cyrilzakka/clinical-trials huggingface dataset:
Rates of Middle Meatus Synechiae Formation Post ESS

The study is designed to evaluate if addition of the steroid to the spacer / stent will improve healing after endoscopic sinus surgery (ESS) compared to spacer without drug.

The study is designed to evaluate basic device usability and confirm safety and effectiveness of the Restora Steroid Eluting spacer compared to a Silastic spacer.

At the completion of their procedure, patients undergoing ESS will receive one steroid eluting spacer placed into the surgical site on one side, and one spacer without drug placed on the other side. Patients will return for standard post-op visits. Between post-op day 6 and 8, both spacers will be removed. Patients will again be seen on post-op day 35 and 90 to evaluate the surgical sites with respect to healing, scarring, infection, degree of inflammation, polyp formation, and the need for secondary intervention. Data from the two sides will be compared to determine if there is a benefit derived from the spacer with steroid vs the one without.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75 years
2. Diagnosis of chronic rhinosinusitis (CRS), per current guidelines
3. Patients who need to undergo primary bilateral complete endoscopic sinus surgery
4. Subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments
5. Subject must understand the research nature of this study and sign an informed consent prior to the performance of any study-specific procedure or assessment

Exclusion Criteria

1. Subject is pregnant or breast feeding
2. Patients with sino-nasal tumors
3. Patients solely undergoing nasal septal reconstruction
4. Patients with previous history of endoscopic sinus surgery
5. Cystic fibrosis or syndromic patients
6. Patients with autoimmune diseases
7. Patients who have taken oral steroids less than 30 days prior to surgery
8. Patients with a history or diagnosis of glaucoma or ocular hypertension
9. Any other circumstance or condition that in the Investigator's opinion causes the subject to be an inappropriate candidate for participating in this study
Effects of Infant Massage on Development of Down Syndrome Babies

The aim of ths study is to know the effects of infant massage in the maturation of the baby with Down syndrome. Scale Psychomotor Development Early Childhood Brunet-Lézine-Revised will be used to measure the maturational development of the baby with Down syndrome . Investigators will analyze two groups of intervention, the experimental group, in which parents will participate and will apply the knowledge learned in the course of Infant Massage and control, which does not receive the Infant Massage course during the study. Babies in both groups will be evaluated twice, at the beginning of the intervention (pretest) and end it after five weeks (posttest). The study population consists of 32 babies with Down syndrome between 4 and 8 months old.

In this study, the investigators will compare the maturational development of the experimental group Down syndrome babies (will receive infant massage in the period between the two measurements) with the maturational development of the control group Down syndrome babies (will receive infant massage after two measurements). Assess both the development partial motor, cognitive, language and social, and also the maturational development global. Finally, measure also the ratio of development, both in the pretest as on the posttest. The test that will use to measure the development of them babies is the scale of development psychomotor of her first childhood Brunet-Lezine-R. The babies of the study may hay between 4 and 8 months old.

Eligibility Criteria:
Inclusion Criteria:

* Babies with Down Syndrome that received Early Attention.

Exclusion Criteria:

Babies with Down syndrome:

* With associated pathology.
* Adopted.
* Have received infant massage course.
Tonsillectomy Using BiZact Tonsilletomy Device

The purpose of this study is to describe how Bizact Tonsillectomy Device might affect operative time and intraoperative blood loss in pediatric patients undergoing tonsillectomy, and compare these parameters to the standard technique in tonsillectomy at our institution, which is electrocautery.

It is a prospective, interventional, single-center study on the performance of Bizact tonsillectomy device on children undergoing tonsillectomy.The required parameters concerning operative time and intra operative blood loss will be obtained during the procedure.There will be no extra clinical visits for the participants.

Operative time will be assessed in 2 ways: 1). By using blade-tipped electrocautery on one tonsil and the BiZact device on the other tonsil for same patient; and 2). using electrocautery for removal of both tonsils and comparing the operative time to an equal number of cases wherein the BiZact device was used for removal of both tonsils.

With regard to intra operative bleeding, it will be quantified into one of 3 groups: 1). No blood in suction tubing, 2). blood in suction tubing but not in the suction canister, and 3). blood in the suction canister.

Eligibility Criteria:
Inclusion Criteria:

1. Children scheduled for tonsillectomy at Alberta Children Hospital
2. Tonsillectomy for either recurrent tonsillitis or sleep-disordered breathing.

Exclusion Criteria:

1. Craniofacial abnormalities
2. Bleeding disorders
3. Complex medical background
Exercise Training for Smoking Students

Smoking can damage lung functions as a result of high carbon monoxide and low hemoglobin oxygen carrying capacity in the blood. Smoking between young people continues to increase, which can cause respiratory function problems and lung diseases at an early age. In the studies, it has been seen that smoking may reduce the oppression and exercise ability.

Students who voluntarily accept participation in the study and sign the illuminated consent form, pulmonary status, gender, age, and body mass index to question data such as demographic data form, nicotine dependence levels Fagerstrom nicotine dependence scale, international physical activity scale (IPAQ), and Beck depression scale will be used. Then the respiratory function test will be evaluated with respiratory parameters and a 6-minute walking test. All evaluations made at the beginning of the study will be applied three times after the 8-week exercise program and the first month of control. First of all, the students will be grouped according to nicotine dependence levels, and exercise groups will be randomized according to each addiction level. Groups to be formed: Group 1: face-to-face exercise group; Group 2: online (telesağlık) exercise group; Group 3: control group.

Eligibility Criteria:
Inclusion Criteria:

* Signing the illuminated consent form,
* To be smoking at least 1 cigarette a day for the last 6 months,
* Not having orthopedic or neurological findings that can prevent the exercises included in the study,
* To have low-medium level physical activity level,
* Not to have any lower respiratory infection in the last 3 months.

Exclusion Criteria:

* To the exercise sessions to be held on time and not to arrive regularly
Rituximab and ABVD for Hodgkin's Patients

Primary Objective:

- To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy.

ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.

Before treatment starts, patients will have a physical exam. Bone marrow samples will be taken. Blood samples (4 to 8 tablespoons) will be taken before and during the study. A chest x-ray, CT scans of the abdomen and pelvis, and a gallium scan will be done if necessary.

Patients in this study will receive rituximab by vein over 3 to 8 hours weekly for 6 weeks in a row. ABVD will be injected over 3 hours every other week for a total of 12 treatments. On the cycles where both rituximab and ABVD are given, rituximab will be given on day 1, and ABVD will be given on day 2. Response to therapy will be determined after 3 months and at the end of therapy (6 months). At the end, patients may receive radiation therapy to areas of large masses. All treatments can be given in an outpatient setting.

Scans and x-rays will be repeated if needed after completion of therapy and every 3 months from then on. If tumors do not shrink after 3 months of therapy, patients will be offered a different treatment.

This is an investigational study. Although ABVD is considered the standard treatment for patients with Hodgkin's disease, the combination of ABVD with rituximab is considered investigational. All drugs involved in this study are commercially available and are approved by the FDA. Up to 85 patients will take part in this study. All will be enrolled at M. D. Anderson. This protocol is partially funded by a research grant from Genentech.

Eligibility Criteria:
Inclusion Criteria:

1. Hodgkin's disease patients who relapse after radiation therapy alone and previously untreated patients with stage II bulky, III and IV who are eligible for ABVD.
2. Must have histologically proven diagnosis of Hodgkin's disease (Nodular sclerosis or mixed cellularity).
3. Must have bidimensionally measurable disease.
4. Must sign a consent form.
5. Must be older than 16 years of age.
6. Must have adequate bone marrow reserve (ANC \> 1,000/microL, Platelet \> 100,000/microL
7. Left Ventricular Ejection Fraction (LVEF) \>/= 50% by multigated acquisition (MUGA) scan or echocardiogram.
8. Serum creatinine \< 2 mg/dl, serum bilirubin \< 2 mg/dl

Exclusion Criteria:

1. HIV positive.
2. Pregnant women and women of child bearing age who are not practicing adequate contraception.
3. Prior chemotherapy.
4. Severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.
Clinical Trial To Study The Anti-scarring Effect Of Cicatricell

This study tries to prove that Cicatricell cream significantly reduces scarring with better wound appearance as compared to no treatment.

At 1st post operative follow up visit, surgical incision(s) will be assessed for healing, after the sutures/staples/steri-strips are removed. To be included in the study the incision must be 5cm or greater. And bilateral incisions as in bilateral mastectomy can be included. The incisions will be divided into two sections, using an imaginary line between top and bottom, or left and right. One side of the imaginary line will have cicatricell cream applied 2 times a day for a minimum of 8 weeks and a maximum 6months. The other side of the imaginary line will remain untreated. In the case of a bilateral incision, as in bilateral breast mastectomy or AAA incisions in the groins, the cream will be applied to one entire incision and the 2nd incision will be untreated. The incision(s) will be its own control group. At the end of the treatment phase the incision(s) will be assessed again to compare the healing.

Eligibility Criteria:
Inclusion Criteria:

* Signed IRB approved, written informed consent.
* Patient from 18 to 60 years of age.
* Patient who recently underwent a surgery involving linear surgical skin incisions of 5cm or more or patients with two exactly symmetrical separate incisions like bilateral inguinal hernia repair or bilateral mastectomy, CT surgery patients will be included.

Exclusion Criteria:

* Known skin allergies.
Comparison of the Effectiveness of 2D Versus 3D Basic Laparoscopic Skills Training

The aim of this study is to find out whether basic laparoscopic skills training (FLS tasks) on a standard pelvic trainer using conventional 2D visualization is at least equally effective in terms of skills improvement compared to practicing with 3D visualization. Furthermore, the progress in basic laparoscopic skills improvement for each visualization modality will be analyzed.

An increasing number of operations are done minimal invasively. For example, appendectomy, cholecystectomy, bariatric procedures, colorectal resections as well as hysterectomy and many other gynecologic procedures, are routinely performed laparoscopically.

Laparoscopy requires psychomotor skills that may be difficult to learn and result in prolonged learning curves. In order to become familiar with the 2-dimensional visualization and to learn and improve laparoscopic skills, training is needed. As traditional training in the operating room is expensive and comprises an increased operating risk for the patient, various training alternatives outside the operating room have been developed and shown to be effective in translating the thereby acquired skills to the operating room. Besides training on live animals or cadavers, there are virtual reality simulators, augmented reality simulators and different box trainers. Each of these training devices has specific advantages and limitations. However, some types could be superior to others in terms of training effectiveness. For instance, with implementation of 3D visualization during laparoscopic interventions which facilitates spatial perception, the question arises as to whether training of basic laparoscopic skills using conventional 2D visualization is at least equally effective compared to training with 3D visualization.

The aim of this study is to find out whether basic laparoscopic skills (FLS tasks) training on a standard pelvic trainer using conventional 2D visualization is at least equally effective in terms of skills improvement compared to practicing with 3D visualization. Furthermore, the progress in basic laparoscopic skills improvement for each visualization modality will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* medical students with limited experience in laparoscopic surgery

Exclusion Criteria:

* any laparoscopic operation performed as the primary surgeon
* regular (e.g., once per month) practice on a box trainer for the last 12 months
3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes

To investigate the surgical outcomes and intraoperative parameters evaluation of 3D visualization system for vitreoretinal diseases in highly myopic eyes

The investigators aimed to compare the safety and efficacy of NGENUITY® 3D Visualization System (Alcon, TX, USA) in vitreoretinal surgery of highly myopic patients with standard binocular microscope pars plana vitrectomy of highly myopic patients. This is a randomized controlled study and will enroll highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery. The enrolled patients will be randomized into "NGENUITY® 3D Visualization System (Alcon, TX, USA) group"(trial group) and "standard binocular microscope pars plana vitrectomy group"(controlled group). The investigators will compare the number of injections of dye (indocyanine green (ICG) or brilliant blue G (BBG)), total surgical time, total peeling time, exposure time of dye, power of endoilluminator, the rate of probe bending, surgical time, postoperative intraocular pressure (IOP), the rate of wound leakage, hypotony, subconjunctival hemorrhage, vitreous hemorrhage, retinal hemorrhage, and endophthalmitis, best-corrected visual acuity (BCVA), structural changes shown on OCT and so on between the two groups.

Eligibility Criteria:
Inclusion criteria:

1. Highly myopic patients (axial length ≥ 26mm, no upper limit)
2. Patient with vitreoretinal pathology that require vitrectomy who had not received previous ICG or BBG-assisted membrane peeling
3. Patient aged ≥ 20 years

Exclusion criteria:

1. Patient who had previous ICG or BBG-assisted membrane peeling
2. Patient who received combined vitrectomy and trabeculectomy
3. Patient with endophthalmitis or intraocular foreign body
Value-based Care in Type 2 Diabetes (Enhancing T2D Care)

The aim of this study is to obtain a better glycemic index score (decrease) by improving the care and quality of life of type 2 diabetic patients for a possible remission of diabetes.

This will be achieved through an intervention that includes a strategy for training primary care physicians and other healthcare professionals in patient therapeutic education (TPE), as well as group and/or individual TPE-related activities/tools made available to patients, funded and encouraged for individualized planning. Intervention follow-up will be carried out by means of quality-of-life questionnaires for patients who have undergone the new method, compared with patients who have received the usual care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed type 2 diabetes (less than 10 years)
* Age (between 40 and 65)

Exclusion Criteria:

* Significant comorbidities linked to worsening diabetes (such as renal failure, previous myocardial infarction, retinopathy, signs or symptoms of severe diabetic neuropathy or diabetic foot ulcers), severe osteoarthritis or as judged by the attending physician.
* Pregnant or breast-feeding women
* Persons who are unable to give signed informed consent
Aronia Berry Consumption on Vascular Function

There is an increasing interest in the effects of various food derived polyphenols on vascular function. Arguably the most well-established vascular benefits are attributed to flavanols from cocoa beans and this has been supported by a successful health claim through the European Food Safely Authority in 2012. Berry fruits are another rich source of polyphenols that have vasoactive properties, and there is a growing body of research exploring these effects in various berries (blueberries, cranberries, strawberries) and other fruit products with similar polyphenol composition. A key (poly)phenol in berries and other fruits believed to provide much of the benefit is anthocyanins. When given as an isolated extract, 320 mg anthocyanins have been found to improve blood vessel function both acutely and in response to chronic consumption over 12 weeks.

Aronia berries are a native North American berry with high naturally occurring anthocyanins among other polyphenols. Based on their polyphenol composition, there is growing interest in the potential for Aronia berries to elicit health promoting cardio-metabolic effects. Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may improve blood vessel function.

Thus, the primary focus of this project is to evaluate the effects of Aronia berry extracts of differing polyphenol dose on vascular endothelial function.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men aged 18-45 years old
* Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
* Are able to understand the nature of the study
* Able to give signed written informed consent
* Signed informed consent form

Exclusion Criteria:

* Manifest cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
* Hypertensive, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal to 90 mmHg
* Obese participants, defined as BMI superior or equal to 30
* Diabetes mellitus and metabolic syndrome
* Acute inflammation
* Terminal renal failure
* Malignancies
* Abnormal heart rhythm (lower or higher than 60-100 bpm)
* Allergies to berries or other significant food allergy.
* Subjects under medication or on vitamin/dietary supplements.
* Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
* Subjects who reported participant in another study within one month before the study start
* Subjects who smoke an irregular amount of cigarettes per day
* Unable to swallow the capsule
* Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
Bleeding Profile With Continuous Hormone Replacement Therapy of Activelle® in Postmenopausal Women

This study is conducted in Europe. The aim of this study is to investigate the bleeding profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)).


Eligibility Criteria:
Inclusion Criteria:

* Healthy women
* At least 3 months on Trisekvens® before screening period
* Ability to understand and comply with the protocol requirements

Exclusion Criteria:

* Less than 12 months or more than 36 months postmenopausal judged by the Investigator
* Known, suspected, or past history of hormone dependent tumor/cancers
* Deep venous thrombosis, active thrombophlebitis, thromboembolic disorders, cerebrovascular accidents or past history of these conditions
* Ischemic heart disease or myocardial infarction within 6 months prior to randomization
A Clinical Study of Xin'an Medicine in the Treatment of Knee Osteoarthritis

Complementary and alternative medicine has been employed over thousands of years to relieve knee Osteoarthritis (OA) pain. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of Knee Osteoarthritis (KOA) Some studies involving animal subjects may explored its mechanism. However, presently, there is a lack of large-sample, multicenter, randomized, controlled trials to evaluate the effects of Xinfeng Capsule treated for KOA. Therefore, the investigators designed a randomized, placebo-controlled, double-blind, multicenter trial to evaluate the effectiveness and safety of Xinfeng Capsule in the treatment of KOA.


Eligibility Criteria:
Inclusion Criteria:

* Participants must meet the American College of Rheumatology (ACR) 1995 revised criteria for KOA.
* Participants must be aged between 40 and 75 years.
* Participants shall not take non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids during the 7 days prior to screening.
* Participants shall not take Chinese medicine for the treatment of KOA during the 7 days prior to screening.
* Joint function in the I-III, X-ray stage in the I-III.
* All participants shall agree to participate in the study and sign an informed consent form.

Exclusion Criteria:

* Patients whose joint clearance is significantly narrow or joint bone bridge connection is formed between a bony rigidity.
* Patients who have knee cancer, rheumatoid arthritis, tuberculosis, acute purulent or intra-articular fractures.
* Persons have obvious inside and outside of the knee varus deformity and a history of limb vascular nerve injury .
* Patients with severe cardiovascular, brain, lung, liver, kidney, or hematopoietic diseases.
* Pregnant women or breastfeeding mothers or individuals with known psychiatric disorders.
* Patients who are hypersensitive to the trial medication.
Breaking Bad News Skills of Doctors and Residents in the Surgical Setting

Breaking bad news is a very stressful and difficult situation for health care professionals, especially clinical doctors and surgeons. Acquiring skills for this sort of communication is very important due to the large volume of times that these professionals will have to deal with it and because it can affect the doctor-patient relationship forever.

The objective of this study is to evaluate the skill of surgeons and residents in surgical specialties in breaking bad news to patients and families across Spanish hospitals. This will be done by analyzing the subjects in terms of their knowledge and experience using a specialized questionnaire based on breaking bad news protocol, designed in the "Hospital Sant Joan de Déu" Children's hospital in Barcelona.


Eligibility Criteria:
Inclusion Criteria:

- Doctors working in the Surgical Setting that accept and answer the specialized questionnaire.

Exclusion Criteria:

* Questionnaire answered out of the time-frame
* Incomplete questionnaires