cyrilzakka/clinical-trials huggingface dataset:
Application of Electrically Driven Atomized Surface Anesthesia in ATI in Patients With Predictably Difficult Airway.

This is a parallel and randomized-controlled clinical study aimed to identify the optimized size of atomized particles of 2% lidocaine that can provide the best topical anesthesia during ATI. To determine the effect of nebulization with different sizes of atomized particles of 2% lidocaine on cough, reaction, and comfort during ATI in patients with predicted difficult airway.


Eligibility Criteria:
Inclusion Criteria:

Patients with distinctly difficult airways：(1) Patients with medical history indicating difficult airways.(2) Patients suffering from severe burn scars.(3) Patients suffering from severe obstructive sleep apnea syndrome.(4)Patients suffering from severe congenital dysplasia.

Patients with suspected difficult airway:

Patients with risk factors underwent a medical history for evaluation:(1)Patients with ankylosing spondylitis.(2) Patients with rheumatoid arthritis.(3)Patients with degenerative osteoarthritis.(4)Patients with epiglottitis. (5)Patients with acromegaly.(6)Patients with morbid obesity.(7)Patients with subglottic stenosis. (8) Patients with enlarged thyroid or tonsils.(9)Patients with mediastinal mass.(10)Patients with throat tumors.

Patients with risk factors underwent a physical examination for evaluation:(1)Patients with BMI \> 26 kg/m2. (2)Patients with Mallampati class 3 or 4. (3)Patients with thyromental distance\<60 mm (corresponding to an average distance of 3 finger breadths).(4)Patients with limited mouth opening with interincisor distance\<30 mm.(5)edentulous patients.(6)When the patient closed his mouth in a natural state, the upper incisor was situated in front of the lower incisor.(7)When the mandible is extended forward, the lower incisors of the patient can not protrude beyond the upper incisors.(8)The patient's jaw exhibits stiffness, with minimal elasticity or presence of a tumor.(9)The patients have a short neck with a thick circumference.(10)The patients are unable to touch their chest wall with their jaw, or extend their neck.(11)The patients's palate shape is either characterized by a high arch or is extremely narrow.

Exclusion Criteria:(1) refusal to participate in the study; (2) airway bleeding; and (3) known allergies to local anesthetics.

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Evaluation of the Acute Effect of Water-Pipe Smoking on the Respiratory System

Title: The acute effect of water pipe smoking on exhaled nitric oxide (eNO) and exhaled breath condensate (EBC) pulmonary function tests in healthy volunteers

Objectives: To evaluate the acute effect of one cession of water pipe smoking on airway inflammation as assessed by exhaled nitric oxide (eNO) and exhaled breath condensate (EBC) in healthy volunteers.

Design: Prospective study evaluating these parameters before and after 30 minutes of water pipe smoking . The changes in inflammatory parameters pre and post smoking will be evaluated blindly.

Sample size: 100 participants Participant selection: Adults subjects who regularly smoke water pipe . Intervention: Each subject will undergo evaluation including a respiratory questionnaire , pulmonary function tests , exhaled nitric oxide (eNO) and exhaled breath condensate (EBC) and carboxy- hemoglobin levels . All measurements will be evaluated before and after one cession of 30 minutes water pipe smoking

Primary outcome parameter: Change in carboxy- hemoglobin Secondary outcome parameter:Change in peripheral eosinophils count, pulmonary function tests, change in FeNO, and in inflammatory parameters in EBC before and after water pipe smoking


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 Y.O.
* Have smoked Water-pipe at least once before.

Exclusion Criteria:

* Breast feeding Women.
* S/P Bacterial Or Viral infection, Last 2 weeks
* P.O. Steroids
* Water-pipe smoking, last 24 hours
* Cigarette smoking, last 6 hours
* Intensive exposure to smoke (fire), last 24 hours
* S/P Intensive Care Hospitalization, last 3 months
A Prospective Longitudinal Collection of Subjects Diagnosed With Small Cell Lung Cancer

The purpose of this study is to collect samples to evaluate the ProGRP and NSE assays independently as aids for monitoring the course of disease and therapy in subjects diagnosed with SCLC.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Confirmed diagnosis of SCLC or mixed SCLC/non-SCLC per histopathology results
* Scheduled to undergo first-, second- or third-line treatment for SCLC, including chemotherapy, chemotherapy + radiation therapy, or combined concurrent chemoradiotherapy.
* Able to understand and willing to provide Informed Consent

Exclusion Criteria:

* No diagnosis of SCLC
* Not scheduled to undergo treatment for the diagnosis of SCLC
* Unable to provide Informed Consent
An Observational Study on The Impact of Insulin Resistance on Sustained Virological Response in Patients With Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

This prospective observational study will assess the insulin resistance and its impact on sustained virological response in patients with hepatitis C treated with Pegasys and Copegus. Data will be collected from each patient during the up to 72 weeks of treatment and for 24 weeks of treatment-free follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic hepatitis C (detectable HCV RNA)
* Initiation of treatment with Pegasys and Copegus

Exclusion Criteria:

* Participation in a clinical trial during the study
Long Head of Biceps as an Anterior Dynamic Sling for Recurrent Anterior Shoulder Dislocation

Purpose: To evaluate the functional outcomes of arthroscopic onlay dynamic anterior stabilization (DAS) using the long head of biceps (LHB) tendon for treatment of anterior glenohumeral instability (AGI) with limited to subcritical glenoid bone loss (GBL).

Twenty-five patients underwent arthroscopic DAS using LHB between March 2022 and October 2022 for treatment of anterior glenohumeral instability (AGI) with limited to subcritical glenoid bone loss (GBL) were included in a prospective study with a minimum follow-up period of 2 years. The shoulder functional outcomes were assessed using the Rowe and the Quick Disabilities of Arm, Shoulder and Hand (Quick DASH) scores both preoperative and at 2 years follow-up. Magnetic resonance imaging (MRI) at 6 months after surgery to evaluate LHB tendon healing to the anterior glenoid.

Eligibility Criteria:
The inclusion criteria were

* Patients complaining of AGI, with one or more events of anterior shoulder dislocation.
* Associated limited (\<13.5%) to subcritical (\<25%) GBL.
* Positive anterior shoulder apprehension.

The exclusion criteria were

* Associated critical GBL (≥25%).
* Concomitant LHB lesion or rupture.
* Multidirectional or voluntary shoulder instability.
* Prior arthroscopic shoulder stabilization procedure.
* Concomitant rotator cuff tears.
* Acute proximal humerus fractures of the involved shoulder.
Study of the Application of Magnetic Fields for the Treatment of Parkinson's Disease

The purpose of this study is to see if a device called the Resonator can help to improve aspects of health and quality of life that are relevant to patients with Parkinson's disease.

This clinical trial will evaluate a new non-invasive, non-significant risk, device therapy as an adjuvant symptomatic treatment for some of the signs and or symptoms of Parkinson's Disease (PD). The device utilizes patented technology involving extremely low level electromagnetic fields.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's Disease
* Stable optimized anti-PD drugs for at least 4 weeks
* PDQ-39 Summary Index between 15 and 45
* Ambulatory
* Willing to maintain regular medication regime throughout study
* Able to abstain from starting in new treatments to improve PD symptoms during course of study.
* No prior surgical interventions for Parkinson's Disease
* Non-demented
* Minimum of 30 years of age, but not older than 85
* Capable of giving full written consent

Exclusion Criteria:

* Atypical Parkinsonism such as progressive supranuclear palsy, multiple system atrophy, CBDG etc.
* Subjects may not have any of the following: active brain tumor, strokes, hydrocephalus, any other neurologic or non-neuro problem which may affect symptomatic expression of patients parkinsonism.
* Consumption of medications that can produce drug induced parkinsonism
* Chronic pain not associated with PD
* Current or past history of major psychiatric disturbance
* No typical or non-typical anti-psychotics for treatment of drug induced psychosis.
* Chronic fatigue
* Epilepsy or history of epilepsy
* Seizures or taking medication for epilepsy
* HIV or other autoimmune disorders
* History of ECT
* Uncontrolled hypertension
* Advanced pulmonary disease
* Unstable cardiac disease
* Prior surgical interventions for Parkinson's disease
* Prosthetics or implants comprised of ferrous metals
* Pacemaker, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain
* Pregnant, breast feeding or planning pregnancy prior to study end
* Dementia, developmental disability, psychiatric disorder or other cognitive impairment
* Any significant medical condition that may require alteration of medical therapy during the study, or major medical condition which may interfere with the study activity.
Effects of Escitalopram on the Sleep EEG Power in Patients With Major Depressive Disorder

The main objective was to compare the differences of PSG parameters and plasma melatonin levels before and after treatment with escitalopram for 8 weeks. Polysomnography (PSG) was detected over a night and blood samples were collected at 4 h intervals for 24 h from 13 male healthy controls and 13 male MDD patients before and after treatment with escitalopram for 8 weeks. The outcome measures included the levels of plasma melatonin, PSG parameters (include sleep architecture and power analysis) and scales.

1. Design and participants: The patients with MDD were screened from the hospital, age- and gender-matched healthy controls were recruited by advertising from the community who signed written informed consent before participation.
2. Assessments: The 17-item Hamilton Depression Rating Scale (HRSD-17) , Montgomery-Asberg Depression Rating Scale (MADRS), the Clinical Global Impression-Severity scale (CGI-S), and 14-item Hamilton anxiety scale (HAMA) were assessed at baseline and after 8 weeks' treatment with escitalopram for patients with MDD. As for healthy volunteer, these measures were evaluated only once. In addition, all participants were assessed Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI).
3. Treatment: Each patient was provided with escitalopram.
4. Collection of peripheral blood samples: Test the levels of plasma melatonin at 4 h intervals for 24 h from all participants.
5. Sleep and EEG recordings: The PSG of participants was evaluated for one night at baseline (all participants) and 8 weeks treatment (MDD).
6. Analysis the PSG architecture and power ratio.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of MDD;
2. Hamilton Rating Scale for Depression 17-items (HRSD-17) total scores ≥ 22;
3. Male patients aged between 18 and 45 years

Exclusion Criteria:

1. Significant suicide risk by HRSD suicide scores \> 2;
2. Accompanied with psychiatric symptoms;
3. Treated with MECT within 6 months.
68Ga-PSMA HBED-PET/CT in the Evaluation of the Biochemical Relapse in Patients With a History of Prostate Cancer Radically Treated

Single-center, prospective, diagnostic trial in radically treated patients with biochemical recurrence of prostate cancer. Patients with radically treated prostate cancer with biochemical relapse and negativity of all traditional morphological and functional imaging (transrectal ultrasound, bone scan, 18F-FMC PET/CT, CT/MRI) or doubtful imaging of 2-deoxy-2-\[fluorine-18\] (18F)-fluoromethylcholine (FMC) PET/CT will receive a Gallio-68 (68Ga)- Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET)/Computed Tomography (CT) scan.

Single-center, prospective, diagnostic trial. The primary objective of this study is to evaluate the sensitivity of 68Ga-PSMA PET /CT defined as the ratio between the number of 68Ga-PSMA PET /CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.

The secondary objectives are:

* Sensitivity for different Prostatic Specific Antigen (PSA) values (ranges)
* Sensitivity for different lesion sites
* Treatment response assessment with a second PET
* False positives detection during Follow Up (FUP) (with other standard methods and eventually optional biopsy) for patient without any treatment
* safety 67 evaluable patients will be injected with 100-200 megabecquerel (MBq) 68Ga-PSMA intravenously

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed prostate cancer
2. Male, aged \>18 years.
3. Radical treatment for prostate cancer (radiotherapy or surgery)
4. 18F-FMC PET/CT negative or doubtful
5. Negativity of all the other traditional morphological and functional imaging (transrectal ultrasound, bone scan, CT/MRI)
6. Patients with PSA progression defined as PSA ≥ 1,0 ng/mL and/or PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
7. Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
8. Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

1. No hormonotherapy in the last 6 months
2. No radiotherapy in the last 6 months.
3. Patients with PSA \< 1.0 ng/ml
4. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
6. Medical or psychological conditions that would not permit the subject to complete to sign informed consent
Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype

The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, 18 to 70 years of age, inclusive
* Treatment-naive OR subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (SVR24) after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had a documented undetectable HCV RNA level at the planned end of treatment of at least 42-week duration
* Subjects have IL28B CC genotype determined during screening
* Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection for at least 6 months, defined by (1) documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or (2) documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required

Exclusion Criteria:

* Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis C
* Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and never achieved undetectable HCV RNA while on treatment
* Subjects have evidence of hepatic decompensation
* Subjects have evidence of cirrhosis
* Subjects have diagnosed or suspected hepatocellular carcinoma
* Subjects have any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis. Steatosis is allowed if clinically asymptomatic
Electronic Nose Identification of Fasting and Non-fasting Breath Profiles

The investigators will study a noninvasive no risk process by which the investigators can quickly screen and assess for fasting and non-fasting states in individuals scheduled for routine endoscopy.

The investigators will study a noninvasive no risk process by which we can quickly screen and assess for fasting and non-fasting states in individuals scheduled for routine endoscopy. In non-fasting individuals, the risk of a sedation related complication such as aspiration increases and often the procedure must be aborted and repeated on another day following more prolonged fasting and medication administration. This adds to increased cost and delay to patient care.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

  1. Adult (18+) patient undergoing scheduled elective outpatient upper endoscopy
  2. Willing and able to consent to research protocol
  3. Fasting as required per routine instruction for upper endoscopy
  4. Able to breath for approximately 10 minutes pre and post procedure into the Aeonose device with a nose-plug on
  5. Able to consume standard refreshments post procedure during recovery per routine endoscopic area policy

     Exclusion Criteria:

  <!-- -->

  1. Non-fasting per protocol, or known to have had food or drink outside of routine protocol
  2. \< 18 years of age
  3. Unable or unwilling to consent to research protocol
  4. Inability to tolerate Aeonose breathing (such as those with claustrophobia, anxiety, nasal trauma, etc.)
  5. Unable to consume refreshment post procedurally
  6. Unable to repeat Aeonose measurement post-procedurally due to tolerance or medical indication (such as instructed to remain fasting)
Comparative Analysis of Serum Lipid Profiles in Patients With and Without Gallstones

Gallbladder disease is one of the most common diseases of the gastrointestinal tract. Various studies have shown an association between gallstones and an alteration in the serum lipids. The objective of this study will be to compare serum lipid profile of gallstone patients with the controls.

This prospective cross-sectional study will be conducted in the Surgical Department of the Services Institute of Medical Sciences. A total of 50 patients will beincluded in the study after screening through the inclusion criteria. A control group of 50 inpatients with no personal or family history of gallstones will be also recruited for comparison. Results will be expressed as mean with standard deviation. Students t- test will be used to compare the data between the patients and the control groups (p\<0.05 will be considered statistically significant). SPSS software, version 20 will be used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with the gall stone disease
* Age from 20 to 70 years
* Gallstones were diagnosed through the ultrasound

Exclusion Criteria:

* Patients with acalculous gallbladder disease on ultrasound,
* Patients with terminal ileal resection,
* Patients with hemolytic diseases (hereditary spherocytosis, sickle cell anemia on history and CBC film),
* Patients with liver cirrhosis (on abdominal ultrasound) and
* Patients on antihyperlipidemic drugs
Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

This is a double-blind, randomized, placebo-controlled trial of melatonin as an add-on therapy to antipsychotics will be performed to examine the effects of melatonin on tardive dyskinesia symptoms and cognitive deficits in 120 patients with established tardive dyskinesia (TD). This study addresses a free radical hypothesis of TD.

1. Since it has been proposed that neuroleptic-induced increases in free-radical production may relate to the development of TD, the investigators hypothesize that melatonin, an effective antioxidant, may attenuate the severity of tardive dyskinesia symptoms.
2. Due to increased cognitive deficits in patients with TD and implication of oxidative stress in cognitive impairment, the investigators hypothesize that both cognitive impairment and tardive dyskinesia symptoms may be induced by the same pathophysiological stimulus--oxidative stress. Hence, the investigators further hypothesize that both tardive dyskinesia symptoms and cognitive deficits in patients with TD may be improved by melatonin simultaneously.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of both schizophrenia and TD;
2. duration of TD symptoms longer than 1 year;
3. on stable doses of antipsychotic drug for at least 6 months;
4. between 18 and 70 years of age.

Exclusion Criteria:

1. comorbid neurological illness other than TD;
2. if they have received vitamin C or vitamin E within 1 month before the start of the study;
3. alcohol/drug abuse;
4. acute, unstable medical condition;
5. pregnant or breastfeeding female;
6. use of other antioxidants.
Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial

This is a randomized controlled trial among women who deliver by cesarean at UNC Women's Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months later than women who plan on receiving an IUD 4-8 weeks after delivery.


Eligibility Criteria:
Inclusion Criteria:

* Women ages 18-45
* Pregnant and greater than or equal to 24 weeks of estimated gestational age
* Live Pregnancy
* States a plan to use an Intrauterine Device (IUD) postpartum for contraception
* Plan for cesarean delivery
* Intend to stay in the Chapel Hill area for at least 6 months after birth
* Fluent in English or Spanish

Exclusion Criteria:

* known uterine anomalies
* allergies to any component of the IUD of their choosing
* known or suspected carcinoma of the breast
* known acute liver disease or liver tumor (benign or malignant)
* known or suspected uterine or cervical neoplasia
* active pelvic inflammatory disease
* genital bleeding of unknown etiology
* history of solid organ transplantation
* positive test for gonorrhea or chlamydia during this pregnancy