cyrilzakka/clinical-trials huggingface dataset:
An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)

This study will evaluate the safety and efficacy of omalizumab for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Cystic Fibrosis aged 12 years and older.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cystic Fibrosis complicated by Allergic Bronchopulmonary Aspergillosis (ABPA)
* Oral corticosteroid use for ABPA flare
* Age 12 years and older (except for Italy; ≥ 18 years)
* Total serum IgE levels ≥ 500 IU/mL

Exclusion Criteria:

* History of cancer in the last 10 years.
* History of severe allergic reactions
* Pregnant and lactating women
* Prior use of Xolair

Other protocol-defined inclusion/exclusion criteria may apply.
Phase II Study of the Effect of CK-1827452 Injection on Myocardial Efficiency

The purpose for this study (CY 1124) is to evaluate the effects of CK-1827452, a cardiac myosin activator, on myocardial systolic performance, myocardial oxygen consumption, and myocardial efficiency in patients with heart failure and to confirm that the unique preclinical pharmacological profile of CK- 1827452 is substantially the same in patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for left and right heart catheterization
* Willing and able to provide informed consent
* Male or female 18 years of age or greater
* Symptomatic heart failure (≥ NYHA Class II)
* Ejection fraction ≤ 35%
* Patient is in sinus rhythm
* Patient is considered to be in suitable health in the opinion of the investigator, as determined by:

  o A pre-study physical examination with no clinical abnormalities which in the opinion of the investigator would preclude participation in the study other than physical symptoms or signs consistent with stable heart failure
* For female patients only: Post-menopausal or sterilized, or if she is of childbearing potential, she is not breastfeeding, her pregnancy test is negative, she has no intention to become pregnant for up to 90 days following the study, and she is using contraceptive drugs or devices

Exclusion Criteria:

* Acute myocarditis
* Hypertrophic, restrictive, or constrictive cardiomyopathy
* Congenital heart disease
* Known left ventricular thrombus
* Significant stenotic valvular disease (severe aortic stenosis, mitral stenosis)
* Poorly controlled hypertension (SBP \> 180 mmHg)
* Pacemaker dependent ventricular rhythm
* Detectable troponin or CK-MB \> ULN at any timepoint within 14 days of enrollment
* Acute coronary syndrome or revascularization procedure within 30 days of enrollment
* ≥ 50% stenosis of the left main coronary artery
* Plan for immediate revascularization procedure (PCI or CABG)
* GFR ≤ 35 ml/min/1.73 m2 by Modification of Diet in Renal Disease (MDRD) Equation or need for renal replacement therapy
* Known hepatic impairment (total bilirubin \> 3 mg/dL, or ALT and AST \> 2 times the upper limit of normal)
* Has received an investigational drug or device within 30 days before enrollment
* Has had any prior treatment with CK-1827452
Upper Airway Physical Therapy for the Treatment of Obstructive Sleep Apnea

The purpose of this study is to determine the effectiveness and feasibility of upper airway muscle physical therapy utilizing negative airway pressure (NAP) breathing training in patients with Obstructive Sleep Apnea Syndrome (OSAS) in reducing both signs (apnea hypopnea index) and symptoms (i.e., daytime sleepiness).The key to the proposed therapy is the use of Negative Air Pressure when awake so that the increased reflex phasic drive to the muscles will result in muscle conditioning. Interestingly, other studies have indicated that upper airway muscle training may be useful in treating OSAS, but these studies used techniques that were not scientifically designed{Puhan, 2006 8195 /id} or used a technique (electrical stimulation) that was not well tolerated.{Lequeux, 2005 7514 /id}

Overview: Subjects with OSAS (but not using continuous positive airway pressure CPAP) will undergo NAP physical therapy of the upper airway, utilizing a physiologically determined training pressure and protocol, three days a week (approximately 30 minute sessions each) for a period of three months. Overnight sleep studies (PSGs) will be performed pre- and post-study. Primary outcome measurements include the pre- and post-study Apnea/Hypopnea index (AHI) and daytime hypersomnolence symptom scores. Each subject's total study time is approximately a 3-4 month period which includes screening visit, pre and post study overnight polysomnography, and therapy sessions of 3-4 a week for three months.

Eligibility Criteria:
Inclusion Criteria:

18 and over and any persons who have been diagnosed with OSAS (AHI over 15) and who are not utilizing CPAP

Exclusion Criteria:

Participants will be excluded if: Pregnant, Breastfeeding or any bleeding abnormalities, there is a major upper airway morphologic abnormality (e.g., retrognathia, Pierre-Robin syndrome), they have had any airway surgery (except tonsillectomy as a child),they regularly use any drugs that are known to depress the central nervous system (such as benzodiazepines, narcotics), they consume 14 alcoholic drinks a week or 2 a day,they are undergoing a current or planned intervention for weight reduction or are morbidly obese (body mass index 40 kg/m2), or they have any unstable medical or psychiatric illnesses.
Diagnostic of Lewy Body Dementia by Combining Scintigraphy (SPECT) Using a Specific Transporter and Magnetic Resonance Imaging (MRI)

The aim of this study is to improve the diagnostic of Lewy body dementia by combining the scintigraphy (SPECT) usig a spécific transporter and magnetic resonance imaging (MRI).

Lewy body dementia is the second leading cause of dementia in France after degenerative Alzheimer's disease.

However its dignosis is difficult. Its comes in large part from the similarity of symptoms with another close dementia syndrome : the Alzheimer disease . Therfore, its is very important to have a mean to distinguish between the two dementias.

One highlight of the Lewy body dementia process being dopaminergic degeneration, the use of specific radioactive tracers is thought to be the way. The radiotracer that has the greatest advantage for these explorations is currently the DaTSCAN because it binds specifically on the dopamine transporter and can be used in Single photon emission computed tomography (SPECT).

The aim of this study is to improve the performance of imaging in the diagnosis of dementia by combining scintigraphy (SPECT) and magnetic resonance imaging (MRI) in the exploration of the striatal region . The development of this method applied to a population of subjects, with hallucinations and cognitive disorders, should demonstrate the value and complementarity of metabolic images (SPECT) and morphological (MRI) within the differential diagnosis of Lewy body dementia and the Alzheimer disease .

From a methodological point of view, the patient will be included in hospital and will have a clinical diagnosis defined according to the criteria of dementia NINCDS-ADRDA for the Alzheimer disease and Mc-Keith criteria for Lewy body dementia. Their MMSE will be over 18 and they have in common recurrent visual hallucinations.

After the inclusion, two steps must be distinguished, a neuropsychological evaluation stage and an scitigraphy exploration . Before the SPECT , all patients should have an MRI.

Eligibility Criteria:
Inclusion Criteria:

* Patients with alzheimer disease following NINCDS-ADRDA scale or Lewy body dementia following Mc Keith scale.
* Aged between 65 et 90 years
* Patients with visual hallucination
* Patients with helping people
* Patients with MMSE (Mini Mental State Examination) equal or more than 18.
* Signed consent

Exclusion Criteria:

* Hospitalized patients without their consent
* Patients who have not passed the neuropsychological tests
* Patients with a MMSE less than 18
* Patients without helping
* Patients with no visual hallucinations
* Patients with severe somatic pathology.
* Pregnancy
* Allergy to iodine
Real World, Pharmacy-assessed Adherence to New Onset Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure

This is a multicenter, non-interventional, single arm cohort study with prospective collection of primary data via pharmacists in community pharmacies to describe adherence to sacubitril/valsartan in study patients at the end of the study. Eligible patients with newly prescribed sacubitril/valsartan will be observed in pharmaceutical routine.

The study duration will last up to about 30 weeks per patient and will consist of a approximately three visits - Baseline visit (V1), week 1-12 (V2) and week 13-30 (V3).

No exact date for visit 2 and visit 3 will be enforced, to avoid interference with usual care.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with first ambulatory sacubitril/valsartan prescription at screening
2. Internet enabled device / smartphone (patient or affiliate)
3. ≥ 18 years of age
4. Written informed consent to participate in the study

Exclusion Criteria:

1. Depression-related medication, depression-related comorbidities (patient-reported)
2. Patients with unstable acute complications or with an advanced illness likely to interfere with participation in this trial as judged by the enrolling pharmacist
3. Simultaneous participation in any interventional trial or simultaneous participation in another Novartis-sponsored non-interventional study with sacubitril/valsartan
Cranial Osteopathy in Functional Disorders of the Newborn

To evaluate, from the maternity stay, the interest of the cranial osteopathy in the reduction of the hyper irritability of the newborn and the improvement of the postural abnormalities


Eligibility Criteria:
Inclusion Criteria:

* Newborns:

  * forward
  * born vaginally or cesarean section
  * with or without general anesthesia
  * with or without epidural or spinal anesthesia
  * with or without instrumental extraction
  * presenting at least 1 of the 4 criteria detailed above, numbered at 3 or 4 or two criteria at 2

Exclusion Criteria:

* Newborns presenting:

  * a score of Amiel \<7, signing a strong suspicion of non-integrity of brain functions (see table) and therefore leaving the framework of functional pathology
  * symptomatic maternal-fetal infection
  * true obstetric trauma: brachial plexus paralysis, fracture
  * or of a mother who has taken during pregnancy drugs or toxic drugs that affect the behavior of the newborn. (benzodiazepines, subutex, methadone, cocaine, heroin or cannabis)
You and Me COVID Free

Observational, study that distributes rapid at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities.

This observational, cohort sub-study is embedded within a larger public health intervention that distributes at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities through the CCPH. Within this sub-study, the investigators will evaluate the socio-behavioral mechanisms of SARS-CoV-2 community transmission, including social interactions, health behaviors, healthcare utilization, knowledge, disease burden, and feasibility of at-home testing. The central hypothesis is that focused community intervention will reduce COVID-19 transmission. The secondary hypothesis is that this intervention will increase vaccine uptake. Surveys and questionnaires will be completed by participants via a QR code from the test kits that directs participants to a link. Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.

Eligibility Criteria:
Inclusion Criteria:

* Self- reported primary residence within the pre-identified communities
* Age \>12 years at enrollment
* Provision of signed and dated informed consent form

Exclusion Criteria:

-None if above are met
Comorbidity After Gastric Bypass

To evaluate effect on comorbid disease and weight loss in the long-term (\>five years) after Roux-en-Y gastric bypass (RYGB) surgery for severe obesity.

Individuals with severe obesity frequently have comorbid diseases, e.g. diabetes, hypertension, hyperlipidemia, and sleep apnea. We will study the remission rate and weight loss in the long-term (10 years) after Roux-en-Y gastric bypass (RYGB) surgery in a nationwide large group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Registered individuals in Scandinavian Obesity Surgery Registry (SOReg) having had gastric bypass

Exclusion Criteria:

* All other operations
A Study That Uses Data From Routine Eye Examinations of Patients Participating in Studies FIDELIO-DKD and FIGARO-DKD to Explore Whether Finerenone Can Delay the Progression of a Diabetes Complication That Affects the Eyes (Diabetic Retinopathy ,DR)

Diabetic retinopathy (DR) is a diabetes complication caused by damage to the small blood vessels inside the retina at the back of the eye. Diabetic retinopathy may cause mild vision problems or eventually blindness. Diabetes is a condition that makes your blood sugar levels higher than they should be.

In the early stages of diabetic retinopathy - called non-proliferative diabetic retinopathy (NPDR)- increased blood sugar levels lead to damage to the tiny blood vessels of the retina. This damage results in small outpouchings of the vessel lumens leading to rupture. At the same time the blood vessels can leak and making the retina swell and can cause so called macula edema. In these early stages of DR current treatment to reduce the risk of this eye complication is focused on controlling blood sugar levels and blood pressure.

Participants in this study have NPDR, Type 2 Diabetes (T2D) and Chronic Kidney Disease (CKD), a condition in which the kidneys become damaged and do not work as they should. These participants are already taking part in one of the phase 3 studies (FIDELIO-DKD and FIGARO-DKD). They study the effect of Finerenone on delaying kidney disease progression and reducing the risk of events that may cause damage to the heart and blood vessels To learn more about the effect of Finerenone on diabetic retinopathy, data from routine eye examinations performed during the two phase 3 studies will be collected and analyzed. All male and female participants included in this study are at least 18 years.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent to participate in ReFineDR
* Included in FIDELIO or FIGARO, and with DR as medical history
* Documented NPDR in at least one eye, as documented by ophthalmological records within 6 months prior to baseline in FIDELIO or FIGARO, and up to one month after baseline in FIDELIO or FIGARO
* An ophthalmological assessment available 6 month before or maximum 1 month after the baseline examination in FIDELIO or FIGARO, and at least one additional assessment afterwards.

Exclusion Criteria:

* Patients with PDR, macular edema or anterior segment complications present at baseline in FIDELIO or FIGARO in at least one eye.
* Patients with any documentation of prior or planned retinal laser treatment, intravitreal injection or vitrectomy at baseline in FIDELIO or FIGARO in at least one eye.
* Patients with any other retinal disease documented at baseline in FIDELIO or FIGARO in at least one eye that would likely interfere with the study objectives (e.g. neovascular age-related macular degeneration or retinal vein occlusion).
Clinical Efficacy of Prophylactic Intravenous Neostigmine and Atropine in Preventing Post-Dural Puncture Headache Among Parturient Undergoing Spinal Anesthesia for Cesarean Section: A Double-blind Randomized Placebo-controlled Trial

Post dural puncture headache is a distressing issue, many measures tried to treat symptoms but few delt with prevention.


Eligibility Criteria:
Inclusion Criteria:

* Parturient ladies
* Age ranges from 18 to 35 years old.
* ASA II with elective caesarean section under sub-arachnoid block

Exclusion Criteria:

* BMI \>35
* Refusal to participate
* surgical complications necessitating a blood transfusion
* Emergency caesarean section
* the need for endotracheal intubation or vasopressors
* any contraindication to regional anesthesia (such as a history of persistent cephalgia, convulsions, cerebrovascular events
Effects of Knee Injections on Patients With Knee Osteoarthritis

Using a double-blind, randomized, placebo-controlled design to compare the immediate, short-term, and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection to hyaluronic acid injection on patients with knee osteoarthritis, under the basis of International Classification of Functioning, Disability and Health.

A total of 60 patients will be collected. The participants will be randomized into three groups, including the hyaluronic acid combined corticosteroid group, hyaluronic acid combined dextrose group, and hyaluronic acid combined normal saline group (placebo group). The functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score), pain (pressure threshold by pain pressure ergometer), and physical activity (10 meters normal and fast walk, up and downstairs, 5 repeated chair-rising time, timed up and go test) and image progression by high-resolution ultrasound will be evaluated before treatment, one week after injections, one month after injections, three months after injections, and six months after injections.

Participants and evaluators will be both blinded to the group's allocation during the whole course of intervention.

Eligibility Criteria:
Inclusion Criteria:

1. clinical diagnosis of knee osteoarthritis
2. can walk for 15 meters
3. Kellgren-Lawrence grade 2 or greater
4. can follow up for 6 months

Exclusion Criteria:

1. Major diseases will affect balance, such as stroke
2. infectious disease,
3. rheumatoid arthritis,
4. malignancy
5. pregnancy or prepare to pregnant
6. received knee injections in the past 6 months
7. previous knee operation history
A Study to Determine the Effect of Multiple Oral Doses and Regimens of KD025 in Healthy Male and Post-menopausal Female Subjects

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple oral doses and regimens of KD025 in healthy male and post-menopausal female participants.

Up to approximately 37 days including safety follow up period of 30 days after participant is treated with the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants between the ages of 18 and 55 years, inclusive.
* Female who was not of reproductive potential.
* Able to provide written informed consent prior to the performance of any study specific procedures.
* Body mass index (BMI) range of 19-30 kilogram per square meter (kg/m2), inclusive.

Exclusion Criteria:

* Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the PK evaluations.
* Known sensitivity to Rho-associated coiled-coil containing serine/threonine protein kinases (ROCK2) inhibitor agents or to any of the constituents of the KD025 formulation.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed Tomography

The aim of the study is to determine relevant hemodynamic parameters for the diagnostics of pulmonary arterial hypertension (PAH) by dynamic contrast enhanced dual-energy CT (DE-CT). In this prospective study the investigators validate DE-CT results of patients against hemodynamic parameters from right heart catheterisation and control the results by other clinical investigations. The investigators expect that using this non-invasive method, parameters relevant for the diagnosis of the patients with PAH, like pulmonary blood volume, blood flow and perfusion heterogeneity, can be determined.

Pulmonary arterial hypertension (PAH) is a rare, life-threatening disease. It is characterized by the elevation of pulmonary arterial pressure and pulmonary vascular resistance. A remodeling of small pulmonary vessels characterized by the proliferation of the adventitia, the hypertrophy of the media and fibrosis of the intima can be observed on the microscopic level.

Non-invasive techniques for hemodynamic assessment and identification of early pulmonary vascular remodeling and pulmonary hypertension have a marked practical advantage as compared to invasive right heart catheterization, however, their accuracy and reliability is not well established.

In the present study the investigators examine patients who are scheduled for a thorax CT with an additional dynamic contrast-enhanced DE-CT protocol and derive established parameters for the diagnosis of PAH as well as novel parameters from the CT scans. These are compared to results from the right-heart catheterization and other investigations routinely carried out on these patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with right heart catheterization data

Exclusion Criteria:

* patients with decreased renal function
* patients who received CT in the previous six months
* intolerance of contrast material
* other standard CT contraindications