cyrilzakka/clinical-trials huggingface dataset:
Efficacy of GONB in Patients of Migraine

The study was carried to determine the analgesic efficacy of greater occipital nerve block in patients of migraine. It was a randomised controlled which took place from april 2022 - october 2022. Fifty patients suffering from migraine were included in the study. Patients in Group G were given greater occipital nerve block (GONB) with lignocaine and dexamethasone under ultrasound guidance while those in Group S were given saline 0.9% as placebo. Pain score using Numeric Rating Scale and number of headache days was assessed at four,eight and twelve weeks after the procedure as a primary outcome. Total headache days were recorded as a secondary outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 to 60 years
* diagnosed case of migraine

Exclusion Criteria:

* Patients with known allergies to local anaesthetics
* pregnancy
* history of cranial or cervical surgery
* head injury
* headaches secondary to medication overuse
* patients with uncontrolled systemic disease like blood pressure, diabetes mellitus
* hypo or hyperthyroidism
* patient who had already received GONB or botulinum toxin type A therapy within last 6 months
* major psychiatric disorder
* history of chronic pain syndromes
Endurant Stent Graft System Post Approval Study (ENGAGE PAS)

The purpose of the study is to demonstrate the long term safety and effectiveness of the Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment, through the endpoints established in this protocol.

The clinical objective of the study is to evaluate the long term safety and effectiveness of the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality (ARM).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Indication for elective surgical repair of abdominal aortic aneurysm (AAA) with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Endurant Stent Graft System
* Signed consent form. The subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information
* Intention to electively implant the Endurant Stent Graft System
* Ability and willingness to comply with the Clinical Investigational Plan (CIP).

Exclusion Criteria:

* High probability of non-adherence to physician's follow-up requirements
* Current participation in a concurrent trial which may confound study results
* Female of childbearing potential in whom pregnancy cannot be excluded or who is lactating.
Post Operative Pain and Oral Health Related Quality of Life Following Pulpotomy VS Extraction of Permanent First Molar

The goal of this clinical trial is to compare between post operative pain and oral health related quality of life in participants receiving two treatments for first permanent mandibular molars with poor prognosis.

Group I (Experimental group): Complete Pulpotomy with the use of MTA followed by stainless steel crown.

Group II (Control group): Non-surgical extraction.

The principal investigator will carry out all treatment procedures, and the patients will be assigned.

For both interventions:

1. Informed consent from participating parents.
2. Baseline records photographs, percussion test, periapical and panoramic radiographs, and personal data collection.
3. A diagnostic chart with personal, medical, and dental history will be filled
4. Baseline Oral Health related quality of life questionnaire for each participant.
5. A clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination).
6. Preoperative and Postoperative photographs will be taken.
7. The radiographic examination will be performed by taking a periapical radiograph and a Panoramic radiograph through a machine to assess the inclusion criteria. The preoperative radiograph will serve as a reference for the follow-up radiographs. Standardization of the technique to avoid any distortion in the vertical dimension and to provide reproducible images using an X-ray holding device.
8. Preoperative and postoperative radiographs in the pulp therapy group will be taken by a parallel technique using an XCP film holder (Super Bite, Hawe Neos DentalSA, Switzerland).
9. Participants will then be allocated into either one of the groups according to the indicated intervention needed as follows:
10. Administration of inferior alveolar nerve block and long buccal infiltration: Septocaine® and epinephrine 1:100,000 (Articaine HCl. 4% and Epinephrine 1:100,000 Injection) at the side of the affected tooth.

Eligibility Criteria:
Inclusion Criteria:

Children aged between 8 years and 9.5 years.

* Decayed Mandibular Permanent first molars.
* Symptomatic Mandibular permanent first molar (caries-related pulpal symptoms or hypersensitivity relating to enamel hypo mineralization)

Exclusion Criteria:

* Children who are not apparently healthy.
* Lack of informed consent by the child patient's parent.
* Patients who are allergic to any of the materials used in the procedure.
* Unable to attend follow-up visits.
* Refusal of participation.
A Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications

A single-center, phase IV, randomized, prospective study investigating the efficacy of various wound closure devices in reducing postoperative wound complications.

The zipper wound technology is a new wound closure device that is an alternative to the commonly used conventional staples and sutures. The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin. The other treatment groups include monocryl + Dermabond (conventional sutures and skin adhesive glue) and polyester mesh + Dermabond. All products have been FDA approved. A randomized control trial will provide the highest level of evidence without altering the potential risks to the patient as all three wound closure techniques have been found to have comparable complication rates. The three different treatment devices will be administered following the normal standard of care. All three wound closure devices are currently being used at NYULMC. No modifications to the normal standard of practice other than the randomization process will be implemented. Given the nature of the application of the wound closure device, which will be visible to the surgeon at the time of application and the patient postoperatively, the study will not be blinded to either the surgeon or the patient. Prior to discharge, a blinded plastic surgeon will be asked to assess the wound based on comesis and overall quality of wound healing.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing joint arthroplasty

Exclusion Criteria:

* Treatment of total joint replacement surgery at an outside institution
Incidence and Mortality of Childhood Cancer Among Children of Farmer Pesticide Applications

Previous studies have estabished pesticide exposure as a possible risk factor for childhood cancer. The Agricultural Health Study (AHS), a prospective cohort study of pesticide exposure among 51,000 pesticide applicators in North Carolina and Iowa, provides an opportunity to study childhood cancer incidence and mortality among the children of pesticide applicators. Name and dates of birth for 21,985 children were previously provided by adult participants in the AHS. The current study seeks to identify cases of cancer among these children through record linkage to state cancer and death registries. Cancer incidence and mortality within the cohort will be compared with national data through standardized incidence and mortality ratios. A limited case-cohort comparison of pesticide exposures will also be performed. Approximately 44 cases of childhood cancer are expected to be identified. No follow-up or contact with cases is anticipated. It is anticipated that the study results will provide insight into the relationship of pesticide and other farm exposures to the pathogenesis of childhood cancer.

Previous studies have estabished pesticide exposure as a possible risk factor for childhood cancer. The Agricultural Health Study (AHS), a prospective cohort study of pesticide exposure among 51,000 pesticide applicators in North Carolina and Iowa, provides an opportunity to study childhood cancer incidence and mortality among the children of pesticide applicators. Name and dates of birth for 21,985 children were previously provided by adult participants in the AHS. The current study seeks to identify cases of cancer among these children through record linkage to state cancer and death registries. Cancer incidence and mortality within the cohort will be compared with national data through standardized incidence and mortality ratios. A limited case-cohort comparison of pesticide exposures will also be performed. Approximately 44 cases of childhood cancer are expected to be identified. No follow-up or contact with cases is anticipated. It is anticipated that the study results will provide insight into the relationship of pesticide and other farm exposures to the pathogenesis of childhood cancer.

Eligibility Criteria:
* INCLUSION CRITERIA:

Subjects will be included in the study if they are children of private pesticide applicators who participated in the AHS, and were born between 1975 and 1996.

EXCLUSION CRITERIA:

Subjects with age greater than 19 years during this period will be excluded as the outcome under study is childhood cancer.
Games to Overcome Late Life Depression

This is a pilot study divided into two phases. IN phase 1 (completed) participants will be randomized to receive 8 weeks of Problem Solving Therapy (PST) alone or 8 weeks of a cognitive training game called, Evolution (Evo) plus clinical management. In Phase 2 (now recruiting), participants will be randomized to Evo, PST, and a different cognitive training program called Words. Words is similar to Evo in that it is an adaptive training program and includes case management. IN both studies participants will be assessed for clinical and functional magnetic resonance imaging (fMRI) outcomes at baseline, 4 weeks and 8 weeks.

Evo is a computer game that targets parts of the brain (i.e. the cognitive control network) that we think may be associated with depressive symptoms. This study is exploratory and will inform future hypotheses the research team will test in subsequent research.

Eligibility Criteria:
Inclusion Criteria:

1. Between 60-80 years of age
2. Meets criteria for Major Depressive Disorder
3. Hamilton Depression Rating Scale (HDRS) of 20 or greater
4. Mini Mental State Exam score of 24 or greater
5. Can speak and read English
6. Able to physically participate in the research protocol (e.g.: is not suffering from a terminal or highly disabling illness)
7. Can participate in MRI scans
8. Able to provide written informed consent

Exclusion Criteria:

1. History of psychosis, mania, or currently using or abusing illicit drugs or alcohol
2. Diagnosis of dementia
3. Taking cognitive enhancers
4. Change in or newly began taking psychiatric medication within the last 6 months
5. Pacemaker
6. Metal in the body that cannot be removed
7. Color blind
8. Movement disorder that prevents participation -
W-Shaped Acetabular Angular Plate (WAAP) Versus Reconstruction Plate

The purpose of this study is to determine whether this new W-Shaped Angular Plate is more effective and more safe to operate than the traditional reconstruction plate in the treatment of the posterior wall fracture of acetabulum.

The posterior acetabular wall fracture is one of the simpler acetabular fracture patterns and the most common type, accounting for approximately one quarter of all acetabular fractures. Most patients achieve excellent outcomes after anatomical reduction and rigid internal fixation with standard screws and buttress plates.However,it is well known that the reconstruction plate need remould in the surgery. So it does not only lead to the extension of operation time, but also cause poor attach of acetabular posterior wall. Moreover, the angulation of the screw placement for the holes of the reconstruction plate in the danger zone was determined with only caution. The intraoperative fluoroscopy was employed frequently to help determine the periacetabular screw location. If the operator lack of experience, intraarticular screw penetration and prolonged operative duration is inevitable. The investigators now introduce a new type of internal fixation device of acetabular posterior wall fracture that improve the shortcomings of existing technology.The plate itself can be thought to consist of three regions: the iliac region, the danger zone region, and the ischial tuberosity region. The organization of these regions causes the plate to resemble the English alphabet letter ''W''.The contour and zygomorphy of the W-shaped plate matched the surface of the posterior column of the acetabulum. There are two rows of drill holes in the danger zone region. A special safe-angled drilling guide was used to assist in the operation. A retrospective study has been indicated that this kind of new plate produce good results. This device may help to avoid intraarticular screw penetration and reduce operative duration and blood loss. The device further provides a stable fixation of the posterior wall that is amenable to early range of motion and weight bearing postoperatively, and results in a good clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older(with no upper age limit)
* Sustained a posterior acetabular wall fracture(ASIF/OTA classification 62-A1)
* Operation was performed within 14 days after the fracture occurring

Exclusion Criteria:

* Presented with a pathologic acetabular fracture
* Neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable
* Refused to participate
* Patients who were unable to walk before injury
Pressure Device in the Treatment of Ear Keloids

Keloids are benign cutaneous lesions, arising from proliferating fibroblasts. Keloids of the ear may occur after helix piercings and are difficult to treat, since they tend to form recurrences. Guidelines suggest multimodal therapy, however, recurrence rates remain high and prospective randomized trials are still missing.

To unravel the most effective combination of therapeutic options for keloids of the ear, 20 patients will be enrolled in a prospective, randomized trial. Patients either undergo surgery using the "fillet technique" and intra-lesional injections of triamcinolone 10mg /ml every 4 to 6 weeks for 6 months, or they are additionally treated with a non-customized pressure device.

The prospective randomized controlled trial will be conducted at the Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Ulm, Germany. 20 patients will be enrolled in the study. Prior to inclusion, informed written consent is obtained from each patient. Patients with immunodeficiency are not included, as well as patients with an infectious disease or patients with a missing capacity for consent. All patients undergo surgery using the fillet technique. To prevent the remaining skin from further damage, the meticulous skin preparation is performed either using the microscope or magnifying glasses. The keloid is "peeled" out of the excessive skin pocket. If necessary skin trimming is performed and non-resorbable monofilament single sutures are placed. The first intracutaneous injection of triamcinolone 10mg/ml is given before wound dressing is placed. A blanching of the lesion marks the endpoint of injection. Cutaneous sutures are removed after approximately 7 days. Injection of triamcinolone is repeated every 4 to 6 weeks for a total of 6 months. When removing the sutures, patients are randomized using consecutive sampling. Patients in group A are treated according to the protocol outlined above, having steroid injections for 6 months after surgical removal of the keloid. Group B involves patients who are additionally treated with non-customized pressure devices. The standardized clips (K. Egner, Dental Technique, Neu-Ulm, Germany) used in our study are available in two different sizes for smaller or larger defects. According to the guidelines of the German Society of Dermatology, patients are advised to wear the clip at least 16 hours per day. Medically approved transparent acrylate is used so that change in skin color and therefore amount of pressure can be observed at all times. Allergic or toxic skin involvement can be visualized through the transparent surface. Adjusting of the clip is done with one or two screws.

Eligibility Criteria:
Inclusion Criteria:

* Keloids of the helical rim of the ear

Exclusion Criteria:

* immunodeficiency
* infectious disease
* missing capacity for consent
The Effectiveness of a Thyme and Honey Spray for Oral Toxicities

Aim: To evaluate the effectiveness of thymus honey on radiation induced-oral mucositis and xerostomia.

Background: Oral mucositis and xerostomia are two of the most severe side effects that head and neck cancer patients confront during and after the completion of radiotherapy. Although several medications are used for their treatment, these fail to provide a fully effective and comprehensive management. Honey and thyme have been studied for the management of various treatment-related side effects.

Design: Α double blinded randomised controlled trial will be used for this study.

Methods: 200 head and neck cancer patients who receive radiotherapy will be included in this study. Patients will be randomised and divided into two equal groups of 100 participants; the intervention group (oral spray with thyme and honey + standard care) and the control group ( placebo spray + standard care). Assessments with xerostomia and oral mucositis scales additionally to 4 self-administered questionnaires will occur in both groups at baseline and then weekly and 6 months following completion of treatment. The duration of the study will be 3 years from the day of approval of this research protocol.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed histologic diagnosis of head and neck cancer
* Patients referred to non-palliative radiotherapy to the oral cavity will be included in the study
* Synchronous or induction chemotherapy, or both, will be permitted.
* Patients aged over 18,
* Patients able to provide informed consent,
* Patients having radiotherapy for at least three weeks (lower limit has been set at 50 Gy),
* Patients able to complete records accurately

Exclusion Criteria:

* Patients with a confirmed and medically treated diabetes mellitus,
* Patients with allergy to honey, thyme or any other ingredient,
* Patients who will refuse to take part in this study and
* Patients with previous radiotherapy or presence of systemic disease.
The Physiologic Effect of the Flow Generated by High Flow Nasal Cannula in Mild Respiratory Failure

High flow nasal cannula (HFNC) oxygen therapy is increasingly used for hypoxemic respiratory failure and is proving useful in avoiding or delaying intubation and mechanical ventilation. However, basic information regarding the physiologic effects of this method is missing. In this study, the effects of oxygen delivery by HFNC on oxygenation, ventilation and cardiovascular vital signs in patients with mild hypoxemic respiratory failure were evaluated.

Oxygen (O2) therapy delivered by means of High Flow Nasal Cannula (HFNC) is being increasingly used. This device, capable of delivering high flow, oxygen enriched gas, has been shown to reduce intubation rates in patients with hypoxemic respiratory failure. The primary components of HFNC are "nasal prongs" (or cannulae) that are inserted into the nostrils, a device which provides a warmed and humidified air / oxygen mixture and regulators that control oxygen concentration, temperature and total gas flow. Commercially available systems can deliver up to 40 - 60 liters per minute (LPM) of oxygen flow.

This method of non-invasive oxygen delivery has several presumed important working principals. Firstly, the high flow rate may meet the patient's own inspiratory flow rate. This enables accurate delivery of a high fractional inspired concentration of oxygen (FiO2). Second, the high gas flow might also produce a certain degree of Continuous Positive Airway Pressure (CPAP). In addition, the heated and humidified gas might also wash out/reduce the physiological airway dead space of the patient. Furthermore, HFNC is more comfortable and might be better tolerated than other Non-Invasive Ventilation (NIV) devices, such as Bi-level positive airway pressure (BiPAP). This, in turn, can prolong the time the patient is comfortably connected to the HFNC device.

Information regarding the basic physiologic influence of HFNC on oxygenation, ventilation and vital signs is missing in the literature. Patients with mild respiratory failure provide an opportunity to examine this topic. On one hand, these patients suffer from respiratory failure manifested by hypoxemia, on the other hand the respiratory failure is mild to the extent that removal of the conventional oxygen therapy (COT) will not lead to immediate respiratory collapse. This prospective study evaluates the physiologic effects of HFNC in 28 patients with mild respiratory failure.

Eligibility Criteria:
Inclusion Criteria:

* Minimal age 18
* The patient had invasive blood pressure monitoring via an arterial line in situ
* The patient had a mild respiratory failure manifested by the need for oxygen support via nasal prongs in order to maintain oxygen saturation (SpO2) above 90% for at least one hour prior to the start of the intervention

Exclusion Criteria:

* Shortness of breath
* Patients regularly using O2 at home
* No patient consent for participation
The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

1. To evaluate the clinical outcomes of ultrasound-guided thermal ablation and thyroid surgery for the treatment of papillary thyroid carcinoma;
2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of papillary thyroid carcinoma;


Eligibility Criteria:
Inclusion Criteria:

1. patients age between 18 and 80 year old, both sex
2. papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration
3. the largest diameter ≤2.0 cm
4. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, nech and chest CT
5. follow-up period ≥12 months,

Exclusion Criteria:

1. patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy
2. history of neck radiation
3. history of thyroid surgery
4. coagulation disorder
5. serious heart, respiratory, liver, or renal failure
6. dysfunction of the vocal cord on the opposite side