cyrilzakka/clinical-trials huggingface dataset:
Nasal Intermittent Positive-Pressure Ventilation for Twin Infants With Respiratory Distress Syndrome

In the present study, we hypothesized that primary mode nIPPV initiated shortly after birth would decrease the incidence of intubation or death in twin infants when compared to nCPAP.

After inclusion of eligible twins infants,one of the twins was supported by nCPAP and another nIPPV.

Eligibility Criteria:
Inclusion Criteria:

* Twins
* Clinical diagnosis of mild-moderate respiratory distress syndrome
* requiring a fraction of inspired oxigen (FiO2 ) \<0.40 to keep oxygen saturation of 90%-95%
* a chest X-ray suggestive of early stage hyaline membrane disease, (i.e. mild microgranulia and air bronchogram)

Exclusion Criteria:

* pneumothorax
* pneumomediastinum
* surgical diseases
* cardiac diseases
* intraventricular hemorrage
* major congenital defects
Infant-Directed Singing for At-Risk Mothers and Infants

The purpose of this study is to figure out if mothers can learn how to use singing to help their babies. Singing can help babies calm down or encourage them to play, both of which are needed for learning.


Eligibility Criteria:
Inclusion Criteria:

Mothers:

* must have infants enrolled at the Linda Ray Intervention Center (LRIC).
* must be 18 years of age or older
* must be able to read and write in English

Infants:

* must be enrolled at the Linda Ray Intervention Center (LRIC).
* must be at least 3 months and no older than 12 months.

Exclusion Criteria:

- Participants who are not enrolled at the Linda Ray Intervention Center (LRIC).
A Study of DARZALEX (Daratumumab) In Indian Participants With Relapsed and Refractory Multiple Myeloma, Whose Prior Therapy Included a Proteasome Inhibitor and an Immunomodulatory Agent

The purpose of this study is to demonstrate the safety profile of daratumumab in routine clinical practice when given as monotherapy in Indian participants with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent.


Eligibility Criteria:
Inclusion Criteria:

* Participants with relapsed and refractory multiple myeloma (as per International Myeloma Working Group \[IMWG\] definitions) whose prior therapy included a proteasome inhibitor and an immunomodulatory agent, being newly initiated on DARZALEX (daratumumab) monotherapy based on independent clinical judgment of treating physicians as per locally approved prescribing information
* Each participant (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the informed consent form (ICF)

Exclusion Criteria:

* Participants who are not eligible to receive DARZALEX as per the locally approved prescribing information
* Participant participating or planning to participate in any interventional drug trial during the course of this study
* Known seropositive for human immunodeficiency virus (HIV)
* Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. exception: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) and a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
* Known seropositive for hepatitis C (except in the setting of a sustained virologic response \[SVR\], defined as aviremia at least 12 weeks after completion of antiviral therapy)
Preconditioning With Sevoflurane and Propofol in Patients Undergoing Minimally Invasive Mitral Valve Surgery

The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory response and platelets function during minimally invasive mitral valve repair or replacement (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes (sevo \\propofol)

The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory response and platelets function during minimally invasive mitral valve repair or replacement (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes:

* Volatile conditioning (sevoflurane) used during induction (preconditioning) and during the operation as maintenance (perconditioning) and no propofol.
* Propofol induction and maintenance (TIVA) and no volatile anaesthetics.

Outlet/residual blood samples coming from routine check will be collected at different time points.

Study will be powered on Troponin I (primary statistical outcome). Original secondary outcome will be considered: platelets activation, left ventricle function, clinical figures (length of stay, inotrops requirements, ventilation times and other relevant).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18
2. Patients undergoing elective (or urgent) first-time minimal invasive mitral valve surgery.

Exclusion Criteria:

1. Cardiogenic shock or cardiac arrest, emergent CABG
2. Renal failure (with a GFR \< 30 ml/min/1.73m2),
3. Glibenclamide or nicorandil (as these medications may interfere with VC)
4. Pregnancy
5. Known intolerance/allergy to sevoflurane or propofol
Pacemaker Therapy in Adults With Congenital Heart Defects

Review the feasibility, safety and outcomes in adults with congenital heart disease who undergo pacemaker implantation for bradycardia, tachycardia or heart failure indications

Survival to adulthood is now common for children born with congenital heart defects (CHD). This improved survival is in large part due to advances in cardiac surgery over the past 4 decades. However, few cardiac surgical repairs are curative. Many 'repaired' children with congenital heart defects later develop problems as adults. Arrhythmias, need for additional surgery, and heart failure are the more common late sequelae of congenital heart disease (1). In addition, many adults with CHD will need a pacemaker for sick sinus syndrome (inability of the inherent pacemaker of the heart to function properly resulting in bradycardia sometimes alternating with tachycardia), tachyarrhythmias or heart block (2, 3). Certain group of patients, such as those with congenital corrected transposition of the great arteries (CCTGA), d-transposition s/p atrial switch procedures and those with single ventricle physiology are at particular risk of developing heart failure (4). Attached figures show the anatomy of these congenital heart defect. Cardiac resynchronization therapy improves exercise tolerance, symptoms and reduces mortality in adults with heart failure due to acquired left ventricular dysfunction.(5-8). In addition, automatic internal cardioverter - defibrillators (ICD) have now been shown to decrease mortality in patients with low ejection fraction due to ischemic or non-ischemic etiologies (9, 10).

Patients with CHD pose a challenge to traditional transvenous pacemaker lead placement due to either complex venous anatomy that precludes conventional percutaneous approaches for pacemaker implantation or occlusions of central venous form multiple prior procedures (11, 12). As evident in the study by Janousek et.al, 7 out of 8 patients enrolled in this study required a thoracotomy for lead placement (4). While thoracoscopic epicardial lead placement has been described for placement of pacemaker leads in adults without congenital heart defects (13, 14), it has not been described for adult patients with congenital heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Congenital heart disease diagnosis
* Pacemaker implantation completed during the period of Jan. 1, 1996 to Dec. 1, 2005
* Age 18 to 80, inclusive

Exclusion Criteria:

* Those who do not meet inclusion criteria
Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer

This is a prospective, single-center, single-arm clinical study, to evaluate the clinical efficacy, safety and tolerance of patients with early breast cancer receiving ddEC adjuvant chemotherapy, accepting PEG-rhG-CSF as primary prevention of neutropenia.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients in need for adjuvant chemotherapy confirmed by histopathology, whom should accept ddEC regimen.
* ECOG\<=1
* Expected survival is greater than 6 months
* Qualified for chemotherapy，WBC\>=3\*109/L, ANC\>=1.5\*109/L, Hb\>=80g/L, PLT\>=80\*109/L. With no bleeding tendency or systemic hematology disorder symptoms.
* No obvious EKG abnormality, no obvious cardiac dysfunction, and normal left ventricular ejection fraction.
* Liver function, ALT and AST should less than 2.5 times of the upper limit.
* Renal function, Cr and BUN should less than 1.5 times of the upper limit.
* Subjects voluntarily participate in this study and sign informed consent.

Exclusion Criteria:

* Total amount of doxorubicin used in previous chemotherapy\>240mg/m2, or epirubicin\>360mg/m2
* Has received hematopoietic stem cell transplantation or bone marrow transplantation
* Other drugs are currently in clinical trials
* There are currently hard-to-control infections, body temperature is higher than 38 degrees.
* Received PEG-rhG-CSF treatment before enrollment
* Received chemotherapy in 4 weeks before enrollment
* Patients with any visceral metastasis
* Patients with severe heart, kidney, liver or any other important organs chronic diseases
* Patients with severe uncontrolled diabetes
* Patients with allergic diseases, or allergies to this product or other biological products derived from genetically engineered e. coli
* Suspected or real drug users, substance abusers, alcoholics
* Pregnant or lactating women
* Severe mental or neurological disorders that affect informed consent and adverse reactions described or observed
Retrospective Observational Study To Update 5-Year Survival Of Subjects Who Participated In Axitinib Trial A4061012

The primary objective of this observational study is to retrospectively collect current survival data for patients originally included in axitinib A4061012 \[NCT00076011\] study to estimate the 5-year survival rate in subjects with metastatic renal cancer cell treated with axitinib.

Subjects participating in this observational study originally participated in study A4061012 \[NCT00076011\], and may have also have participated in study A4061008 \[NCT00828919\]. Subjects participating in this observational study originally participated in study A4061012 \[NCT00076011\], and may have also have participated in study A4061008 \[NCT00828919\].

5-year survival information to be updated.

Eligibility Criteria:
Inclusion Criteria:

* Subjects participating in this observational study originally participated in study A4061012 \[NCT00076011\] and may have also participated in study A4061008 \[NCT00828919\]

Exclusion Criteria:

* Subjects who withdrew from the original study A4061012 \[NCT00076011\] or the continuing access study A4061008 \[NCT00828919\]
Effect of rhBMP-2 or rhBMP-7 on Long Bone Fractures and Non-unions.

Delayed fracture healing continues to cause significant patient morbidity and economic burden to society. Biological stimulation of acute fractures and non-unions includes application of rhBMP-2 and rhBMP-7. However, BMP use continues to be a matter of controversy as literature shows scarce evidence for treatment effectiveness. The aim of this study is to compare acute fractures and non-unions in the long bones humerus, femur and tibia with and without BMP treatment of acute fractures. Furthermore, the investigators want to identify complications and risk factors on union-rate and time to union.

Primary Objective:

The primary objective is to assess time to union and union rate after rhBMP-2 and rhBMP-7 application at long bone fractures and non-unions.

Secondary Objective(s):

* Analysis of secondary complications
* Analysis of risk factors

Hypothesis and Statistical considerations and estimated enrollment:

The investigators hypothesize that with the use of rhBMP-2 and rhBMP-7 there will be a faster timer to union and higher union rate compared to no-BMP. Outcomes will be assessed prospectively.

This study is exploratory in nature. Therefore, there is no formal statistical hypothesis and no formal sample size calculation. Approximately 150 long-bone fractures and non-unions are expected.

Data will be analyzed with the use of simple summary statistics. Depending on the volume and quality of the collected data, different statistical analyses will be applied. Exploratory analyses will be conducted to investigate relationships between the different treatment options and the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Long bone fracture or long bone non-union.
* Signed informed consent, if required by IRB/EC

Exclusion Criteria:

Prisoner at date of inclusion
Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants

This is an open-label, longitudinal observational study evaluating the imaging characteristics of the tau positron-emission tomography (PET) radioligand \[18F\] Genentech Tau Probe 1 (GTP1) in the brain of participants with prodromal, mild, and moderate Alzheimer's disease (AD) compared to healthy participants. The overall goal of this protocol is to evaluate the longitudinal change in tau burden using \[18F\]GTP1, a tau targeted radiopharmaceutical.


Eligibility Criteria:
Inclusion Criteria:

For All Participants:

- Availability of a study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to accompany the participant and provide information at visits

For Healthy Participants:

* Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the Baseline \[18F\]GTP1 imaging visit
* Have no cognitive complaint
* Have a Clinical Dementia Rating Scale (CDR) global score = 0
* Have a Mini-Mental State Examination (MMSE) score of 28-30

For Participants With a Diagnosis of AD:

* Participants with mild or moderate AD must meet National Institute on Aging - Alzheimer's Association (NIA-AA) core clinical criteria for probable AD dementia, with an amnestic presentation
* Participants with prodromal AD must meet NIA-AA core clinical criteria for mild cognitive impairment (MCI)
* Have screening \[18F\]florbetapir PET imaging demonstrating amyloid binding based on qualitative visual read
* A brain MRI consistent with a diagnosis of AD, with no evidence of non-AD disease to account for dementia or MRI exclusion criteria
* Medications taken for symptomatic treatment of AD must remain stable for at least 30 days prior to screening visit
* Satisfy one of the following subgroups: Approximately 20 prodromal AD (MMSE 24-30, CDR = 0.5); Approximately 20 mild AD (MMSE 22-30, CDR = 0.5 or 1); Approximately 20 moderate AD (MMSE 16-21, CDR = 0.5 or 1 or 2)

Exclusion Criteria:

* Current or prior history of any drug or alcohol abuse
* Participants with any significant psychiatric, neurological, or unstable medical disorder expected to interfere with the study
* Participants unable to undergo MRI and PET scan
* For participants contributing CSF samples, any contraindication to lumbar puncture
* Prior participation in other research protocols or clinical care in the last year such a radiation exposure combined with that from the present study exceeds an effective dose of 50 millisievert (mSV), the allowable annual limit for research participants as stipulated by the Food and Drug Administration (FDA)
Post Operative Feeding After Cesarean Section

3 different post ceseraen secton feeding regmen are compared

300 women admitted to the labor and delivery unit in kasr Elainy teaching hospital, Following the decision to perform a cesarean section because of obstetric indications. The study involved only elective cesarean sections.

The 300 patients participated in this work and will be randomly and equally divided into three groups:

1. Group A :

   It consists of 100 patients that will be allocated for early post-operative oral feeding receiving water and clear fluid approximately 2 hours after surgery, followed by soft food and regular diet 4 hours later irrespective to intestinal sounds, flatus or stool.
2. Group B :

   It consists of 100 patients that will be allocated for early Postoperative oral feeding receiving water and clear fluid approximately 2 hours after surgery till the return of intestinal sounds, then soft food and regular diet later on.
3. Group C :

It consists of 100 patients that will receive no oral feeding till passage of flatus instead 2 to 3 Litres of intravenous fluid will be used for feeding. Water and fluid will be then offered, followed by soft foods and then a regular diet.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age from 20 to 40.
* Primigravida and previous 1 or two cesarean section.
* Elective cesarean section.
* Regional anaesthesia.
* Singleton pregnancy

Exclusion Criteria:

* Medical disorders as (sever preeclampsia, diabetes, liver or kidney diseases).
* Intraoperative intestinal injury.
* Previous major abdominal surgery except cesarean section.
* Obstructed labor with
Effects of Spray and Stretch on Postneedling Soreness and Sensitivity After Dry Needling of a Latent Myofascial Trigger Point.

Pain after dry needling or injection in the muscle is a frequent secondary effect in the treatment of myofascial pain syndrome. In this trial spray and stretch technique is evaluated as a method to reduce this soreness. As well, the characteristics and the different factors that influence in this pain will be described.


Eligibility Criteria:
Inclusion Criteria:

* Subjects presenting latent trigger points in the trapezius muscle

Exclusion Criteria:

* Subjects with active trigger points or absence of trigger points.
Collagen Membrane Combined With HUC-MSCs Transplantation in Patients With Nasal Septum Perforation

The purpose of this study is to assess the safety and efficacy of collagen membrane combined with human clinical grade umbilical cord mesenchymal stem cells(HUC-MSCs) transplantation in patients with chronic nasal septum perforation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with nasal septum perforation area less than 1cm², and requires minimally-invasive treatment.
2. Male or female, 18-45 years old.
3. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

Exclusion Criteria:

1. Cystic fibrosis, immotile cilia syndrome and other genetic diseases.
2. Syphilis, leprosy, tuberculosis and other specific infections.
3. Severe Sinusitis.
4. Autoimmune diseases or long term treatment with corticosteroids.
5. Alzheimer's disease.
6. Systemic diseases (e.g.,hypertension, diabetes and so on).
7. Previous history of nasal cancer or after receiving radiotherapy.
8. Drug abuse.
9. History of mental illness.
The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice

Antimicrobial resistance rates have reached alarming levels and the Worlds Health Organisation (WHO) states it constitutes a serious public health concern by threatening one of the most effective and mortality lowering interventions in modern medicine. Part of the solution to this problem includes minimizing overuse of antibiotics. But clinical signs alone are often not reliable to guide antibiotic treatment decisions and additional tests may be warranted to assist the doctor. Such tests include point-of-care biomarkers of infection like C-reactive protein (CRP) and procalcitonin (PCT). Targeting antibiotic use to the few patients with a high probability of benefit and withholding in the many with non-serious respiratory infection is a promising strategy and readily implemented in clinical practice.

The Procalcitonin guided Antibiotics in Respiratory Infections (PARI) study will assess the effect of a novel point-of-care PCT guided antibiotic stewardship in acute respiratory tract infections in general practice.

The overall aim of the PARI study is to reduce antibiotic use in patients with acute respiratory tract infections by targeting antibiotic treatment only to patients with a suspected bacterial etiology and thus likely to benefit from antibiotic therapy.

The main research questions are:

Does the addition of a point-of-care Procalcitonin test to standard care reduce antibiotic use in primary care? Is the intervention safe for the patients? The PARI study is a pragmatic two-arm (intervention and control (standard care) open randomized non-inferiority trial (up to 1 day difference in recovery) in general practice.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Able to read and understand patient information about the PARI trial and willing to give written informed consent prior to enrollment
* Acute cough e.g. less than 2 weeks probable acute upper or lower respiratory tract infection (pharyngitis, tonsillitis, otitis media, sinusitis, exacerbations of asthma or Chronic Obstructive Pulmonary Disease (COPD), bronchitis or pneumonia)
* C-Reactive Protein \>20 mg/m

Exclusion Criteria:

* Symptoms present for more than 2 weeks
* Verified immunodeficiency or presently neutropenic (neutrophile granulocytes ≤0,5 x 109/L within the last 7 days)
* Severe liver failure
* Severe kidney failure including dialysis
* Sore throat and positive test for Group A streptococcus
* Prior antibiotic exposure last 14 days up to inclusion
* Need for acute admission to hospital
* Pregnancy or breastfeeding