intraarterial access (e.g. AF/VT ablation, EP study, coronary angio) within the last 3 months or is scheduled for such a procedure while enrolled in the study.
8. Prior history of surgical infection, prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months.
9. Patient has a central venous port, an atrio-venous fistula, or a prosthetic valve
10. Patient requires conscious or moderate sedation to receive LINQ™
11. Patient is already implanted with a loop recorder
12. Patient is implanted or indicated for implant with a pacemaker, ICD, CRT device
13. Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
14. Patient's life expectancy is less than 6 months
15. Patient is pregnant
Erector Spinae Plane Block For Analgesia Following Video-Assisted Thoracoscopic Surgery

Erector spinae (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It is meant to block the ipsilateral trunk. The aim of the study is to demonstrate the efficacy of the ESP block as postoperative analgesia for VATS surgery.

A growing number of thoracic surgeries are performed with a minimally invasive approach called video-assisted thoracoscopic surgery (VATS). VATS has reduced the incision size, the postoperative pain and the morbidity associated with thoracic surgery. Optimal postoperative analgesia for VATS surgery remains an open issue because although it is a lot less painful than a thoracotomy, VATS is a painful procedure with the associated risk of developing chronic pain. Adequate relief leads to early mobilization, potentially improves respiratory functions, and decreases the global stress response secondary to the surgery.

Invasive analgesic techniques such as epidural or paravertebral block for VATS surgery are frequently being replaced for less invasive plane blocks to provide postoperative analgesia. At our center, anesthesiologists tend to perform epidurals only when there is a significant risk of transitioning to an open thoracotomy. Patient controlled analgesia (PCA), remains the usual analgesic technique for VATS surgery at our institution.

Erector spinae (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It is meant to block the ipsilateral trunk. The aim of the study is to demonstrate the efficacy of the ESP block as postoperative analgesia for VATS surgery.

Eligibility Criteria:
Inclusion Criteria:

• Patients \> 18 years old with to ASA status I-III, undergoing VATS for lobectomy or wedge.

Non-inclusion Criteria:

* \< 18 years old
* BMI \> 35
* Chronic pain history with regular opioid and/or gabapentinoids use during the 2 weeks before surgery
* Regular marijuana use
* History of thoracic surgery on the operated side
* Epidural analgesia preferred due to an anticipated high risk of conversion to thoracotomy
* Unable to communicate with the investigators
* Receiving anticoagulation or experiencing any bleeding disorder
* Surgery for empyema and sympathectomy
* Known allergy to local anesthetics, fentanyl or hydromorphone
* Active infection at injection sites
* Preexisting neurological deficit or psychiatric illness
* Severe cardiovascular disease
* Liver failure
* Renal failure (estimated glomerular filtration rate \<15 mL/ min/1.73 m2)
* Pregnancy

Exclusion Criteria:

* Perioperative conversion to thoracotomy
* Severe intra- or postoperative bleeding
* Patients requiring postoperative mechanical ventilation
* Technical inability to proceed with the blocks