cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection

The purpose of this study is to evaluate the diagnostic utility of BIOTRONIK's subcutaneous cardiac rhythm monitor for the detection of AF prior to an ablation procedure.

BIO-Precision is a post-market study investigating the utility of atrial fibrillation (AF) detection using BIOTRONIK's subcutaneous cardiac rhythm monitor, BIOMONITOR. The purpose of this study is to evaluate the diagnostic utility of BIOTRONIK's BIOMONITOR for the detection and confirmation of AF prior to an ablation procedure. Study population includes patients with paroxysmal AF being evaluated for an AF ablation. Holter monitoring for 48 hours will be performed after insertion of the BIOMONITOR but prior to AF ablation. This study will enroll up to 100 subjects, to obtain 60 usable Holter recordings, at 5 study sites within the United States (U.S.). Study subjects will be followed for three months after the completion of a 48 hr Holter monitor.

Eligibility Criteria:
Inclusion Criteria:

* Meet the indications for subcutaneous cardiac rhythm monitor insertion according to local regulations
* Patient is able to understand the nature of the study and provide written informed consent
* Inserted within the prior 30 days, or scheduled for insertion within 14 days, with BIOTRONIK's most current subcutaneous cardiac rhythm monitor
* Diagnosed with paroxysmal atrial fibrillation and being evaluated for an AF ablation
* Agree to wearing a 48 hr Holter monitor
* Able and willing to complete all study visits at the study site for the study duration
* Able and willing to use a CardioMessenger® and accepts Home Monitoring concept
* Age greater than or equal to 18 years

Exclusion Criteria:

* Patient meets none of the indications for a BIOMONITOR
* Patient is planned to have an ablation prior to BIOMONITOR insertion or 48 hr Holter monitoring visit
* Patient is currently diagnosed with long-standing persistent or permanent AF
* Patient is enrolled in another study that may change or alter the cardiac rhythm that occurs prior to the completion of the Holter
* Currently indicated for or implanted with a pacemaker, ICD device, or hemodynamic monitoring system
* Life expectancy less than 6 months
* Patients reporting pregnancy at the time of enrollment

For patients enrolled after BIOMONITOR insertion:

• R-wave sensing \<0.25 mV according to the most recent remote or in-person device interrogation available prior to enrollment

After the pre-Holter observation period but prior to 48 hr Holter monitoring initiation, confirm the absence of the following exclusion criteria based on the remote interrogation collected at the end of the observation period:

* No AF episodes observed or transmitted during pre-Holter observation period
* R-wave sensing \<0.25 mV during pre-Holter observation period as reported by the 24 hr mean or mean value since last follow-up
Lifitegrast 5% Ophthalmic Solution and Contact Lens Dryness

The most common reason for contact lens discontinuation is contact lens discomfort. The investigators believe that inflammation plays a role in contact lens discomfort and the use of lifitegrast 5% ophthalmic solution may reduce end of the day contact lens discomfort. This study will enroll 21 contact lens users who will be receiving lifitegrast 5% ophthalmic solution and monitor the contact lens discomfort for a 8 week period while.

Contact lens discontinuation is mostly associated with ocular discomfort. Most patients identifying dryness as the primary reason for contact lens discontinuation. Patients often resort to contact lens solutions, lubricating and/or rewetting drops to temporality improve their contact lens wearing experience. Clinicians often resort to changing contact lens designs, solutions and wearing modalities to improve comfort.

Contact lens discomfort is believed to be mediated by many factors including inflammation and very similar in clinical symptoms of dry eye disease and symptoms of dryness.

Lifitegrast 5.0% ophthalmic solution is an FDA approved solution for the management of signs and symptoms of dryness of dry eye disease. Studies have shown lifitegrast 5% ophthalmic solution may work by blocking the interaction between ICAM-1 and LFA-1 leading to a decrease in activation and recruitment of T-cells, an initial step in inflammation.

The safety and efficacy of Xiidra has been studied in four, 12 week clinical trials involving over 2,100 patients for signs (https://www.xiidra-ecp.com/efficacy-treating-signs) and symptoms (https://www.xiidra-ecp.com/efficacy-symptom-improvement).

The purpose of this open label, interventional study is to examine the effect of lifitegrast 5% ophthalmic solution in contact lens wearing experience by using the CLDEQ-8.

Eligibility Criteria:
Inclusion Criteria:

1. Agree with study protocol
2. Provide Informed Consent
3. Age 21 or over
4. Previous 10 months history of self-assessed comfortable wear samfilcon A contact lenses

Exclusion Criteria:

1. Unable or unwilling to comply with study protocol
2. Unable of unwilling to provide Informed consent
3. Self-reported symptomatic intolerance of contact lenses
4. History of an active anterior segment, eyelids, eyelashes, corneal or conjunctival pathology, ongoing ocular infection, inflammation or any other ocular problem that would require management with additional topical ophthalmic medications.
5. Have had a history of corneal surgery (corneal transplants, LASIK, PRK).

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Effect of Continuous Glucose Monitoring on Course of Glucose in Type 1 Diabetes

The objective of this cross over study is to access if continuous glucose monitoring (CGMS) with a real time feed back and hypoglycemic as well as hyperglycemic glucose alerts vs. only retrospective analysis of glucose values is able to improve course of glucose with special regard to time spent in hypoglycemic glucose ranges in type 1 diabetic patients with impaired hypoglycemia awareness or a history of severe hypoglycemia. The second objective is to access satisfaction with CGMS during both conditions

The objective of this cross over study is to access if continuous glucose monitoring (CGMS) with a real time feed back and hypoglycemic as well as hyperglycemic glucose alerts vs. only retrospective analysis of glucose values is able to improve course of glucose with special regard to time spent in hypoglycemic glucose ranges. The second objective is to access satisfaction with CGMS during both conditions.

This study is conducted in an inpatient setting with type 1 diabetic patients. Partisans are asked to have twice a continuous glucose measurement with the GlucoDay System (Menarini Diagnostics). Each measurement period is limited to maximal 48 hours. In one condition the have real time access to current glucose values and alerts are given if glucose is dropping below 70 mg/dl or exceeding 180 mg/dl. During the other condition the participants are blind against their current glucose values and no alerts are given. Glucose course is retrospectively analyzed.

The order of these two conditions is randomized.

Expected outcome:

The primary outcome variable is the daily time spent in hypoglycemic range in type 1 diabetic patients with and without impaired hypoglycemia awareness or a history of severe hypoglycemia. Additionally the patients will also complete questionnaire about satisfaction with CGMS, diabetes related distress, treatment satisfaction, depressive and anxiety symptoms which belongs to the secondary variables.

Inclusion criteria:

* Type 1 diabetes
* Age \> 18 years
* Informed consent

Exclusion criteria:

* Diagnosis and/or treatment of a current psychiatric disease
* Severe late complications

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes
* Age \> 18 years
* Informed consent

Exclusion Criteria:

* Diagnosis and/or treatment of a current psychiatric disease
* Severe late complications
Study of the in Vivo Expression of MU Opioid Receptors Using PET and the Selective Tracer [C-11] Carfentanil in Normal Weight and Obese Subjects

Positron emission tomography (PET) is a nuclear medicine technique that allows the measurement, in vivo in humans, with a non-invasive method, of the regional distribution of substances marked with positron emission isotopes such as C-11, in different districts bodily. Using this method it is therefore possible to directly measure at the level of the brain the distribution of receptors, enzymes, reuptake sites, as well as their interaction with various classes of drugs and the related modifications that may be present during the pathology.

The evaluation of the endogenous opiate receptor system will be implemented by comparing the in vivo binding maps of 11C carfentanil in the two groups of subjects under examination (normal weight, NOR and obese, OB, based on body mass index, BMI); in fact, experimental data deriving from previous studies support the hypothesis that the basis of obesity and incorrect eating behaviors is a dysregulation of the endogenous ligand-mu opioid receptor interaction. The comparison of the data deriving from the analysis of the PET exams performed on the two groups of subjects will therefore allow us to evaluate the alterations of the opioid system possibly present in obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 40 years;
* structured sports activity \< 2 hours per week

Exclusion Criteria:

* drug allergy;
* clinical evidence of neuropsychiatric pathologies.
The Comparison of Comprehensive Multi-disciplinary Program and Conventional Care Program on Fragility Fracture Elderly

Fragility fractures are one of the commonest injuries among elderly people in Hong Kong and account for 12% of the disease burden in elderly aged 65 or above.

A good management healthcare program and training helps elderly to restore full functional level and prevent re-fracture in the following 2 years after primary fracture, but Hong Kong lacks of such program. Some reports from other countries pointed out a well-organized multi-disciplinary management programs are cost-effective to identify and treat osteoporosis, reduce the fracture rate, improve quality of life and raise awareness of fragility fracture.

This study aims to compare the cost-effectiveness of multi-disciplinary management program with conventional care controls. The clinical effectiveness outcomes (re-fracture rate, fall rate, mortality, mobility, quality of life and specialist follow-up time) of the fragility hip fracture patients in New Territories East receiving the proposed management program will be compared with those from Kowloon Central with usual care as controls. The findings will provide useful data for the policy maker to evaluate the current clinical service for fragility fracture patients and consider the implementation of new multi-disciplinary management program into our healthcare system.


Eligibility Criteria:
Inclusion Criteria:

* Fragility hip fracture patients within age 65-90

Exclusion Criteria:

* Taking medication affecting bone metabolism or intensive exercise training;
* Those living in old age homes or anyone who is not able to comply with our program
Oral Treatment With BIBF 1120 Together With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer

The primary objective of this study was to determine the safety and Maximum tolerated dose (MTD) of BIBF 1120 combination therapy with docetaxel and prednisone in patients with hormone refractory prostate cancer. Secondary objectives were to characterise the pharmacokinetic profiles of BIBF 1120 and docetaxel and possible Pharmacokinetic (PK) interactions between BIBF 1120 and docetaxel and to obtain preliminary information on anti-tumour activity.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically-proven metastatic prostate adenocarcinoma
2. Progression after hormonal therapy
3. Progressive disease as follows:

   * Increase of PSA \> 5 ng/ml on two occasions despite castrate levels of testosterone before screening
   * AND/OR Progressive measurable disease (RECIST criteria)
   * AND/OR Progressive bone metastases (presence of new lesion(s) on a bone scan)
4. Life expectancy of at least three months
5. ECOG performance status ≤ 2
6. Patient written informed consent obtained prior to any trial procedures and that is consistent with ICH-GCP (International Conference on Harmonization - Good Clinical Practice) guidelines.

Exclusion Criteria:

1. Prior treatment for hormone refractory prostate cancer (HRPC) including chemotherapy, biologic response modifier therapy, or any investigational drug
2. Participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
3. Major injuries and surgeries within the past 4 weeks. Planned surgical procedures during the trial
4. Brain metastases
5. Radiotherapy superior to 30% of the medullar volume
6. Other malignancy diagnosed within the past 5 years (other than non-melanomatous skin cancer)
7. Gastrointestinal abnormalities that would interfere with intake or absorption of the study drug, such as a requirement for intravenous alimentation, prior surgical procedures affecting absorption, treatment for peptic ulcer disease within the last 6 months, active gastrointestinal bleeding unrelated to cancer (as evidenced by either hematemesis, or melena in the past 3 months and without endoscopic documented resolution), or malabsorption syndromes
8. Previous history of stroke, angor pectoris, ischemic cardiomyopathy, cerebral ischemia, arteritis in the past 6 months
9. Recent history of hemorrhagic or evolutive thrombotic event (including transient ischemic attacks) in the past 6 months
10. Patients who require full-dose anticoagulation or heparinization
11. Absolute neutrophil count (ANC) \< 1,500/μl, platelet count \< 100,000/μl, or hemoglobin \< 8 mg/dL
12. Total bilirubin \> upper limit of normal (ULN); alanine amino transferase (ALT) and/or aspartate amino transferase (AST) \>1.5 X ULN
13. Serum creatinine \> 1.5 mg/dL (\> 132 μ mole/L, SI Unit equivalent)
14. Known or suspected active alcohol or drug abuse
15. Patients unable to comply with the protocol
Double GnRH Antagonist Daily Dose in Hyperresponding IVF/ICSI Cycles May Prevent the OHSS

The possibility to prevent the early ovarian hyperstimulation syndrome (OHSS) by doubling the daily dose of GnRH-antagonist in women stimulated with the antagonist protocol who are at risk for OHSS was evaluated. Thirty-eight women of a study group who underwent ovarian stimulation using the GnRH-antagonist protocol and might have had their cycle cancelled because of OHSS were compared to 76 women of a control group. All cases of the study group were IVF women presenting a rapid rise of E2 ≥ 3500 pg/ml on the 7th day of stimulation or later while the follicles (\> 12mm) were \> 15 in total and the biggest one was ≤ 16mm in diameter. By decreasing the rFSH dose to 100IU a day and adding an additional dose of GnRH-antagonist (0.25 twice a day), estradiol levels were lowered or reached a plateau before hCG was given. A marked decrease or plateau of estradiol levels was observed the day of oocyte retrieval while the pregnancy rate was not adversely affected when compared with an optimum ovarian response cycles. None of the women were cancelled or developed OHSS.

In overresponding IVF cycles, doubling the usual GnRH-antagonist daily-dose during the ovarian stimulation, the estradiol rise could be blocked while a minimal follicular stimulation may continue without the risk of OHSS or adversely affect pregnancy rate.


Eligibility Criteria:
Inclusion Criteria:

* Women stimulated with the antagonist protocol who are at risk of ovarian hyperstimulation syndrome

Exclusion Criteria:

* Has chosen other preventive protocols (coasting and/or cryopreservation)were excluded
Hyaluronic Acid Hydro-dissection Use in Idiopathic Carpal Tunnel Syndrome Guided by Ultrasonic Study

carpal tunnel syndrome (CTS) is the most common compression syndrome in the upper extremities, CTS is characterized by typical anatomic changes, the most probable swelling of the median nerve in the proximal part of the CT.

Local infiltration of corticosteroids easily leads to atrophy of the median nerve, subcutaneous fat, and systematic complications, surgical treatment decision is always taken by the patient who sometimes wants to delay or avoid the surgery because of psychological or medical concerns, It would be interesting if low molecular weight sodium hyaluorinate injection is used as an alternative conservative treatment of CTS. This study aims to investigate if, and to what extent, hydro-dissection using 1% lidocain followed by injection of Sodium hyaluronate versus 1% lidocain followed by injection of 40 mg of triamcinolone acetonide, under ultrasound guidance.

60 CT patients, blindly divided into two groups. Both will underwent median nerve hydro-dissection using 1% lidocain followed by group I injection of Sodium hyaluronate and group II injection of 40 mg of triamcinolone acetonide, under ultrasound guidance. Baseline VAS pain and nerve conduction study, patient satisfaction, and therapeutic duration, will be determined in 2nd week, 3rd and 6th month after the procedure. US measurements of the median nerve cross-sectional area (CSA) in the CT inlet will be compared pre and post procedure in 6th month and use NCS results as the gold standard diagnostic test.

Eligibility Criteria:
Inclusion Criteria:

* patients with mild or moderate carpal tunnel diagnosed by nerve conduction study

Exclusion Criteria:

* secondary carpal tunnel to any other disease and peripheral neuropathy patients
The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe

This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.


Eligibility Criteria:
Inclusion Criteria:

* Be female, greater or equal to 18 years of age
* Be willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant
* Be willing to undergo mastectomy with healthy, well vascularized skin flaps anticipated by the surgeon
* Be in good health other than breast pathology and be suited to general anesthesia and planned treatments

Exclusion Criteria:

* Have undergone breast radiation treatment and/or is preoperatively evaluated to require radiation treatment to the breast area during the course of the study
* Have a known allergy to silk
* Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
* Have undergone previous breast surgery with the exception of mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation
* Have had a prior soft tissue support device implanted in the breast
* Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
rTMS Study to Improve Functional Performance for Patients With Stroke

To use repetitive transcranial magnetic stimulation (rTMS) to treat stroke patients is getting a popular idea. Previous studies seemed to support its effects on facilitating motor recovery after stroke. This study focuses on the motor recovery of lower extremities. Investigators conducted the study to evaluate the treatment effect of rTMS on the functional performance of lower extremities in terms of postural control, balance, and mobility in stroke patients. Investigators hypothesized that these performances could be improved through the better motor control of lower extremities caused by rTMS.

Protocol:

1. Setting: inpatient rehabilitation department of Shuang-Ho Hospital.
2. Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH).
3. Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH.
4. Study design: controlled trial with stratified randomization
5. Blinding

   1. The patients were blinded by the real or sham coil of rTMS
   2. The assessors who performed the outcome measurements were blinded to the assignment of treatment.
6. Measurements.

   1. Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention.
   2. Clinical assessments.

      * Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS)
      * The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
      * The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)
      * Timed Up and Go (TUG) test was used to assess the gross mobility.
      * Barthel Index (BI) for the ADL independence
      * modified Rankin Scale (MRS) for disability classification were also collected.
   3. These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements.
7. Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.

Eligibility Criteria:
Inclusion Criteria:

* unilateral hemiplegia caused by the stroke,
* first ever stroke,
* time since stroke: 10-90 days,
* age: 18-80 y/o,
* Functional ambulation classification (FAC): 0-2,

Exclusion Criteria:

* contraindication to TMS (eg, pacemaker, seizure history, pregnancy),
* cranial metal implants
* intracranial hemorrhage associated with tumor or arteriovenous malformation, craniotomy
* able to complete Timed Up and Go (TUG) test within 2 minutes
* unable to walk normally before the stroke
* those whose motor evoked potentials (MEP) of M1-UH were absent in the pretest