cyrilzakka/clinical-trials huggingface dataset:
Nordic Adjuvant IFN Melanoma Trial

The aim of this study is to evaluate the effect of giving adjuvant treatment with intermediate doses of interferon-alpha2b to patients operated for high risk melanoma. Patients are randomly assigned to either observation only or interferon treatment for 2 different durations. The outcome with respect to overall survival, relapse-free survival, side effects and quality of life is analysed.

This is an open multicenter, prospective randomised phase III trial evaluating the efficacy of two different schedules of Interferon-alpha2b (IFN-alpha2b) administered in an adjuvant setting after adequate surgery in high risk cutaneous melanoma patients (T4N0M0/TxN1-2M0). The patients have been operated for either a thick primary melanoma (\> 4 mm) without evidence of distant metastasis or have undergone surgery for regional lymph node metastases.

The study consists of a control arm (A) and two treatment arms, B and C. The outcome in arms B and C with adjuvant treatment with IFN-alpha2b will be compared to the outcome of arm A in which the patients will only be observed after the surgery. The primary endpoint is overall survival. Secondary endpoints are relapse-free survival, safety-toxicity and health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* T4 N0 M0 - Thick primary melanoma: \> 4.0 mm Breslow depth, without lymph node involvement, or
* Tx N1-2 M0 Primary melanoma of any thickness with regional lymph node metastases confirmed by lymphadenectomy, or
* Tx N1-2 M0 Recurrent melanoma in regional lymph node(s) confirmed by lymphadenectomy.
* ECOG performance status of 0-1
* No active medical or psychiatric disorder requiring therapy that would prevent completion of protocol
* Written informed consent

Exclusion Criteria:

* Patients with unknown primary site of melanoma or primary melanoma originating apart from the skin, except subungual melanoma
* Patients who have clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or distant metastatic disease
* Patients who have had prior adjuvant radiotherapy, chemotherapy, immunotherapy including preoperative infusion or perfusion therapy
* Female patients who are pregnant or lactating
Association Between CRSA and OSA

This goal of this study is to know the association between the central serous chorioretinopathy and the obstructive sleep apnea. Many studies have been done in order to assess the association between the central serous chorioretinopathy and obstructive sleep apnea and the results are always controverses actually.


Eligibility Criteria:
Inclusion Criteria:

* Central serous chorioretinopathy since 6 months at least
* Patients beyond 18 years old

Exclusion Criteria:

- All retina pathology will be excluded : diabetes with affected retina, maculopathy, retina central veinous oclusion, epithéliopathy
Use of 68Ga-dotatate PET Scan in Neuroendocrine Carcinoma of the GI Tract

The purpose of the study is to understand the extent and degree of somatostatin receptor expression in poorly differentiated neuroendocrine carcinomas . This may help to make a determination if a radiolabeled somatostatin analog therapy, also referred to as peptide receptor radiotherapy (PRRT), can be a potential alternative in the future. At this time, radiolabeled somatostatin analogs have not been tested in patients with poorly differentiated neuroendocrine carcinomas, and their efficacy in this disease is not well known Understanding the extent and degree of somatostatin receptor expression is important in order to evaluate the potential of radiolabeled somatostatin analog therapy for treatment of poorly differentiated neuroendocrine carcinomas.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female ≥ 18 years old
* Histologically confirmed diagnosis of poorly-differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract or unknown primary
* Evidence of measurable disease per RECIST 1.1 on another imagine modality (CT, MRI or FDGPET) with at least 3 tumors \>1cm in largest diameter. CT, MRI or Fluorodeoxyglucose (FDG)-PET must have been performed within 2 months of the study scan. (Of note, participants may sign consent for the study prior to scheduling of said CT, MRI or FDG-PET, but will be considered screen failures if the CT/MRI/FDG-PET does not reveal at least 3 tumors \>1cm).

Exclusion Criteria:

* Participants with well-differentiated neuroendocrine tumors
* Participants who have undergone 68Ga-dotatate PET scan in the past
* Pregnant women and/or breastfeeding women. Women of child bearing potential must have a negative pregnancy test prior to scan.
Proton Boost for Locally Advanced HEAD AND NECK TUMORS

The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days).

Local response and acute toxicity are primary endpoints of the trial. At CNAO a proton boost is delivered on the PTV1rx (area at high risk of relapse) up to at least 70 Gy \[RBE\] in 2-3 Gy \[RBE\] per fractions for 8-15 total fractions.

PTV2 rx (area at low or intermediate risk of relapse) will be irradiated with photon IMRT up to a total dose of 50-60 Gy \[RBE\].

Secondary endpoints of the trial are local control, relapse free survival, overall survival, tumor specific survival, intermediate and long term toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologic/cytologic diagnosis of primary epithelial malignant or neuroendocrine tumour
* Inoperable tumour, locally advanced stage
* Seated in rhinopharynx, nasal and paranasal sinuses, hypopharynx, larynx, oral cavity and oropharynx
* At least one lesion measured according to the RECIST criteria
* Enrollment for irradiation with IMRT up to 50-60 Gy RBE\] on the PTV1rx and PTV2 rx to be followed at CNAO with irradiation with proton boost on thePTV1rx.

Exclusion Criteria:

* Metastasis
* Previous radiotherapy
* Any metallic implants or other conditions such to prevent an adequate imaging of target volume
* Unavailability of previous IMRT first phase radiotherapy plans
Efficacy of Changing to TRAVATAN® From Prior Therapy

The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® solution without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to tolerability issues.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye;
* On latanoprost ophthalmic solution 0.005% monotherapy (including BAK-containing generics) for at least 4 weeks prior to the Screening Visit, but would benefit from a switch to TRAVATAN® BAK-free because of tolerability issues, in the opinion of the investigator;
* Intraocular pressure (IOP) \<30 millimeters of mercury (mmHg) in both eyes while on latanoprost ophthalmic solution 0.005% monotherapy;
* IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period;
* Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study;
* Able to follow instructions and willing and able to attend all study visits;
* Best corrected Snellen visual acuity of 6/60 (20/200; 1.0 LogMAR) or better in each eye;
* Must sign an informed consent form;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator;
* Any abnormality preventing reliable applanation tonometry in either eye;
* Corneal dystrophies in either eye;
* Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye;
* Any clinically significant, serious, or severe medical condition;
* Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study;
* Severe dry eye or keratoconjunctivitis sicca which has been or is currently being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids;
* Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit;
* Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment;
* Progressive retinal or optic nerve disease from any cause;
* Women who are pregnant, lactating, or not using reliable means of birth control;
* Other protocol-defined exclusion criteria may apply.
Neurodynamic Interventions for Multiple Sclerosis

A randomized, parallel-group, clinical trial will be conducted to compare the immediate effects of the inclusion of a neurodynamic intervention into a multimodal physiotherapy program on pressure pain sensitivity, pain and manual dexterity in patients with multiple sclerosis


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of multiple sclerosis according to the modified McDonald criteria;
* symptoms of paresthesia and lack of sensitivity in the upper extremity;
* Expanded Disability Status Scale (EDSS) between 0 and 6.5 points;
* absence of cognitive deficit.

Exclusion Criteria:

* any exacerbation of multiple sclerosis during the previous 3 months;
* previous hand surgery or steroid injections treatment in the upper extremity;
* multiple diagnoses on the upper extremity (e.g., cervical radiculopathy);
* cervical, shoulder, or upper extremity trauma;
* other comorbid musculoskeletal medical conditions;
* mini-mental state examination \<25
Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)

It is hypothesised that, in individuals being considered for cardiovascular preventative therapy, computed tomography coronary angiography guided management will reduce the future risk of coronary heart disease death or non-fatal myocardial infarction compared to management guided by the current standard of care, a cardiovascular risk score.

Prevention of cardiovascular disease is currently guided by probabilistic risk scores that both over and under treat individuals, commit most middle-aged people to pharmacotherapy, and have little evidence base. It has been demonstrated that use of computed tomography coronary angiography (CTCA) is associated with changes in the diagnosis and treatment of patients presenting with stable chest pain, and that this leads to a marked reduction in the future risk of myocardial infarction. Importantly, the proportionate reduction in coronary events was most marked in those with non-anginal chest pain irrespective of their cardiovascular risk score which again demonstrated poor discrimination. The research team propose a randomised controlled trial of at least 6,000 middle-aged individuals at risk of cardiovascular disease that will compare these two strategies of targeting preventative therapies: a probabilistic cardiovascular risk score, and screening with CTCA. This trial will determine if CTCA guided management will be associated with better targeted intervention, prevent over medicating the general population, and result in fewer future coronary heart disease events than the current standard of care using a cardiovascular risk score.

Eligibility Criteria:
INCLUSION CRITERIA

* ≥40 and ≤70 years of age
* Resident in Scotland and have a Community Health Index (CHI) number
* One or more of the following risk factors:

  * \>60 years of age
  * Current or recent (within 12 months) smoker
  * Clinical diagnosis of hypertension
  * Known hypercholesterolaemia or total cholesterol \>6.0 mmol/L or receiving statin therapy
  * Diabetes mellitus
  * Rheumatoid arthritis
  * Systemic lupus erythematosus (SLE)
  * Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease below 60 years)
  * Chronic kidney disease stage 3 (estimate glomerular filtration rate 30-59 mL/min/1.73 m2).

EXCLUSION CRITERIA

* Inability to undergo CTCA
* Known coronary heart disease or other major atherosclerotic cardiovascular disease
* Prior invasive or non-invasive coronary angiography within the last 5 years
* Chronic kidney disease stage ≥4 (estimate glomerular filtration rate \<30 mL/min/1.73 m2)
* Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy
* Intolerance of all statins
* Statin therapy for \>2 years.
* Previous coronary artery imaging completed specifically for cardiovascular risk assessment with a result of \>10 AU.
Endoscopic Quality Improvement Program

Effective colorectal cancer (CRC) screening relies on early identification and removal of both polypoid and non-polypoid lesions with neoplastic potential. The investigators hypothesize that an intensive training program designed to enhance both recognition and classification of lesions with neoplastic potential, will result in an increase in non-polypoid adenoma detection in addition to and independent of an increase in overall adenoma detection rates.

Our Endoscopic Quality Improvement Program (EQUIP) was a prospective educational intervention with our staff endoscopist as our study population. The investigators measured adenoma detection rates for a baseline period then randomly assigned half of the endoscopists to undergo EQUIP training. The investigators then examined baseline and post-training study adenoma detection rates (ADR's) for all endoscopist (trained and un-trained) to evaluate the impact of training.

Eligibility Criteria:
Inclusion Criteria:

* Colonoscopies performed at Mayo clinic ambulatory surgical center

Exclusion Criteria:

* Procedures for the indication of acute GI hemorrhage
* Active colitis
* Hereditary polyposis syndrome
* Inflammatory bowel disease
* Incomplete procedures
* Procedures with surgically altered anatomy (i.e. prior colectomy)
* Poor bowel preparation (Boston Bowel preparation score \<5) were also excluded.
Entral Feeding in Acute Severe Pancreatitis

• A total of 60 patients admitted to King Abdulaziz Specialists Hospital between June 2018 and April 2020 with both a clinical and biochemical presentation of acute pancreatitis with the following inclusion criteria: Abdominal pain \> 6 on the visual analogue scale without given analgesia , abdominal distension and tenderness with serum amylase and serum lipase at least 3 times the upper limit of the reference range (considering normal lipase level from 0-160 U/L, and normal amylase level from 0-100 U/L) with confirmed abdominal computerized axial tomography of grade D and E on Ranson and colleagues criteria(28) of inflamed pancreatic picture.

* The study was conducted on monitoring of four pillar for 13 days (data collected one day before feeding and every three days for 12 days). the first pillar comparing the effect of the two enteral feeding methods on the clinical condition of the acute severe pancreatitis and this monitored clinically and laboratory by fixed parameters, clinically, by abdominal pain which assessed by visual analogue scale (VAS). and laboratory, by both markers of severity of pancreatic acini destruction which assessed by serum amylase, lipase and Markers of severity of interstitial pancreatic tissue destruction which assessed by the level of Lactate Dehydrogenase level (LDH), Aspartate aminotransferase (AST), C-reactive protein, prostacyclin and interleukin 8. The second pillar include effect of the two enteral feeding methods on the patient's tolerance and these monitored in our study by both post-feeding vomiting and post feeding attacks of osmotic diarrhea and also abdominal pain. Third pillar include effect of the two enteral feeding methods on the patient's general condition and these monitored by follows the APACHE II Score, hemodynamics of the patients in both groups (Mean arterial blood pressure and pulse) and arterial oxygen saturation (Spo2). Fourth pillar include effect of the two enteral feeding methods on achieving satisfactory nutrition parameters of the patients and both albumin level, radium blood sugar and electrolytes (sodium and potassium level) used as indicator for this.
* All parameters observed one day before starting feeding and every 3 days for 12 days (duration of the study).

Eligibility Criteria:
Inclusion Criteria:

* acute pancreatitis

Exclusion Criteria:

* systemic disease as hypertension or diabetes
Non-penetrating Deep Sclerectomy Versus Trabeculotomy- Trabeculectomy Operation in Treatment of Primary Congenital Glaucoma

The high success rate of the non-penetrating deep sclerectomy (NPDS) procedure in adult glaucomatous patients motivated some glaucoma specialists to try it as an alternative procedure in childhood PCG. In deep sclerectomy, the surgeon fashions a partial-thickness scleral flap and excises the outer parts of both Schlemm's canal and trabecular meshwork without opening the eye, leaving a thin trabeculo-descemetic membrane. This membrane will guard against early postoperative hypotony due to the non-penetrating nature of the procedure.

The aim of this study is to assess the safety and efficacy outcomes of non-penetrating deep sclerectomy versus combined trabeculotomy-trabeculectomy in the treatment of congenital primary glaucoma


Eligibility Criteria:
Inclusion Criteria:

* patients with PCG younger than 6 years old with a HCD between 12-14 mm ware

Exclusion Criteria:

* patients with anterior segment anomalies,
* secondary glaucoma
* previous anterior segment surgeries
* patients more than 6 years old
Circulating Oxidative Stress and Gestational Hypertension. Study of the Evolution of Free-radical Markers of Oxidative Stress From Before to After Childbirth in Two Groups of Women: Normal Pregnancy and Pre-eclampsia.

The aim of this study is to explore a mechanism that could potentially explain why women with a pregnancy complicated by pre-eclampsia are described as having an increased risk of cardiovascular disease later in life.

If the hypothesis of this study turns out to be true, that is to say that women with pre-eclampsia have a higher level of oxidative stress than women with a normal pregnancy and that this difference persists after the delivery (6 months), a controlled randomized interventional study aiming to evaluate either therapeutic supplementation with antioxidant vitamins (Vit C and E) or modifications in diet could be envisaged.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided written informed consent
* Patients covered by a Health Insurance scheme
* Age \> 18 years
* Normal pregnancy
* or pre-eclampsia defined according to the following classical criteria: (i) de novo hypertension defined by arterial blood pressure of at least 140 mm Hg (systolic) or at least 90 mm Hg (diastolic) confirmed by at least two measurements separated by at least 4-6 h, occurring after the 20th week of gestation in a women known beforehand to have a normal blood pressure, (ii) proteinuria defined by urinary excretion of at least 300 mg of protein per 24 h. If 24-hour urine is not available, proteinuria is defined as a concentration of urinary protein of 300 mg/L or more (or \>1 + on the urinary dip) in at least two samples of urine taken randomly, but at an interval of at least 4-6 h \[7\]. Pre-eclampsia is defined as severe if: persistent systolic BP \> 170 mm Hg and/or diastolic BP \> 110 mm Hg, and/or diuresis \< 30 ml/hour, and/or at least 2 of the following signs (headache, phosphenes, epigastric pain or vomiting, pyramidal-type patellar reflexes, papilledema, hepatic pain, thrombopenia \< 100x106 /l, ALT AST \> 70 UI/l and or hemolysis manifesting as haptoglobin \< 0.06 g/l, or a fall in LDH or the presence of schistocytes, the latter three signs define the HELLP syndrome) and/or seizures.
* Term\> 26 SA.

Exclusion Criteria:

* Refusal to provide consent
* Context of patent infection.
* Premature rupture of the fetal membranes.
* preexisting or gestational diabetes.
* Vasculoplacental diseases other than pre-eclampsia: placental abruption or infarction, intrauterine growth retardation of in utero fetal death not occurring in a context of pre-eclampsia.
* Chronic or gestational AHT not meeting the criteria for pre-eclampsia.
* Twin/multiple pregnancies
The Effects of Anodal Stimulation on Echocardiographic Outcome in Patients With Cardiac Resynchronization Therapy

To investigate the hemodynamic, inter and intraventricular desynchrony effects of anodal stimulation and triple site pacing compared with the usual dual site pacing by echocardiography and Tissue Doppler Imaging.

Thirty patients who underwent CRT and had evidence of anodal stimulation will be included in the study. All patients undergo a conventional echocardiography after 10 minutes of continuous triple site pacing and after 10 minutes of continuous dual site pacing (Customary biventricular pacing).Echocardiography studies will be performed to measure dP/dT using continuous flow Doppler velocity profiles of mitral regurgitation, LV volumes and Left ventricular ejection fraction. Left intraventricular desynchrony is assessed by using TDI.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biventricular pacemakers who met currently accepted indications for CRT, including dilated cardiomyopathy with LV ejection fraction \< 35% (ischemic and nonischemic etiologies) with New York Heart Association class III to IV congestive heart failure and QRS duration \> 120 ms.

Exclusion Criteria:

* Patients with first generation CRT device
* Integrated bipolar defibrillator device
* Atrial fibrillation during the screening phase
* Patients who cannot tolerate triple site pacing for several minutes (i.e diaphragmatic pacing)
* Patients with epicardial LV leads
* Patients with LV leads located out of the lateral or posterolateral areas
Opting for Breast Reconstruction After Mastectomy or Not: Search for Influencing Factors

The purpose of this study is to investigate the factors influencing the decision about breast reconstruction after breast amputation for breast cancer.

The study will be conducted at the University Hospital in Brussels using only a questionnaire. The results might help us to evaluate and improve the satisfaction among patients about the received information and guidance.

The questionnaire will be completed during one interview. This interview will take place preferably right after the patient visited her doctor at the Breast Clinic at the University Hospital in Brussels.

Before starting the interview all the necessary information to decide whether or not to participate in the study will be given as well as the time to read the informed consent carefully.

Eligibility Criteria:
Inclusion Criteria:

* female
* Dutch speaking
* must have undergone a mastectomy for breast cancer in the following period: 2010 - 2015
* must be a patient of the Breast Clinic at the University Hospital in Brussels

Exclusion Criteria:

* bilateral preventive mastectomy (and therefore no history of breast cancer in any of the breasts)
Development and Validation of the BVQ

The main aim of this study is the development of the Beliefs about Ventilation Questionnaire (BVQ).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Indication to Non Invasive Ventilation (NIV), in three slots: \<4; \>4 e \<12; \<12 hours
* Outpatients or Inpatients
* Obstructive or restrictive reparatory disorder
* Voluntary agreement to be involved in the Study

Exclusion Criteria:

* Psychiatric Disorder
* Glasgow Coma Scale (CGS) \<14
* Pure Obstructive Sleep Apnea Syndrome (OSAS)
* Tracheostomy with Invasive Ventilation (TIV) o Invasive Ventilation (IV)