cyrilzakka/clinical-trials huggingface dataset:
Preoperative IMRT for Soft Tissue Sarcoma of the Extremities and Trunk: Low Rate of Wound Complications

Postoperative wound healing complications following preoperative radiotherapy represent a severe problem in the treatment of malignant soft tissue tumors, and are reported to be 34% and more. The literature discusses intensely the advantages and disadvantages of this multimodal treatment concept and there are different opinions. The Canadian prospective randomized NCIC SR2 trial showed increased wound complication rates in the study arm receiving preoperative radiation. The Sarcoma Center Zurich pursues mainly this treatment concept and the results shall now be analysed and published. The approach is to show that not only the complication rates are comparable to international bench marks, but also the (still intermediate time) local control rates.

Introduction: The Canadian prospective randomized NCIC SR2 trial tested the sequence of radiation and surgery for soft tissue sarcoma of the extremities. Similar disease control rates following pre- versus postoperative non-intensity modulated radiation therapy (non-IMRT) was found, with increased wound complications (17% vs 35%) in the preoperative radiation arm, \[95% CI 5-30\], p=0·01).

The investigators assessed a single center preoperative IMRT (or IMRT-equivalent highly conformal three dimensional conventional RT (3DcRT)) cohort with respect to the wound complication rate (WCR). The hypothesis was that a lower WCR rate was achieved in the era of IMRT as compared to the non-IMRT era when the Canadian Trial was conducted.

Methods: 67 consecutive patients irradiated with 50Gy in 25 fractions between 3/2008-3/2016 with preoperative IMRT (n=48, 72%) or highly conformal IMRT-equivalent 3DcRT dose distribution (n=19, 28%) were assessed. All patients were previously discussed at the weekly interdisciplinary sarcoma board of the Sarcoma Center Zurich.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a malignant soft tissue tumour
* Patients who underwent preoperative radiotherapy at the department of radiation oncology, University Hospital Zurich (USZ)
* Surgical treatment at Balgrist University Hospital between 2007 and 2016

Exclusion Criteria:

* Vulnerability
* Previous chemotherapy
* Previous radiotherapy on the affected site
* Patient's wish
Prospective Controlled Cohort Study on the Safety of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate (2.5mg) and 17ß-estradiol (1.5mg)

This study compares the risks of short- and long-term use of NOMAC-E2 (containing a fixed dose of nomegestrol acetate and estradiol) compared with levonorgestrel-containing combined oral contraceptives (COC-LNG) in a study population representative of the actual users of the individual preparations.

NOMAC-E2 is a novel monophasic oral contraceptive containing a fixed dose of nomegestrol acetate (2.5mg) and 17ß-estradiol (1.5mg) which is taken for 24 days followed by 4 days of placebo. The most relevant adverse clinical outcome that has been linked to the use of COCs is venous thromboembolism (VTE). Data from randomized clinical trials did not show any serious health concerns for NOMAC-E2. However, the statistical power to detect rare adverse events is limited in these studies.

PRO-E2 is a large, prospective, controlled, long-term active surveillance study to investigate the safety of NOMAC-E2 with regard to the outcomes of interest. This study follows the European Active Surveillance (EURAS) design methodology with some modifications due to country- and product-specific characteristics. The outcomes of interest will be validated via the attending physicians. A multi-faceted follow-up procedure will ensure a low loss to follow-up rate. This study will involve women from Europe and Australia who will be followed for up to 2 years. Data analysis will include multivariable techniques such as Cox regression.

Eligibility Criteria:
Inclusion Criteria:

* First ever user of a COC ("starter")
* User who restarts hormonal contraceptive use with a COC (same COC as before or a new COC) after an intake break of at least two months ("restarters")
* Women willing to participate in the active surveillance

Exclusion Criteria:

- Women who do not understand the major aspects of the study
Non-invasive Tear Film Dynamic Measurements in Normal, MGD and ADDE Subjects After Saline Instillation

Compare the objective tear film dynamic measurements in three different populations (MGD \[Meibomium Gland Dysfunction\], ADDE \[Aqueous Deficient Dry Eye\] and normal/control \[non-dry eye\]) and the subjective experience before and after instilling a single drop of saline in each eye.

Currently available office-based tests for dry eye do not reliably correlate with patients' subjective symptoms. This study is interested in assessing how individuals with these two different ocular surface diseases compare with the normal population when measured objectively using two different instruments.

There will be one study day with a single visit that will consist of taking two sets of measurements. Baseline measurements are taken in both eyes using a wavefront sensor to measure visual quality followed by saline instillation. Five minutes after drops, visual quality is again measured to evaluate changes in tear dynamics.

Eligibility Criteria:
General Inclusion Criteria:

* Good general Health
* The subject must appear able and willing to adhere to the instructions set forth in this protocol (such as not use warm compresses or artificial tears/lubricant or excessive eye makeup before the visit on the study day).

General Exclusion Criteria:

* Ocular disease, infection or inflammation (allergy, blepharitis) that is clinically significant (grade 3 or 4) that in the opinion of the PI would not be a good subject.
* Systemic disease or use of medication that in the opinion of the PI would not be a good subject.
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Contact lens wearer.
* Pregnancy or lactation.
* Diabetes.
* Inclusion or exclusion criteria of the other cohorts.

Cohort Specific Inclusion Criteria:

* ADDE cohort: Schirmer I \< 10 mm, BUT ¬\< 5 seconds, Fluorescein 0 or 1, currently using an artificial tear for ocular comfort at least occasionally.
* MGD cohort: Diagnosis of moderate or severe MGD
* Normal/Control (Non Dry-Eye): meets general inclusion and exclusion criteria
EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension

The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension in clinical routine practice.

This is a post market, multi-center, open label, observational study. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located in Germany and will be followed for 1 year post procedure.The expected duration of the investigation will be approximately 4 years.

Eligibility Criteria:
Inclusion Criteria:

* Subject is planned to undergo a renal denervation procedure for the treatment of hypertension
* Subject is ≥18 years of age at time of consent
* Subject must be able and willing to provide written informed consent
* Subject must be able and willing to comply with the required follow-up schedule
* Subject has office Systolic Blood Pressure (SBP) ≥ 140 mmHg
* Subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE-I/ Angiotensin Receptor Blocker (ARB), Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs

Exclusion Criteria:

* Subject has known significant renovascular abnormalities such as renal artery stenosis \> 30%
* Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
* Subject has a history of hemodynamically significant valvular heart disease
* Subject has blood clotting abnormalities
* Subject life expectancy is \< 12 months, as determined by the Study Investigator
* Subject is participating in another clinical study which has the potential
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOG-AD)

The purpose of the study is to evalute the efficacy, safety and tolerability of rozanolixizumab for treatment of adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD).


Eligibility Criteria:
Inclusion Criteria:

* Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent
* Confirmed diagnosis of MOG-AD consistent with published diagnostic criteria for MOG-AD
* Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization
* Participant must be clinically stable at the time of the Screening Visit and during the Screening Period

Exclusion Criteria:

* Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant
* Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP)
* Participant has a current or medical history of primary immunodeficiency
* Participant tests positive for aquaporin-4 antibodies at Screening
* Participant has a serum total IgG level ≤ 5.5g/L
Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment

In case of free flap failure, time is of utmost importance as salvage rates have been reported to be inversely related to the time interval between the onset of ischemia and its clinical recognition. Consecutively, monitoring of free flaps remains of major importance. Currently, combined Laser-Doppler and Spectrophotometry is available to determine microcirculation of free flaps in reconstructive surgery as a scientific method of reliable assessment of flap perfusion. The investigators thought to analyze the correlation of free flap skin temperature and free frap microcirculation as an accurate tool of postoperative flap monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Age between 16 and 65 years

Exclusion Criteria:

* soft tissue inflammation or osteomyelitis, peripheral arterial occlusive disease, vasculitis, chronic kidney or liver disease, cardiac dysfunction, arterial hypotension and any type of vasoactive medication, i.e. ß-blockers, calcium channel blockers, nitroglycerin or equal.
Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer

This study is being done to determine whether levels of prostate cancer derived extracellular vesicles from blood and urine specimens correlate with response to primary local treatment (surgery) in prostate cancer.

PRIMARY OBJECTIVES:

I. Determine the levels of prostate cancer-derived extracellular vesicles pre- and post-RP.

II. Determine the correlation between levels of prostate cancer-derived extracellular vesicles and PSA.

OUTLINE: This is an observational study. Participants are assigned to 1 of 2 cohorts.

COHORT I (RADICAL PROSTATECTOMY): Prostate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed.

COHORT II (NEOADJUVANT): Prostate cancer patients undergo blood and urine sample collection throughout the study. Patients' medical records are also reviewed.

COHORT III (NEGATIVE CONTROLS): Female urology clinic patients and female volunteers undergo blood and urine sample collection on study.

Eligibility Criteria:
Inclusion Criteria:

* \* PROSTATE CANCER PATIENTS:

  * Age 18+
  * Able to give informed consent
  * Patients with prostate cancer
  * Patients treated with primary prostatectomy

    * The focus will be on high-risk patients with at least one of either criterion:
  * PSA \>= 20 ng/ml
  * AND/OR Gleason \>= 8
  * AND/OR clinical stage \>= T3
* \* FEMALE CONTROL PATIENTS:

  * Age 18+
  * Able to give informed consent

Exclusion Criteria:

* \* PROSTATE CANCER PATIENTS:

  * Unable or unwilling to provide informed consent
  * Metastatic prostate cancer - defined evidence of metastatic disease on pre-procedural testing
* \* FEMALE CONTROL PATIENTS:

  * Unable or unwilling to provide informed consent
Effectiveness of Integrated Care on Delaying Chronic Kidney Disease Progression in Rural Communities of Thailand

If primary health-care officers and Villages Health Volunteers (VHVs) be trained to render proper CKD care, it is interesting if their intimate relationship and commitment to their responsible village households will result in better outcomes when compared with the conventional care model as mention above. In this project, we plan to compare the effectiveness of a conventional care program against an integrated multidisciplinary CKD care program provided by nephrologists in conjunction with well-trained paramedical personnel and VHVs on CKD progression.

Background The unique characteristic of community-health care in Thailand is a system of primary- health care officers and Village Health Volunteers (VHVs) providing basic health care to more than 90% of Thai population. Should these allied personnel be trained on how to render proper chronic kidney disease (CKD) care, it would be interesting to study whether their role play care will result in better quality of CKD care.

Design This study is a community-based cluster randomized controlled trial to be conducted in 2 districts of Kamphaeng Phet Province, located about 400 kilometers north of Bangkok. About 300 stage 3-4 CKD patients will be enrolled to each of the 2 treatment groups. Patients in both groups will be treated according to The National Kidney Foundation Kidney Disease Outcomes Quality Initiative guidelines. The District 1 (control group) patients will be provided a conventional CKD care. For the District 2 (intervention group) patients, an integrated CKD care program will be provided by the multidisciplinary team of district hospital in conjunction with the community CKD care networks (i.e. primary-health care officers and VHVs). The key activities of integrated CKD care program are live demonstration about treatment and optimal diets for CKD patients which will be provided during each hospital visit and quarterly home visits. Clinical and laboratory parameters of all cases will be assessed every 3 months. Duration of the study is 24 months. The primary outcome of this study is the rate of eGFR decline. The secondary outcomes are time of initiation of dialysis, cardiovascular mortality, and all-cause mortality.

Eligibility Criteria:
Inclusion Criteria:

* ages 18-70 years and known to have diabetes and/or hypertension.
* eGFR are in a range of 15 - 59 ml/min/1.73m2 estimated twice at 3 months.

Exclusion Criteria:

* unstable/advanced cardiovascular disease
* active glomerular disease, obstructive uropathy, end-stage renal disease, HIV infection, pregnancy, body mass index (BMI) less than 18 or more than 40 kg/m2, being under treatment for malignancy, urine protein-creatinine ratio more than 3.5 g/g creatinine and active urinary sediment (urine red blood cells \>3 cells/high power field or urine white blood cells \>10 cells/high power field).
Long Term Daily Use of JARDIANCE® Tablets in Japanese Patients With Type 2 Diabetes Mellitus

Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus


Eligibility Criteria:
Inclusion criteria:

Male and female Japanese patients with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment

Exclusion criteria:

None
Fluoroscopically-guided Epidural Block in the Midthoracic Region: A Comparison of Anterioposterior Versus Oblique View Approach

A comparison of anterioposterior versus oblique view approach method for fluoroscopically-guided epidural block in the midthoracic region. The investigators evaluate differences on total radiation time and technical feasibility between anterioposterior and oblique view approach method.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who were scheduled for the transforaminal epidural injection in midthoracic region (T5-T7)

Exclusion Criteria:

* Local anesthetic allergy, coagulopathy
Ventricular Pace Suppression Study

Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.

The aim of this study is to investigate the percentage of reduction of ventricular pacing using the VpS feature of the EVIA/ENTOVIS pacemaker in a controlled clinical investigation.

Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal AV block and/or Sinus Node Dysfunction
* DDD(R)-ADI(R)-Mode (VpS Algorithm) applicability

Exclusion Criteria:

* Permanent AV block III°
* Permanent Atrial Fibrillation/ Flutter
* Require mode other than DDD(R)-ADI(R) or DDD(R)
* Have a life expectancy of less than six months
* Expected to receive heart surgery within six months
* Enrolled in another cardiac investigation
Updating Deep Learning Algorithms for OSA Monitoring

The objective is to enhance the reliability of the algorithm to match that of Level 1 polysomnography by leveraging the diverse data obtained from Level 1 polysomnography to refine the deep learning algorithm.

Patients undergoing Level 1 polysomnography are equipped with the CART-I PLUS device, for collecting polysomnography data alongside concurrent photoplethysmography (PPG) signals.

The collected data is categorized into apnea, hypopnea, and normal segments based on the polysomnography results. Utilizing the PPG and accelerometer (ACC) signals from the CART-I PLUS, metrics such as SaO2 (oxygen saturation), respiratory rate, heart rate (HR), heart rate variability (HRV), and body movement are calculated for each segment. These metrics, along with the PPG and ACC signals, are then used to develop a deep learning model that classifies the segments into apnea, hypopnea, or normal.

Participants are divided into training and validation sets. The deep learning model is trained on data from the participants in the training set, and its performance is evaluated using the validation set.

The algorithm is constructed using convolutional neural networks (CNN), recurrent neural networks (RNN), attention mechanisms, and other advanced techniques recognized for their efficacy in classification tasks, specifically for identifying apnea, hypopnea, and normal segments.

Eligibility Criteria:
Inclusion Criteria:

Patients scheduled for Level 1 polysomnography at a sleep center who meet all of the following criteria:

* Aged 19 years or older
* Have listened to and understood a thorough explanation of the clinical study and voluntarily agreed to participate

Exclusion Criteria:

* Under 19 years of age
* Unable to collect normal signals during the pre-test or wearing of the CART-I PLUS device
* Refuse to participate in the clinical study
* Have cognitive impairments to the extent that they cannot understand the explanation of the clinical study and therefore cannot make a voluntary decision to participate (e.g., legally incompetent individuals)
Extension Study of Hetrombopag in Severe Aplastic Anemia

This is a multicenter, placebo-control, phase 3 study of hetrombopag in patients with treatment-naive severe aplastic anemia. All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study.

Subjects will receive the same study drug (hetrombopag or placebo) as in study HR-TPO-SAA-III, with the same doses and administration schedule or with modifications based on the actual conditions.

The primary objective of this extension study is to give the subjects participating in the HR-TPO-SAA-III study the continued access to the study drug (hetrombopag or placebo) after the completion of the HR-TPO-SAA-III study.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have completed or withdrawn from the HR-TPO-SAA-III study
2. Subjects who have signed the informed consent form
3. Female and male subjects of childbearing age who agree to take adequate contraceptive measures during the extension study period and within 28 days after the last dose
4. Subjects who have completed the end-of-treatment evaluation in the original study

Exclusion Criteria:

1. Any unstable situation or situation that will compromise the safety of the subject
2. Evidence of clonal cytogenetic abnormalities at the end-of-treatment examination of the HR-TPO-SAA-III study
3. Subjects with uncontrollable hemorrhage and/or infection after standard treatment
4. Subjects who have experienced deep vein thrombosis, myocardial infarction, stroke, or peripheral arterial embolism within 1 year
5. Any situation that may compromise the subject and the safety or compliance thereof during the study
Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial

Cataract surgical techniques have significantly changed in recent years with the widespread adoption of smaller and smaller clear corneal incisions for phacoemulsification. Microincision surgery has many advantages, including reduced surgically induced astigmatism, faster visual recovery, and reduced intra and postoperative inflammation. Curently, microcoaxial phacoemulsification is being performed through 1.8 as well as 2.2 mm incisions. However, there is still a debate as to which is the best absolute incision size for microcoaxial cataract surgery.

The aim of this study is to evaluate incision stability following microcoaxial phacoemulsification performed through 1.8 and 2.2 mm systems, as well as compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification performed through these two incision sizes.

Cataract surgical techniques have significantly changed in recent years with the widespread adoption of smaller and smaller clear corneal incisions for phacoemulsification. Microincision surgery has many advantages, including reduced surgically induced astigmatism, faster visual recovery, and reduced intra and postoperative inflammation. In the recent times, microcoaxial phacoemulsification has gained popularity. The main advantage of this newer technique is that it uses the same methods as the conventional method but with smaller incisions. Curently, microcoaxial phacoemulsification is being performed through 1.8 as well as 2.2 mm incisions. However, there is still a debate as to which is the best absolute incision size for microcoaxial cataract surgery.

The aim of this study is to evaluate incision stability following microcoaxial phacoemulsification performed through 1.8 and 2.2 mm systems, as well as compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification performed through these two incision sizes.

Eligibility Criteria:
Inclusion Criteria: Uncomplicated age related cataracts, NO grade II III, IV (LOCS III classification)

-

Exclusion Criteria:

* Ocular comorbidity, glaucoma, uveitis, shallow anterior chamber, maximal pupillary dilatation \<6mm, high myopia (axial length \> 25mm), previous ocular trauma or surgery, pseudoexfoliation, traumatic cataract, subluxated cataract