cyrilzakka/clinical-trials huggingface dataset:
The Effects of Coffee

In this study, participants will be eligible to participate in a paid research study that will examine the effects of regular coffee drinking. The study takes approximately 2 hours total, 55 min. on 2 separate days. Participants will be asked to do computer tasks and drink only coffee provided to them during the study.

The purpose of the experiment is to evaluate how coffee affects different individuals while completing computer tasks. If an individual agrees to participate, particpants will be asked to come to the laboratory to drink coffee on 2 days. During each visit, participants will be asked to drink coffee, complete forms, and perform computer tasks. To be eligible to participate, participants must be medically healthy.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be regular coffee drinkers.

For more information or to set up an appointment, please send a contact number (and a convenient time to call) via e-mail and a BPHP laboratory member will contact you or call the BPHP laboratory at the number listed below.
Pivotal Response Intervention Minimal Responders Study

Early intervention (EI) using naturalistic behavioural methods have shown benefits for the development of communication and other skills for young children with autism spectrum disorder. The publicly funded autism EI program in Nova Scotia (NS) is based on such a method, Pivotal Response Treatment (PRT), and pre-post studies indicate benefits for children and families. However, not all children benefit equally. In this study, the investigators test the efficacy of a brief parent-mediated intervention designed to prime responsivity to PRT in children with a minimal responder profile derived from previous studies of the PRT-based EI program.

Investigators will enroll preschoolers with the minimal responder profile who are scheduled to begin the PRT-based public EI program. Consenting parents will be offered a virtual intervention in which they will be randomized to 1 of 2 arms to receive coaching in either (a) PRIMeR intervention, designed to target areas of weakness in the minimal responder profile, or (b) PRT, the treatment model used in the EI program. Coaching will take place on a virtual (video-conferencing) platform. Each child's progress on treatment targets will be assessed in a single case experimental design (SCED) using data from blind-coded video-recordings of parent-child play episodes using a standard set of toys. Overall study effects will be based on aggregated data for an anticipated n of 20 participants assigned to each arm (4 SCED series with 5 participants each contributing to each arm). The primary outcome is gains in children's social initiations (video-coded); the secondary outcome is gains in children's communication levels (multi-method assessment). Mixed methods will be used to evaluate aspects of parents' experiences,

Eligibility Criteria:
Inclusion Criteria:

1. upcoming enrollment in NS EI program for preschoolers with autism spectrum disorder (ASD), based on confirmed or provisional ASD diagnosis by a qualified clinician
2. significant delay in cognitive abilities (assessed formally by psychologist or estimated by psychologist or developmental pediatrician at time of diagnosis)
3. current spontaneous functional use of ≤ 10 words (clinician's observations; parent report using MacArthur-Bates Communicative Development Inventory - Words \& Gestures (CDI-WG)
4. limited use of toys / objects (clinician's impression or parent's report with no contrary observation by clinician)
5. low levels of expressed positive affect (smiles, laughter) or limited positive and high negative affect (clinician's impression or parent's report with no contrary observation by clinician)

Exclusion Criteria:

1. Severe sensory or motor impairment in child
2. Parent unable to complete consent process (and receive coaching) in English
A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants

The purpose of this study is to evaluate the effect of cytochrome P450 3A4 inhibition by Itraconazole on the pharmacokinetics of BMS-986256.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participant, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, and abnormal clinical laboratory determinations that in the opinion of the Investigator would compromise the conduct, results, or interpretation of the study findings
* A negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 3 months of the screening visit
* Weight greater than or equal to (\>=) 50 kilogram (kg) and body mass index between 18.0 and 32.0 kilogram per meter square (kg/m\^2) inclusive at screening

Exclusion Criteria:

* Prior exposure to BMS-986256
* Previous investigational drug or placebo exposure within 6 weeks before nonbiologic study drug administration or 12 weeks before biologic study drug administration
* History or presence of malignancy including hematological malignancies. However, participants with a history of basal cell or squamous cell carcinoma that has been completely and successfully treated with no evidence of recurrence may not be excluded, at the discretion of the investigator

Other protocol defined inclusion/exclusion criteria could apply
Changes in iOS in IPF

Idiopathic pulmonary fibrosis (IPF) is a condition where scar tissue (called fibrosis) builds up in the lungs. It usually gets worse over time. Fibrosis causes the lungs to become stiff, and reduces the amount of oxygen that the lungs can take up. People with IPF complain of worsening breathlessness, which limits their day to day activities.

Lung function tests are breathing tests that measure how well your lungs are working, and are used by doctors to decide whether to start or stop medicines in people with IPF. However, people with IPF tell us that lung function tests require a lot of effort, can make them cough and feel very short of breath. About 1 in 5 people with IPF are unable to perform lung function results accurately. This might unfairly lead to some people with IPF not receiving the right medications or for their medications to be stopped too soon.

Impulse oscillometry (iOS) uses sound waves to measure the stiffness of the lung, and has been used successfully in children who are unable to perform normal lung function tests.

The overall aim of the research is to see whether changes in iOS measures can give useful information about the lungs in patients with IPF; for example, by judging the overall impact of the disease on the lungs, or predicting future deterioration.

We will look at how iOS changes over time in patients with IPF, and to see whether these measurements can tell us about whether IPF is getting worse or predict important health events, such as hospital admission. We will compare change in iOS with changes in other tests used to monitor IPF and with patient reported ratings of change in their condition. This will help decide the amount of iOS change that is noticed and considered meaningful by people with IPF.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic pulmonary fibrosis made by specialist multidisciplinary team according to international standards
2. Able to provide written informed consent

Exclusion Criteria:

1. Contraindication to performing conventional lung function tests, e.g untreated TB, haemoptysis, pneumothorax, unstable cardiovascular status, recent eye, thoracic or abdominal surgery, thoracic, abdominal or cerebral aneurysm, acute illness (including diarrhoea and vomiting).
2. Unable to create seal on mouthpiece
Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents

The objective of this study is to evaluate the long-term efficacy and safety of coronary stenting with the various types of drug-eluting stents (DES) and to determine clinical device and procedural success during commercial use of DES in the real world.

The investigators will compare EES (Xience V/Promus and Xience Prime), SES (Cypher), ZES (Resolute Integrity, Endeavor Resolute, Endeavor), and BES (Biomatrix, Biomatrix Flex, and Nobori).

The Grand Drug-Eluting Stent (Grand-DES) Registry incorporated five different multicenter registries in South Korea. The EXCELLENT prospective cohort and the EXCELLENT-PRIME registry were dedicated for durable polymer-coated everolimus-eluting stents (DP-EES; Xience V/Promus and Xience Prime) or 1st-generation sirolimus-eluting stents (Cypher), the HOST-RESOLINTE and RESOLUTE-Korea registry for durable polymer-coated zotarolimus-eluting stents (DP-ZES; Resolute Integrity and Endeavor Resolute) or 1st-generation Endeavor-ZES, and the HOST-BIOLIMUS-3000-Korea registry for biodegradable polymer-coated biolimus-eluting stents (BP-BES; Biomatrix, Biomatrix Flex, and Nobori). During the period of 2008 through 2014, all registries enrolled all-comers without any exclusion criteria except patient's withdrawal of consent.

Eligibility Criteria:
Inclusion Criteria:

* The patient agrees to participate in this study by signing the informed consent form.
* Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.

Exclusion Criteria:

* There are no exclusion criteria for this registry.
Comparison of Two Different Flap Methods in the Treatment of Pilonidal Sinus Disease

Sacrococcygeal pilonidal sinus disease (PSD) has been defined as a disease characterized by chronic inflammation and recurrent infections caused by the movement of hair toward the gluteal sulcus. This condition is especially seen in young men and negatively affects the quality of life of patients and prevents them from performing their work and school activities. The treatment options for PSD range from the use of antibiotics alone to reconstructed excision with tissue flaps. Although the optimal surgical treatment option remains controversial, expectations from the ideal surgical treatment include low recurrence and postoperative complication rates, early wound healing, short hospital stay, early return to work, and good cosmetic outcomes. The aim of this study was to compare the efficacy of the different flap techniques in the surgical treatment of PSD and evaluate the long-term outcomes of patients.


Eligibility Criteria:
Inclusion Criteria:

* Underwent surgery due to pilonidal sinus disease

Exclusion Criteria:

* Patients with a history of previous pilonidal sinus surgery,
* An acute pilonidal abscess,
* immunodeficiency,
* using immunosuppressive drugs,
* refuse to participate in the study
Deep TMS for the Treatment of Patients With Parkinson's Disease and Progressive Supranuclear Palsy

Background: Progressive supranuclear palsy (PSP) is a rare neuro-degenerative disease, counted among atypical parkinsonism (AP). Medical treatment and rehabilitation are extremely limited in AP, therefore it would be very useful to find new ways to improve motor and non motor symptoms in PSP. The Brainway Deep Transcranial magnetic stimulation (DTMS) is a new technology of TMS using a particular coil, i.e. H-coil, able to stimulate deeper regions of the brain. Only few studies in literature have evaluated the efficacy of DTMS in Parkinson's Disease and parkinsonism; in particular in PSP patients, a case report showed an improvement in language.

Materials and Methods: This study was a pilot, randomized, cross-over, double blind trial. It was designed to evaluate the efficacy of Deep TMS in terms of recovery of motor functions, freezing of gait, and cognitive decline in patients with PSP. Nineteen subject underwent 14 session of high frequency DTMS over a 4 weeks period. The target were the left Broca and dorsolateral prefrontal cortex.

Eligibility Criteria:
Inclusion Criteria:

* outpatients with PSP according to NINDS-SPSP criteria

Exclusion Criteria:

* contraindications for DTMS (history of seizures, pacemakers, or any other electric device)
Effective Dose of Dexmedetomidine for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia With or Without Fentanyl by Age Groups: Randomized Comparative Study

Recently many studies reported that intraoperative dexmedetomidine administration undergoing spinal anesthesia give a satisfactory sedation in elderly patients and cause less respiratory depressions compared other sedatives(e.g. benzodiazepine) But the optimal dose of dexmedetomidine for sedative effect in elderly patients undergoing spinal anesthesia was not got general consensus.

The investigators hypothesized that the dose requirements would be lower than in elderly patients than young patients. Furthermore, intrathecal small dose opioids enhance the analgesia provided by bupivacaine due to synergistic effects and it would reduce the dose of dexmedetomidine.

The purpose of this study was to determine the dose of dexmedetomidine to provide satisfactory sedation undergoing spinal anesthesia with or without additive small dose intrathecal opioids.

Elderly patients(65\~85 years old) undergoing TURP or TURB were enrolled in this single-blinded study. Forty patients were randomly assigned to receive intrathecal hyperbaric bupivacaine 6mg coadministered with 20mcg fentanyl or placebo normal saline 0.4cc. After the induction (bilateral T10 sensory level to pinprick within 5 mins of intrathecal drug administration), continuous intravenous dexmedetomidine was started in dose of 0.8, 0.6, 0.5, 0.4, 0.3, or 0.2mcg. Successful sedation was defined as OASS score 3 or 4 within 20 minutes of dexmedetomidine infusion. The dose of dexmedetomidine was selected for each patient according to an up and down method. Intraoperative arterial pressure, heart rate, and bispectral index was compared. Postoperative pain score, the time for the regression of sensory and motor was recorded for further analysis.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients aged 65\~85 years olds undergoing TURB or TURP.
* No contraindication of spinal anesthesia.
* ASA class I and II.
* Patients consented to spinal anesthesia were enrolled.

Exclusion Criteria:

* Patients with hypovolemia, coagulation disorders, local infection at the site of operation, history of headache, heart diseases, and history of allergy, chronic alcohol use or abuse, anemia, congenital heart diseases, bundle block, congestive heart failure or arrythmias, and patients who had recently received sedative drugs or were under antidepressant treatment were not included in the study.
Results of a New Fully Tapered Implant at One Year

Objective: The aim of this prospective observational clinical study is to evaluate the bone level changes in a new implant design, fully tapered and platform switching with the one-time one-abutment protocol after one year of loading.

Material and methods: Thirty patients received 1 or 2 implants (6, 8 and 10 mm in length, 3.5, 3.75 or 4.5 mm diameter and bone level design) to replace a single or multiple gap. Radiographic, clinical, esthetic and survival success rate were evaluated after one year of loading.

Results: At 12 months post final loading, there were no peri-implant bone loss in any of the cases. Mean marginal crestal bone loss between surgery and crown placement was 0.19 ± 0.17 (p \<0.0001). Between surgery and 12 months of follow-up, the mean marginal crestal bone loss was 0.25 ± 0.24 (p \<0.0001). There were a SSD between 1 year follow-up and crown placement in PI in the mesial (0.33 ± 0.54 p= 0.003) and distal aspect (0.5 ± 0.73 p= 0.001). The PPD was SSD deeper at 1 year follow-up than at crown placement only in the mesial and distal probing (averaged depth=0.75 and p\<0.0005). No statistically significant differences were found for any of the other clinical and est


Eligibility Criteria:
Inclusion Criteria:

* Males or females with, at least 18 years old.
* Single and multiple gaps (premolars \& molars) that require single and partial fixed restorations (2 implants, 1 pontic).
* Adequate bone quantity at the implant site to allow the placement of diameter 3.5, 3.75 or 4.5 mm and lengths of 6 mm, 8 mm, 10 mm, 12 mm or 14 mm.
* Patients had to be informed of the follow up visits and willing to attend to the clinical centre for these appointments.

Exclusion Criteria:

As systemic exclusion criteria, patients with systemic diseases that could interfere with dental implant therapy, smokers of more than 10 cigarettes per day, alcoholism or drug abuse, physical or mental disabilities, pregnant or lactating women and/or conditions or circumstances, in the opinion of the investigator, that could prevent the completion of the participation in the study or interfering with the analysis of study results (non-compliance).

The presence of one of the following circumstances was considered a local exclusion criterion: patients with inadequate oral hygiene (plaque control \> 25%) (Mombelli et al., 1987), untreated endodontic lesions, any bone augmentation procedure before or during the implant placement, local inflammation (including untreated periodontitis), mucosal diseases such as erosive lichen planus, history of local irradiation therapy in the head-neck area and/or extraction sockets with less than 12 weeks of healing.
Echocardiographic Manifestation in Patient With COVID-19 （EARLY-MYO COVID-19）

The cardiovascular effects of coronavirus disease 2019 (COVID-19) are not yet fully known. We conducted a prospective and dynamic echocardiographic study to investigate the cardiac structural and functional changes in COVID-19 patients in intensive care unit (ICU).

The ongoing pandemic of coronavirus disease 2019 (COVID-19) caused by the newly discovered severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) has become a global health crisis, resulting in 3,435,894 confirmed infections and 239,604 deaths worldwide by 4 May 2020 1. Although acute respiratory syndrome is the main manifestation of the disease2, the understanding of the impact of the virus on other organs is of importance in terms of multiple organ dysfunction/failure that contributed to the increased mortality in patients with COVID-19.

With the increase of confirmed cases and the accumulation of clinical data, the cardiovascular manifestations caused by COVID-19 has raised concern3. Some studies have reported that a certain percentage of patients presented cardiac injury as indicated by elevated cardiac biomarkers such as high-sensitivity cardiac troponin-I (hs-cTnI) and brain natriuretic peptide (BNP) 2,4,5. Cardiac complications, including acute heart failure, cardiac rupture and even sudden cardiac arrest, has also been described in several case reports 6-8. However, autopsy studies failed to find the evidence of direct assaults by the virus in myocyte or apparent myocyte necrosis/apoptosis in the heart 9. Typical pathological finding reported was mononuclear inflammatory infiltration in the myocardial interstitium but no substantial damage in cardiomyocytes in the heart 10,11. Thus, a significant gap exists in our knowledge between the clinical investigation and postmortem findings. At present, the in vivo morphological and functional features of cardiac injury remain unknown.

We therefore performed a prospective and dynamic echocardiography study to investigate the cardiac structural and functional changes in patients with COVID-19 who were admitted to intensive care unit (ICU), and to compare the cardiac characteristics between deceased and survived patients.

Eligibility Criteria:
Inclusion Criteria:

Patients had been diagnosed of COVID-19 according to the criteria established by the WHO interim guidance and admitted to ICU because of severe or critical condition

Exclusion Criteria:

Patients who were \< 18 years and whose entire stay in hospital lasted for \< 48 hours.
Tactile Acuity, Right-left Discrimination, and Motor Imagery in Chronic Rotator Cuff-related Shoulder Pain

A common finding in various chronic musculoskeletal pain conditions is changes in the cortical sensorimotor region. Functional brain changes associated with chronic pain include changes in the working body schema and associated mechanisms. However, the number of studies on this subject is quite limited, especially in the shoulder joint. There is no study on rotator cuff-related shoulder pain. In the light of this information, the present study aims to compare tactile acuity, right-left reasoning ability and motor imagery ability in chronic rotator cuff-related shoulder pain with healthy controls. In addition, the relationship of these markers with pain level, pressure pain threshold, range of motion, functionality, pain-related fear and central synthesis level will be investigated as a secondary objective.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Participants were classified with chronic Chronic Rotator Cuff-related Shoulder Pain if duration was equal or greater than 6 months, as recommended by the International Association for the Study of Pain for research purposes
* Pain at rest maximum 2 out of 10 on verbal numerical rating scale
* Pain over the deltoid and/or upper arm region for more than 4 weeks, pain associated with arm movement, and familiar pain reproduced with loading or resisted testing during abduction or external rotation of the arm
* Patient had to test positive at least 3 out of 5 symptoms-provoking tests: pain during Neer test, Hawkins-Kennedy test, Jobe test, painful arc between 60° and 120°, pain or weakness during external rotation resistance test

Exclusion Criteria:

* Bilateral shoulder pain
* Corticosteroid injections less than 6 weeks prior to the enrolment
* Participants who were pregnant, Mini Mental State Examination score \>24
* Clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests or drop arm test)
* Evidence of adhesive capsulitis (50% or more than 30° loss of passive external rotation)
* Previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder
* Symptoms of cervical radiculopathy as primary complaint (tingling, radiating pain in the arm associated with neck complaints)
* Primary diagnosis of acromioclavicular pathology, shoulder instability
* Previous medical imaging confirming full-thickness rotator cuff tears or calcifications larger than 5mm
* Patients with competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy)
* History of cancer, neurologic, systemic, rheumatic or vascular disorder and use of psychiatric medication
* Participants performing overhead sport activities for more than 4hours/week
Short and Long-term Psychological Impact of Covid-19 on The Egyptians

The World Health Organization (WHO) has recently declared coronavirus disease 2019 (Covid-19) a public health emergency of international concern. Impact of the pandemic of covid-19 on the mental health of patients, health care workers and general population would be affected.

Health care workers and general population will be included in the study. A questionnaire will be used to assess their knowledge and practices regarding covid-19 and its impact on mental health.

Patients Mental health will be assessed regarding anxiety, depression and obsessive compulsive disorder, sleep disorder will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Egyptian population

Exclusion Criteria:

* Patients not accepting to participate in the questionnaire