cyrilzakka/clinical-trials huggingface dataset:
Use of Gelronate Gel vs. Aloevera in Preventing/Minimizing Radiation-induced Dermatitis in Breast Cancer Patients

The aim of the study is to evaluate the effect of Gelronate gel, NaHA based product (medical device for topical application) vs. Aloevera gel, in prevention or minimizing of radiation induced skin reaction in breast cancer patients

Gelronate is gel composed of 1% high molecular weight pharmaceutical grade sodium hyaluronate and preservatives dissolved in pharmaceutical grade purified water. Gelronate supply in an airless pump bottle contain \~30 ml gel. In the study, 120 female patients planned to receive whole breast radiation (with or without lymphatic drainage) in the radiotherapy unit at Sheba Medical Center.

Patients will undergo CT simulation with 3D treatment planning (as routine done) and will receive 42.4 Gy in daily fraction of 2.65 Gy, five times per week to the whole breast according to the standard department protocol, with or without concomitant or subsequent lumpectomy cavity boost. Patients data including demographics, staging, systemic therapy, radiation details, other medications will be recorded the protocol's forms.

The gel will be applied as a thin lotion twice a day, immediately after radiotherapy treatment and once more in the evening/morning. The therapy will continue for 10 days following the end of radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged at least 18 years with unilateral breast following lumpectomy +/- chemotherapy
* Planned to receive 42.4 Gy whole breast irradiation +/- boost to tumor bed.
* ECOG performance status 0-2.
* Capable of giving written informed consent.
* No co-morbidities known to affect radiotherapy reactions.
* No co-existing acute or chronic skin disease.
* No evidence of infection or inflammation of breast to be treated.
* Not receiving chemotherapy during radiotherapy course. Biological therapy (e.g. Herceptin) or hormone therapy will be allowed during the study.

Exclusion Criteria:

* Chemotherapy within 4 weeks prior to planned start of radiation or chemotherapy planned during radiation.
* Prior radiotherapy to the chest wall.
* Collagen vascular disease.
* Participation in other clinical study.
Genetics of Epilepsy and Related Disorders

Investigators at Boston Children's Hospital are conducting research in order to better understand the genetic factors which may contribute to epilepsy and related disorders. These findings may help explain the broad spectrum of clinical characteristics and outcomes seen in people with epilepsy.

Many individuals with epilepsy experience seizures which respond well to treatment. Some types of epilepsy, however, are characterized by seizures which begin very early in childhood and are associated with severe intellectual and/or developmental disabilities. These conditions are often difficult to treat.

The investigators' research effort is focused on identifying genetic changes (known as "DNA variants") that cause epilepsy. By doing so the investigators hope to improve diagnosis and treatment for this epilepsy.

We have two specific aims:

1. Identifying genetic findings in patients with epilepsy and related disorders.
2. Correlating genetic findings with epilepsy phenotypes.

Eligibility Criteria:
For Gene-STEPS:

inclusion: seizure onset at less than 12 months of age, must be enrolled within 6 weeks of first seizure-related presentation to BCH exclusion: simple febrile seizures, provoked seizures, genetic or acquired cause already identified, MRI findings consistent with specific genetic etiology

For BCH CRDC:

inclusion: diagnosis of epilepsy, patient at BCH exclusion: existing genetic diagnosis or known cause for epilepsy, structural malformation of the brain

For Core cohort:

inclusion: diagnosis of epilepsy exclusion: existing genetic diagnosis or known cause for epilepsy, structural malformation of the brain

For Phenotyping cohort:

inclusion: diagnosis of a genetic epilepsy exclusion: no genetic diagnosis or diagnosis of other genetic condition that does not include epilepsy phenotype
Periodontal Outcomes and Digital Volumetric Variation Following BOPT Restorations

Technology is becoming increasingly essential in dentistry, and many procedures now require the use of an intraoral scanner. The goal of scanning the oral cavity is to create digital impressions, which are crucial for the fabrication of any dental prosthesis, as three-dimensional models of the dentition are needed.

Alongside technological advancements, new techniques for preparation in fixed dental prosthetics are being developed. An example is the BOPT technique, which involves vertical tooth preparation without a finishing line, associated with gingival sulcus curettage. The technique aims to improve the health and stability of gingival tissues over time.

Since it is a technique still not widely used, there is a need to intensify studies on the subject, justifying the conduct of this observational research aimed at assessing, through scanning and image overlay programs, the volumetric change of gingival tissues after the installation of ceramic prostheses with BOPT-type carving

The aim of this study was to analyze the behavior of the periodontal tissues around teeth in the anterior region when restored with zirconia single crowns, using a biologically oriented preparation technique (BOPT). The study will investigate tooth-supported single crowns in the anterior region that were fabricated with a full zirconia core, in 18 patients, in the past 3 years. Follow-up analysis will measure periodontal responses by evaluating the following variables: plaque index (PI); probing depth (PD); gingival index (GI); and gingival thickness adjacent to the restoration using intraoral scanning.

The images of the scanning before and after BOPT restoration will be overlap by using a software tool named Geomagic. This program can quantify the changes of gingival thickness in different points defined by the investigator.

Eligibility Criteria:
Inclusion Criteria:

* patients who had been treated previously by BOPT technique.
* patients aged over 18 years.

Exclusion Criteria:

* Cases where the scanners cannot be overlapping.
Intubation With McGrath Video Laryngoscope and Boedeker Intubation Foreceps in a Population of Patients With Predictors of Difficult Airway

Tracheal intubation with videolaryngoscopes have been widely studied, and is now often used in the management of difficult airways.

Videolaryngoscopes with angulated blades can improve laryngeal view, however this does not always match with a higher intubation succes. To adress this matter the aim of this study is gathering experience with intubation with mcgrath videolaryngoscope and a blade-shape intubation foreceps (Boedeker intubation foreceps, Karl Storz, Germany).

The hypothesis is that intubation with this combination is easy and can be a good alternative when using the McGrath videolaryngoscope in patients with predictors of difficult airway.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for elective surgery
* age over 18 or more
* planned intubation with mcgrath videolaryngoscope
* informed conscent obtained
* patients are
* patients shall be able to read and understand Danish

Exclusion Criteria:

* Patients planned to awake intubation
* stridor
* hypoxia defined by saturation under 90% without oxygen supply
* patients with oxygentreatment at home
* patients that need a wired tube
* patients that need a preshaped tube
* patients that need crash induction
* use of gastric tube
Efficacy CompariSon of Pre-stenting Atherectomy Versus Scoring ballooN for calcifieD Coronary Lesions Coronary Lesions

Design: The proposed study is a randomized study comparing the relative effectiveness of three lesion modification strategies (RA, SBS, or OAS) in the treatment of obstructive CCLs using the change in lumen size measurements (MLA, RLA, MSA and the ratio of MSA/MLA) obtained with IVUS or OCT. Patients will be blinded to treatment assignment for the duration of the study.

Treatment: Patients who are randomized to RA will undergo coronary wiring of the CCL and subsequent advancement of the RA burr. The RA system is performed using standard technique under intravenous infusion of heparin. The atherectomy burr size will be determined by the operator.

Patients who are randomized to OAS will undergo coronary wiring of the CCL and subsequent advancement of the OAS according to the manufacturer's guidelines.

Control: Patients who are randomized to SBS will undergo coronary wiring and balloon inflation with SBS performed by standard technique under intravenous infusion of heparin. SBS will be used according to the AngioSculpt manufacturer's guidelines.

Duration: 30 days follow-up.

The primary trial objective is to determine which of the three treatment strategies for treating calcified coronary lesions (RA, SBS, or OA) is superior for obtaining higher ratio of final in-stent minimum lumen area/reference lumen area, as determined by IVUS or OCT (primary study endpoint).

The secondary objectives are to compare the following:

1. Difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain), as determined by IVUS or OCT (secondary endpoint)
2. Mean final minimal stent area (MSA), as assessed by IVUS or OCT (secondary endpoint)
3. Ratio of final in-stent minimum lumen diameter/reference lumen diameter, as determined by quantitative coronary angiography (secondary endpoint)
4. Incidence of major adverse cardiac events (death, myocardial infarction, target vessel revascularization) during 30 days of follow-up (secondary endpoints)
5. Procedure time, fluoroscopy time, and contrast volume (secondary endpoints)


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Clinical indication for coronary intervention such as ischemic symptoms and/or a positive functional study
3. Found to have a de novo severe calcification (radio opacities noted without cardiac motion on contrast injection, lesion length \>15 mm, or presence of \>270° calcification on one cross-sectional view of IVUS) in a native coronary artery on fluoroscopy or IVUS

Exclusion Criteria:

1. Subject is currently participating in an investigational device or pharmaceutical treatment protocol
2. Persistent (\>10 minutes) hypotension (systolic blood pressure \<90 mmHg)
3. Need for revascularization of multiple lesions during the index PCI
4. Unprotected left main (\>50%) or equivalent left main disease
5. Non-calcified lesions
6. Chronic total occlusions, extreme lesion tortuosity including Type B/C lesions
7. Severe left ventricular dysfunction (ejection fraction \<25%)
8. History of bleeding diathesis or coagulopathy
Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).

Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of R-R MS. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties. The study treatment duration is 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of confirmed and documented MS defined by the Revised McDonald criteria.
2. Subjects must be of the relapsing-remitting (R-R) type.
3. Subject has experienced prior to screening at least one documented relapse in 12 months or at least 2 documented relapses in the 24 months or one documented relapse between 12 - 24 months with at least 1 documented T1-Gd enhancing lesion in the MRI performed 12 months prior screening.
4. Disease duration for at least 6 months.
5. Ambulatory with converted Kurtzke EDSS score of 0 - 5.
6. Relapse free and stable neurological condition at least for 30 days prior screening.
7. Age - 18-55 (inclusive)

Exclusion Criteria:

1. Previous use of Copaxone (glatiramer acetate)
2. Treatment with corticosteroids within 30 days prior screening or between screening and baseline.
3. Chronic corticosteroids treatment - more than 30 consecutive days.
4. Subject with any clinically significant or unstable medical condition.
5. Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
6. Known history of sensitivity to Gadolinium and inability to successfully undergo MRI scanning.
Confusion in the Elderly After Colon Surgery

A study will be conducted to determine if there is any cognitive benefit in elderly patients having open versus minimally invasive colon cancer surgery.

Cognitive changes in the elderly are common after surgery. It is not known if minimally invasive or laparoscopic surgery can prevent these changes. A study will be conducted on patients scheduled to have abdominal surgery. The patients will have cognitive evaluations before and after surgery. A small amount of blood, about 2 tablespoons, will be collected no more than 5 times in 6 months. The results will be analyzed to determine if there are changes between those having open surgery versus patients having laparoscopic or minimally invasive surgery, and if these changes coincide with cognitive changes.

Eligibility Criteria:
Inclusion Criteria:

* Patients over age 65.0 years and in need of elective colon resection for adenocarcinoma

Exclusion Criteria:

* Inability to complete preoperative cognitive screening
* Inability to complete study in English since CANTAB is timed and not validated with interpreters
* Emergency surgery
* Depression or psychiatric comorbidity
* Pre-existing dementia
* Previous cerebrovascular accident or "stroke"
* Previous myocardial infarction
* Cardiac ejection fraction below 55%
* Propranolol, metoprolol or other betablocker use
* Digoxin, procainamide, or amiodarone use
* Calcium channel blocker use
* History of vascular surgery or arterial vascular disease
* History of alcohol dependence
* Lovastatin or other HMG-CoA reductase inhibitor use
* Ace inhibitor use
* Neuroendocrine or catecholamine associated tumors
* Hypertension
* Diabetes
* Benzodiazepine use
* Dimenhydrinate or other medications to treat motion sickness
* Metaclopramide use
Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea

For six hours following drug administration, subjects will rate the severity of specific symptoms. At the end of the six hour study, subjects will rate the overall effectiveness of the product.

A six-hour study to evaluate multiple early efficacy endpoints in loperamide-simethicone therapy to help identify speed of onset of symptomatic treatment of acute nonspecific diarrhea (ANSD).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute diarrhea with gas-related abdominal discomfort, meeting specific criteria
* Willing to follow the protocol requirements and comply with protocol restrictions, including use of contraception
* Able to understand the informed consent process and sign the form
* Cooperative, reliable and willing to comply with the protocol requirements and schedule, and able to record efficacy and safety assessments.

Exclusion Criteria:

* Female subjects who are pregnant, lactating or experiencing perimenstrual abdominal or pelvic discomfort
* Illness requires hospitalization, IV fluids or antibiotics
* Has taken antibiotics in the past 7 days or a symptomatic antidiarrheal compound in the past 12 hours or any analgesic in the past 6 hours
* History of significant underlying enteric, pulmonary, hepatic, cardiac, renal disease, seizure disorder, IBD, cancer, uncontrolled diabetes, or any other unstable medical condition
* History of hypersensitivity to loperamide or simethicone
* Has previously participated in this study or received an investigational drug within the 30 day period before screening
Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

Medications available for the treatment of seasonal allergic conjunctivitis include antihistamines. These medicines block the release of histamine, a substance in the body that is released when an allergic reaction occurs. Novartis (NVS) has developed an eye drop formulation of a well tried antihistamine called ketotifen. This study will compare the efficacy and the tolerability of ketotifen eye drops with emedastine, which is a popular treatment for seasonal allergic conjunctivitis in China.


Eligibility Criteria:
Inclusion Criteria:

* Age 3 years or older.
* History of seasonal allergic conjunctivitis
* Presence of bilateral ocular itching/conjunctival hyperaemia (redness) at baseline:

  1. at least intensity degree 2 for itching, and
  2. at least intensity degree 4 for composite score of itching and conjunctival hyperaemia

Exclusion Criteria:

Other systemic/ophthalmic conditions

* Presence of any form of allergic conjunctivitis other than seasonal allergic conjunctivitis (e.g. perennial allergic conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis, giant papillary conjunctivitis).
* Active bacterial or viral conjunctivitis or history of ocular herpes.
* Presence or history of severe dry eye.

Previous treatments

* Any systemic or ocular corticosteroids within two (2) weeks prior to randomization.
* Any systemic or ocular mast cell stabilizers within two (2) weeks prior to randomization.
* Any other ophthalmic medication within three (3) days prior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply
Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients with Oral Cavity or Skull Base Tumors

This phase IV trial studies how well serial magnetic resonance imaging (MRI) after radiation therapy works in predicting radiation-induced changes in the normal tissue of patients with oral cavity or skull base tumors. Performing MRIs after radiation therapy for patients with oral cavity or skull base tumors may help to predict osteoradionecrosis (a change in non-cancerous tissue).

PRIMARY OBJECTIVES:

I. Demonstrate the feasibility of serial magnetic resonance (MR) imaging biomarkers for assessment of early, intermediate, and late radiotherapy-attributable physiologic alteration of tumor and normal tissues and the kinetics thereof.

II. Develop MR-biomarker inclusive predictive models for development of radiotherapy-attributable normal tissue injury.

III. Define dose-response relationships between imaging biomarkers and subsequent radiation-induced effects.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT I: Patients may receive a contrast agent intravenously (IV) and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy.

COHORT II: Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven malignant neoplasms of the oral cavity and skull base
* Patients whom, currently or previously, dispositioned to treatment with radiotherapy
* Patients with good performance status (Eastern Cooperative Oncology Group \[ECOG\] score 0-2)
* Patients willing to give written informed consent

Exclusion Criteria:

* Patients unable to tolerate diffusion weighted (DW)-MRI or dynamic contrast-enhanced (DCE)-MRI or having an estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73m\^2
* Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)
Multi-Modal Intervention In Frail And Prefrail Older People With Type 2 Diabetes

The MID-Frail STUDY project focuses on the use of interventions designed to improve functional status and enhance quality of life (rather than traditional treatments such as glucose- and blood pressure- lowering) by acting on the mechanisms involved in producing frailty and its progression to adverse outcomes.

Detailed Description: Subjects enrolled in the main study will also be invited to join the following sub-studies:

GENEFRAIL: this sub-study aims to determine the polymorphisms of several genes associated to frailty, in order to establish its predictive value for developing disability and response to treatment as well METABOFRAIL: this sub-study aims to investigate the metabolomic profile of frail and pre-frail patients. SARTRAIN: the combination of the assessment tools used in SARTRAIN (ARFI US, MRI, posturographic measurements) will provide a comprehensive study of the structural and functional characteristics of muscle and adjacent tissues and their change with time and the intervention. MID- POW: this sub-study aims to investigate changes in muscle power.

The project also include an randomized controlled ancillary study: SENSOLE for which the aim is to investigate the potential effects of vibrating insoles device on gait and posture.

Eligibility Criteria:
Inclusion criteria:

* Participant is willing and able to give written informed consent for participation in the study.
* Subjects aged 70 years or older, with a diagnosis of type 2 diabetes mellitus for at least 2 years.
* Require to fulfill Fried ́s criteria for frail or pre-frail individuals.

Exclusion criteria:

* Barthel score lower than 60 points.
* Inability to carry out SPPB test (total score=0).
* Mini Mental State Examination score less than 20 points.
* Subjects unwilling or unable to consent or unable to participate safely in intervention program.
* Previous history of myocardial infarction within 6 months, unstable angina or congestive heart failure in III-IV NYHA stage.
* Clinically instable patients in the clinical judgment of the investigator.
* Terminal illness (life expectancy \< 6 months).
* Any other condition that, in the clinical judgment of the investigator, means that it would not in the patient's best interests to enter the study.
* Current participation in clinical trial or any other investigational study.
TAPP and Open Repair for Recurrent Inguinal Hernia

The objective of this study was to explore the clinical efficacy of transabdominal preperitoneal approach (TAPP) and open tension-free hernia repair in the treatment of recurrent inguinal hernia. This study aims to provide a basis for selecting the optimal treatment methods for recurrent hernias.

The patients were randomly allocated to the TAPP group and the open tension-free repair group. We recorded the general situation, operation time, and intraoperative complications; postoperative visual analogue pain scale (VAS) scores at 24 and 48 h; and the incidence of complications such as seroma, chronic pain, inguinal numbness, foreign body sensation, and recurrence at 1 week, 1 month, 3 months, 6 months and 1 year after surgery. These indicators were compared between the two groups of patients.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* the diagnosis of recurrent inguinal hernia made by ultrasound or computed tomography (CT) during the present visit
* ability to tolerate general anesthesia and local anesthesia surgery
* all patients and their families agreed to participate in this study and sign relevant informed consent.

Exclusion Criteria:

* patch infection during the first surgery
* multiple (≥ 2) relapses
* inability to cooperate to complete follow-up after surgery