cyrilzakka/clinical-trials huggingface dataset:
Natural Sleep and Drug-induced Sleep Endoscopy

Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the site and configuration of upper airway obstruction in patients with obstructive sleep apnea (OSA). However, there are no studies comparing DISE to sleep endoscopy during natural sleep. Objectives: To compare DISE to natural sleep endoscopy in OSA patients referred for surgical treatment.

Methods: OSA patients referred to surgical treatment (lateral pharyngoplasty) will be enrolled in this study. Natural sleep endoscopy will be performed at the sleep lab during the night. Propofol induced sleep will be performed at the operating room before surgery. The VOTE (velum, oropharyngeal lateral walls, tongue base and epiglottis) classification will be used to compare site and configuration of collapse between studies. Peak inspiratory flow will also be compared between studies.

Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the site and configuration of upper airway obstruction in patients with obstructive sleep apnea. However, there are no studies comparing DISE to sleep endoscopy during natural sleep. Objective: to compare natural sleep endoscopy to drug induced sleep with propofol.

The study population will include 28 patients who are candidates to surgical treatment.

Methods Detailed clinical history and physical examination will be performed before natural sleep endoscopy. A 2-hour fast will be required. During both natural sleep and propofol-induced sleep, pharyngeal pressure will be measured using a pressure-tipped catheter (model TC-500XG; Millar).The nasopharynx will be numbed with xylocaine (10%) and oxymetazoline (0.05%), the catheter will be passed through a nasal mask into one nostril, and placed at the tongue base as confirmed by visual inspection of the oropharynx.A 2.8mm pediatric bronchoscope (Olympus) will be passed through the mask and into the other nostril. A nasal mask will be fitted and a heated pneumotachograph with differential pressure transducer connected to the mask will quantify airflow. The endoscope will be located at velopharynx, lateral wall of the pharynx and 2 cm above tongue and epiglottis.The VOTE Endoscopic Classification will be used to describe site and configuration of pharyngeal collapse in each study. The study will be scored by two experienced investigators, blind to the patient identification and type of study (natural sleep or drug-induced). Propofol-induced sleep will be performed at the operating room before surgery.

Eligibility Criteria:
Inclusion Criteria:

* BMI less than 35kg/m2
* Apnea-hypopnea index \> 5 events/hour of sleep
* Clinical indication of surgical treatment for sleep apnea

Exclusion Criteria:

* Severe or decompensated cardiac or respiratory diseases
* Previous pharyngeal surgery
* Tonsils grade III or IV
* Other sleep disturbance (parasomnias, primary insomnia, narcolepsy)
* Sedative medication use (opioids, benzodiazepines and muscle relaxants)
* Uncontrolled diabetes or hyperthyroidism
Effect of Herbal Formulation on Thrombocytes Count

Effect of Herbal Formulation Karika Syrup on Thrombocyte Count.

In this study, we will evaluate the effect of Herbal Formulation Karika (composed of Carica papaya leaf extract and Tinosporacordifolia) on Complete Blood Count, specifically on Platelet Count. Low Platelet Count is highly observant during multiple diseases namely dengue, malaria, typhoid, chikungunya, viral infections, and other Diseases.

The proposed study is a randomized, open, prospective, multicenter clinical trial. Extracts found in Karika syrup are beneficial in escalating platelet count, and also have anti-inflammatory and antipyretic activity. The therapeutic indication of Karika is proven through this clinical study in patients with low platelet count associated with dengue, typhoid, malaria, viral fever, and chikungunya fever.

Dengue is a tropical disease caused by the RNA virus which resides in mosquitoes. Symptoms include high-grade fever, visual disturbances, pain in the eyes and head, nausea, vomiting, musculoskeletal pain, stiffness of joints, mild to moderate and severe bleeding, and sometimes puerperal rash appearing on the skin due to a deficiency of thrombocytes.

The Chikungunya virus is spread by the bite of an infected mosquito. Typhoid is caused by Salmonella typhi a bacterium. Typhoid fever symptoms are seen widely in the human body that may observe from relatively minor cases of diarrhea with low-grade fever to high-grade fever and profound diarrhea with involvement of multiple systems.1

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

  1. Female and Male patients of age 14 to 60 years.
  2. Patient suffering from complaints of Weakness, Fatigue, Puerperal Rashes, Shortness of Breath, Low Hemoglobin, and History of Fever on \& off, Epistaxis.18
  3. Patients from Karachi and Kapri Mori(Labors, Employed, Multigravida females, Housewives, Domestic helpers, Working women, School, College, and University Students).
  4. All socioeconomic classes are included in the study.
  5. Patients having a history of Covid-19, Viral fever, Typhoid, and other illnesses in which there has been a low platelet count.2

Exclusion Criteria:

* Exclusion Criteria:

  1. Pregnant females are excluded.17
  2. Patients with co-morbidities like uncontrolled hypertension and liver disorder are excluded.4,5,6
  3. Patient having known drug reaction from any content of formulation is excluded.7
  4. Patients suffering from serious illnesses like encephalitis, coma, meningitis, or head injury that make them bedridden or hospitalized are excluded.4,6
Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children

African American (AA) children carry a disproportionate burden of mortality and morbidity in asthma. A major contributor to racial disparity in asthma is lack of adherence to guideline-recommended use of daily inhaled corticosteroids (ICS). Symptom-based adjustment (SBA) of ICS is a recently described patient-centered approach to asthma therapy in which patients adjust their ICS on a day-to-day basis guided by their symptoms. The overall goal of our study is to identify an acceptable, pragmatic and effective approach to asthma management in high-risk AA children. Our primary hypotheses are that SBA of ICS use is more acceptable than provider-based adjustment (PBA), equally effective in improving pediatric asthma outcomes, and will reduce the cumulative dose of ICS needed for asthma control. Therefore, in the Asthma Symptom based adjustment of Inhaled Steroid Therapy in African American children (ASIST) study, we propose a randomized, open-label, 2-arm, parallel, pragmatic trial in which we will randomly assign 200 AA children to either receive SBA or PBA for 12 months. The primary outcome is asthma control as measured by the Asthma Control Test (ACT). We propose that asthma control in the SBA group will be equivalent to the PBA group after 12 months. Secondary outcomes include monthly cumulative ICS dose, exacerbation rate, quality of life, lung function, adherence and satisfaction with the treatment plan.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 6-17 years old with physician diagnosed asthma for at least 6 months
2. Self or parent reported AA Race, or mixed race with at least one grandparent with AA race
3. Receiving asthma care by the participating primary care pediatrician
4. Prescribed low dose ICS monotherapy (up to Beclomethasone 160mcg for 6-11 y/o, 240 mcg per day for over 12 year old or equivalent), or leukotriene receptor antagonist (LTRA), or low dose ICS plus LABA (for over 12 year old) for at least the past 12 weeks, regardless of adherence (see ASIST low dose ICS inclusion table for conversion of dose)
5. Asthma Evaluation Questionnaire Score (AEQ)17 0 or 1 on all 3 questions
6. Pre-BD FEV1 ≥80% of predicted
7. No history or current history of smoking
8. Ability to provide baseline information at phone screening and randomization visit
9. Ability and willingness to provide informed consent

Exclusion Criteria:

1. Pre-BD FEV1\<80% of predicted within 3 months
2. Asthma requiring daily combination therapy with medium to high dose ICS with LABA
3. History of Intubation, noninvasive ventilation or ICU admission for asthma exacerbation
4. Chronic oral corticosteroid therapy
5. Chronic disease that in the opinion of the investigator/primary care provider would prevent participation in the trial
6. No landline telephone or cell phone to communicate with study staff
7. Non-English speaker
8. Another participant of ASIST in the same household
Design and Evaluation of Mobile X-ray for Rapid and Accurate Diagnosis of Thoracic Disease

Computed tomography (CT) is the most accurate test for evaluating patients with thoracic disease. However, access to CT is limited due to long wait times and for the sickest patients in Hospital who cannot be transported from the ward to the CT scanner. The investigators propose to modify a standard X-ray unit to provide more detailed information of the chest such that a CT scan is not required for all patients.

Dual-energy (DE) imaging consists of acquiring paired "low" and "high"-energy x-ray images. The use of DE to improve radiological contrast was first described by Jacobson et al in 1958; followed by Mistretta et al and Alvarez and Macovski in the mid-1970s. With the advent of new digital X-ray detectors that provide high dose efficiency and rapid readout of digital X-ray projections, there has been renewed interest in using DE x-ray imaging for lung nodule detection. More recently, portable x-ray detectors have made bedside DE imaging possible. Jabri et. al. presented a portable DE system with novel respiratory and cardiac gating, and Hoggarth et. al. investigated the potential for DE subtraction in improving the visualization of lung tumors while performing image-guided radiotherapy.

The investigators group is experienced in investigating DE for lung nodule detection, this theoretical framework was instrumental in optimizing a clinical prototype for high-performance DE chest X-ray. It identified optimal DE image acquisition and decomposition techniques, and validated the approach in comparison to human observer performance. The analysis further demonstrated that - given a high-performance flat plate detector, optimal acquisition and decomposition - DE chest X-ray is possible at the same dose as conventional computer radiography (CR) and digital radiography (DR) chest X-ray, while significantly improving conspicuity of subtle lung nodules by the reduction of overlying background noise. The DE work undertaken by our group is unique in terms of providing a clear theoretical framework for optimizing a clinical prototype for best performance in terms of image quality and patient exposure to ionizing radiation.

Eligibility Criteria:
Inclusion Criteria:

* the presence of lung disease (nodules, masses, consolidation and collapse), pleural disease (effusion, thickening), mediastinal and hilar lymph node enlargement, on thoracic CT

Exclusion Criteria:

* unable to consent
The Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience

The purpose of this study is to evaluate the potential effect of Avena Sativa L. on wellbeing during smoking reduction/cessation

The duration of the study will be 90 days (12 weeks). The consumption time will be set at 60 days (8 weeks), the remaining 30 days will be for follow up, the product will not be consumed. Each day of the study will be recorded in a diary by each subject.

Subjects are randomized based on the number of cigarettes and the Richmond test. In addition, subjects with a high score on the DASS-21 test items could not participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age: 18 - 65 YO)
* Willingness to reduce/quit daily cigarettes (Richmond test)
* Regular smokers: ≥10 CPD for the last 6 months (mean of \~16)
* At least 6 months of smoking
* Exhaled CO level≥10 ppm
* Healthy adults:

  1. Normal blood profile at screening
  2. Subject is in a good physical health as established by medical history, vital signs, self-declaration and physical examination
  3. Without depression/ anxiety or stress (based on a psychological evaluation and DASS21 questionnaire)
* Able to participate fully in all aspects of the study and had understood and signed the informed consent
* Negative drug test (THC, Amphetamines, Methamphetamines, Cocaine and Opioids)
* For women: Negative pregnancy test

Exclusion Criteria:

* Use of any mineral/vitamin/drug or other supplements during the past month prior to study
* Participate in another clinical trial in the last 6 months
* Using (past 30 days) other smoking cessation aids, for example treatments for tobacco dependence or an investigational drug
* Smoke other nicotine-containing products such as hookah smokeless tobacco or electronic cigarettes
* Allergic or intolerance to one of the ingredients of the investigated product
* Diagnosed or treated for mental illness/ disorder in the past year
* Recent history (past year) of alcohol or drug abuse or dependence
* Reported any active/chronic disease (such as: Celiac disease/active peptic ulcer) or chronic medications (except Hyperlipidaemia or hypertension that are stable on medications)
* Any other laboratory abnormality, medical condition or psychiatric disorder which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
* Pregnant, lactating women or women that plan to get pregnant
RMP-A03 Ocular Suspension in Patients With Pterygium

The goal of this clinical trial is to test the safety and efficacy of an ocular medication on the treatment of pterygium.

Following informed consent, patients with pterygium who meet all eligibility criteria will be randomized to an 84-day double-blinded study to measure the safety and efficacy of the study drug as compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years old
* Diagnosis of pterygium with specified characteristics
* BCVA of 20/200 or better
* Willingness to attend all study visits and comply with the study procedures

Exclusion Criteria:

* Presence of ocular disease
* Double pterygium
* History of ocular surgery
* Presence of ocular trauma
* Use of any ocular medication
* Use of contact lens
* Allergy to any of the components of study drug
* Cannot properly administer study drug
* Clinically significant systemic disease that may place the subject at risk or confound study results
* Participation in an investigational study within 30 days prior to screening
* Female participants who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control (WOCBP).
A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis

This is a prospective, multicenter, observational, non-interventional study (NIS) in patients with Multiple Sclerosis (MS) and routinely assessed serum neurofilament light (sNfL) values in Germany

Prospective, primary data will be collected from patients with sNfL outcomes in the context of switching to ofatumumab or continuing their current therapy. Data collection will cover a maximum period of 24 months.

The observational period will not be dictated by the protocol. Baseline and follow-up visits will take place at a frequency defined as per Investigator´s discretion following clinical routine. The diagnostic or monitoring procedures are only those ordinarily applied to therapeutic strategy and routine clinical care. During the observation phase of the study, data will be collected according to standard of care as recommended by KKNMS (Competence Network Multiple Sclerosis in Germany).

Eligible participants for the study are patients who have received treatment with category 1 DMTs and those who have included sNfL into their treatment decision-making process. These patients have the option to either continue their current DMT or switch to ofatumumab. According to local treatment guidelines, DMT category 1 include dimethylfumarate/diroximelfumarate, glatirameroids, Interferon beta and teriflunomide. The decision to switch to ofatumumab or to continue the current DMT category 1 therapy must be made by the treating physician independently of the decision to enroll the patient in the study.

Eligibility Criteria:
Inclusion Criteria:

Participants eligible for inclusion in this study must meet all the following criteria:

1. Written informed consent must be obtained before participation in the study.
2. RMS patients aged 18 or older.
3. Treated in label with EU-approved DMTs for MS category 1 according to current guidelines (Hemmer et al 2023) for at least the last 3 months.
4. Presence of a sNfL test result from a commercially available test not older than 3 months.

Exclusion Criteria:

Participants meeting any of the following criteria are not eligible for inclusion in this study:

1. Patients being treated outside of the approved label of the respective DMT.
2. Simultaneous participation in any interventional study or simultaneous participation in another Novartis-sponsored non-interventional study with ofatumumab.
Peer Interactions and Food Are Substitutable in Youth

This study examines the effects of increasing the cost of social interactions and food on overweight and non-overweight youth. Using a computerized operant task youth will earn points exchangeable for food and social activity.

The investigators predict that both overweight and non-overweight children will substitute food for interactions with an unfamiliar peer when this alternative is made expensive. Also, the investigators predict that both overweight and lean participants will defend their choice to spend time with a friend even when this alternative is made expensive.


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls ages 9-11
* Children must have a BMI equal to or greater than 15th percentile for their age
* Children must report at least a moderate liking of the study foods

Exclusion Criteria:

* Children should not have any food allergies
* Children should not have any dietary restraint
* Children should not a cold or upper respiratory distress
* Children should not have any psychopathology
* Children should not have any developmental disabilities
* Children should not be taking any medications that could influence their sense of smell and taste and activity level
Immediate Implant Using Socket Shield Technique With Xenogenic Bone Graft

Adequate bone volume and a proper aesthetic outcome have become the main focus of interest in implant dentistry. Alveolar bone resorption is a natural course occurring after tooth removal. Partial extraction therapy through root preservation has been reported to help in bone maintenance at the extraction site. In 2010, Hurzeler et al. evaluated a new approach, at that time, called socket shield technique. Han et al. in 2018 reported the modification of this technique and leaving the jump gap between the shield and the implant non-grafted. The importance of bone grafting of the gap between the implant and the labial shield in improving quality of regenerating bone and prevention of the soft tissue ingrowth has been described. Thus the hypothesis, of improving the modified socket shield technique by bone grafting could be tested.

Aim of this study is to evaluate the clinical and radiographic outcomes of using xenogenic bone graft on outcome of immediate dental implant placement using the modified socket shield technique.

16 patients who are admitted to the outpatient clinic of Oral and Maxillofacial Surgery Department, are divided into two study groups. Control group will receive an immediate implant with modified socket shield technique. Test group will receive immediate implant with modified socket shield and deproteinized bovine bone mineral (DBBM) put in the buccal gap. Outcome measurement is primary and secondary implant stability measurement and CBCT evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old irrespective of the gender
* One or more of non-restorable (fractured or decayed) tooth/teeth in the upper aesthetic regions (incisors, premolars).
* Free from periodontal diseases.
* Sufficient bone volume to allow placement of an implant.
* Ability to read and sign an informed consent form
* Adequate buccolingual width to allow for a buccal gap presence.

Exclusion Criteria:

* A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immuno-compromised status, radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosphonates).
* Untreated periodontal disease.
* Vertical root fractures on the buccal aspect.
* Tooth /teeth with horizontal fractures below bone level.
* Tooth /teeth with external or internal resorptions.
Patient Satisfaction in the Orthopedic Surgery Clinic

Patients in the orthopedic surgery clinic routinely fill out a patient- reported outcome measurement survey prior to their visit. These scores are stored in Epic, but are not routinely reviewed with patients during their office visit. Study subjects will be randomly assigned into one of two groups: those who have their patient- reported outcome measurements reviewed with them by their physician, and those who will not have their patient-reported outcome measurements reviewed during the visit. Following the visit, patients will complete a patient satisfaction survey.

This patient satisfaction survey is a modified version of the Press-Ganey Outpatient Medical Practice 10-question survey. The patient satisfaction survey scores will then be compared between the two groups to quantify the effect of reviewing of patient-reported outcome measurements with patients on their satisfaction with the office visit

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Ages 18 and 100 years
* Men and women will be included in this study
* Willing and able to provide consent
* Able to communicate in English
* All patients of the Principal Investigator(s) that have an clinic appointment during the study date range will be considered for inclusion in the study

Exclusion Criteria:

* Patients whose visit is related to workman's compensation, a disability claim, or a "no-fault" case (i.e. a law suit related to personal injury)
* Patients that do not complete the patient satisfaction survey following their visit
* Patient with mental disabilities or other handicap that would interfere with their capability of completing the surveys