cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Tetrathiomolybdate in Patients With Idiopathic Pulmonary Fibrosis

This study will evaluate the safety of the administration of a copper chelating agent, tetrathiomolybdate, for patients with idiopathic pulmonary fibrosis that have failed previous treatment. The primary endpoint for this study is safety with secondary endpoints including change in pulmonary function, exercise capacity, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic pulmonary fibrosis
* Disease progression despite six months of treatment (steroids with/without azathioprine or cyclophosphamide) defined by at least one of the following:

  * Increased symptoms
  * Decline in forced vital capacity of at least 10%
  * Decline in diffusion capacity for carbon monoxide of at least 20%
  * Increased infiltrate on CXR or high resolution CT scan
* Taking \< 15 mg prednisone for at least 30 days prior to screening
* Age 35-80, inclusive
* Able to understand a written informed consent and comply with the study protocol

Exclusion Criteria:

* Significant environmental exposure
* Diagnosis of collagen vascular disease
* Evidence of active infection
* Clinically significant cardiac disease:

  * Myocardial infarction, coronary artery bypass or angioplasty within 6mo
  * Unstable angina pectoris
  * Congestive heart failure requiring hospitalization within 6 months
  * Uncontrolled arrhythmia
* Poorly controlled or severe diabetes mellitus
* Pregnancy or lactation
* Women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm, Norplant)
* Current enrollment in another experimental protocol

Physiologic Criteria:

* FEV1/FVC \< 0.60

Laboratory Criteria:

* Total bilirubin \> 1.5 X upper limit normal
* AST or ALT \> 3X upper limit normal
* Alkaline phosphatase \> 3X upper limit normal
* White blood cell count \< 2,500/mm3
* Hematocrit \< 30%
* Platelets \< 100,000/mm3
* Prothrombin time INR \> 1.5
Biobeat Digital Home Monitoring Feasibility

To assess the feasibility of evaluating postoperative home monitoring with Biobeat digital monitoring. The investigators hypothesize that the Biobeat digital home monitoring platform will lead to a decrease in unplanned visits to the ED (Emergency Department). In addition, patients' quality of life is postulated to be improved compared to patients receiving the current standard of care without home monitoring.

This trial will be a single centre, parallel arm, randomized controlled feasibility trial. The investigators will evaluate postoperative home monitoring with the Biobeat digital monitoring and two-way communication through the digital portal for 4 weeks post-operatively to the standard of care (no digital monitoring) in thoracic surgery patients undergoing elective thoracic surgical procedures. The investigators will assess whether conducting a larger randomized trial of digital home monitoring vs. standard of care is feasible in terms of recruitment, data collection and logistics.

Eligibility Criteria:
Inclusion Criteria:

* Patient willing to provide informed consent
* Wi-fi or cellular connectivity at the patient's home
* Patient undergoing elective lung cancer surgery
* Patient familiar/comfortable with the use of technology such as online banking.

Exclusion Criteria:

- Patients who are not comfortable with the use of technology.
Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine

The purpose of this study is to compare and explore bioavailability of mosapride, the main component of DWJ1252(Test drug) and mosapride medicine(Reference drug).


Eligibility Criteria:
Inclusion Criteria:

* a healthy adult male within the range of 20 to 50 years old at the time of screening
* with weight of more than 55kg, in the range of IBW 20%: IBW(kg)={height(cm)-100}\*0.9
* who understood completely about this study after the detailed explanation is given, decided to volunteer and gave written informed consent to participate in study in compliance with the requirement of the entire protocol.

Exclusion Criteria:

* one with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history
* one with gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug.
* one with genetic disease like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
* one who is allergic or has clinically significant allergic history to the component of the investigational drug (mosaprisde), and any component from same family, or to other drugs(Aspirin, antibiotics, etc)
* one who shows different rhythm than sinus rhythm in screening, like QTc \>450ms on electrocardiogram, PR interval\>200msec or QRS interval 120\>msec
* one who shows the following result in clinical laboratory test: AST,ALT\>1.25 times of the upper limit of normal range
* one who shows vital signs with the number of systolic blood pressure of 160 mmHg or 100 mmHg, and the number of diastolic blood pressure of 95mmHg or 60mmHg
The Use of Artificial Intelligence to Predict Cancerous Lymph Nodes for Lung Cancer Staging During Ultrasound Imaging

This study aims to determine if a deep neural artificial intelligence (AI) network (NeuralSeg) can learn how to assign the Canada Lymph Node Score to lymph nodes examined by endobronchial ultrasound transbronchial needle aspiration(EBUS-TBNA), using the technique of segmentation. Images will be created from 300 lymph nodes videos from a prospective library and will be used as a derivation set to develop the algorithm. An additional100 lymph node images will be prospectively collected to validate if NeuralSeg can correctly apply the score.


Eligibility Criteria:
Inclusion Criteria:

* must be diagnosed with confirmed or suspected lung cancer and be undergoing EBUS diagnosis/staging

Exclusion Criteria:

* None
Effects of Chocolate in Patients With Chronic Heart Failure

The aim of the present study is to investigate whether in patients with chronic heart failure endothelial dysfunction and baroreceptor function is altered by ingestion of a flavonoid-rich dark chocolate in comparison to placebo chocolate (Nestlé Placebo Chocolate) on top of standard medication.

Moreover, we will evaluate the effect of chocolate on oxidative stress, platelet adhesion as well as systemic inflammatory response such as C-reactive protein and pro-inflammatory cytokines in patients with chronic heart failure.


Eligibility Criteria:
Inclusion Criteria:

1. Heart failure ( NYHA ≥II, LVEF\<50%, independent of aetiology)
2. Nonsmokers
3. Age: 30-80
4. Written obtained informed consent

Exclusion Criteria:

1. Decompensated Heart failure
2. Instable Angina pectoris
3. Smokers
4. Ventricular tachyarrhythmias or AV-Block \>I°
5. Renal failure (\>200 umol)
6. Liver disease (ALT or AST \>150 IU)
7. Diabetes mellitus
8. Obesity (BMI \>30 kg/m2)
9. Symptomatic hypotension, hypertension \>160/100mmHg
10. Known allergy to compounds of Nestlé noir intense
11. History of gastric ulcer or bleeding, current diarrhea
12. Venous thrombosis or pulmonary embolism, at present or recurrent history of Infectious disease, acutely or chronic
13. Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
14. Neoplasia (unless healed or remission \>5 years)
15. Participation in another study within the last month
16. Concomitant vitamin supplements
Effect of Rotator Cuff Training on Hand Grip in Adults

Purpose of the study:

* To investigate the effect of rotator cuff training on hand grip strength in adults with different body mass index.
* To investigate the effect of rotator cuff training on hand grip static endurance in adults with different body mass index.
* To investigate the effect of rotator cuff training on hand grip dynamic endurance in adults with different body mass index.
* To investigate the effect of rotator cuff training on upper limb function in adults with different body mass index.

Rotator cuff muscles are considered to be the key dynamic muscles in shoulder stabilization since they contribute significantly to shoulder stability in a number of different ways. They work not only as a dynamic stabilizer but also as static stabilizers because of their orientation and location around the shoulder joint. Several studies revealed the strong relationship between the rotator cuff muscles and hand grip strength. Studies proved the strong correlation between grip strength and rotator cuff strength ,which suggests that assessment of grip strength could be used to monitor the function of the rotator cuff, once baseline readings have been attained during training and rehabilitation .

Previous publications revealed significant positive associations between handgrip strength, body mass index (BMI) and physical activity in adult men and women. Worldwide, 31.1% of adults are reported to be physically inactive. Some studies and reports indicate that 20% of the global populace within the age range of 18-64 years comply with the minimum physical activity guidelines for improved health. Overweight and obesity are identified as a constant negative influence on physical activity, regardless of age.

Studies proved that weight, height, and BMI have a significant correlation on hand grip strength. As the weight increase hand muscle strength and endurance time also decrease.

Subjects in this study will be recruited from the students , employees and faculty members of the faculty of physical therapy, Cairo University.

Eligibility Criteria:
Inclusion Criteria:

1. Adult Subjects of both genders their ages between (18 : 35) years old.
2. Body mass index between (18.5 : 34.9 ) Kg/ m2.
3. Dominant hand is the right hand.

Exclusion Criteria:

The subjects will be excluded if they have:

1. Traumatic conditions of the upper limb.
2. Previous orthopedic disorders or neurological deficit of the upper limb.
3. Previous surgery of the upper limbs.
4. Any sensory problems.
5. Neuromuscular disease like multiple sclerosis.
6. Pregnancy.
7. Cancer Patients.
8. Subjects under chemotherapy.
9. Immunodeficiency diseases.
10. Psychological disorders (depression - anxiety).
11. Chronic diseases as (diabetes - hypertension).
A Study on the Effect of Changing From Preserved Prostaglandin Formulations to Preservative Free Tafluprost on Tear Film Thickness

Studies have shown that ocular surface disease (OSD) is common among patients with glaucoma with a prevalence of 50% or more. The percentage of affected patients appears to increase with increasing number of topical anti-glaucoma products instilled. Both pre-clinical and clinical work has indicated that the preservatives used in anti-glaucoma drops, particularly benzalkonium chloride, are mainly responsible for this detrimental effect. As such more and more anti-glaucoma drugs without preservatives entered the market.

To prove that switching from preserved to unpreserved antiglaucoma medication improves the signs and symptom of OSD is, however, not easy. This is on the one hand related to the physiological variability of these parameters over time and on the other hand to the poor association between signs and symptoms. Recently, a new method for measuring tear film thickness (TFT) using ultra-high resolution optical coherence tomography (OCT) has been introduced. Using this method, it has been shown that there is a correlation between reduced TFT and OSD symptoms. In the present study, it is hypothesized that changing patients who are on preserved prostaglandin formulations to preservative free tafluprost may be associated with an increase in TFT.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years
* Diagnosed primary open angle glaucoma treated with preserved prostaglandins for at least 6 months OR
* Patients with ocular hypertension treated with preserved prostaglandins for at least 6 months
* IOP ≤ 21 mmHg in the study eye at the screening examination (under treatment)
* Mean TFT at the screening visit ≤ 6µm in the study eye
* At least 2 symptoms of dry eye syndrome in the study eye (itching, stinging, blurred vision, foreign body sensation, debris, conjunctival redness) since at least one month
* Tear break up time ≤ 10sec

Exclusion Criteria:

* Participation in a clinical trial in the 3 weeks before the screening visit
* Severe visual field loss as defined as an MD of -15 or worse in the study eye
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
* Sjögren's syndrome
* Stevens-Johnson syndrome
* Presence or history of a severe ocular condition that will interfere with the study aim as judged by the clinical investigator
* Presence or history of allergic conjunctivitis
* Treatment with corticosteroids in the 4 weeks preceding the study
* Wearing of contact lenses
* Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except glaucoma medication or topical lubricants
* Ocular infection
* Ocular surgery in the 6 months preceding the study (except laser trabeculoplasty)
* Pregnancy, planned pregnancy or lactating
* Contraindication against the use of topical prostaglandin therapy
Study of M5049 in Healthy Japanese and Caucasian Participants

The purpose of this study is to evaluate and determine the safety, tolerability and pharmacokinetics of single-doses of M5049 up to 3 dose levels administered as film-coated tablet under fasted conditions in healthy Japanese and Caucasian participants.


Eligibility Criteria:
Inclusion Criteria:

* Japanese participants must be first generation (born in Japan) with both biological parents and all 4 biological grandparents being Japanese native born. Caucasian participants must have both biological parents and 4 biological grandparents of Caucasian descent
* Overtly healthy participants as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring (blood pressure, heart rate and 12-Lead resting ECG)
* Participants with body weight within 45 to 90 kilograms (kg) (female) and 55 to 90 kg (male) and body mass index (BMI) between 18.5 and 29.9 kilograms per meter square (kg/m\^2)
* A Caucasian participant will be matched by body weight (± 20% body weight \[kg\]), height (± 15% height \[centimeter (cm) \]) and sex to each Japanese participant
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participants with history of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant
* Participants with history of relevant drug hypersensitivity
* Participants with history of splenectomy, epilepsy, other neurological disorders or neuropsychiatric conditions
* Participants with history of a tuberculosis and positive Screening test for hepatitis B surface antigen
* Participants with history of alcoholism or drug abuse
* Other protocol defined exclusion criteria could apply
Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B

Long-term safety and efficacy follow-up for participants with Hemophilia B who were previously treated in the C0371005 (formerly SPK-9001-101) study, and a dose-escalation sub-study evaluating safety, tolerability, and kinetics of a higher dose with long-term safety and efficacy follow-up. Participants in the substudy do not need to have participated in C0371005.

Evaluation of the long-term level of persistence and potential late or delayed adverse events associated with PF-06838435 (formerly SPK-9001), assessment of the durability of the transgene expression, and determination of the effects of PF-06838435 on clinical outcomes in individuals who have previously received a single administration of PF-06838435 in the C0371005 study. Amendment 2 of this study incorporates a dose-escalation substudy to evaluate the safety, tolerability, and kinetics of a single IV infusion of PF-06838435 at a higher dose than that used in the C0371005 study. The dose-escalation participants will also be followed for long-term safety and efficacy.

Eligibility Criteria:
This study is currently only enrolling into the dose-escalation substudy with subsequent long-term follow-up. The Eligibility Criteria for entry into the dose-escalation substudy is presented below:

Inclusion Criteria:

1. Able to provide informed consent and comply with requirements of the study
2. Males age 18 to 65 years with confirmed diagnosis of hemophilia B (≤2 IU/dL or ≤2% endogenous factor IX)
3. Received ≥50 exposure days to factor IX products
4. No measurable factor IX inhibitor as assessed by the central laboratory and have no prior history of inhibitors to factor IX protein
5. Agree to refrain from donating sperm and either abstain from intercourse or use reliable barrier contraception until 3 consecutive semen samples are negative for vector sequences

Exclusion Criteria:

1. Evidence of active hepatitis B or C
2. Currently on antiviral therapy for hepatitis B or C
3. Have significant underlying liver disease
4. Serological evidence\* of HIV-1 or HIV-2 with CD4 counts ≤200/mm3 (\* participants who are HIV+ and stable with CD4 count \>200/mm3 and undetectable viral load are eligible to enroll)
5. Neutralizing antibody titers to the capsid portion of PF-06838435 above the established threshold
6. Sensitivity to heparin or heparin induced thrombocytopenia; sensitivity to any of the study interventions, or components thereof, or drug or other allergy
7. Previously dosed in a gene therapy research trial at any time or in an interventional clinical study within 3 months of screening visit
8. Any concurrent clinically significant major disease or condition
9. Unable or unwilling to comply with the study procedures
Delirium Detection in Pediatric Intensive Care Unit Through a French Translation of the CAPD : a French Monocentric Observational Study

The purpose of this study is to introduce delirium detection and try to determine the prevalence of delirium in Pediatric Intensive Care Unit (PICU) using a validated tool : the Cornell Assessment of Pediatric Delirium (CAPD) for every patient twice a day.

Delirium is a frequent affection in ICU. In adult population, its prevalence is 20-50% in non intubated patients and 60-80% in patients under invasive ventilation. It is also frequent in paediatric population, but less diagnosed, whereas it can lead to higher duration stay, higher morbidity, traumatic injuries, acute stress, memory losses and post-traumatic stress syndrome. Since 2016, international guidelines recommend to look for delirium in paediatric population in PICU. There are 3 recommended tools to diagnose this affection: psCAM-ICU (6 months-5 years old), pCAM-ICU (5 years old-18 years old) and CAPD (birth-18 years old).

None of these validated tools have been translated in French.

The principal objective is to study the practicability of twice a day detection of delirium in PICU using the CAPD.

Investigators will first used a validation process to translate the CAPD in French, based on the validation method for psychological questionnaires suggested by Vallerand.

Then they will ask the paramedics to evaluate through the CAPD every consecutive patient/12 hours, every day during their stay in PICU, except for those completely unresponsive or under curare. This systematic evaluation will take place for 2 consecutive months.

For every patient, data will be collected about their age, sexe, term of birth, mental affection status, diagnosis at entry, and daily risk of mortality score, length of stay, ventilation, pain evaluation and treatment, withdrawal evaluation, surroundings, use of hypnotic treatment, steroids, opioids and ketamine.

The secondary aims are to determine the prevalence of delirium with the data collected, to ask whether or not the French version of CAPD has been easily and correctly used, can help to diagnose delirium, and whether investigators can find some associated parameters to delirium.

Eligibility Criteria:
Inclusion Criteria:

* Being hospitalized in PICU during the inclusion period
* Age 0 to 18 years old

Exclusion Criteria:

* Patient with a state of sedation that does not allow the assessment of a change in the state of consciousness or cognitive functioning (equivalent score Richmond Agitation-Sedation Scale RASS \<-3 or COMFORT B \<11)
* Patient or Parental opposition to the observational study
Sinonasal Risk Factors for Occurrence of Unilateral Versus Bilateral Allergic Fungal Rhinosinusitis .

This study aims to assess Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhino sinusitis regarding::

1. anatomical variations and correlate radiological finding with intraoperative finding.
2. other associated factors like demographic ,environmental, immunological and climatic risk factors .

Introduction Allergic fungal rhinosinusitis (AFRS) is a subtype of CRS with nasal polyposis (CRSwNP) that is characterized by eosinophilic mucin within expanded sinus cavities and immunoglobulin E (IgE)-mediated type 1 hypersensitivity to fungal elements. This noninvasive disease process typically affects immunocompetent, younger patients in geographic regions with warm temperatures and high humidity, which facilitate fungal proliferation.

AFRS has a worldwide distribution pattern with varying prevalence. AFRS is presented in variable rates in different climatic, socioeconomic, and geographic factors. The disease prevalence showed predilection toward climatic factors

Eligibility Criteria:
Inclusion criteria:

Denovo cases . any Age Any sex. Patients diagnosed with unilateral or bilateral allergic fungal rhino sinusitis, meeting classic Bent and Kuhn criteria for AFRS:(10).

Nasal polyposis. Fungi on staining. Eosinophilic mucin without fungal invasion into sinus tissue., Type I hypersensitivity to fungi. Characteristic radiologic findings with soft-tissue differential densities on computed tomographic (CT) scanning

Exclusion criteria:

Diagnosis of benign or malignant neoplasm of the sinonasal cavity. Prior radiation therapy to the head or neck. Significant prior facial trauma. Autoimmune disorder. Craniofacial anomaly. Fungus ball. Immunodeficiency. Cystic fibrosis. Patients unfit for surgery. Previous nasal surgery or recurrent cases .