cyrilzakka/clinical-trials huggingface dataset:
Radiotherapy Treatments for Neoplasms in the Head and Neck Region

The aim of this study is the evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of radiotherapy treatments in the head and neck region.

Eligible patients undergoing radiotherapy for primary or secondary neoplasms localized in the head and neck anatomical region.

Approximately 60% of patients with neoplasms receive radiotherapy as part of their oncological treatment.

Various primary tumors as well as metastases of various origins can be localized in the head and neck anatomical region. Patients with such neoplastic localizations will therefore receive radiotherapy treatment possibly associated with other systemic or surgical treatments.

Treatment choice is usually established following multidisciplinary discussions, based on disease characteristics and stage, concurrent pathologies and pharmacological treatments, patient preferences, and functional aspects.

The collection of data related to radiotherapy plays a crucial role in understanding various clinical aspects of the treatment itself. The availability of data from an increasing number of patients will allow the identification of clinical situations or technical parameters of radiotherapy correlated with treatment tolerance and effectiveness, aiming to identify the best treatment for these oncological pathologies.

This project aims to collect data related to radiotherapy treatments for primary or secondary neoplasms of the head and neck region for scientific dissemination with the goal of establishing the basis for evaluating achieved results over time, and deriving from these elements useful for guiding the most effective treatment strategies and appropriate operational protocols.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the head and neck region include those with:

  * Primary bone tumors,
  * Primary soft tissue tumors,
  * Primary tumors of the cardio-circulatory system,
  * Primary tumors of the lymphatic system,
  * Primary tumors of the nervous system and skin,
  * Secondary metastases from various origins localized in that district.
* Signed informed consent

Exclusion Criteria:

• Radiotherapy in districts other than the head and neck region
Serum and Uterine Progesterone Levels and ERA Test.

Since the implantation is related with endometrial receptivity, the patient specific plasma progesterone concentration influences this pattern.

Following this hypothesis, the study establishes a correlation between the serum progesterone measured on the day of the endometrial biopsy and the endometrial receptivity with the ERA test.

In patients who have had problems of assisted reproduction it is essential to establish the factors that contribute to the success of a cycle: correcting these factors means increasing the possibility of the cycle culminating in pregnancy.

In patients with embryonic implantation failures, a prevalence of non-receptive endometrium has been described after performing the ERA test of around 20%. On the other hand, a study that shows embryonic generation values below a certain threshold (25th percentile), presents a rate of evolutionary clinical gestation and lower embryo implantation.

It is logical to think that progesterone levels are lower than the state of endometrial receptivity, since the hormone is responsible for the endothelial changes that prepare the uterus for implantation. It is ERA. The result of this study is the result of the evaluation of the lifetime of the endometrial biopsy is related to the result of the same.

If desired, the determination of the probability of the day of the transfer is predictive of the pregnancy rate through the impact that the hormone has on the endometrial receptivity. This would allow to decide in the same cycle, if the patient should be in a transfer to another dimension, or should it defer to another cycle where obtain the optimal values of progesterone.

Nowadays, there are no publications in the literature that have related the concentration of progesterone with endometrial receptivity through ERA. This is the first prospective study that analyzes this relationship.

The ERA test has been chosen for the evaluation of endometrial receptivity, which is a tool that has been widely used and used in the usual clinical practice of our clinic.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women \<50 years
* One or more failed IVF treatments
* Undergoing an artificial endometrial preparation cycle with hormonal replacement therapy in order to perform an endometrial receptivity analysis through ERA test.
* Endometrial thickness after estrogen treatment \> 6.5 mm with trilaminar structure

Exclusion Criteria:

* Uterine alterations (fibroids, polyps or Müllerian abnormalities)
* Adnexal pathology
Remotely Supervised Exercise for Adults With Cystic Fibrosis

Cystic fibrosis (CF) is a genetic disease characterized by abnormal chloride transport in epithelial tissues. Inflammation is a key component contributing to the main alterations induced by the disease. The increase in life expectancy comes with a higher prevalence of CF-related comorbidities, but also with new emerging complications directly related to aging. Physical fitness and exercise practice have been previously associated to survival and better quality of life in patients with cystic fibrosis. Thus, the aim of this study is to assess the effects of a remotely supervised resistance exercise program on lung function, muscle strength, body composition, quality of life and inflammatory markers in adult patients with cystic fibrosis.

This study aims to assess the effects of a remotely supervised resistance exercise program on lung function, muscle strength, body composition, quality of life and inflammatory markers in adult patients with cystic fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed clinical and genetic diagnosis for cystic fibrosis;
* Age from 16 years.

Exclusion Criteria:

* Musculoskeletal disorders that do not allow the performance of physical exercise;
* Pregnancy;
* Absence of registration of clinical required.
Same-day, Reduced Volume Bowel Preparation

We seek to evaluate whether a same day, reduced liquid volume (2liters) polyethylene glycol (PEG-ELS) bowel preparation can achieve adequate colon cleansing in patients scheduled for afternoon colonoscopies. The primary outcome will be adequacy of the bowel preparation. Secondary outcomes will include Boston Bowel Preparation Scale score, patient compliance with completing the preparation, tolerability of the preparation, willingness to repeat the preparation, side effects, duration of procedure (endoscope insertion and withdrawal times), and polyp detection.

The diagnostic accuracy of colonoscopy depends on the quality of the preparation. The adequacy of the preparation determines whether complete visualization of the mucosa and identification of pathologic lesions is achieved. For reasons that are not entirely clear, colonoscopies scheduled in the afternoon have been identified as a risk factor for having an inadequate preparation. Standard bowel preparation regimens at BMC include polyethylene glycol- electrolyte solutions (PEG-ELS) in full (four liters) and reduced (two liters) forms. These laxatives are typically administered either the evening prior to the colonoscopy or in "split dose" (a portion the evening before and a portion the morning of the colonoscopy). The percent of failed colonoscopies due to a fair/poor preparation in our endoscopy unit is 17-20%. Our trial seeks to establish the efficacy and safety of a reduced volume PEG-ELS laxative given on the day of the colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* English speaking patients referred for colonoscopy.

Exclusion Criteria:

* Age \< 18,
* Pregnancy,
* History of bowel resection,
* Allergy to PEG-ELS, and
* Inability to provide informed consent.
Zilver® PTX® in China

The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of peripheral arterial disease corresponding to Rutherford Classification 2-4
* Stenotic (\>50% diameter stenosis) or occluded lesion of the above-the knee femoropopliteal artery
* Reference vessel diameter of 4-9 mm
* Lesion length up to 140 mm

Exclusion Criteria:

* Unsuccessful arterial interventional treatment of the legs within 30 days prior to the study procedure
* Previous stent in the study vessel
* Bypass graft with an anastomosis in the study vessel
* Significant stenosis or occlusion of inflow tract not successfully treated prior to treating the study lesion
* No patent vessel of runoff
Does Fluid Requirement Decrease With the Use of Pneumatic Compression Device on Lower Limbs

Impact of intraoperative use of pneumatic peristaltic compression device on hemodynamics vis a vis on fluid requirement during general anaesthesia and surgery.

Induction of general anaesthesia is associated with cardiac depression and peripheral vasodilatation resulting in hypotension .This hypotension can be corrected by giving intravenous fluid, or the vasoconstrictor. While optimum fluid balances in the perioperative period is of vital importance in overnight fasting patients to correct the fluid deficit, any fluid overload is not only counterproductive to the heart function but is associated with fluid retention in body and edema in postoperative period.

Peristaltic pneumatic compression device, a variant of intermittent sequential compression of legs, uses higher pressure and longer compression cycles to avoid venous stasis in immobilized patients. Sequential compression devices have sleeves with pockets of inflation, which works to squeeze on the appendage in a milking action .The most distal areas will inflate initially, and the subsequent pockets will follow in the same manner. The primary aim of the device is to squeeze blood from the underlying deep veins to proximal side. When the inflatable sleeves deflate, the veins will replenish with blood. The intermittent compressions of the sleeves will ensure the movement of venous blood . Peristaltic Pneumatic Compression of the legs significantly reduces fluid demand and enhances stability during minor ear, nose, and throat surgery. Peristaltic Pneumatic Compression has the potential to support fluid restriction regimens during surgery .

Eligibility Criteria:
Inclusion Criteria:

* ASA(American Society of Anaesthesiologists) grade I or II, of both genders
* Age group of 25 to 50 years
* Patients undergoing surgeries under GA(General Anaesthesia) for 2-3 hours

Exclusion Criteria:

* Patients expected to get major blood loss
* Burns patients.
* Patients with significant cardiac diseases.
* Patients with pulmonary diseases and impaired renal function.
* Lower limb surgeries and abdominal surgeries
Frusemide Infusion for the Prevention of Deterioration in Renal Function Post Cardiac Surgery.

The purpose of the project is to test whether or not the commonly used medication frusemide, given after heart surgery, and aiming to increase urinary output can have an effect on kidney function.

All patients will receive standard supportive care based on current established management practice of cardio-thoracic patients. The only difference in treatment will be the randomisation of patients to receive/not receive protocolised administration of frusemide targeting a urine output.

There will be 2 groups of patients. The control group-which will receive frusemide bolus doses if required as determined by the surgeon/consultant physician. The frusemide infusion group-which will be monitored to achieve a trial specified hourly urine output target range of 1-2mls/kg/hour. In order to achieve this target the patient may need to receive a loading dose of frusemide and may also then require a frusemide infusion. The aim will be to maintain the urine output within the target range for the first 48 hours after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

All patients admitted for cardiac surgery will be assessed for eligibility. Participants will be approached for inclusion, from the pre-admission clinics and wards of the Cardiothoracic surgery unit. Potential participants will be identified by the daily review of planned cardiothoracic surgery schedule.

Exclusion Criteria:

1. Already in established dialysis dependent chronic renal failure.
2. Known allergy to frusemide
3. Age \< 18 years
4. Pregnant
Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin, Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease (NILE)

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin + bevacizumab therapy in patients with histologically or cytologically documented inoperable, locally advanced, metastatic (Stage IV), or recurrent non-squamous NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented inoperable (Stage IV) or recurrent non-squamous non-small cell lung cancer (NSCLC). Diagnoses of non-squamous NSCLC that are based on sputum cytology alone are not acceptable. Mixed tumors should be categorized according to the predominant cell type.
* ECOG performance status of 0 or 1
* Life expectancy \>12 weeks
* Measurable disease, as defined by RECIST 1.1
* Adequate hematologic and end organ function

Exclusion Criteria:

* Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors,radiotherapy, immunotherapy, hormonal therapy or investigational therapy) before Day 1 of Cycle 1 for the treatment of Stage IV or recurrent NSCLC. Patients who received prior adjuvant chemotherapy or radiotherapy for NSCLC are not excluded if the time interval from completion of adjuvant therapy until disease progression is \> 12 months.
* Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
* Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
* Pregnant and lactating women
* Active infection requiring IV antibiotics

Bevacizumab-Specific Exclusions:

* Histologically or cytologically documented inoperable, locally advanced, mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
* Evidence of tumor invading major blood vessels on imaging
* Evidence of central nervous system (CNS) metastases
* History of stroke or transient ischemic attacks (TIAs) within 6 months prior to Day 1
* Significant vascular disease within 6 months prior to Day 1
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1
Comparison of Ketamine and Esketamine in Patients Suffering From Fibromyalgia Syndrome.

Ketamine and Esketamine intravenous perfusions can modulate chronic pain. The purpose of this study is to determine if Ketamine or Esketamine are favorable for outpatients suffering from fibromyalgia.

Ketamine and Esketamine intravenous perfusions in Pain Clinic can modulate chronic pain and are therefore part of the therapeutic arsenal of the Anesthesiologist in pain management. Patients with fibromyalgia syndrome have elevated levels of glutamate in the brain. This is demonstrated by functional brain imaging techniques. Elevation of glutamate is demonstrated in the posterior insular cortex, positively correlating with lower pain thresholds which is a hallmark of fibromyalgia syndrome. Ketamine has (e.a.) an inhibitory role of the N-methyl-D-aspartate (NMDA) receptor: it is a non-competitive antagonist of the NMDA receptor. In this context, Esketamine is available recently. This is the levorotatory form of Ketamine.

The main objective of this study is to measure if there is a difference between Ketamine and Esketamine on patients with fibromyalgia syndrome via the fibromyalgia impact questionnaire (FIQ) and measurement of side effects after intravenous perfusion. The fibromyalgia impact questionnaire is a global assessment of symptoms: pain, function, fatigue, stiffness, discomfort when walking up stairs, difficulties at work, anxiety, depression, days not worked and days of good quality in the past week.

Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Between 18 and 75 years old
* Reads and writes French
* Diagnosis of fibromyalgia syndrome according to Widespread Pain Index (WPI) and Symptom Severity Scale (SSS) score ≥ 13/31
* Both molecules (Ketamine and Esketamine) were administered at least once during an analgesic infusion session in Pain Clinic
* Patient with regular medical follow-up by a pain specialist at least 3 times a year

Exclusion Criteria:

* Allergy or intolerance to Ketamine or Esketamine
* Current infection, fever
* Pregnant or breastfeeding woman
* Serious cardiovascular disorders and severe hypertension
* Increased pressure of cerebrospinal fluid and severe intracranial disease
* Acute intermittent porphyria
* Untreated epilepsy
* Untreated glaucoma
* Difficult or impossible intravenous access
* Chronic Liver Disease Child-Pugh C
A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease

The primary objective of the study is to assess the safety of long term therapy with Certolizumab Pegol in those subjects participating in study C87085 \[NCT00552058\].

This study consisted of:

* Induction Period (dosing at Weeks 0, 2, and 4)
* Maintenance Dosing (dosing every 4 weeks up to Week 260)
* End of Treatment Visit that occurred at Week 262/Withdrawal Visit and a Safety Follow-up Visit (SFU; 12 weeks after final dose)

Eligibility Criteria:
Inclusion Criteria:

* Subject participated in study C87085 \[NCT00552058\] in which the subject completed the study at Week 6
* Subject is capable of providing informed consent, which must be obtained prior to any study related procedures
* Have a chest X-ray taken at Visit 1 that is read by a qualified radiologist or pulmonary physician, with no evidence of current active Tuberculosis (TB) or old inactive TB
* Subject has taken a TB survey and is committed to comply with TB prophylaxis if applicable

Exclusion Criteria:

* Subject is experiencing an ongoing serious adverse event assessed as being related to study medication or is experiencing a serious adverse event that is still not assessable
* Subject has an intercurrent illness that requires termination of treatment, such as a serious infection (e.g. TB, pneumonia, sepsis, pyelonephritis, fistula abscess)
* Subject is non-compliant with TB prophylactic treatment (if applicable)
* Subject has had a chest X-ray at Visit 1 that shows an abnormality suggestive of a malignancy or active infection, including TB
* Female who is pregnant or breast feeding
* Female of child bearing age or post puberty males not practicing effective birth control
* Subject is expecting to receive any live virus or bacterial vaccination within 3 months of first Study Medication administration, during the trial or 3 months after last dose of study drug
Effect of CAUTI Prevention Alert - A Randomized Control Trial

This study proposes to expand upon previous research by studying the effects of a urinary-catheter removal alert on duration of urinary catheter use and frequency of CAUTIs with a large, randomized controlled trial within a three-hospital academic medical center.

Hypothesis The proposed urinary-catheter removal alerts will decrease the number of catheter days and decrease the number of catheter associated urinary tract infections (CAUTIs), but will not affect the catheter re-insertion rate.

Primary Objectives

* Specific Aim 1: Investigate the effect of a urinary-catheter removal alert on the rate of catheter associated urinary tract infections (CAUTIs).
* Specific Aim 2: Investigate the effect of a urinary-catheter removal alert on the number of catheter days.
* Specific Aim 3: Evaluate the effect of a urinary-catheter removal alert on the rate of catheter re-insertion.
* Specific Aim 4: Evaluate the effect of a urinary-catheter removal alert on overall mortality in patients with indwelling catheters.

Eligibility Criteria:
Inclusion Criteria:

* All admissions with an indwelling urinary catheter will be randomly assigned to intervention vs. control (usual care) conditions.

Exclusion Criteria:

* Neonatal Intensive Care Unit and pediatric patients
Heartflow (AFFECTS)

The overall objective of the AFFECTS Study is to assess agreement between SPECT and FFRct in identifying vessel-specific, hemodynamically significant CAD in patients scheduled for invasive coronary angiography (ICA) based on abnormal SPECT myocardial perfusion scans. In particular, the study will evaluate the ability of FFRct to correctly rule out hemodynamically significant CAD in patients with non-significant CAD or normal coronary arteries who had positive SPECT scans.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Providing written informed consent
* Subjects with abnormal SPECT myocardial perfusion imaging results who have been referred for clinically indicated ICA within 90-days of SPECT.
* Ability to undergo cCTA

Exclusion Criteria:

* Acute coronary syndrome (ACS).
* Prior, clinically documented, myocardial infarction (MI).
* Prior coronary artery bypass grafting (CABG)
* Prior coronary stenting
* Evidence of ongoing or active clinical instability including unstable angina, intractable arrhythmia, cardiogenic shock, unstable BP, and severe CHF (NYHA class III or IV) or acute pulmonary edema
* Contraindications for cCTA such as:

  1. Presence of pacemaker or internal defibrillator leads such that coronary visualization is impaired
  2. Chronic atrial fibrillation with uncontrolled ventricular response
  3. Known anaphylactic allergy to iodinated contrast that cannot be pre-medicated
  4. Pregnancy or unknown pregnancy status in women of childbearing age
  5. Contraindication to acute beta blockade
  6. Contraindication to acute sublingual nitrate administration
  7. Prosthetic heart valve such that coronary visualization is impaired
* Contraindications for FFRct such as:

  1. Complex congenital heart disease other than anomalous coronary origins alone
  2. Ventricular septal defect with known Qp/Qs \> 1.4
* Requiring an emergent procedure within 48 hours of presentation
* Any active, serious, life-threatening disease with life expectancy less than 2 months
* Inability to comply with study procedures
* Current participation in any other clinical trial involving an investigational device, drug, or dictating care pathways at the time of enrollment
The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes

In this study, the investigators are going to investigate the efficacy of choline alfoscerate on improvement of cognitive function assessed by MMSE compared to plaebo.

The investigators will enroll patients with type 2 diabetes whose age is equal to higher than 60, and randomly assigned study drug or placebo at 1:1 ratio. The treatment duration is 6 months and extension study will be continued to 12 months.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* baseline MMSE score 25-28

Exclusion Criteria:

* type 1 diabetes
* diabetes ketoacidosis or hyperosmolar hyperglycemic crisis
* HbA1c over than 9.0%
* MMSE less than 25
* abnormal TSH levels
* vitamin B12 deficiency
* severe infection, perioperative state, trauma
* hypopituitarism or adrenal insufficiency
* any conditions that lead to hospitalization
* chronic alcoholics within 1 year
* any drugs that can influence to cognitive function within 3 months