cyrilzakka/clinical-trials huggingface dataset:
Phase I Hypofractionated Stereotactic Boost (Radiotherapy) for Non-Small Cell Lung Cancer

This study will help researchers test the safety of hypofractionated dose of radiotherapy (HySBst) at different dose levels before or after chemo-radiation for Non Small Cell Lung Cancer.

Patients are assigned to Sub-group 1 or 2 based on the primary lesion size and location. This protocol will utilize a standard 3 + 3 phase I design with three patients enrolled per cohort.

Patients will be offered the opportunity to participate in the blood specimen component of the study.

Patients will be followed up to 2 years post radiation therapy.

Sub-group 1 will receive HySBst for 1 week. Weeks 2-7 will be standard chemo-radiation therapy. Patients have the option of consolidative chemotherapy at week 12.

Sub-group 2 will receive standard chemo-radiation therapy for weeks 1-6 then receive HySBst during week 7. Patients have the option of consolidative chemotherapy at week 12.

HySBst dose escalation for each sub-group is listed below:

Optional: 4 Gy x 4 daily fractions Level 1: 5 Gy x 4 daily fractions Level 2: 5.5 Gy x 4 daily fractions Level 3: 6 Gy x 4 daily fractions

DLTs will be based on events occurring during the course of HySBst.

Chemo-Radiation Therapy is defined as:

Standard Carboplatin \& Paclitaxel Doublelet Regimen with weekly Carboplatin AUC 2/week and Paclitaxel 45 mg/ m2/ week during conventionally fractionated IMRT

Image-guided IMRT to 60 Gy, 5 x per week for 6 weeks

Consolidative chemotherapy is defined as Carboplatin AUC 6 and Paclitaxel 200 mg/m2 every 21 days x 2 cycles will be given after ALL radiotherapy is delivered.

Eligibility Criteria:
Inclusion Criteria:

* Stage II - III Non Small Cell Lung Cancer

Exclusion Criteria:

* Primary tumor directly invading into any mediastinal structures, such as the heart, major blood vessels, esophagus, trachea, and the proximal bronchial tree.
* Prior chemotherapy for NSCLC
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
* Severe, active co-morbidity
* Pregnancy or women of childbearing potential
* Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin
* Uncontrolled neuropathy ≥ grade 2.
A Comparative Efficacy and Safety Study Between Two Silver Containing Dressings In Post-Op Wound Healing

Study objective:

The objective of this study is to evaluate through clinical criteria the clinical efficacy and safety of BCT Silver Bandage role in obstetrical and gynecological wound healing is as effective and safe as Aquacel® Ag. Dressing.

Study devices:

* Study device: BCT Silver Bandage
* Comparator device:"ConvaTec"Aquacel® Ag Hydrofiber Dressing

Study design:

* Randomized, Open-label, interventional, comparative, preventive study with Blinded evaluator.
* All subjects must meet all the inclusion \& exclusion criteria to enter this study in pre-operative phase.
* Eligible subjects will be enrolled after a scheduled operative procedure.
* There is SEVEN visits in this study (one screening eligibility phase up to 7 days before OP day, and four post-op treatment scheduled visits consisting on 1st , 3rd day, 5th day, 12th day and two follow up visit on the 28th and the 42nd post-operative day.
* During each scheduled visit, each subject will have colored picture of his wound after dressing been removed, and on visit V6 for wound evaluation by blinded PI.

Number of subjects: It is expected to recruit ≧150 eligible subjects.

Study Duration: About eighteen month.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female of any race aged between 18 - 70 years old
* The subject is willing and able to understand, sign and date the study Informed Consent, and be able to adhere to the scheduled visits regimen.
* The subject is having surgery (Cesarean pfannenstiel or Open Laparotomy incision) within 1 week

Exclusion Criteria:

* Patients with known allergy or topical hypersensitivity to ionic silver or alginate
* Any systemic or local active dermatological disease that might interfere with the evaluation of the surgical site such as eczema, psoriasis, skin cancer, scleroderma, chronic urticarial
* Patients undergoing MRI (Magnetic Resonance Imaging) examination.
* Subject residence is outside the study center city
* Patients was participating in another clinical trial less than 30 days before participation in this trial
Efficacy and Safety of a New Sperm Capacitation Method

Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to evaluate the efficacy and safety of HyperSperm, a new sperm capacitation method, in 300 semen samples with various characteristics and abnormalities, in an in vitro study over 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide a semen sample via masturbation

Exclusion Criteria:

* Current diagnosis of a sexually transmitted infection (STI)
* Previous diagnosis of hepatitis A, B, C, D, or HIV
* Prior participation in this study
* Participation in a clinical trial involving an intervention within the last 3 months
Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial.

Double blind single center clinical trial to compare the incidence of radial artery occlusion (RAO) using standard doses of Unfractionated Heparin (UFH) vs. high doses of UFH.

Radial artery occlusion (RAO) is one of the most common complications in transradial artery interventions (up to 30% of cases if specific measures are not taken to prevent it) and is related to the prothrombotic state of the patient, the scarce distal flow to the access site and the trauma caused to the artery during the procedure.

Currently worldwide, the transradial (TRA) access is the most widely used access for coronary angiography (in up to 90% of the procedures) because the transradial approach is associated with lower rates of vascular complications and event mortality (compared to the femoral access).

Although TRA access is safer, it is not free of complications, being one of the most important the RAO.

There are universal efforts to reduce RAO improving every aspects of the technique, from the type of introducer to the hemostasis time to a distal TRA, with evidence suggesting that higher doses of UFH can also decrease RAO to a greater extent. The decrease in the incidence of RAO have been proposed to be up to 2.8 times with high doses of UFH (single-center, retrospective study that compared regular not standard doses of UFH versus higher doses of UFH) although no proper prospective clinical trial have been undertaken to prove this.

The standard dose that has shown a lower rate of RAO is 5000 IU, which will be compared with 100 IU / Kg of UFH, with a randomized, prospective, double-blind design, with short-term (24-hour) follow-up with Doppler ultrasound (DUS) and its correlation with plethysmography to document RAO, and in occluded arteries, there will be a 30-day follow-up to determine the recanalization (or persistent occlusion) rates by DUS (and plethysmography). In order to address safety concerns of higher UFH doses, all the potential hemorrhagic complications will be evaluated during the study follow-up time and higher hemorrhagic risk patients are going to be excluded.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age, both genders.
* Successful transradial acess for an elective diagnostic coronary angiography.

Exclusion Criteria:

* Weight \<50 Kg
* Puncture of the ipsilateral radial artery in the last month.
* Still ongoing effect of pre-procedural recently used oral anticoagulants.
* Use of enoxaparin in the past in the last 12 hours prior to the procedure.
* Use of unfractionated heparin in the last 6 hours prior the procedure
* Alterations in coagulation or platelets prone to bleeding or thrombotic complications.
* Anatomical alterations at the radial access site or radial artery.
* Arteriovenous fistula in the ipsilateral arm.
* History of major bleeding associated with the use of UFH.
The Effectiveness of At-home , In-office and Combined Dental Bleaching System ：A Randomized Controlled Clinical Trial

This randomized controlled clinical trial aimed to investigate the effectiveness of at-home , in-office and combined dental bleaching system.

The participants with at least one maxillary tooth demonstrating shade A3 or darker will be recruited and randomly allocated into 4 groups according to the different tooth bleaching protocol：at-home bleaching for group 1,in-office bleaching for group 2 ,combined bleaching for group 3 and group 4.Participates in group 1 will receive two weeks of at-home tooth bleaching （Lasts 14 days and at least 8 hours every day ）with 10% Carbamide peroxide(Opalescence PF 10%) , group 2 will receive two sessions （with a 1- week interval ）of in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%)，group 3 will receive one week of at-home tooth bleaching （Lasts 7 days and at least 8 hours every day ）and then the eighth day receive one session of in-office tooth bleaching , group 4 receive one session of in-office bleaching and lasts 7 days at-home bleaching start on the eighth day . Colour parameters (CIE L\*, a\*, b\*) will be measured with a spectrophotometer (Vita Easyshade Advance 4.0) at baseline (T1), after the first bleaching session (T2), after the second bleaching session (T3), 1 month after the completion of bleaching (T4). CIEDE2000 colour difference (△E00), the Whiteness Index for Dentistry (WID) and Tooth sensitivity (TS) will also be calculated. The data will be statistically analysed through repeated ANOVA and Tukey's test (α = 0.05).

Eligibility Criteria:
Inclusion Criteria:

* patients between 18 and 30 years of age, with fully erupted upper and lower incisors and canines without dental or periodontal disease or restorations, and with at least one maxillary tooth presenting color score A3 or darker, as measured with the Vita Classical guide (Vita Zahnfabrik, Bad Sa # ckingen, Germany) ordered by brightness

Exclusion Criteria:

* patients with systemic diseases or oral mucosal disorders, previous bleaching treatment, patients undergoing orthodontic treatment, pregnant or lactating women , people with known allergy to the product ingredients, smokers, and alcohol abusers, had severe internal tooth discoloration (e.g. tetracycline stains), had bruxism or any other pathology that could cause TS (such as gingival recession or dentin exposure).
VRQOL in Cataract Patients During the COVID-19 Pandemic

The aim of this questionnaire survey is to evaluate the improvement in vision-related quality of life before and after cataract surgery using the National Eye Institute Visual Function Questionnaire 25 and the delay of improvement in the COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years
* Senile cataract
* Indication for unilateral or bilateral cataract surgery
* Postponed cataract surgery due to the COVID-19 pandemic
* Signed and dated declaration of consent

Exclusion Criteria:

* Complex form of cataract (traumatic cataract, secondary cataract after intraocular inflammation)
* Amblyopia on the eye that is to be operated on
* Severe, visually impairing eye disease on the eye that is to operated on
* Known dementia or memory problems
Non-invasive Neurological Evaluation During CPR

Cardiac arrest remains a leading cause of death, currently affecting \>250,000 Europeans outside the hospital each year. Manual cardiopulmonary resuscitation (CPR) provides between 15 to 30 % of normal blood flow to the heart and brain. For out-of-hospital cardiac arrest, the return of spontaneous circulation (ROSC) is possible only for 20-40% of patients with trained resuscitation teams. However, only 5-10% of patients will survive with good neurological status. A good quality CPR, a short time before initiation of the resuscitation and a short delay before the first defibrillation have been associated with improved neurological outcome. Unfortunately it is currently impossible to obtain reliable information on the quality of the perfusion and oxygenation of organs during CPR. The current monitoring during CPR is limited to heart rhythm analysis, pulse rate evaluation and end tidal CO2 (EtCO2). The last one is the only parameter which have been linked with probability of ROSC and its value gives no indication of the long-term prognosis nor the neurological status.

Cerebral spectroscopy (near-infrared spectroscopy - NIRS) allows to measure with a noninvasive method the local oxygen saturation of the prefrontal cortex (rSO2), reflecting the balance between need and supply of brain oxygenation. This technique has been recently used in cardiac arrest showing a possible association between rSO2 measured during CPR and the occurrence of ROSC or survival. The quantitative measurement of the pupillary light reaction has been described to predict neurological outcome in the hospital for patient successfully reanimated after out-of-hospital cardiac arrest (OHCA). Recently, a feasibility study has shown that its use was also possible during CPR in the pre-hospital setting.

The investigators aim to study a composite prognostic factor combining quantitative rSO2 and automated pupillometry measured during CPR. The investigators hypothesized that the rate of survival with good neurologic outcome at 30 days will be lower in patients with rSO2 \<30% for more than 5 min and an absent pupillary reflex more than 5 min or decreasing during CPR .


Eligibility Criteria:
Inclusion Criteria:

* All adults with nontraumatic, out-of-hospital cardiac arrest

Exclusion Criteria:

* Traumatic cardiac arrest
* Patients who had achieved ROSC before inclusion patients with a do-not-attempt resuscitation order
* Patients \< 18 years old
* Subjects known to be pregnant or breastfeeding
Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)

The study is a prospective randomised controlled study. The patients get monolateral IOL implantation of POD F GF and POD F in the contralateral eye. Both IOLs are trifocal IOLs consisting of the same optical design. The difference between the IOLs is the material (hydrophilic and hydrophobic).

To decide which eye receives POD F and which eye receives POD F GF, a randomization table will be provided to the principle investigator.

The examinations consist of visual acuity data, contrast sensitivity exams and slitlamp examinations.

Follow up will be up to 6 months postoperative.

Eligibility Criteria:
Inclusion Criteria:

* Cataractous Eyes with no comorbidity
* Patient older than 50 years old
* Regular corneal astigmatism \<0.75 dioptres by an automatic keratometer (regularity determined by the topography of the keratometry) or \<1.0 dioptres if the steep axis of cylinder is between 90° and 120°
* Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Unrealistic expectation
* Irregular astigmatism
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
Feasibility Study - Integrated Sensor and Infusion Set. Trial III

The purpose of this study is to collect performance data on the Integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities. The hypothesis of this study is that having the infusion of insulin in close proximity to the sensor does not interfere with the sensor accuracy. This study focuses on high bolus patients. A high bolus is defined as 12 units or more.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 21-70 years of age at time of screening (age criteria chosen in order to comply with other studies in the same field of research).
* Subject has a clinical diagnose of type 1 or type 2 diabetes, as determined by investigator.
* Subject has one or more established insulin carbohydrate ratio.
* Subject has one or more established insulin correction ratio.
* Subject is a high bolus user (\>10 units/meal) for at least one meal a day.
* Subject is currently using a Medtronic insulin pump and has been so for a minimum of 3 months at time of enrollment.
* Subject has been using insulin for more than one year.
* Subject is willing to wear two pumps, one sensor, one infusion set and one Integrated sensor and infusion set at one time (first night).
* Subject is willing to perform frequent SMBGs during Visits 3 and 4.
* Subject is in good general health without other acute or chronic illnesses.

Exclusion Criteria:

* Vulnerable population will not be included in the study
* Subject is pregnant as per urine test or lactating (if female), as self-declared by patient.
* Subject plans to become pregnant during the course of the study.
* Subject is unable to tolerate tape adhesive in the area of sensor placement.
* Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection).
* The subject has complications such as advanced autonomic neuropathy, legal blindness, or symptomatic cardiovascular disease as evidenced by a cardiovascular episode within the last six months.
* The subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening or which might confound the collection or interpretation of the study data.
* The subject has experienced two or more severe hypoglycemic events - seizures/coma requiring assistance in the past 6 months.
Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip

To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis.

This is a 13 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen.

Eligibility Criteria:
Inclusion Criteria:

* Men and women (40 or older) with a diagnosis of primary OA of the hip
* Must be a current chronic user of NSAIDS or acetaminophen
* Must discontinue all analgesic therapy at Screening

Exclusion Criteria:

* Uncontrolled Hypertension or Diabetes
* Hepatic or renal impairment
* Current or expected use of anticoagulant
* Clinically relevant abnormal ECG
* A history of alcohol or drug abuse
* Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
* Current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy
* Candidates for imminent joint replacement
* Participation within 30 days prior to screening in another investigational study
Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis

* Study Population: Patients admitted or seen in Out Patient Department, Department of Hepatology, Institute of Liver and Biliary Sciences.
* Study Design: Prospective Open Labeled Randomized Controlled Trial.
* Study Period: January 2017 to December 2017
* Intervention- Subjects will be randomized to 3 groups
* All patients will receive Standard medical therapy - Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.

Group A - Subjects will receive Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) Group B - Midodrine 7.5 mg TDS x 3 days Group C - Standard medical therapy only

* Monitoring and Assessment: Clinical evaluation will be done at regular intervals.
* Adverse Effects: Rise in blood pressure, arrthymias, hyponatremia and rarely cardiovascular side effects have been noted.
* Stopping Rule: Development of PICD, hypertension ( BP\>160/90mmhg-JNC class II)


Eligibility Criteria:
Inclusion Criteria:

1. Patients with cirrhosis who undergo Large volume paracentesis (\> 5L)
2. Patients with age from 18-75 years

Exclusion Criteria:

1. Renal failure ( Creatinine\>1.5mg/dl)
2. Recent Gastrointestinal bleeding within 7 days
3. Spontaneous bacterial Peritonitis
4. Patients with Cardiovascular disease (Electrocardiogram, 2D Echo)
5. Systemic arterial hypertension ( \>160/90mmhg) Presence of hepatocellular carcinoma or portal vein thrombosis, Budd chiari syndrome
6. Patients with active untreated sepsis
7. Pregnancy
8. Patients with hepatic encephalopathy
9. No use of drugs affecting systemic hemodynamic 3 days prior to enrollment
10. Refusal to participate