cyrilzakka/clinical-trials huggingface dataset:
Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal LINQ insertable cardiac monitor and accompanying system in patients indicated for an insertable cardiac monitor

The Reveal LINQ Usability Study is a prospective, non-blinded, non-randomized, multi-center clinical trial. Subjects will transmit device data via manual interrogation on a weekly basis during the first month and will be evaluated in the office at 1-month post-implant, in addition to an automatic nightly wireless data transmission using the MyCareLink® home monitor. All subjects will be requested to wear an external Holter for 48 hours at approximately 4 weeks post-insertion. Follow-up visits will continue at 6 and 12 months post-implant, with monthly manual interrogations. Subjects will be exited at their 12 month follow-up visit. The overall study will be conducted in 2 phases which differ primarily on inclusion criteria: Phase I subjects (initial 30 subjects) will have any indication for an ICM, Phase II subjects (all subjects following the initial 30 subjects) will be atrial fibrillation (AF) pre-ablation patients. The study will assess functionality of the Reveal LINQ device by assessing sensing performance and data transmission.

Eligibility Criteria:
Inclusion Criteria:

* Subject is willing to sign and date the consent form.
* Subject is indicated for a Reveal device within the existing market approved indications
* Phase I (initial 30 subjects): Any indication for a Reveal LINQ Device
* Phase II (after the initial 30 subjects): Subject has atrial fibrillation and is indicated for and identified as an AF pre-ablation candidate\*

  \*Note: Atrial fibrillation must be documented in the subject's medical history.
* Subject has a life expectancy of 18 months or more.
* Subject is willing and able to set up and utilize MyCareLink® home monitor and be remotely monitored (i.e., Medtronic CareLink® Network)
* Subjects who are female of childbearing potential (last menses less than 1 year prior to enrolment) must:
* have a negative pregnancy test at enrollment.
* not be breastfeeding.
* either be surgically sterile, postmenopausal (cessation of menses for at least 1 year), or agree to use a medically accepted, highly effective method of contraception during the entire duration of the study.

Exclusion Criteria:

* Subject has an active implanted cardiac medical device (e.g., IPG, ICD, CRT, etc).
* Subject is unwilling or unable to comply with the study procedures
* Subject is legally incapacitated and unable to provide written informed consent.
* Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological diagnosis)
* Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager.
* Local law prohibits participation (e.g., minor status as specified by local law)
Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

This study is designed to investigate whether adjuvant radiotherapy after complete resection has a better survival for stage II or III thymoma.

It is confirmed by many studies that patients of thymoma with complete resection have better prognosis than those with either incomplete resection or without surgery. However,whether patients with stage II or III thymoma could benefit from adjuvant radiotherapy after complete resection remains controversial. The purpose of this study is to investigate whether adjuvant radiotherapy after complete resection can improve survival for stage II or III thymoma.

Eligibility Criteria:
Inclusion Criteria:

18\~75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed masaoka stage II or III thymoma; Have adequate bone marrow, hepatic, and renal function; Patients receive complete resection within 3 months; Written informed consent.

Exclusion Criteria:

Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; Active clinical pulmonary infection; Pregnant or nursing.
Effectiveness of Mobile-phone Career Competencies Intervention for Malaysian Public Sector Managers

This study aims to evaluate the effectiveness of a user and expert centric mobile phone-based career intervention program of career competencies among Malaysian public managers.

This study aims to evaluate the effectiveness of a user and expert centric mobile phone-based career intervention program of career competencies among Malaysian public managers. In this study, the Social Cognitive Career Theory (SCCT) is adopted as the framework to develop mobile phone-based intervention for career competencies. There is two phases in the study whereby in Phase 1, a qualitative approach developing the components in the career intervention module and mobile phone application features. Phase 2 that evaluates the mobile phone-based career intervention program. Validation will be conducted to meet the objectives of (i) the usability of the mobile communication career intervention application (survey), and (ii) evaluation of the effectiveness of the intervention program for career competencies delivered through mobile phone application (randomized controlled trial). The primary outcome of this study is career competencies. The career competencies score will be compared between participants in the intervention and control group at the baseline, and follow-ups at week four and week 12 respectively, using mixed design ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* Must be Administrative and Diplomatic Officers (ADO) who use mobile application (Android)
* Must be in Grade 41
* Informed consent obtained

Exclusion Criteria:

* The officer that use IPhone
* The officer that involved in disciplinary issues
Modified Limberg Procedure Versus Lateral Advancement Flap With Burrow's Triangle Procedure in the Treatment of Pilonidal Sinus

The investigators want to share our study that is the "Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burrow's Triangle in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus.

Pilonidal Sinus Disease (PSD) is a common and chronic entity of the young adults. So far, many options regarding the surgical treatment of the disease has been described, the consensus about treatment stills remains unsatisfactory, as all the surgical methods have encountered with different rate of recurrences. Our aim in this study is to compare the widely used technique in pilonidal sinus surgical treatment Modified Limberg Flap Transposition and relatively less used technique Lateral Advancement Flap Transposition with Burrow's Triangle, in the terms of VAS scores, recurrence, postoperative complications, surgical site infections in the first 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Pilonidal Sinus Disease
* Must be able to suitable for the surgery

Exclusion Criteria:

* Patients with Recurrent Pilonidal Sinus disease
* Patient whom is not suitable for surgery
"Neutral Head Position" and "Head-lift Position" for Orotracheal Intubation With "Trachway" Intubating Stylet in Adults

The purpose of this study is to investigate two different patient's head and neck positions(neutral head position and head-lift position) for the effectiveness of orotracheal intubation with using the "Clarus Video System (Trachway®)" intubating stylet.

The sniffing position has traditionally been considered the optimal head position for direct laryngoscopy, However, it may aggravate cervical spine injury. The Trachway® video stylet is an intubating device that may avoid cervical movement during intubation. Nonetheless, the effectiveness of limited neck movement in patients with neutral head or head-lift position using the Trachway® video stylet remains unclear. The purpose of this study was to compare the intubation time of the two positions with the Trachway® video stylet.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for various surgeries requiring general anesthesia with tracheal intubation
* American Society of Anesthesiologists(ASA) physical status classification I-III

Exclusion Criteria:

* pneumothorax
* room air saturation by pulse oximeter saturation less than 96%
* vocal cord palsy
* craniofacial anomaly
* congenital upper airway anomaly
* upper airway disease
* cervical spine pathology
* head and neck tumor status post radiotherapy
* an increased risk of regurgitation or pulmonary aspiration
* a history of difficult tracheal intubation
Optical Coherence Tomography Angiography Compared to Maternal Doppler in Screening for Hypertension in Pregnancy

Pregnancy related hypertension is one of the most prevalent obstetric complications. The aim of the study is to evaluate the validity and sensitivity of OCT angiography in prediction of pregnancy induced hypertensive disorders in comparison to maternal doppler in the first and second trimesters of pregnancy


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in the first and second trimesters

Exclusion Criteria:

* pregnant females with associated systemic vascular disease as diabetes, SLE
Analgesic Efficacy of Trans-muscular Quadratus Lumborum Block After Unilateral Inguinal Hernia Repair

A significant component of pain experienced after abdominal surgery is related to incision of the abdominal wall and adequate analgesia can be a challenge.

The ultrasound-guided (USG) quadratus lumborum block QLB was first described by Rafael Blanco in a presentation at ESRA 2007 at the XXVI Annual ESRA Congress in Valencia, Spain. Blanco described a potential space posterior to the abdominal wall muscles and lateral to the quadratus lumborum muscle where Local anesthetics can be injected. This technique provide analgesia after abdominal surgery due to spread of LA from its lumbar deposition cranially into the thoracic paravertebral space where lateral and anterior cutaneous branches from Th7 to L1 can be blocked . This was proved by Carney et al. who found traces of contrast agent in the TPVS following application of this block A novel USG QL block is the transmuscular approach which relies on clearly identifiable sonographic bony landmarks, Where the needle is advanced through the QL muscle, penetrating the ventral proper fascia of the QL muscle and LA is finally injected between the QL and Psoas major (PM) muscle. The transmuscular QL block does not result in redundant antero-lateral spread of the injectate. This may indicate that lower volumes of LA potentially can be used and yet provide extensive thoracolumbar anesthesia.

This study was designed to compare the duration of analgesia provided by the original QLB and transmuscular QLB in patients undergoing surgical repair of unilateral inguinal hernia.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II, scheduled for unilateral inguinal hernia repair

Exclusion Criteria:

* Patients with systemic hypertension, cardiovascular disease, cerebrovascular insufficiency, coagulation abnormities, renal or hepatic insufficiency, infection at the injection site, strangulated hernia and hypersensitivity to the local anesthetics
Assessing the Impact of Health Information Exchange (HIE) on Healthcare Utilization

The purpose of this study is to assess usage of the virtual health record (VHR), and determine the effects of this technology on healthcare utilization.

National efforts are underway to support the implementation of technology that enables providers to electronically access and view community-wide clinical information for their patients, which has the potential to improve quality of care and reduce health care costs by providing timely and complete health information at the point of care. However, few empirical studies have been conducted to evaluate the economic effects of this technology. Along with other stakeholders, New York State is funding regional health information organizations (RHIOs) to deploy a virtual health record (VHR), which is technology that enables providers to electronically access community-wide clinical data for patients who have consented to have their clinical data accessed via a web portal. RHIOs bring together multiple stakeholders, including physician practices, hospitals, pharmacies, and laboratories, for the purpose of exchanging clinical information electronically across communities. The investigators will conduct a multi-RHIO retrospective pre-post, cohort study of adult patients who have consented to have their clinical data viewed by their providers using the VHR portal. Examining the effects of electronically accessing clinical data on healthcare utilization across multiple settings and communities can help inform the national health IT initiative that is underway and allow assessment of the economic value of these technologies.

Eligibility Criteria:
Inclusion Criteria:

* Patients that are aged 18 and older who have consented during the year 2009 to allow their provider use of their VHR data and had at least one visit to a healthcare provider that is a VHR user within 6 months after they consented to allow their provider use of their VHR data. (Note: we only wish to include individuals who have had the opportunity for their data to be viewed using the VHR web portal). Providers who are participating in the Regional Health Information Exchange (RHIO).

Exclusion Criteria:

* Patients and providers who do not meet the above criteria
Prospective Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients

The purpose of this study is to determine if placement of a forced-air warming device prior to institution of regional anesthesia improves perioperative temperature control in patients undergoing total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing total hip arthroplasty under neuraxial anesthesia,
* age 55-85,
* BMI 18-40

Exclusion Criteria:

* allergy to local anesthetics,
* patients electing to have general anesthesia for their total hip arthroplasty,
* pregnancy,
* prisoners,
* patients unable to give informed consent,
* English as a second language,
* active infectious or febrile illness (measured temperature \> 37.5 degrees Celsius).
A Study of Adavosertib (MK-1775) in Combination With Topotecan/Cisplatin in Participants With Cervical Cancer (MK-1775-008)

This study will be conducted in two parts. Part 1 will determine whether administration of adavosertib in combination with topotecan and cisplatin is generally well-tolerated and causes clinical objective responses in patients with cervical cancer. Part 1 will also define the recommended Phase 2 dose and maximum tolerated dose (MTD) of the combination of adavosertib with topotecan and cisplatin. Part 2 of the study will evaluate whether treatment with adavosertib in combination with topotecan and cisplatin causes an improvement in progression-free survival (PFS) compared to treatment with topotecan and cisplatin alone and will further evaluate the tolerability of the combination treatment. The primary hypothesis is the combination of adavosertib, topotecan and cisplatin causes objective radiological responses (assessed per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria) in ≥30% of participants. Due to the early termination of the study by the sponsor, no participants were enrolled in Part 2 of the study.


Eligibility Criteria:
Inclusion Criteria:

* Has advanced, metastatic, and recurrent squamous cell, adenosquamous, or adeno-carcinoma of the uterine cervix (Stage II - IVb)
* Has received cisplatin in combination with radiation as initial or adjuvant treatment for their cervical cancer
* Has not received any other treatment for their cancer following the cisplatin-based chemo-radiation or targeted therapy except non-cytotoxic targeted therapy
* Recurrence must be at least 6 months post cisplatin-based chemotherapy
* Has measurable disease
* Performance status on the Eastern Cooperative Oncology Group (ECOG) Performance Scale is less than or equal to 1
* Has a negative pregnancy test within 72 hours of the first dose of study medication

Exclusion Criteria:

* Has had chemotherapy, radiotherapy, or biological therapy within 6 months of entering the study
* Has a history of vascular thrombotic events or vascular reconstruction
* Has active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has a primary CNS tumor
* Requires the use of medications or products that are metabolized by, or inhibit or induce CYP3A4 (Cytochrome P450 3A4)
* Is expecting to reproduce within the duration of the study or is pregnant or breastfeeding
* Is known to be Human Immunodeficiency Virus (HIV)-positive
* Has known active Hepatitis B or C
* Has a known history of interstitial lung disease or pulmonary fibrosis
* Has symptomatic ascites or pleural effusion
* Has a clinical history suggestive of Li-Fraumeni Syndrome
Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. CT-guided radiofrequency ablation may be effective treatment for lung cancer.

PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have refractory or advanced lung cancer.

OBJECTIVES:

* Determine the safety and toxicity of radiofrequency ablation in patients with refractory or advanced pulmonary malignancies.
* Determine the efficacy of this treatment, in terms of local control, in these patients.
* Determine whether CT scan is a reasonable imaging assessment tool for treatment delivery and follow-up in these patients.

OUTLINE: Patients undergo percutaneous CT-guided radiofrequency ablation directly to the tumor over 2 hours.

Patients are followed at 1, 3, 6, and 12 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a primary or secondary intrathoracic malignancy

  * Any cell type or origin
  * Involving the intrapulmonary, mediastinal, or pleural/chest wall
  * Inoperable primary or metastatic cancer to the lung
* Refractory to or not amenable to conventional therapy (e.g., surgery, chemotherapy, or radiotherapy)
* Single or multiple lesions that are non-contiguous with vital structures or organs such as:
* Trachea
* Heart
* Aorta
* Great vessels
* Esophagus
* Less than 5 cm in largest dimension
* Accessible via percutaneous transthoracic route
* Hepatic:

  * Coagulation profile normal
Spinal Cord Stimulation Research Study

The purpose of this study is to characterize subjects' response to spinal cord stimulation with postural changes.


Eligibility Criteria:
Inclusion Criteria:

* Be ambulatory
* Be 18 years of age or older
* Have chronic low back pain and/or leg pain due to neuropathic causes
* Be implanted with the Restore or Restore Advanced system for greater than or equal to 3 months
* Be implanted with percutaneous thoracic leads
* Have stable pain control
* Adjust stimulation parameters manually on a regular basis
* Be willing and able to complete protocol requirements
* Be willing and able to provide written informed consent
* Be male or nonpregnant female

Exclusion Criteria:

* Plan to enroll in another clinical study during participation in this study, or currently enrolled in another clinical study
* Be morbidly obese
* Had pain-related surgery in the previous 12 weeks of enrollment or intend to undergo surgery during the period of the study
Clinical Validation of a Fractional Administration Device for Holmium-166 SIRT

To investigate the in vivo performance and safety of a novel medical device for the injection of holmium-166 microspheres during radioembolization. The main potential advantage of this device is that it allows for injection of a during treatment determined dose, which is not possible with the current administration tool.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of hepatocellular carcinoma or liver metastases originating from colorectal cancer.
2. At least one lesion of ≥10 mm in the longest diameter on contrast-enhanced MRI or contrast-enhanced CT
3. Patient is eligible for SIRT as determined by the tumour board (in Dutch: MDO)
4. Patient has a life expectancy of 12 weeks or longer
5. Patient has a WHO performance score of 0-2

Exclusion Criteria:

1. Significant extrahepatic disease (2x sum of diameters of lesions outside the liver \> sum of lesions inside the liver)
2. Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment
3. Serum bilirubin \> 2.0 x the upper limit of normal
4. ALAT, ASAT, alkaline phosphatase (AF) \> 5x the upper limit of normal
5. Glomerular filtration rate (GFR-MDRD) \<35 ml/min
6. Leukocytes \<4.0 \* 109/L or platelet count \<60 \* 109/L
7. Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia.
8. Pregnancy or breast feeding
9. Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum
10. Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc)
11. Portal vein thrombosis of the main branch (more distal branches are allowed)
12. Evidence of clinically relevant, untreated grade 3 portal hypertension
13. Untreated, active hepatitis
14. Body weight \> 150 kg (because of maximum table load)
15. Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist)
16. Lung shunt \> 30 Gy, as calculated using scout dose holmium-166 SPECT/CT
17. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted.
Relationship Between Spinopelvic Parameters and Clinical Symptoms of Low-grade Lumbar Isthmic Spondylolisthesis

This was a retrospective study.PI and LL greatly influence IS and its progression. However, relationships between the spinopelvic parameters and clinical symptoms of patients with IS were not fully investigated in previous studies. Investigators hypothesized that spinopelvic parameters might be related to the clinical symptoms of IS patients. Therefore, the purpose of the present study was to investigate whether differences in spinopelvic parameters, especially spinopelvic alignment, may be associated with the clinical symptoms of low-grade IS patients.

Isthmic spondylolisthesis (IS) is one of the most common types of spondylolisthesis, and spinopelvic parameters are closely related to the clinical symptoms of spinal diseases. In this study, investigators attempted to investigate the relationship between spinopelvic parameters and clinical symptoms of patients with low-grade (Meyerding grade I-II) isthmic spondylolisthesis (IS).

A total of 120 patients with low-grade IS and 106 asymptomatic adults were included in this study. Sex, age and body mass index (BMI) were also collected. Various spinopelvic parameters were evaluated in whole-spine standing-position X-rays. The following spinopelvic parameters were measured: pelvic incidence (PI), sacral slope (SS), pelvic tilt (PT) and lumbar lordosis (LL). The clinical symptoms of the IS patients were assessed with the Japanese Orthopaedic Association (JOA) score and the visual analogue scale (VAS). Investigators compared spinopelvic parameters between the asymptomatic adults and the IS patients. Additionally, investigators investigated correlations between spinopelvic parameters and clinical symptoms.

Eligibility Criteria:
Inclusion Criteria:

* isthmic spondylolisthesis subjects had spondylolisthesis at L4 or L5 (Meyerding grade I-II) with whole-spine standing lateral images

Exclusion Criteria:

* spondylolisthesis of other types (Degenerative, dysplastic, etc.);
* Lumbar infection and/or tumor diseases;
* A previous history of lumbar fusion surgery.