cyrilzakka/clinical-trials huggingface dataset:
Aetiology of Asymmetrical Hearing Loss: A Retro-spective Study Thesis Submitted for Partial Fulfillment of Master Degree in Audio-Vestibular Medicine

Hearing loss maybe: -Symmetrical: in which the severity and pattern of hearing loss are the same in each ear. Or -Asymmetrical: is defined as binaural difference in bone conduction thresholds of \>10 dB at two consecutive frequencies or \>20 dB at one frequency (0.25-8.0 kHz), Poorer speech perception will often accompany poorer hearing and may be the reason for the patient's presentation .Unilateral or asymmetrical sensorineural hearing loss is important to discern, as it is an important risk factor for auditory nerve tumors (i.e. vestibular schwannoma) which is a life threatening condition, and in such cases further investigation is required (i.e. MRI scan) unless there is a known reason for the asymmetry, Several reports have recommended that further evaluation, especially expensive imaging studies, be conducted to rule out acoustic tumors when AHL is present


Eligibility Criteria:
Inclusion Criteria:

* Age: 6 years old and more.
* Sex: male and female.

Exclusion Criteria:

* Age: less than 6 years old.
* Patients with symmetrical hearing loss.
Standardized Dysphagia Diet in Clinical Evaluation of Swallowing Function

Diet modification has been a vital component in the management of dysphagia. The lingual manipulation of bolus, pharyngeal propulsion, and initiation of swallowing reflex are all affected by the texture of bolus. However, there is a limited literature and consensus regarding how to apply different food consistency in the swallowing function evaluation of dysphagic patients. Recently, International Dysphagia Diet Standardization Initiative (IDDSI) has provided a universal standard of food consistency. The present study aims to evaluate the accuracy of clinical swallowing evaluation using IDDSI standardized food in dysphagic patients, in an attempt to establish protocols of clinical evaluation and diet selection in dysphagic patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 years or older with a swallowing disorder on the Functional Oral Intake Scale (FOIS) of 1-6.

Exclusion Criteria:

* Unconscious, unable to communicate via gestures or words and cooperate with commands.
* Acutely infected or requiring respirator use.
* The oropharyngeal structure is abnormal and cannot be examined by endoscopy.
* Presence of tracheostomy tube
Effect of Vitamin D Replacement on Bone Healing in Mini-dental Implants

1. Title
2. Executive team
3. Research line
4. Summary
5. Research problem
6. Justification
7. Literature review
8. Objectives
9. Materials and methods
10. Dissemination of knowledge generated
11. Schedule of activities
12. Budget
13. References
14. Annexes

This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled clinical trial. Background: Vitamin D replacement could aid in the osseointegration of dental implants. Objective: to evaluate the effect of vitamin D replacement on osseointegration of dental implants in humans. Materials and methods: Twenty individuals with hypovitaminosis D underwent dental miniimplants and randomized to two equal groups for treatment with vitamin D (5000 IU / day) or placebo for 2 months. After two months, the miniimplants will be removed and prepared for histomorphometric analysis, which will evaluate bone implant contact in percentage. Testing the hypothesis that the contact between bone and implant and the bone density in the threaded area in the test group is higher than in the control group. Test t will be used to compare the differences between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes;
* No medical, temporary or intra-oral contraindications;
* Good general health;
* Need of implant in the maxilla in the posterior region (with a minimum of 5 mm of bone height visualized radiographically) or in mandible in posterior region;
* With vitamin D deficiency / deficiency (considering serum level of ≥ 15 ng / ml at ≤ 25 ng / ml).

Exclusion Criteria:

* Medical, temporary or intrabuccal contraindications;
* Smokers;
* Use of corticoid;
* Post-operative of bariatric surgery;
* Bone height less than 5mm;
* Need for maxillary sinus lift;
* Vitamin supplementation D.
The Effect of Velaglucerase Alfa (Vpriv) on Skeletal Development in Pediatric Gaucher Disease

The purpose of this trial is to study the effect of Velaglucerase Alfa on skeletal bone development of children with Type 1 or Type 3 Gaucher Disease. In addition, the natural history and neurological status of children with Type 3 Gaucher Disease will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Enzyme Replacement Therapy naive,
* confirmed diagnosis of Gaucher disease type 1 or 3,
* able to travel to Dallas, Texas 1x per year for baseline plus 3 consecutive years,
* able to tolerate all study procedures,
* skeleton not fully formed as confirmed by DXA and MRI),
* and willing to receive velaglucerase alfa infusions every other week for the duration of the study.

Exclusion Criteria:

* Clinically unstable,
* taking or have taken bisphosphonates,
* Gaucher type 2,
* pregnant female,
* or deemed inappropriate for participation by the principal investigator.
Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis

The purpose of this study is to determine whether one type of anesthetic (numbing medicine) will work better at numbing the nerve in a tooth than using a different type of anesthetic. A second purpose is to see if the time needed to numb the nerve in a tooth is different between the two anesthetics.

40 subjects with a mandibular molar diagnosed with symptomatic irreversible pulpitis will be randomly allocated into 2 groups. One group will receive a total of 3 cartridges of a standard, unbuffered 2% lidocaine with 1:100,000 epinephrine via inferior alveolar nerve block (IANB) followed by supplemental buccal and lingual infiltrations, while the other will receive the equivalent yet buffered formulation. An electronic pulp tester (EPT) will be used to objectively determine baseline pulpal status of the affected tooth, followed by 2-minute interval testing following the administration of all local anesthesia. The onset of pulpal anesthesia is defined by the first of 2 consecutive EPT=80 readings, and the endodontic treatment may begin. Profound pulpal anesthesia is ultimately determined if the patients report a comfortable pulpotomy as reflected on the Wong-Baker FACES Visual Analog Scale.

Eligibility Criteria:
Inclusion Criteria - In order to participate, subjects must:

* Be between the ages of 18 and 80 years old
* Have the ability and willingness to independently consent to treatment and study participation
* Have an uncomplicated medical history (ASA I and II)
* Not be pregnant
* Have no allergies local anesthetics/sulfites (confirmed or self-reported)
* Not be taking any medications that may affect the proper assessment of the anesthetic (no acetaminophen or short-acting NSAIDs such as ibuprofen within the previous 6 hours; no long-acting NSAIDs such as naproxen within the previous 16 hours)
* Not require nitrous oxide during treatment, and the injection area should appear healthy with no other pre-existing conditions or infections that may compromise an accurate collection of data
* Be experiencing signs of irreversible pulpitis (an exaggerated response to cold that lingers longer than 10 seconds) in a mandibular molar at the time of conducting the study

Exclusion Criteria - No subjects will have:

* A negative response to cold in the proposed treatment tooth
* A radiographic periradicular pathosis more advanced than a widened periodontal ligament or have an intraoral swelling
Clinical Validation Trial of a Single-use Bronchoscope (Ambu® aScope ™ 4)

The aim of this study is to evaluate the usefulness of the new Ambu® aScope ™ 4 bronchoscope, in the usual practice of low complexity diagnostic bronchoscopy managed by bronchoscopists who meet the minimum training requirements (having performed 100 supervised procedures \[ 10\]) and maintenance of competition (with more than 25 bronchoscopies per year \[10\]).

Muticentric trial to evaluate three outcomes

1. Describe the experience of bronchoscopists performing low complexity bronchoscopic procedures with the Ambu® aScope ™ 4.
2. Collect the opinion of bronchoscopists about the technical characteristics of the device subject to study through a standardized questionnaire.
3. Analyze the quality of both microbiological and cytological samples obtained through the disposable bronchoscope.

Eligibility Criteria:
Inclusion Criteria:

* Low complexity bronchoscopies in patients that need to undergo a low complexity bronchoscopy in the sites of the study

Exclusion Criteria:

* No acceptance of the informed consent
* Any procedure out of a low complexity bronchoscopy in the sites of the study
the Effect of Endometrial Compaction Caused by Progesterone Effect on Pregnancy Outcomes

The purpose of this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes

For a pregnancy to occur, the embryo must implant in a receptive endometrium during the window of implantation, which is thought to occur from day 22 to 24 of an idealized 28-day cycle. Early studies have suggested that assessing endometrial thickness with the use of ultrasound may be an alternative to invasive techniques such as endometrial biopsy for attempting to determine a receptive endometrium for frozen-thawed embryo transfer (FET).

A preovulatory endometrial thickness of 7 mm or more is considered to be the cutoff for endometrial receptivity, below which many physicians would cancel an embryo transfer. However, in most studies in the literature, endometrial thickness was measured either on the day of hCG in fresh embryo transfer cases or on the last day of estrogen treatment in thawed embryo transfers. There are a limited number of studies evaluating the luteal period, embryo transfer day and endometrial thickness.

Accordingly, in this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes

Eligibility Criteria:
Inclusion Criteria:

1. Woman aged 18-40 years
2. Presence of high quality (\>2BB) blastocyst
3. Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles
4. presence of high quality blastocyst cryopreserved by vitrification method.
5. A single embryo transfer

Exclusion Criteria:

1. Presence of uterine pathology
2. Participants whose optimal endometrial image cannot be obtained due to uterine position
3. Participants whose treatments were canceled for any reason before embryo transfer
4. Participants which had embryo transfer on the day 2 or 3 (at the cleavage stage)
5. Participants who had 2 embryo transfer
6. Presence of low quality (\<2BB) blastocyst
7. \> 15% loss of viability in the embryo during embryo thawing
Testing e-Mental Health in Lebanon

The study objective is to test a guided e-mental health intervention called Step-by-Step for people living in Lebanon. Step-by-Step is a self-help programme delivered through an app or website and aims to treat symptoms of depression and other symptoms of psychological distress. First, a small study will be conducted to test the research procedure. Second, a large study will be conducted to test the effectiveness of Step-by-Step.

People residing in Lebanon (i.e. Lebanese, Palestinians and Syrian displaced people), above the age of 18 with symptoms of depression will be recruited through social media, posters, radio and television adverts, etc. Minors (under the age of 18) and people who have plans to end their life will be excluded from the study.

To test whether the use of Step-by-Step improves symptoms of depression, two groups will be compared. Participants in the intervention group will receive Step-by-Step, while those in the control group will receive basic information about depression and a list of health centres where they can get face-to-face help that is based on evidence. In addition, participants in the intervention group will receive weekly phone or chat support (up to 15 minutes) provided through lay helpers who were trained and work under the supervision of a trained clinical psychologist. The study hypothesises that participants who receive Step-by-Step will have a higher symptom improvement than participants who receive basic information.

In order to assess symptoms of depression and other symptoms of psychological distress, participants in this study will complete several questionnaires three times: At the beginning of the study, after 8 weeks, and then three months later (i.e. 5 months after the beginning of the study).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above
* PHQ-9 sum score above 9
* WHODAS 2.0 sum score above 16

Exclusion Criteria:

* Serious thoughts or plans to end one's life
The Chit-Chat Educational Intervention to Promote Advance Care Planning in the Community

The purpose of this study is to estimate the effect size of the Chit-Chat intervention on ACP engagement among family members of older adults with multi-morbidity.

After being informed about the study and potential risks, all eligible participants will be asked to provide written informed consent for study entry. At week 0, participants will be randomized in an assessor-blinded randomized controlled trial in a 1:1 ratio to received the Chit-Chat intervention (two 2-hr weekly educational sessions) or wait-list control group.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or above;
* a family member of a relative who aged 60 or above and lives with at least two severe chronic diseases such as cancer, dementia, lung, heart, liver, and renal disease.
* they perceived themselves will take part in taking care of their relatives in the near future;
* able to read and communicate in Cantonese.
* they are self-reported as cognitively intact

Exclusion Criteria:

* their relatives have been referred to palliative care service before the study.
Robotic OCT for ER Anterior Eye Exams

The purpose of this study is to develop and test a robotically assisted imaging system for the front of the eye with a goal of helping eye care through the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years of age and older
* Presenting with ocular complaints potentially indicative of an anterior segment pathology (e.g., foreign body sensation, red eye, pain)

Exclusion Criteria:

* Hemodynamically unstable patients (e.g., undergoing active resuscitation efforts)
* Patients with potential penetrating trauma to the eye who may need immediate surgical care
The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study

The purpose of this study is to evaluate the the efficacy and safety in the real-world settings of glofitamab among Chinese R/R DLBCL participants.


Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed as R/R DLBCL
* Participants who will be treated with glofitamab (known as being recommended and having the intention to be treated with glofitamab at the time of signing informed consent) or have initiated glofitamab treatment within 6 months prior to enrollment and after the indication approval will be observed in this study.

Exclusion Criteria:

* Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.
A Study of MK-4700 Alone or With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors (MK-4700-001)

The goal of this study is to learn about the safety of different doses of MK-4700 and if people tolerate them. The study will also measure what happens in a person's body over time when MK-4700 is given alone or with pembrolizumab (MK-3475) in order to find a dose that is safe, tolerated, and may work to treat certain types of cancer.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Has histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and have received, been intolerant to, or refused all treatment known to confer clinical benefit
* Has head and neck squamous cell carcinoma (HNSCC), melanoma (cutaneous), non-small cell lung cancer (NSCLC), cervical cancer, triple negative breast cancer (TNBC), urothelial carcinoma (UC), or renal cell carcinoma (RCC; clear cell, papillary)
* If human immunodeficiency virus (HIV) infected, must have well controlled HIV on antiretroviral therapy (ART)
* Has normal cardiac function

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* If HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has known additional malignancy that is progressing or has required active treatment within the past 2 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
* Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids
* Has current pneumonitis/interstitial lung disease
* Has active infection requiring systemic therapy
* Has known history of Hepatitis B (defined as Hepatitis B surface antigen reactive) or known active Hepatitis C virus infection
* Has had an allogeneic tissue/solid organ transplant in the last 5 years
Combined Amiodarone and Electrical Cardioversion for Postoperative Atrial Fibrillation After Cardiac Surgery

To determine the efficacy of cardioversion and amiodarone for cardiac patients who develop postoperative atrial fibrillation

New-onset atrial fibrillation (AF) after cardiac surgery is a well-recognized phenomenon with significant outcome implications. Incidence after coronary artery bypass grafting (CABG) is estimated at 26-33%, while those undergoing valvular surgery bear a greater burden at 33-49%. Clinical and socioeconomic complications resulting from postoperative atrial fibrillation include an increased risk of death (10%), congestive heart failure (4%), prolonged hospital stays, and increased rate of discharge to care facilities over those who remain in sinus rhythm, (7%). Although a body of evidence exists for electrical or pharmacological cardioversion to sinus rhythm postoperatively, there is a marked paucity in the literature regarding efficacy and outcomes combining the two. More specifically, we seek to evaluate the efficacy of DC cardioversion when combined with amiodarone. Improved outcomes with multimodal cardioversion may decrease the postoperative clinical burden of atrial fibrillation on cardiac surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who underwent CABG and/or cardiac valve surgery involving cardiopulmonary bypass and develop postoperative atrial fibrillation within 7 days after surgery

Exclusion Criteria:

* Subjects who had any form of atrial fibrillation prior to surgery
* Subjects who were on antiarrhythmic medications preoperatively, including but not limited to procainamide and amiodarone
Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

The purpose of this study is to assess the efficacy and safety of subcutaneous administration of a liquid formulation of C1 esterase inhibitor for the prevention of angioedema attacks in adolescent and adult subjects with hereditary angioedema.


Eligibility Criteria:
The maximum duration of participation is approximately 9 months. Patients will complete a screening period of up to 21 days. Following screening, eligible patients will be randomly assigned to 1 of 3 treatment sequences. Each patient will undergo 2 14-week treatment periods for a total of 28 weeks (Treatment Period 1 and Treatment Period 2). After completing the 2 treatment periods, patients will enter a 1-month follow-up period.
Messaging Strategies to Increase Peer Education on COVID-19 Vaccination and Climate Change

The primary objective of this protocol is to develop and evaluate peer communication interventions to encourage peer education around COVID-19 vaccination and climate change.

Investigators will use a RCT peer education intervention to address climate change-related behaviors as a control condition for the vaccination intervention. Both issues represent serious public health priorities and are sufficiently unrelated in order to act as control conditions for each other.

As a control topic, investigators will address climate change communication. This parallel topic was selected because it is (1) reasonably unrelated to the COVID-19 condition, (2) has clear individual-level behaviors that can be targeted for intervention, (3) has diversity in public attitudes like COVID-19 vaccines,18 (4) has parallels in COVID-19 in terms of polarization and discrediting of scientific research, (5) represents a significant threat to population health, and (6) has significant racial and ethnic disparities paralleling those of COVID-19.

Investigators will recruit a second sample of up to 800 eligible participants who will be asked to complete an intervention session, where they will receive training on how to talk to members of their social network about either COVID-19 vaccination or climate change. The two intervention conditions will differ based on topic (vaccination/climate change) but the intervention components will be comparable. During the intervention, participants will watch a series of videos that teach key communication skills for having conversation about the assigned topic. Additional videos will provide training in how to use social media as a communication platform to share information in case participants are unfamiliar. Participants will then complete practice activities where they will construct hypothetical conversations and react to/critique example conversations to practice implementing the communication skills. Upon completing the intervention, participants will be asked to try to talk to others in their social network about the topic area they were assigned to.

Two to four weeks after the intervention, participants who completed the intervention will be asked to complete a follow-up survey to assess whether participants had conversations with others in their social networks, if they used social media/text/e-mail to share accurate information, and to understand the outcome of the conversations (i.e. did they result in behavior change).

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* English-reading
* Reside in the United States
* Over 18 years of age
* Have passed Prolific's data quality checks on their previously submitted work
* Have heard of COVID-19 and the COVID-19 vaccine

Exclusion Criteria:

* Do not provide informed consent.