cyrilzakka/clinical-trials huggingface dataset:
Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer:

Impact of stimulation of parasympathetic activity by transcutaneous auricular vagus nerve stimulation (taVNS) on quality of life (QoL) relating to digestive symptoms in patients undergoing first-line treatment for ovarian cancer, as compared to shame taVNS

Impact of stimulation of parasympathetic activity by transcutaneous auricular vagus nerve stimulation (taVNS) on quality of life (QoL) relating to digestive symptoms in patients undergoing first-line treatment for ovarian cancer, as compared to shame taVNS

Randomization between:

* Experimental group: transcutaneous auricular vagus nerve stimulation (taVNS)
* Control group: placebo using the same device that does not deliver electrical stimulation

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* ECOG 0-2
* Histologically proven epithelial ovarian carcinoma
* FIGO stage ≥ IIB
* Patient candidate for first line chemotherapy treatment (alone, neoadjuvant or adjuvant)
* Patient affiliated to an appropriate social security system
* Patient who has signed informed consent obtained before any trial related activities

Exclusion Criteria:

* Patient with an active implantable medical device or any other implanted electronic or electrical device (pacemaker, defibrillator, etc.)
* Dermatological problems in the area where stimulation electrodes are applied
* Recent history (\<2 years) of epileptic seizures
* Proven severe cardiovascular disease (such as known FEV \<40%, severe valvulpathy...) or HRV analysis not possible (such as uncontrolled atrial fibrillation)
* Serious ear pathology
* Documented vegetative neuropathy
* Unusual morphology of the left ear which does not allow the use of the device
* Patient with a cochlear implant near to the stimulation site
* Impaired cognitive abilities
* Concurrent other malignancy (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
* Pregnant or breastfeeding woman
* Simultaneous participation in another clinical study that may compromise the conduct of this study.
* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
* Patient deprived of liberty or placed under the authority of a tutor
GRID Therapy for Extremity Soft Tissue Sarcoma

Patients with extremity soft tissue sarcoma (STS) are at high risk of recurrence. Pre-operative radiotherapy is used to increase the safe removal of tumors and improve local control in these patients. Increasing the preoperative radiotherapy dose with standard techniques might lead to normal tissue toxicity and postoperative wound complications.

GRID radiation therapy is a technique that may increases radiation dose with minimal added toxicity. It is hypothesized that GRID radiation dose will improve tumor response without increasing post-operative wound complications. While GRID has been used in many patients, there have been few formal studies to evaluate the safety and efficacy of the technique. In this study, a single priming dose of GRID will be administered to subjects with high-risk extremity soft tissue sarcoma prior to standard radiotherapy and tumor resection to determine the safety and clinical efficacy of the GRID dose. This single-arm pilot study will assess the safety of spatially fractionated grid radiation therapy (GRID) on 20 subjects with resectable extremity soft tissue sarcoma, followed by standard-of-care conventional radiotherapy (XRT) and tumor resection.


Eligibility Criteria:
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

1. Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
2. Age ≥ 18 years at the time of consent.
3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2 (Karnofsky Performance Status equivalent of 50 - 100).
4. Histological or cytological evidence/confirmation of extremity soft tissue sarcoma as determined by core-needle biopsy or excision biopsy. If the diagnostic tissue is not available or sufficient to perform correlative studies, must be willing to provide the mandatory pre-treatment core-needle biopsy. In some cases of extremity STS, subjects undergo an attempted surgical resection for a presumed benign condition and the specimen reveals malignancy. Such subjects are allowed so long as a complete, oncologic, resection was not performed/attempted and there is ≥ 5 cm of the remaining primary tumor.

Exclusion Criteria:

Subjects meeting any of the exclusion criteria listed below at baseline will be excluded from the study.

1. Subjects who have received prior radiotherapy to the tumor site.
2. Subjects who have undergone complete tumor resection of the primary tumor or who have developed tumor recurrence after resection.
3. History of serious or non-healing wound, ulcer, or bone fracture in the treatment limb within the last 5 years.
4. History of clinically significant lymphedema in the treated limb.
5. History of lupus, scleroderma, Sjogren's syndrome, Ehlers-Danlos syndrome (any type), or other collagen vascular disease that may pose a relative contraindication, due to increased risk of skin or soft tissue toxicity, with radiation.
Breath Analysis for Evaluation of Radiation Exposure in Lung Cancer Patients Treated With Radiation

Patients treated with radiation therapy for lung tumors can experience inflammation after treatment. This study hopes to evaluate the use of breath analysis to evaluate changes in the composition of exhaled breath in patients undergoing radiotherapy. If changes can be detected, this may ultimately serve as biomarkers for identifying patients at highest risk for radiation-induced lung injury (radiation pneumonitis).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of any type of lung tumor
* Medical recommendation (independent of the study) that the patient undergo thoracic radiation therapy. Radiation therapy may be either fractionated or hypofractionated (i.e. radiosurgery)
* Age \>= 18 years old
* Any gender and any ethnic background will be recruited
* Capable of giving written informed consent

Exclusion Criteria:

* Inability of giving written informed consent
* Pregnancy or breast-feeding
The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors

The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442. Hydroxyurea (HU) may be added.

Patients receive a regimen of didanosine, stavudine, nevirapine, and MKC-442 for 24 weeks. Throughout the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. Patients who experience virologic failure have the option of adding hydroxyurea to their treatment regimen or discontinuing from the study. After Week 24, patients with documented virologic response may continue treatment with didanosine, stavudine, nevirapine, and MKC-442, and, if applicable, hydroxyurea until a change in virologic status occurs (i.e., the patient experiences virologic failure). Follow-up visits are conducted every 4 to 12 weeks until permanent discontinuation from the study.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are at least 18 years old.
* Are HIV-positive.
* Have experienced treatment failure on a previous anti-HIV drug combination that contained at least one protease inhibitor. Your viral load must be between 5,000 and 50,000 copies/ml after 6 months of continuous treatment with that drug combination.
* Agree to use a barrier method of birth control (such as condoms) during the study.

Exclusion Criteria

You will not be eligible for this study if you:

* Have a history of certain serious medical conditions, including pancreatitis, neuropathy, untreated seizures, or AIDS-related cancers, except Kaposi's sarcoma (KS).
* Are enrolled in another anti-HIV drug study while participating in this study.
* Have ever taken NNRTIs (such as NVP or MKC-442).
* Have ever taken ddI or d4T.
* Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system (such as corticosteroids, interleukin-2, or interferon).
* Abuse alcohol or drugs.
* Have received chemotherapy or radiation therapy within 30 days prior to study entry. (Local radiation therapy is allowed.)
* Are allergic to any of the study drugs.
* Are pregnant or breast-feeding.
A Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes

This study aims to see if outcomes for patients that receive the traditional total knee replacement surgical technique are different than the outcomes for patients that receive robot-assisted total knee replacement. The outcomes we will be tracking include:

1. Patients' self-reported awareness of their artificial joints during activities of daily living;
2. Patient's self-reported pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life;
3. Patients' self-reported general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health;
4. The accuracy of implant placement and limb alignment


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the Virtua JRI
3. Willing to provide informed consent, participate in study, and comply with study protocol

Exclusion Criteria:

1. Pregnant or contemplating pregnancy prior to surgery;
2. Worker's compensation or personal injury related to knee (clinical outcomes have been shown to be less predictable and often poorer in this patient group; there may also exist potential issues with reimbursement)
3. Post-traumatic arthropathy (clinical outcomes have been shown to be less predictable; pre-operative deformity and risk factors are greater and difficult to propensity-match between groups)
4. Self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative CT scans
Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction

To assess strut coverage in patients presenting an acute myocardial infarction and treated either with the SYNERGY stent or the Bioresorbable Vascular Scaffold, through a parallel group design.

Single center, simple-blind randomized controlled trial, comparing the SYNERGY stent with the BVS device through a parallel group design.

Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome with ST-elevation,
* One culprit lesion eligible for percutaneous coronary intervention (PCI) with stent implantation,
* Reference vessel measuring 2.5 mm to 3.75 mm per visual estimation, without extreme vessel tortuosity,
* thrombolysis in myocardial infarction (TIMI) 3 flow before stent deployment in the target vessel,
* Patient with at least 1 lesion eligible for planned PCI next to the culprit lesion,
* Patient affiliated to the French national health care system,
* Patient agreed to participate after full information on the study (signature of an informed consent).

Exclusion Criteria:

* Acute coronary syndrome with ST-elevation,
* One culprit lesion eligible for percutaneous coronary intervention (PCI) with stent implantation,
* Reference vessel measuring 2.5 mm to 3.75 mm per visual estimation, without extreme vessel tortuosity,
* TIMI 3 flow before stent deployment in the target vessel,
* Patient with at least 1 lesion eligible for planned PCI next to the culprit lesion,
* Patient affiliated to the French national health care system,
* Patient agreed to participate after full information on the study (signature of an informed consent).
Observational Study to Assess the Incidence Rate of the Major Adverse Cardiovascular Events (MACE) and Safety of Fenofibrate (Lipilfen Capsule)

The purpose of this study was to assess the incidence rate of the major adverse cardiovascular events (MACE) and safety of fenofibrate (Lipilfen capsule) add-on statin therapy in patients who have history of acute myocardial infarction and are diagnosed with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* patients \>20 years of age.
* history of acute myocardial infarction
* metabolic syndrome diagnosis

Exclusion Criteria:

* current liver disease or AST or ALT greater than 3 times the upper limit of reference range
* pre-existing gallbladder disease
* moderate to severe renal disorder (serum creatinine \>2.5mg/dL)
* pancreatitis diagnosis
Infusion of a Single Dose of Erythropoietin to Prevent Injury in an Ischemia Reperfusion Forearm Model

Rationale:

The investigators hypothesize that EPO protects against apoptosis after acute ischemia in man and that it is detectable using the annexin-A5 model.

Objective:

Does infusion of a single dose of Epoetin Alfa, a short-acting EPO, protect against apoptosis in man after acute ischemia?

Study design:

A double blinded randomised cross-over study.

Study population:

12 Healthy male volunteers, between 18 and 40 years old.

Intervention:

All 12 volunteers will receive a single dose of EPO and placebo in a randomized order. A six week wash-out period is obtained in order to avoid interference of both treatments.

Main study parameters/endpoints:

The percentage of difference between radioactivity (quantified as counts per pixel) of the experimental and control thenar muscle at one and four hours after reperfusion.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between 18 and 40 years of age
* male
* Volunteers are not allowed smoking 24 hours before the start of the experiment

Exclusion Criteria:

* Female
* Hypertension (SBP \>140 mmHg, DBP \>90 mmHg)
* Diabetes Mellitus (DM) (fasting glc \>6.9 mmol/l, glc \>11.0 mmol/l)
* Hypercholesterolemia
* Renal dysfunction (eGFR \< 60 ml/min, calculated using MDRD formula)
* Any known hypersensitivity/allergic reaction to one of the constituents of Epoetin Alfa
* A history of use of any form of EPO
* Any current medication use
* Cardiovascular disease in medical history
* Smoking less than 24 hours prior to Epoetin alpha infusion
* Participation in research in the last 5 years in which any form of radioactivity was used
* No participation in any research trial in the last 30 days or 5 times the half-life of the used substance
Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes

This is a two part study. During period one there will be a comparison of Etanercept (ETN) against a placebo with both arms maintaining the background anti inflammatory drug prescribed by their Physician. The hypothesis is that Etanercept will be superior to the placebo arm as determined by the proportion of subjects achieving Assessments in Ankylosing Spondylitis (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension where everyone in the trial receives Etanercept (ETN) and a background non steroidal anti inflammatory drug(NSAID).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of axial spondyloarthritis as defined by Assessments in Ankylosing Spondylitis (ASAS)criteria
* Active symptoms defined as Ankylosing Spondylitis Disease Activity Index{BASDAI) \> or = 4
* Axial symptoms of back pain with a less than favorable response to on steroidal anti inflammatory drugs at optimal dosage for greater than 4 weeks

Exclusion Criteria:

* Evidence of current or recent episode of uveitis
* Evidence of IBD flare within 6 months
* Previous treatment with an anti Tumor necrosis factor(TNF)
* Active tuberculosis
* Radiographic sacroiliitis grade 3-4 unilaterally or \>= 2 bilaterally
Caloric Stimulation on Cerebral Blood Flow

This is a prospective, non-randomized study designed to generate preliminary data to assess the effect of a new portable non-invasive caloric stimulator on EEG waveform and cerebral blood flow on normal healthy volunteers.

Study activities include monitoring with bilateral transcranial Doppler (TCD), EEG and continuous EKG monitoring at 30 second intervals for 5 minutes. This is followed by placement of the caloric stimulator investigational device for 20 minutes. An additional 20 minutes of TCD and EEG monitoring will also be recorded. This will end study participation.

Eligibility Criteria:
Inclusion Criteria:

* no history of neurological disease

Exclusion Criteria:

* persons under the age of 18
* pregnant or nursing women
* history of neurological disease
* history of psychiatric disease
* congenital heart defect, known cardiac shunt
* inner ear or pulmonary disease
Prospective Evaluation of the Relation Between Different Questionnaires Measuring Radiation-induced Side-effect

To learn more about how you would rate the intensity or severity of your symptoms during or after radiation therapy using questionnaires with different rating scales.

Primary Objectives:

• To investigate how different toxicity questionnaires with different scoring systems can be reliably translated to each other by estimating different measures of correlation between items and summary scores across different questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* English as a primary language
* Participants with a diagnosis of HNC undergoing active curative RT or having received curative RT within the past 5 years at MD Anderson
* Ability to complete the survey(s) of their own volition

Exclusion Criteria:

* Age \< 18 years
* Non-English speaking participants
* Participants who are receiving or have received RT in a non-HN site.
* Participants in follow up and over 5 years from post-treatment
* Neurocognitive deficits that render patients unable to complete the survey(s) on their own.
Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction

The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective and objective outcomes of primary anterior cruciate ligament reconstruction.

The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective (patient-reported outcome measures) and objective (instrument-tested and imaging studies) outcomes of primary anterior cruciate ligament reconstruction.

The study will recruit 60 patients per each of two arms.

Eligibility Criteria:
Inclusion Criteria:

* chronic anterior knee instability with MRI-confirmed anterior cruciate ligament tear

Exclusion Criteria:

* revision anterior cruciate ligament surgery
* other lower limb injuries
Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial

The purpose of this study is to determine whether daily use of a lower limb venous-return assist device, "Venowave', improves leg symptoms, ability to perform activities of daily living, and quality of life in subjects with severe PTS.

Eligible consenting patients will be randomly allocated to receive either the veno-device (active or placebo for 8 weeks and crossed over for a further 8 weeks (active or placebo) following a 4 week 'wash out' period.( A randomized controlled 'crossover' study}

Eligibility Criteria:
Inclusion Criteria:

* Past History of objectively documented deep vein thrombosis
* Daily leg swelling with discomfort (i.e. report at least one of the following symptoms: heavy legs, aching legs and/or throbbing) for a minimum of 6 months
* Over 18 years of age (and of either gender).
* Villalta score of greater than 14(i.e.severe post phlebitic syndrome)

Exclusion Criteria:

* Episode of objectively documented deep vein thrombosis occurred less than 6 months before recruitment
* Subjects report that their symptoms have been unstable (worsening, improving or variable over the previous month).
* Active venous ulceration
* Baseline leg circumference greater than 50 cm (cuff will not fit subject)
* Symptomatic peripheral arterial disease Peripheral neuropathy
Population-based Chronic Kidney Disease Cohort at Northern Taiwan

CKD is a global endemic disease with increased comorbidities and mortality. The prevalence and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan. The prevalence of CKD remains high; however, the awareness remains low. Screening of unique risk factor and early diagnosis of CKD can improve outcome. Furthermore, data of renal education deep into the community remains limited. The aims of this study are:

1. Explore risk factors associated with CKD in the community
2. Establish multidisciplinary care model in the community
3. Investigate mechanistic mediators for CKD and multidisciplinary education approached in behavioral , physiological, immune and metabolomics aspects
4. Provide bio-specimen repository for future study


Eligibility Criteria:
Inclusion Criteria:

* residents of Northern Taiwan

Exclusion Criteria:

* pregnancy women, unwilling to participate
Sugammadex Versus Neostigmine Use in Patients Undergoing Septoplasty Operations

The purpose of this study to determine the effectiveness of sugammadex in septoplasty patients whose mask ventilation would be difficult after extubation.

Patients undergoing septoplasty operation will be included to this study. After coming to operation room all the patients will have standard monitorisation and induction. After intubation they will have inhalational anesthesia as maintenance. According to the TOF (train of four) measurement all patient will have neuromuscular relaxant if needed. After the operation they will be extubated according to TOF or clinical parameters. And time for extubation, mask assistance need, any complication, mask difficulty, and time spent in postoperative care unit will be recorded. Then the results will be compared, whether sugammadex or neostigmine is better for these patients in means of extubation and postoperative status.

Eligibility Criteria:
Inclusion Criteria:

ASA (American Society of Anesthesiologist) I-II patients undergoing septoplasty operation

Exclusion Criteria:

* patient refusal
* any allergy to any medication used