cyrilzakka/clinical-trials huggingface dataset:
Anesthetic Effect Duration Assessment

The purpose of this study is to evaluate the duration of anesthetic effect produced , Lidocaine7% + Tetracaine 7% cream when applied with 2 different application times on the face and thigh.

Subjects will have 4 target zones defined; 2 on the face and 2 on the anterior thighs. Upon inclusion into the study, subjects will have the study drug applied with a different application time to one side of the face and anterior thigh according to the randomization. After the completion of the application process, study drug on both sides of the face and on both anterior thighs will be removed by peeling.

After drug removal, the duration of anesthetic effect of the study drug will be tested using a pinprick test. Five (5) pinpricks using a 21-gauge needle will be performed at the 4 target zones (each side of the face and both anterior thighs). The pinprick test will be repeated up to 8 hours after drug removal. There will be a total of 20 post drug removal pinprick test completed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male of female subjects aged 18 or older with a normal not excessive hairy skin,

Exclusion Criteria:

* Female subjects who are pregnant or breast-feeding; or plan to become pregnant,
* Subjects who have a known allergy to one of the components of the test drug lidocaine, tetracaine or other local anesthetics,
* Subjects who are at risk in terms of precautions, warnings, and contra-indication with the study product.
Analysis of Blood-based Biomarkers of Asthma

The purpose of this study is to analyze markers of inflammation in blood and in induced sputum for the purpose of identifying molecular markers of specific asthma phenotypes. The investigators' specific interest is demonstrating that periostin levels are higher than normal in blood. The investigators already have solid preliminary data to support this hypothesis, and our goal here is to replicate preliminary findings and extend them by examining further the characteristics of the asthma subgroup with elevated periostin levels.

This is a cross-sectional study in patients with asthma and healthy controls in which we will analyze markers of inflammation in blood and in induced sputum for the purpose of identifying molecular markers of specific asthma phenotypes. Our specific interest in demonstrating that periostin levels are higher than normal in blood. We already have solid preliminary data to support this hypothesis, and our goal here is to replicate preliminary findings and extend them by examining further the characteristics of the asthma subgroup with elevated periostin levels. In this regard, we propose detailed phenotyping of the asthmatic subjects and the healthy controls, including measures in induced sputum, exhaled air and detailed physiologic measures including measures of airflow, lung volumes, and methacholine responsiveness. In earlier work we have found that periostin is a marker of Th-2 driven asthma, and we will use the data collected here to further explore this possibility. The biospecimens collected here will also allow us to expand existing plasma, DNA, RNA, and sputum samples in the UCSF Airway tissue bank, so that we can continue to build this resource for future research questions.

Eligibility Criteria:
Asthmatic Subjects Inclusion criteria

1. Male and female subjects between the ages of 18 and 70 years with a history of asthma who may or may not be taking inhaled corticosteroids for asthma control.
2. Physician diagnosis of asthma
3. PC20FEV1 methacholine ≤ 8.0 mg/mL, except for those taking daily inhaled corticosteroids, for which the PC20 methacholine should be \< 16 mg/mL.
4. Ability to provide informed consent.

Healthy Subjects Inclusion criteria

1. Healthy male and female subjects with no history of asthma between the ages of 18 and 70 years. Subjects should not be taking inhaled or oral corticosteroids.
2. No lifetime history of asthma or allergic rhinitis.
3. Ability to provide informed consent.

Exclusion Criteria for both subject groups

1. Lung disease other than asthma.
2. History of an upper or lower respiratory tract infection in the 4 weeks preceding the study.
3. Females who are pregnant or breast-feeding
4. Subjects must be non-smokers (patients who have never smoked or patients who have smoked ≤5 cigarettes per month and have a total pack-year smoking history \< 10 packs).
5. Use of marijuana \>1 time per month in the last year and use of marijuana in the 6 weeks prior to enrollment
6. Use of recreational drugs other than marijuana in the 12 months preceding the study.
7. Use of Beta blocker medications
Evaluation of an Oxygen Enhanced Magnetic Resonance Imaging Method on Patients With Chronic Obstructive Pulmonary Disease During 8 Weeks Treatment With Either Symbicort Turbuhaler or Oxis Turbuhaler

The main purpose of this study is to evaluate the sensitivity of a new oxygen enhanced magnetic resonance imaging (OE-MRI) method in detecting changes in the lungs of patients with moderate to severe chronic obstructive pulmonary disease (COPD) following treatment with either Oxis Turbuhaler or Symbicort Turbuhaler.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 40 years
* Male and female
* Clinical diagnosis of moderate to severe COPD according GOLD guidelines
* Current or ex smoker with a smoking history equivalent to at least 20 cigarettes smoked per day for 10 years
* A Modified Medical Research Council (MMRC) dyspnoea scale score of ≥2.
* FEV1/FVC \< 0.7 (post-bronchodilator)
* FEV1 \> 40 % PN and \< 70 % PN (post-bronchodilator)

Clinical Study Protocol Local Amendment affects UK:

- FEV1 \> 30 % PN and \< 80 % PN (post-bronchodilator)

Exclusion Criteria:

* Current diagnosis of asthma according to GINA guidelines
* Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures as judged by the investigator
* Significant upper or lower respiratory tract infection not fully recovered in the 4 weeks prior to visit 1
* Participation in or scheduled for an intensive COPD rehabilitation program
* Claustrophobia, pacemaker, clips within the brain, previous brain or heart surgery, history of metal in the eye or other MRI contraindication such as obesity or inability to stay in the supine position for 60 minutes
Assessing Effectiveness of ThoughtFullChat Application in Improving Mental Well-Being

* To determine the state of mental health among house officers, IMU corporate staff, IMU students and IMU faculty
* To find out the effectiveness and user experience of text-based mental health coaching applications among house officers, IMU corporate staff, IMU students and IMU faculty

IMU - International Medical University

The text-based mental health coaching application that the investigators are using is ThoughtFullChat Application. ThoughtFullChat Application provides mental health coaching through text by licensed mental health professionals. Participants of this research will be required to answer a set of questionnaires which consists of DASS-21, Satisfaction with Life Scale and Brief Resilience Scale at the start of the study. Participants will be randomly distributed into 2 groups which are intervention and control groups. Participants in the intervention group will be using the application for 3 months. Post-intervention questionnaires will be given to all participants after 3 months. Data collected from these 2 groups will be analyzed by using SPSS.

Eligibility Criteria:
Inclusion Criteria:

* House Officers in Malaysia (UD41)
* Corporate staff in IMU, IMU Faculty Members
* All students who are currently studying in IMU who give their consent
* Competent in English Language
* Experiencing none to severe stress, anxiety or depression based on DASS-21 score

Exclusion Criteria:

* Medical students, Medical Officers (UD44)
* Contract staff, Outsourced staff or international staff in IMU campuses
* Students who refuse to give their consent and those that have already or just graduated from IMU
* Competent in other languages except English
* Experiencing extremely severe stress, anxiety or depression based on the DASS-21 score
Effects of Chinese Medicine on Patients With Severe Acute Exacerbation of COPD

The purpose of this study was to evaluate the effects of Chinese Medicine on patients with severe AECOPD, and to provide a basis for the establishment of integrated CM and Western medicine diagnosis and treatment scheme for patients with severe AECOPD.

Aiming at the key problems such as the lack of high-quality clinical research evidence of Chinese medicine in the prevention and treatment of severe AECOPD, this study adopted a multi-center, randomized, double-blind, placebo-controlled parallel trial design, taking 468 severe AECOPD patients as the research object, to evaluate the clinical efficacy and safety of Chinese medicine combined with western medicine in the treatment of severe AECOPD. To establish an integrated Chinese and western medicine diagnosis and treatment plan to reduce the treatment failure rate of severe AECOPD patients, and to form high-level evidence-based evidence.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with severe AECOPD.;
2. Age 40-80 years old;
3. Chinese medicine diagnosis consistent with external cold and internal drink syndrome, or phlegm-heat congestion of the lungs syndrome, or phlegm turbidity obstruction of the lungs syndrome;
4. Voluntarily accept the treatment and sign the informed consent form;

Exclusion Criteria:

1. Pregnant and lactating women.
2. delirious, dementia, various mental patients and other people who cannot communicate normally.
3. Patients with severe cardiac insufficiency (NYHA grade IV), malignant arrhythmia and hemodynamic instability.
4. Patients with acute respiratory failure who require tracheal intubation or invasive mechanical ventilation.
5. Complicated with bronchiectasis, active tuberculosis, severe liver and kidney disease (severe liver disease refers to cirrhosis, portal hypertension and varicose vein bleeding, etc., serious kidney disease including dialysis, kidney transplantation, etc.), pneumonia, HIV infection or immunosuppressive state, advanced malignant tumor, etc.
6. long-term bedridden patients for various reasons.
7. Out-of-hospital treatment for more than 3 days.
8. Participate in other drug clinical investigators within 1 month before enrollment.
9. Allergic to therapeutic drugs.
Acute Caffeine Effects on Cardiac Autonomic and Cardiorespiratory Parameters Responses After Aerobic Exercise

Check the acute influence of caffeine on the autonomic modulation and cardiorespiratory parameters after aerobic exercise. Hypothesized that caffeine can promote a slower recovery of the cardiorespiratory parameters and the SNA recovery after aerobic exercise.

The experimental procedure is divided into three phases, all performed on a treadmill, with a minimum interval of 48 hours between them, in order to allow adequate recovery of the participants. Before the start of the first stage of the experimental protocol or control anthropometric measurements will be carried out, body weight by a digital scale (Plenna, TIN 00139 MAXIMA, Brazil)) and then, using a stadiometer (Plenna, TIN 00139 MAXIMA, Brazil)). The protocols are:

I) Maximum stress test protocol: assessment of the maximum oxygen consumption (VO2max) on a treadmill (Inbrasport / Millennium), using the Bruce protocol.

II) Control Protocol (PC): at this stage the volunteer will ingest compressed form of placebo similar to Protocol III and remained at rest after 15 minutes in the supine position, followed by 30 minutes of aerobic exercise on a treadmill, 5 minutes with speed 6.0 km / h followed by 25 minutes with 60% of VO2max and the final 60 minutes lying recovery.

III) Experimental protocol (PE): In this stage, the volunteer had performed activities similar to the PC, but will make the tablet intake consists of 300mg of caffeine, a value that is within the maximum daily amount allowed under the FDA.

Eligibility Criteria:
Inclusion Criteria:

* healthy men.

Exclusion Criteria:

* cardiovascular, orthopedic, respiratory and neurological disorders reported or other pathological conditions that prevent the subject to perform the protocols;
* smokers, alcoholics, or who use drugs that influence the activity of the heart.
Safety, Tolerance and Immunogenicity of EuCorVac-19 for the Prevention of COVID-19 in Healthy Adults

Phase I/II study to determine safety, tolerance and immunogenicity of EuCorVac-19, a recombinant protein vaccine, for the prevention of COVID-19 in healthy adults


Eligibility Criteria:
Inclusion Criteria:

1. Individuals who voluntarily decide to participate in this study and provide written informed consent

   * Healthy male and female adult at the age of 19 to 50 years (Part A)
   * Healthy male and female adult at the age of 19 to 75 years (Part B)
2. Individuals who are available for all visit procedures including telephone visits during the study period

Exclusion Criteria:

1. COVID-19 positive based on RT-PCR using upper respiratory tract or lower respiratory tract sampling or COVID-19 antibody positive
2. History of SARS-CoV, MERS-CoV or SARS-CoV-2 infection
3. History of vaccination against SARS-CoV, MERS-CoV or SARS-CoV-2
4. Immune system disorders including immunodeficiency disease
5. Clinically significant abnormalities in clinical laboratory test, ECGs and chest X-ray during screening in the opinion of the investigator
6. Fever within 3 days prior to screening or serious acute or chronic infection within 7 days prior to screening requiring systemic antibiotics or antivirals
7. Evidence or history of serious acute, chronic, or progressive disease which, in the opinion of the investigator, makes the individual ineligible for the study
8. History of severe allergic reactions or severe hypersensitivity reactions to the IP or any of its components
9. History of therapy that might affect immunity: treatment with immunosuppresants or immune modifying drugs, anticancer therapy, or radiotherapy within 3 months prior to screening
10. Women of childbearing potential who do not agree to use medically allowed methods of contraception or to be heterosexually inactive until 60 days after the last dose of the IP
11. Pregnant or breastfeeding woman
12. Treatment with other IPs within 6 months prior to participation in this study
13. Other reasons including medical reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator
Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study

The aim of this study is to evaluate the effect of repeated low-frequency Transcranial Magnetic Stimulation (rTMS) of the right dorsolateral prefrontal cortex, combined with gambling cues, on gambling craving. Participants are pathological gamblers. A single real stimulation and a single shame stimulation are administered in a random order for each participant (cross-over study).


Eligibility Criteria:
Inclusion criteria:

* Pathological gambler (DSM-IV criteria)
* Seeking treatment at the University Hospital of Nantes
* Right-handed
* 18-65 years old
* Increase in the intensity (at least 50%) of the gambling craving with gambling cues

Non-inclusion criteria:

* pregnant woman
* no effective contraception
* Substance use disorders (excluding nicotine)
* Benzodiazepine use
* Chronic neurological disease
* History of head injury
* History of neurosurgery
* Cochlear implant or other metal objects in the head
* History of Transcranial Magnetic Stimulation or repeated Transcranial
* Magnetic Stimulation
* Difficult to read or write French

Exclusion criteria:

* Occurrence of side effects (like seizures)
* Psychoactive substance use 12 hours before the rTMS (excluding nicotine)
Rhinogenic Headache Improvement After Nasal Operation

Objective: To determine the efficacy of surgical correction of intranasal mucosal contact points in improving quality of life and decreasing medication use in patients with rhinogenic headaches.

Significance: Chronic, debilitating headaches that resist maximal medical treatment by various headache specialists are sometimes linked to structural anomalies within the nose that exert pressure on apposing mucosal surfaces. A number of otolaryngologists have reported success in alleviating rhinogenic headaches with contact point correction surgery. This practice is supported by anecdotal reports along with retrospective and observational studies; however, a prospective study with an appropriate surgical control group has not been conducted. Because the specific effect of contact point correction has not yet been differentiated from the placebo effect of surgery itself, many headache specialists are reluctant to recommend surgical evaluation for their patients. To demonstrate the efficacy of contact point correction surgery to both the headache and otolaryngology communities - and thus, to make this treatment option more widely available to rhinogenic headache sufferers - a randomized controlled trial is needed.

Eligibility Criteria:
Inclusion Criteria:

* Chronic (\> 2 months) pain or pressure over nasal bridge, glabella, or forehead
* Unilateral or bilateral nasal septal deviation that is chronically symptomatic (e.g. nasal airway obstruction)
* Failure of standard medical therapy for headache
* Symptomatic contact points as demonstrated by physical examination, sinus CT and nasal endoscopy
* Relief of headache after application of topical anesthetic to contact points
* Contact points that remain after mucosal decongestion
* Absence of any other obvious cause of headaches after a thorough evaluation by a neurologist, ophthalmologist, dentist, internist, or other related specialist

Exclusion Criteria:

* Previous sinonasal surgery
* Active acute sinonasal disease:

  1. Seasonal allergic exacerbations with mucosal swelling
  2. Acute infectious rhino-sinusitis
* Chronic sinonasal problems:

  1. Severe nasal polyps mimicking contact points
  2. Mucoceles protruding from sinuses into nasal cavity
  3. Nasal and sinus tumors
* General medical condition that precludes elective surgery (including pregnancy)
Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients At High Risk of Postoperative Pulmonary Complications

The objective of the study is to evaluate, in a clinical trial, the efficacy of peri operative administration of long-acting inhaled ß-2 mimetics on the occurrence of postoperative pulmonary complications


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years)
* Lung cancer eligible for surgical management by lung resection (non-small cell lung carcinoma = NSCLC) by any route
* Naïve to long-term inhaled bronchodilator therapy
* High risk of post-operative pulmonary complications (Pre-operative FEV1 \< 80%)

Exclusion Criteria:

* Patient refusal
* Pregnancy
* Emergency surgery
* Patient with a physiological status of WHO IV or ASA ≥ IV
* Asthma
* Patients treated with long-acting bronchodilators
* Severe heart failure (NYHA IV), unstable ischaemic heart disease (angina or recent infarction \< 3 months), obstructive hypertrophic cardiomyopathy, subvalvular aortic stenosis, severe uncontrolled hypertension Recent stroke \< 3 months
* High-grade unresponsive conductive disorders or unstable arrhythmia
* Thyrotoxicosis, pheochromocytoma
* Unbalanced diabetes
* Hypersensitivity to ß-2 mimetics or lactose
* Current participation in a trial of another drug therapy
Adverse Effects of Ivermectin Used in Egypt During COVID-19

retrograde study of common and rare adverse effects of multiple doses of ivermectin used during the coivd 19 pandemic in egypt

ivermectin was used in Egypt during the pandemic of covid-19 and it was registered in the MOH protocol that has been published in November 2020 the study will document the adverse effects of many patients used ivermectin as aprophylaxis and as a treatment with multiple dose regimens

Eligibility Criteria:
Inclusion Criteria:

* all people used ivermectin as a treatment or as a prophylactic in covid 19 pandemic in egypt with explained dose

Exclusion Criteria:

-
A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers

The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC) tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.

This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as a fixed dose combination (FDC) tablet (ie, canagliflozin and metformin IR in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.

Eligibility Criteria:
Inclusion Criteria:

- Body mass index (BMI) between 18.5 and 30 kg/m² inclusive and a body weight of not less than 50 kg

Exclusion Criteria:

- History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study

The aim of this study is to assess the feasibility of conducting a study to compare the patient recorded and clinical outcomes for the surgical management of Hallux Valgus correction. A prospective trial will randomise the patients into two groups - Open Scarf/Akin osteotomy and Minimally Invasive Chevron/Akin osteotomy.

This study will assess the feasibility of a prospective trial that would randomise the patients into two groups for surgical correction of Hallux Valgus - Open Scarf/Akin osteotomy and Minimally Invasive Chevron/Akin osteotomy. Patients will complete a validated questionnaire (Manchester Oxford Foot questionnaire) preoperatively and post operatively at 6 months and 1 year. Range of motion of the Great Toe Metatarsal Phalangeal Joint will also be measured by goniometer. This study will assess the ability to recruit and retain patients and thus determine if a study comparing the surgical techniques would be feasible. In addition, for data collected statistical differences of the change in patient reported outcomes, range of motion between the two groups will be calculated with a significance level of p\<0.05. This study will assess if a larger study comparing minimally invasive to open Hallux Valgus correction would be able to be performed

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Patients with Hallux valgus deformity suitable for treatment by both Open Scarf/Akin and MICA procedures.
* Patients with no significant co-morbidities that would increase their risk of procedure.
* Patients able to understand and complete questionnaires.
* Patients with the capacity to provide informed consent.
* Patients who have, in addition to Hallux Valgus Deformity, lesser toe deformities requiring correction distal to the metatarsal phalangeal joint at time of procedure.
* Patients without significant other mid foot or hind foot pathology

Exclusion Criteria:

* Patients under 18 years of age
* Patients with severity of Hallux valgus deformity necessitating Open procedure
* Patients with significant co-morbidities that would increase the risk of surgery
* Patients unable to understand or complete questionnaires.
* Patients without the capacity to provide informed consent.
* Patients with additional deformity requiring additional procedures proximal to the metatarsal phalangeal joint.